Deterioration
16. When we look at any complaint, we first establish what should happen by using relevant clinical standards and guidance. We then go onto consider the accounts from all parties to understand what did actually happened and if this falls below the standard. Where we consider the care and treatment falls significantly below what we expect to happen, we refer to this as an indication of a failing.
17. The relevant guidance here is GMC Good medical practice. It states under domain one medical professional should provide a good standard of practice and care, and work within their competence.
18. Ms O was on a pembrolizumab trial (PORT trial) for her T-cell lymphoma cancer.
19. T-cell lymphomas are rare forms of non-Hodgkin lymphoma. T-cell lymphomas develop in the lymphoid tissues of the body, including the skin, lymph nodes gastrointestinal tract and spleen.
20. Pembrolizumab is a type of immunotherapy and works by helping the immune system to kill cancer cells.
21. From the clinical records we can see Ms O signed the consent form for the PORT trial in January 2020. The first treatment was scheduled to commence in February 2020 with six planned number of cycles.
22. Mrs O complains the Trust did not appropriately manage her daughter’s deterioration. She says Ms O felt weak, her legs were ‘oozing’/she was ‘leaking from her legs’ and was in a lot of pain and discomfort.
23. In its complaint response the Trust said Ms O informed the team she had occasional diarrhoea, and she was advised to take Imodium to help with this. There was no recent record of Ms O informing she was tired.
24. It further explained there was one episode where skin sepsis was suspected on 14 August 2020. She was treated quickly and given a dose of intravenous antibiotics and intravenous fluids on the acute oncology unit. Each time Ms O was reviewed in clinic, her performance status was assessed.
25. A performance status (PS) is a measure of how well a person is able to carry on ordinary daily activities while living with cancer.
26. The Trust said Ms O’s skin was examined and blood tests checked. Her performance status was always recorded as 0, meaning that there was no impact on daily life or 1, reflecting minimal impact in strenuous activities. It explained feeling shivery and weakness are common symptoms of skin lymphoma because the skin loses its ability to control temperature and the extensive skin involvement makes patients feel weak.
27. The Trust explained Ms O was reviewed every three weeks in clinic throughout 2020 and 2021 whilst she was on the trial. The team regularly reviewed Ms O and her symptoms and took appropriate action when she had any worsening symptoms of pain by providing further pain relief.
28. Our adviser explained there no relevant guidance for Ms O’s diagnosis, as this is a very rare subvariant of lymphoma.
29. We have seen from the records Ms O was seen every three to six weeks as part of the trial. Our adviser said this condition (T-cell lymphoma) fluctuates, meaning there are times when the condition flares up, progresses, then it calms down.
30. We tried to understand what would be expected as a form of deterioration that would indicate a patient with this condition needed a hospitalisation.
31. From clinical advice we know an indication for an emergency admission for a patient with a chronic illness on treatment with immunotherapy would be a complication of the treatment, for example severe diarrhoea, sickness, or other immunotherapy complications which can affect any organ which could not be managed in the community.
32. A further indication for emergency admission would be untreated infection or severe deterioration in the skin requiring inpatient treatment.
33. From clinical advice we further understand assessment of PS is a crucial part of planning oncological therapy and attendance and physical examination is mandatory at each of the outpatient assessment visits. We have seen Ms O’s PS was taken in person during the clinical trial appointments.
34. This measure is used to determine whether patients can receive chemotherapy, whether dose adjustment is necessary, and as a measure for the required intensity of palliative care. It is also used in oncological randomized controlled trials as a measure of quality of life.
35. The NICE guidance on Carmustine implants and temozolomide can be used here. Although this guidance is not specific to Ms O’s diagnosis, it helps us understand the PS scoring. The guidance says the WHO (world health organisation) performance status classification categorises patients as: • zero: able to carry out all normal activity without restriction • one: restricted in strenuous activity but ambulatory (able to walk) and able to carry out light work • two: ambulatory and capable of all self-care but unable to carry out any work activities up and about more than 50% of waking hours • three: symptomatic and in a chair or in bed for greater than 50% of the day but not bedridden • four: completely disabled, cannot carry out any self-care; totally confined to bed or chair.
36. We understand PS scores are subjective on how the patient says they are coping with their condition.
37. PS scores can fluctuate, and they do not always reflect a patient’s deterioration as they are based on the patient’s ability to function and not on their objective oncology information (e.g. blood tests, etc). For example, a high level of pain caused by cancer medication might influence the PS score. However, high PS score does not always translate into/mean patient’s deterioration.
38. From the records we know Ms O’s PS score before her appointment on 14 January 2021 was one, which tells us she was restricted in strenuous activity but ambulatory (able to walk) and able to carry out light work. On 14 January her PS score was two, meaning she was ambulatory and capable of all self-care but unable to carry out any work activities up and about more than 50% of waking hours.
39. On 14 January Ms O felt poorly and tired (reflecting her PS score of two). From clinical notes we understand this was potently due to COVID-19. The Trust arranged for a COVID-19 test which, our adviser said was appropriate. Therefore, the increased PS score (from one to two) on 14 January does not necessarily indicate a deterioration but Ms O’s ability to cope with potential COVID-19 symptoms.
40. From clinical advice we know it is common and expected for Ms O to feel tired, week and have pain on account of skin soreness due to the nature of her diagnosis.
41. We note Ms O had diarrhoea in September 2020 and suspected sepsis in August 2020.
42. As severe diarrhoea and other immunotherapy complications can be an indication of an emergency admission we tried to understand if this was appropriately managed by the Trust and if these events necessitated an emergency admission to the hospital.
43. We have seen from the records the first description of diarrhoea symptoms was on 30 September 2020. The Trust advised Ms O to take Imodium to help with the diarrhoea and it was recorded her symptoms settled in the morning. Our adviser told us this management was appropriate.
44. The records show Ms O had suspected sepsis in August 2020. From clinical advice we know sepsis and infection are expected and common complications, due to open skin wounds which are the major feature of this condition.
45. From the clinical records we have seen around 13 August Ms O ‘spiked a temperature on the day of treatment due to infection and required intravenous antibiotics and fluids in the unit before going home the same day’. It was also recorded Ms O felt ‘her skin has slightly improved’ and was feeling ‘a bit better in herself although is having some side effects on the antibiotics, including bloating’.
46. Our adviser clarified Ms O had a fever not sepsis and this was appropriately managed with fluids and antibiotics.
47. We next tried to understand if Ms O’s legs were ‘oozing’ and if they were, did the Trust provided the appropriate treatment/management for this.
48. From clinical advice we know patients with this condition often ‘leak protein’ through their skin. Therefore, when legs ooze, the fluid that comes out has protein in it.
49. Our adviser reviewed photographs of Ms O’s skin, and explained they show plaque disease rather than lesions that were oozing disease. Plaque diseases are hard, solid looking and ‘oozing’ are wet appearing.
50. We consider the photographs and records (including Ms O’s last appointment on 14 January) do not support oozing legs but instead show plaque disease (hard/solid looking).
51. We note the photographs do not specify the date they were taken. Ms O’s skin might have progressed/deteriorated, and she might have at some point leaked protein though her legs. The records do not show Ms O ever complained of oozing legs.
52. Mrs O says her daughter’s legs were oozing and we do not have a reason to doubt her account of events. From the photographs and records (which do not show oozing legs) we will never be able to determine for certain if she was leaking protein or if she did, quantify how much she was leaking.
53. We know any oozing/leaking of fluid and protein would have been a consequence of the skin disease, which was what the treatments were trying to address. There is no management of this apart from dressing the wounds. We have not seen evidence of this deterioration.
54. Finally, we considered Ms O’s objective test results, such as her blood test results. From clinical advice we know her albumin levels steadily diminished over the second half of 2020 and early 2021, whilst other blood tests showed the kidney function and blood count remained satisfactory over that time.
55. Albumin levels are a measure of the amount of albumin in your blood. Albumin is a protein that helps regulate fluid balance and transport substances in the body.
56. From clinical advice we know the lowering albumin is a sign of general deterioration, which is due to a combination of factors including progressive disease.
57. We recognise how distressing it is to witness a family member be treated for a rare type of cancer. It is natural to have many questions about the care they received. We have seen the Trust acted in line with GMC Good medical practice. It provided appropriate care to Ms O and she her symptoms were regularly reviewed. From Ms O’s records and our independent clinical advice, we have not seen an indication of a failing in the management of Ms O’s condition.
Home nursing care
58. Mrs O said from January 2021, based on her condition the Trust should have arranged for Ms O to have nursing care at home.
59. In its response the Trust explained, from a review of the documentation on Ms O’s records, the whole multi-disciplinary team offered Ms O every support possible and asked at every visit what they could do to help her further.
60. It said the skin cancer CNS (clinical nurse specialist) team support patients with their personal wound care and skin care plans. If patients express an inability to cope with managing this at home, then the team would support by referring patients to community or district nursing teams, with consent from the patient. It explained in Ms O’s case, the CNS team reviewed her skin care plan in her clinic appointments and Ms O did not express to the team that she required further support and wanted to remain independent with her skin care.
61. The Trust said Ms O also received regular support from the skin cancer psychology service, who record if there are any risks identified during their sessions. Ms O did not disclose to the psychology team that she was struggling to cope at home with her skin care.
62. We sought clinical advice to understand if the Trust should have arranged Ms O with nursing home care.
63. GMC Good medical practice under domain one states medical professionals should provide a good standard of practice and care, and work within their competence.
64. From Ms O’s clinical notes, we know during her appointment with the clinical psychologist on 19 November 2020 Ms O reported struggling more with her cancer and acknowledged she is open to accepting more help from her daughter.
65. During her next appointment with the psychologist on 21 December Ms O reported her skin has remained sore and she was experiencing side effects in relation to treatment. Ms O shared she tends to struggle more in January and February when the weather is cold as she experiences more pain in her skin and body, and it is harder for her to leave the house and maintain healthy routines.
66. During her clinical appointment on 11 February Ms O reported ‘feeling well’ with no issues were voiced.
67. We can see from the records Ms O experienced pain and discomfort, which we understand is common and to be expected with her condition. The records on 14 January 2021 and December 2020 do not provide any evidence Ms O was struggling with her daily dressings or not coping at home. There is nothing to suggest additional nursing care was required at home.
68. We note Trusts cannot arrange nursing care in a patient’s home particularly when it is out of area. This is typically requested by the GP for community input as required. From clinical advice we know there is nothing in the records around December 2020 and January 2021 to indicate this was necessary.
69. We understand Mrs O says the Trust should have arranged nursing care for Ms O as she was struggling to cope at home. We acknowledge this must have been very distressing for Ms O’s family to witness her finding things difficult.
70. From Ms O’s clinical records and the independent clinical advice, there is no evidence in the records of Ms O communicating her struggles to the clinical team. We have seen the Trust acted in line with GMC Good medical practice talking to Ms O about her symptoms and asking if further support was needed. We have not seen an indication of a failing here.
COVID-19 vaccination
71. The Independent report on Vaccination and Immunisation says individuals considered extremely clinically vulnerable should be offered vaccine alongside those aged 70 to 74 years of age (Joint Committee on Vaccination and Immunisation: advice on priority groups for COVID-19 vaccination, 30 December 2020 - GOV.UK (www.gov.uk)).
72. Mrs O said Ms O was not offered a COVID-19 vaccine by the Trust despite being clinically vulnerable. Mrs O said not providing the vaccination caused Ms O to contract COVID-19 and die.
73. Ms O was clinically a vulnerable patient who got COVID-19 on in February 2021. She was admitted to hospital on 22 February. Ms O sadly died on 1 March 2021.
74. The Trust explained Ms O was offered a vaccine by the Trust and her GP. It explained all high-risk cancer patients were contacted by text message to book an appointment with the COVID-19 booking team for their vaccines. It said all patients attending the Trust’s Cancer Centre were triaged for COVID-19 and were also informed they could have an on the day vaccine appointment and where to go to book a time.
75. The Trust were not unable to recall why Ms O did not have the vaccine, but confirmed it was recommended to all cancer patients and the vaccine would have been provided to her at the time if a booking had been made.
76. We’ve asked the Trust if they have records of any text sent to Ms O regarding the COVID-19 vaccine. The Trust said due to the time that has passed, they cannot obtain the list of text messages. They said the COVID-19 vaccine information and invite may not have come from the Trust but from a central point, such as the Department of Health and Social Care if the patient was on the clinically extremely vulnerable (CEV) list.
77. The Trust explained it does not have a record of the text anymore and considering the passage of time we would not expect them to.
78. We have reviewed Ms O’s clinical records and have seen no record of her asking about or requesting the COVID-19 vaccine.
79. We understand Mrs O says the Trust should have offered Ms O the vaccine. We recognise to find out her daughter had not had a vaccine and then contracted COVID-19 would cause her concern. We are unable to determine if a text about the vaccine was sent/received. We note the decision to get vaccinated is an individual choice and it was the individual’s responsibility to make a booking for this either with their GP or hospital.
80. We are sorry to hear Ms O contracted COVID-19 and subsequently died at the hospital in March. We recognised how distressing this must have been for Mrs O and her family.
81. Considering the information, it is not proportionate for us to look into this matter further. We will never be able to reach a robust decision on this. This is because we do not have any records to inform a decision and we recognise an individual’s choice and responsibility to booking a vaccine. There would have been plenty of information at the time about COVID-19 vaccines and we will never know if Ms O chose not to have the vaccine.
82. Therefore, we will take no further action on this.
83. This ends our primary consideration.