Immunotherapy treatment (Trust A)
25. Mrs U says Trust A should not have given R immunotherapy treatment.
26. She also says staff did not communicate to R and the family about the potential side effects of this treatment. She is particularly concerned staff did not mention about toxicity and pneumonitis.
27. She further complains that staff did not communicate soon enough with R and the family that he had COPD as she is concerned COPD can be contraindicated for immunotherapy treatment. COPD (chronic obstructive pulmonary disease) is the name for a group of lung conditions that can cause breathing difficulties including emphysema (damage to the air sacs in the lungs) and chronic bronchitis (long term inflammation of the airways).
28. Trust A said when R started Durvalumab, staff told him of known side effects including toxicity and pneumonitis. It said R gave written consent for the treatment.
29. Trust A said a doctor told R and Mrs U he had COPD via letter in early November 2022 and told them again in mid-February 2023.
30. NICE, Durvalumab for maintenance treatment of unresectable non-small-cell lung cancer after platinum-based chemoradiation, outlines how Durvalumab treatment is recommended as an option for treating locally advanced non-small-cell lung cancer in adults when patients have had concurrent platinum-based chemoradiation and their disease has not progressed.
31. We understand from our oncologist adviser that R’s response to chemoradiation showed his disease had not progressed meaning the Trust was correct to offer and provide Durvalumab immunotherapy treatment to him in June and July 2022.
32. We also understand from our oncologist adviser that although the NICE guidance was not approved until later in June 2022 (shortly after R started the treatment), this guidance is based on a five year clinical trial which had been on-going until this point. They said the clinical trial demonstrated Durvalumab offered significant improvement in survival when compared to treatment by chemoradiation alone.
33. We consider the NICE guidance is relevant for the whole period of R’s Durvalumab treatment and would have been in the final stages of being published when R started his treatment.
34. We are satisfied that Trust A acted in line with NICE guidance by offering R Durvalumab following him completing chemoradiation treatment.
Communication
35. The records show that in mid-May 2022, a member of staff spoke to R about the risks associated with immunotherapy treatment including possible infection and inflammation of the lungs. R signed written consent to receive immunotherapy treatment. Mrs U was present at this appointment.
36. Relevant guidance is GMC, Good Medical Practice which says clinicians must be satisfied they have consent before carrying out treatment.
37. It also explains that staff must give patients the information they want or need to know in a way they can understand.
38. Informed by our oncologist adviser we consider the member of staff detailed the risks of immunotherapy treatment at the appointment in mid-May 2022 when they gained consent in line with GMC guidance.
COPD
39. Trust A diagnosed R with COPD when a CT scan in mid-October 2022 reported this condition. A doctor spoke to Mrs U by telephone in early November 2022 about R having COPD.
40. There is no specific guidance as to when patients should be informed that they have COPD.
41. GMC, Good Medical Practice says staff must give patients the information they want or need to know in a way they can understand. In practice this means staff should tell patients when they have a confirmed diagnosis.
42. Informed by our oncologist adviser we consider staff explained R’s diagnosis of COPD in line with GMC guidance. This is because they ensured they kept R and Mrs U updated with accurate information when this diagnosis was reported.
43. We also asked our oncologist adviser about contraindications to immunotherapy treatment. They explained that COPD is not a contraindication to immunotherapy treatment and that typical contraindications are immune-related conditions such as rheumatoid arthritis or idiopathic pulmonary fibrosis. They said R did not have any contraindications for immunotherapy treatment.
44. We hope Mrs U is reassured by this.
45. In summary, we consider staff acted in line with relevant guidance in providing immunotherapy treatment to R and communicated to him and the family about the risks associated with it. We will take no further action because we have seen no indication Trust A did anything wrong.
46. Our decision here is not made without recognising how difficult a time R had once he started immunotherapy treatment and that unfortunately staff decided to discontinue the treatment. We also appreciate how challenging the family will have found this.
Post immunotherapy treatment (Trust A)
47. Mrs U says in November 2022, after R became ill following his immunotherapy treatment, Trust A did not provide the right care and treatment for his condition.
48. Mrs U also says she contacted Trust A in November 2022 and reported that R was struggling with his breathing. She says on this occasion staff told her to take R to Trust B instead. Mrs U says staff at Trust B admitted him for several days so that he could be treated with antibiotics and oxygen before they sent him home with steroids.
49. Trust A said Trust B can provide treatment relating to immunotherapy and its acute oncology team liaises with Trust A’s services every day. It also said that the respiratory team at Trust B is able to manage inflammation of the lungs including having access to a respiratory high dependency unit which it does not have.
50. Trust A also explained that it arranged follow-up care in the form of scans but the respiratory team at Trust B was best placed to manage subsequent treatment for R.
51. Our oncology adviser explained that there are no relevant UK guidelines in relation to the care and treatment staff should have provided to R after he presented with immunotherapy complications.
52. We understand from our oncologist adviser standard treatment in the first instance is to provide steroids and to stop immunotherapy. If a patient’s condition does not improve, additional therapies such a Mycophenolate mofetil (MMF) can be considered. This is supported by an article from European Society of medical oncology called Management of toxicities from immunotherapy: Clinical Practice Guidelines for diagnosis, treatment and follow-up, 2017. MMF is an immunosuppressant drug.
53. Our oncologist adviser explained that R needed MMF therapy. They said this is a complex therapy that is often administered and supervised by other teams (rather than oncologists) such as the respiratory team at Trust B in R’s case.
54. Our adviser outlined how clinicians properly discussed R’s care following his immunotherapy complications at an acute oncology MDT (multi-disciplinary team meeting) and Trust A arranged appropriate care for R (via the respiratory team at Trust B) to which it provided advice.
55. The Ombudsman’s Clinical Standard outlines how organisations must act in accordance with recognised quality standards, established good practice or both when delivering clinical care. In this situation, where there are no relevant clinical guidelines or standards, we have considered the professional judgement of our adviser which is based on established good practice.
56. We consider Trust A arranged appropriate care and treatment for R following his immunotherapy treatment complications in line with the Ombudsman’s Clinical Standard.
Sent to Trust B (November 2022)
57. Our oncologist adviser explained that oncology units often have an acute assessment service which at the time was limited to patients receiving active treatment for cancer or having completed it within several weeks.
58. They further explained that in November 2022 Trust A was appropriately relying on specialist chest physicians at Trust B to manage his pulmonary condition and there was no reason for Trust A to provide antibiotic or oxygen treatment. They outlined how oxygen and antibiotics are supportive measures and not the mainstay of his treatment for immune-related pneumonitis which Trust B was providing (as outlined further above).
59. Trust A’s policy, 24 hour telephone triage service for patients receiving cancer treatment under [hospital], explains this service is intended for use by all patients who are currently receiving cancer treatment and those who have been treated within the previous three months. It also says all cancer patients who contact the service will go through the triage process to ensure they receive appropriate care.
60. R’s immunotherapy treatment for his cancer finished by early August therefore in November it would have been appropriate for the telephone service to have triaged R.
61. We are satisfied the clinician on the telephone was correct to advise Mrs U to go to Trust B when he was struggling with his breathing in November 2022.
62. In summary, we will take no further action in relation to Trust’s A’s actions post November 2022 as we have seen no indications staff did anything wrong.
63. Again our decision does not, in anyway, detract from the incredibly worrying time this was for both R and his family.
Care and treatment (Trust B)
64. Mrs U is concerned when he was admitted in late March 2023 staff gave R too much oxygen given his symptoms of COPD, poor lung capacity and an infection. She also says nursing staff failed to reduce the amount of oxygen for R until a doctor saw him several hours later.
65. Trust B said staff treated R for a severe chest infection and possible lung inflammation. It said R needed respiratory support and high levels of oxygen due to the severity of his illness.
66. R was brought by ambulance to Trust B and staff in A&E provided him with antibiotics within nine minutes of arriving.
67. A&E staff escalated R’s care to the medical team and he was later transferred to the acute medical unit and respiratory unit for further care.
68. Staff regularly recorded R’s oxygen saturation levels (the amount of oxygen in the blood) and checked his arterial blood gas levels (the level of carbon dioxide in the blood).
69. Staff provided R with oxygen therapy which they later increased.
70. We understand from our respiratory adviser that R presented with type 1 (hypoxic) respiratory failure. This is because his oxygen saturation levels were low and his carbon dioxide level was also low. If his carbon dioxide level had been high alongside low oxygen saturation levels this would have indicated type 2 (hypercapnic) respiratory failure.
71. Our respiratory adviser explained that R never maintained an oxygen saturation level between 94 and 98%. They said he needed the oxygen therapy staff provided and without it he would have died much sooner from extreme hypoxia (a dangerous lack of oxygen in the blood).
72. Our A&E adviser also explained that A&E staff provided appropriate oxygen therapy before the medical team took over his care.
73. BTS, Guideline for oxygen use in adults in healthcare and emergency settings tells us that for patients with a diagnosis of COPD who have a low/normal carbon dioxide level the treatment treatment for type 1 respiratory failure is oxygen therapy to meet an oxygen saturation target of 94-98%
74. We consider staff acted in line with BTS guidance in the oxygen treatment they provided to R. This is because for his condition of type 1 respiratory failure on a background of COPD he never maintained an oxygen saturation level between 94 and 98%.
75. Given we are satisfied staff acted in line with BTS guidance in relation to the oxygen treatment they provided to R and they continued to provide him with the oxygen he needed, we do not think nursing staff delayed reducing his oxygen treatment.
76. In summary, we have seen no indication Trust B did anything wrong in relation to the oxygen treatment it provided to R.
77. We very much appreciate how difficult these events were for the family and R given how poorly he was.
Communication (Trust B)
78. Mrs U says staff did not communicate to R or the family about the seriousness of his oxygen levels and the associated risks. She also says staff did not communicate soon enough to R or the family that he could die and was end of life.
79. Trust B said staff contacted Mrs U after 5am on the day he died and told her that R’s condition had deteriorated. It said staff stopped active treatment at 6.20am and explained to Mrs U that his chest infection had worsened, he was not responding to treatment and was dying.
80. The on-call medical registrar spoke to R at 6.13pm on the day he was admitted and discussed DNACPR with him. They also explained that in terms of escalating his care ITU (intensive care) would not be appropriate for him given his condition. They outlined how he would need level two ward based care. The on-call medical registrar arranged for a doctor from ITU to visit him to confirm their assessment that it was not appropriate for R to go to ITU. Level two ward care is where staff provide enhanced monitoring and support for patients who are too unstable for a general ward.
81. At 10pm, the ITU registrar visited R. They discussed with R and Mrs U that his condition was very serious but because of his condition including other co-morbidities ITU would not be of benefit to him. They outlined that while R was currently stable if he deteriorated his survival chances would not be helped by being intubated or ventilated in ITU.
82. At 11.50pm another on-call registrar discussed the futility of attempting CPR with R should his condition deteriorate. It is documented that R understood.
83. At 5.45am the following morning, the same on-call registrar called Mrs U to ask her to come into the ward as R’s condition had recently deteriorated.
84. At 6.20am because R was now not responding to any of the treatment, the same on-call medical registrar explained to Mrs U that R’s infection had worsened, he was not responding to treatment and he was dying. Staff stopped active treatment at this time.
85. At 7.45am nursing staff spoke to the family about making R comfortable. It is documented the family were aware of his prognosis.
86. GMC, Good Medical Practice explains how staff should give patients the information they need to know. It also outlines how they should be considerate to those close to the patient by being sensitive and responsive in sharing information and providing support.
87. Our respiratory adviser explained that given how poorly R was the first on-call medical registrar who spoke to him at 6.13pm should also have spoken to Mrs U.
88. They further explained that this medical registrar appropriately explained to R how serious his condition was because they outlined he would not be escalated to ITU and the ceiling of his care would be level two ward based care.
89. We understand from our respiratory adviser that throughout R’s admission the most important issue in terms of communication was for clinicians to discuss the overall seriousness of R’s illness, which they did. In addition, when active treatment stopped and the focus was on end of life care, staff appropriately spoke to the family. Our respiratory adviser said clinicians would not be expected to specifically talk about and document that they had shared information about oxygen.
90. It is not clear from the records whether the first medical registrar communicated with Mrs U how unwell R was. If they did not they should have. We are pleased to see that at 10pm, the ITU doctor told both R and Mrs U about how serious his condition was.
91. Overall, informed by our respiratory adviser, we consider staff acted in line with GMC guidance in the way they communicated with R and the family. This is because they explained how serious his condition was and when active treatment stopped they spoke to the family about him being on end of life care and the focus being making him comfortable.
92. We respect the family feels that staff did not communicate with them as they would have liked.
93. We also appreciate how particularly upsetting the final day of R’s life was given how quickly he died. Our decision is not in anyway meant to undermine this.