21. Before we decide if we should conduct a detailed investigation of a complaint, we look at whether there are signs the organisation has got something wrong. We do this by what should have happened with what did happen. We have done this for each part of Mr U’s complaint.
Prognosis
22. Mr U complains the Trust failed to identify Mrs U’s cancer had spread to her brain and her prognosis was significantly shorter than she was told on 4 January.
23. The report of the PET scan done on 18 December 2023 concluded the findings indicated disease progression. Mrs U had a consultation with an advanced nurse practitioner (ANP) on 3 January to discuss the PET scan. The ANP told her the scan showed activity in her lymph nodes in her abdomen and surgeons felt this was not removeable by surgery. Mrs U was referred to a consultant oncologist to discuss further possible therapy.
24. Mrs U attended her first clinic appointment with the consultant oncologist on 4 January. The consultant oncologist wrote to Mrs U with a summary of the consultation and said they discussed the findings from recent investigations with her and told her the PET scan showed progressive disease. They said they discussed the options for further treatment with Mrs U and she opted for combination immunotherapy. The consultant oncologist gave Mrs U details of the Checkmate 067 trial (a long-term study which shows the overall survival rates for patients with advanced melanoma after combined immunotherapy treatment)(including possible side effects) and said the: • one-year overall survival rate was 73% • two-year overall survival rate was 64% • six-and-a-half-year overall survival rate was 53%.
25. A member of Trust staff called Mrs U on 8 January to see how she was managing following the clinic appointment. Mrs U said she felt fine and understood the information she had been given and wanted to go ahead with the immunotherapy treatment.
26. After the appointment on 4 January, the consultant oncologist made a referral for a MRI scan to exclude brain metastases. The MRI was completed on 20 January. A consultant neuroradiologist reviewed the scan on 22 January and said the scan confirmed the findings of the PET scan (that the cancer had spread) and there was a raised suspicion of bone metastases in the spine.
27. Our clinical adviser told us the MRI scan did not identify any brain metastases.
28. Mrs U contacted the consultant oncologist on 22 January and said she had a rash and blisters on her thigh, near to the scar from her operation. They arranged for Mrs U to see a consultant dermatologist later that day. The consultant dermatologist recorded the symptoms were ‘likely metastatic disease’ and took a biopsy.
29. The biopsy was reviewed by a consultant histopathologist on 8 February. They reported it was consistent with malignant melanoma. Mrs U attended a clinic appointment with the consultant oncologist the same day and they told her the biopsy confirmed there was a recurrence in the skin over her right groin which had increased in size after the first cycle of immunotherapy treatment.
30. Mrs U attended another clinic appointment with the consultant oncologist on 22 February. They recorded she had ‘increasing disease’ on the right groin and a pea sized lesion on the back of her neck.
31. Mrs U had no further outpatient appointments with the consultant oncologist before she was admitted to hospital on 14 March. T he consultant oncologist examined Mrs U on 15 March as an inpatient and told her the melanoma in her groin could be true progression of the cancer in which case it would continue to progress and cause pain and impact on her quality of life, or it could be pseudo progression (which is an increase in the size of the primary tumour, or the appearance of a new lesion followed by tumour regression) n which case over the coming weeks they would see regression of the groin disease. The consultant oncologist told Mrs U they were monitoring the lumps in her groin and on the back of her neck but there was nothing additional that could be done, the management plan would not change and they were waiting to see if the immunotherapy would work.
32. Mrs U remained in hospital and the CT scan done on 27 March confirmed she had brain metastases. Mrs U and her family were informed of on 28 March and discussions began about end of life care.
33. The guidance we have looked at when we considered this complaint is GMP. Section 2, paragraph 28 of the guidance says doctors must give patients the information they want or need in a way they can understand. This includes information about their condition(s), likely progression, and any uncertainties about diagnosis and prognosis.
34. Our adviser says the prognosis the consultant oncologist gave Mrs U at the appointment on 4 January based on the Checkmate 067 trial results was in line with guidance, given Mrs U’s diagnosis. They explained it would take some weeks before it could be established if the immunotherapy treatment was working and any symptoms Mrs U reported in the meantime could be attributed to the treatment. They said Mrs U’s prognosis or treatment plan would not have changed in any case. Our adviser specifically referred to the MRI scan of 20 January which did not show any brain metastases. They also explained Mrs U did not report any symptoms between 4 January and 14 March which might have prompted the consultant oncologist to consider if the cancer had spread to Mrs U’s brain.
35. This is in line with the Trust’s complaint response to Mr U on 9 October 2024. It said the consultant oncologist told Mrs U on 4 January the disease was inoperable and incurable, but the treatment option of palliative immunotherapy was discussed. The prognosis for Mrs U was based on statistics from the Checkmate 067.
36. We recognise that, when she was given the Checkmate 067 statistics on 4 January, Mrs U might have been optimistic about her life expectancy despite the diagnosis of inoperable stage three cancer. We acknowledge her family would have been distressed when Mrs U died just three months later.
37. We are satisfied the Trust provided Mrs U with relevant information at the appointment on 4 January, and in the summary letter the consultant oncologist sent. We have seen Mrs U was told the disease was progressing. We have not seen any opportunity for the Trust to identify Mrs U’s cancer had spread before she was admitted to hospital. We think the Trust acted in line with GMP guidance when it gave Mrs U the Checkmate 067 and had no reason to revise the prognosis before she was admitted to hospital. We have not seen any indication of failings by the Trust relating to this matter and will not be looking into it further.
Pain management
38. Mr U complains Mrs U was not given appropriate pain medication to manage her increasing pain between 4 January and 14 March.
39. NICE guidance says a stepwise approach should be considered for cancer pain using the World Health Organisation (WHO) analgesic ladder (a framework for managing pain, particularly in cancer patients). The original WHO model involves three main steps: • mild pain: treat with non-opioid analgesics, such as paracetamol or non-steroidal anti-inflammatory drugs).
• moderate pain: if pain persists, add a weak opioid, such as codeine, to the non-opioid.
• severe pain: if pain is still not controlled, switch to a strong opioid, like morphine, and continue with appropriate medications for co-existing symptoms.
40. Mrs U’s records do not make any reference to pain and/or medication before 5 February. Mrs U had a phone consultation with the consultant oncologist on 5 February when she said she was in pain all the time and was taking paracetamol and ibuprofen. The consultant oncologist prescribed codeine (an opioid which treats mild to moderate pain) and oramorph (an opioid which treats moderate to severe pain) in addition.
41. During a phone consultation on 15 February Mrs U told the consultant oncologist her pain was relieved by codeine.
42. On 22 February Mrs U attended a clinic appointment with the consultant oncologist. She said her pain was increasing and, in addition to Mrs U’s existing medication, the consultant oncologist prescribed gabapentin (which is used to treat nerve pain in cancer patients). At some point between 22 February and 12 March Mrs U was also prescribed zomorph (similar to oramorph).
43. The consultant oncologist spoke to Mrs U by phone on 29 February. Mrs U said she had significant pain, and the consultant oncologist said they would make a referral to the community palliative care team to help with pain management. A referral was made the next day and the palliative care team visited Mrs U on 6 March. They completed a medication sheet which explained when to take her medication to give the best possible relief.
44. Subsequent records show us Mrs U spoke with the Trust on several occasions when she referred to her pain. Specifically: • on 8 March she said her pain had got worse and was told the palliative care team would contact her and could go to Accident and Emergency (A&E) for a pain assessment or call NHS111 if she was struggling with pain • the Trust called Mrs U on 11 March, and she said her pain was a little better and she thought the medication had started working; • on 12 March Mrs U said the pain was reducing her mobility and she was told the palliative care team would be asked to visit (it is unclear if a visit was done before Mrs U was admitted to hospital on 14 March).
45. Our adviser explained the Trust appropriately applied the WHO analgesic ladder when trying to address Mrs U’s pain, specifically from 5 February when she first told the consultant oncologist her pain was increasing. They said she was regularly reviewed by primary and secondary care, when her pain was discussed, including the community palliative care team, before she was admitted to hospital, and her pain medications were increased or amended as appropriate.
46. We recognise how distressing it must have been for Mrs U’s family to see her in so much pain. We can see the Trust followed the appropriate NICE guidelines and applied the WHO analgesic ladder over the course of two months. We have not seen any indications of failings by the Trust in the way her increasing pain was managed. For this reason, we will not look at this matter further.
CT scan
47. Mr U complains the Trust delayed referring Mrs U for a CT scan after she was admitted to hospital on 14 March. He says her symptoms should have prompted the Trust to do a scan which would have confirmed her cancer had spread to her brain.
48. GMP guidance says in providing clinical care doctors must adequately assess a patient’s condition and promptly provide (or arrange) suitable advice, investigation or treatment where necessary.
49. Mrs U went to A&E on 14 March with a high temperature and leakage from a wound in her groin area. She was diagnosed with an infection, prescribed intravenous antibiotics and moved to the oncology ward on 15 March.
50. The consultant oncologist examined Mrs U on 15 March and noted she might have pseudo progression, in which case they would see a regression in the coming weeks or, the cancer would continue to progress. They said they would not do a biopsy because it would not change the current management plan.
51. Mrs U continued to be treated for an infection, as well as ongoing pain management. The plan was to work towards discharge but because her temperature remained high that did not happen.
52. On 21 March Mrs U told staff she was nauseous, dizzy when walking, and had blurred vision. She repeated those symptoms when she spoke to a palliative care nurse on 22 March. The nurse asked for consideration to be given to a review of these symptoms and an oncologist reviewed Mrs U later that day. They noted the MRI of 20 January did not show brain metastases and her symptoms should continue to be monitored. Another doctor reviewed Mrs U the same day and said if her nausea did not settle a referral should be made for a MRI. The Trust explained in its complaint response, that this was the reason for the delay in her discharge, originally planned for 22 March.
53. Mrs U reported similar symptoms on 25 March and a palliative care nurse noted they should be monitored.
54. A referral was made for a CT scan on 26 March because Mrs U was confused, and this might be due to new brain metastasis. The scan was done the following day and sadly confirmed the cancer had spread to Mrs U’s brain.
55. Our adviser explained the earliest symptoms that indicated Mrs U’s cancer had spread to her brain is when she told staff of her new symptoms on 21 March. They said although in hindsight, when Mrs U complained of nausea from 2 March onwards this might have pointed to the cancer spreading to her brain, there were other plausible reasons for it at the time, specifically a side effect of the medication she was prescribed.
56. Our adviser said it is acceptable for Mrs U’s symptoms to have been monitored before asking for a CT scan. They explained the treatment plan would not have changed even if the secondary brain cancer had been identified earlier. Unfortunately, due to lack of space, Mrs U could not be transferred to the hospice until 3 April.
57. We recognise Mrs U’s family would have been distressed at seeing her deterioration after she was admitted to hospital. Although we think a referral for a MRI or CT scan could possibly have been made several days earlier than 26 March, we are only able to say this with the benefit of hindsight. Staff continued to monitor Mrs U’s symptoms in the days between her first reporting them on 21 March and when the referral was made. Based on the information available to staff at the time, we are satisfied the Trust followed the GMP guidance we refer to above when managing Mrs U’s symptoms. We will therefore not look into this matter further.
Capacity and consent
58. Mr U complains the Trust refused to discuss Mrs U with him because it said she had capacity. He says this cannot be the case when they also said, on 26 March, she was showing signs of confusion.
59. GMP decision making and consent guidance says all patients have the right to be involved in decisions about their treatment and care and to make informed decisions if they can. Doctors must start from the presumption that every adult patient has capacity to make decisions about their treatment and care. GMP also says doctors must be considerate and compassionate to those close to a patient and be sensitive and responsive in giving them support and information.
60. We have seen Mr U contacted the Trust on 6 March (this is the first record he spoke to Trust staff) and said he was concerned Mrs U was not giving staff a full picture of how she was feeling, specifically how much pain she was in. A member of staff called Mr U and told him a referral had been made for palliative care on 1 March.
61. We have seen no other records which show Mr U contacted the Trust to speak on behalf of Mrs U before she was admitted to hospital.
62. The records we have seen between 14 and 24 March, after Mrs U was admitted to hospital, do not show evidence that would raise concerns about Mrs U’s capacity. Specifically: • on 18 March it was noted there was ‘no disturbance of mind or brain’ • on 22 March a risk assessment was done which scored Mrs U nil for neurological deficit.
Daily nursing records also say she was ‘alert and orientated’.
63. The consultant oncologist saw Mrs U on 22 March and noted she said she did not want them to ‘discuss anything with any family’.
64. On 25 March Mrs U told staff she was feeling muddled and staff recorded she was not always communicating clearly, and conversation did not flow readily. The next day, a doctor examined Mrs U during a ward round. They noted she was alert and orientated, was frustrated about her situation and felt she was not being taken seriously. The doctor said they would arrange a meeting with Mrs U’s family to discuss her issues and she agreed that would be the best course of action.
65. A doctor spoke to Mr U by phone later that day. The notes refer to Mrs U becoming confused in the last week (it is not clear from the notes if Mr U said this or the doctor).
66. A doctor spoke to Mr U on 27 March and told him the CT scan demonstrated very rapid disease progression. On the same day nursing notes say Mrs U was alert and able to communicate her needs.
67. Records show Mrs U was sometimes confused from 28 March onward but was able to understand and verbally communicate with staff as her condition deteriorated. She was transferred to a local hospice on 3 April.
68. The records we have seen do not suggest Mrs U did not have capacity to be involved in discussions and decisions about her own care. We have seen that as late as 22 March, Mrs U asked the consultant oncologist not to discuss her condition with her family although on 25 March she agreed staff could speak to her family. Once it was clear Mrs U’s condition was deteriorating, especially from 28 March onwards, the family was regularly included in discussions with staff. We have not seen any indications of failings by the Trust relating to communicating with Mrs U’s family. We think it followed the GMP guidance we have referred to earlier and for this reason we will not be looking at this matter further.
69. We acknowledge how distressing it must have been for Mrs U’s family to see her rapid deterioration after she was told on 4 January that she had inoperable stage three cancer. It is clear Mrs U’s cancer advanced much more quickly than anyone expected. We hope our explanations that the Trust acted in line with guidance in relation to the care and treatment have gone some way towards putting Mr U’s mind at rest.