The Trust failed to provide the chemotherapy treatment soon enough to prevent Mr R’s condition from deteriorating
13. The NHS cancer waiting time guidance says:
‘there is a set of waiting time performance measures for which the NHS is held to account for delivering by NHS England. There are a number of government pledges on waiting times, including:
• a maximum 31-day wait from the date a decision to treat is made to the first definitive treatment for all cancers • a maximum 31-day wait for subsequent treatment where the treatment is an anti-cancer drug regimen.’
14. Mr R was diagnosed with cancer by his wife’s personal health provider on 7 November 2019. The records indicate he was referred to the Trust on 8 November 2019 and his oesophageal cancer was confirmed on 18 November 2019. The Trust clinicians decided to provide cancer treatment and Mr R had an oesophageal stent inserted on 13 December 2019. This was to widen his oesophagus so that he could continue to eat and drink. We are satisfied that this was his first definitive treatment for cancer and that it was provided within the timeframe set out in the NHS cancer waiting time guidance.
15. The records indicate Mr R was reviewed by the Trust oncologist on 23 December 2019 and referred for chemotherapy. Due to capacity issues in the Trust’s chemotherapy unit, Mr R was not scheduled to start chemotherapy straight away and was advised there would be a six week wait. Mr R was scheduled to start chemotherapy on 10 February 2020.
16. Mr R had to wait 51 days after his initial treatment which is almost twice as long as the NHS cancer waiting time guidance recommends. Mr R also had to wait six weeks after his consultation with the Trust oncologist before his chemotherapy could start. We think this delay exceeded the timeframe set out in the NHS cancer waiting time guidance by 28 days.
17. The records indicate that during this period Mr R’s performance status had gone from one (meaning able to do day to day activities) on 23 December 2019 to two (meaning frail sedentary and unable to do day to day activities) on 21 January 2020, three weeks before his chemotherapy was due to start. The records also indicate Mr R had lost 10kg in weight during this period and by the time his chemotherapy was due to start on 10 February 2020 he had become too frail and unwell to have the treatment. Mr R died six weeks later on 29 March 2020
18. Our oncologist adviser said the records indicate the deterioration in Mr R’s condition was due to a combination of the delay in staring chemotherapy and the progression of his cancer. It was also due to the significant weight loss and increasing frailty Mr R suffered as he waited for his chemotherapy.
19. The NHS Constitution sets out the rights for patients with suspected cancer. It states patients should expect:
‘to access certain services commissioned by NHS bodies within maximum waiting times, or for the NHS to take all reasonable steps to offer you a range of suitable alternative providers if this is not possible’
20. In its investigation report the Trust has cited capacity issues in its chemotherapy unit as the reason for the delay in Mr R starting chemotherapy and it has confirmed it was fully aware of the capacity issues at the time. We think it would have been in keeping with the NHS Constitution for the Trust to have referred Mr R to an alternative provider to ensure he could have his treatment within the maximum waiting time, as set out in the NHS cancer waiting time guidance.
21. We found the Trust did not make any efforts to refer Mr R to an alternate provider and we consider this a failing.
22. The JCO study supports the view that treatment with chemotherapy, as a palliative treatment, may allow the patient a modest longer life expectancy. Our oncologist adviser said chemotherapy is generally given for patients with a performance status of two or better and the records indicate Mr R had a performance status of one up until 21 January 2020. Our adviser said that, on the balance of probabilities, it is likely that chemotherapy provided in line with the NHS cancer waiting time guidance may have resulted in Mr R experiencing an improvement, albeit modest, in his symptoms and life expectancy.
23. We carefully considered the advice from our oncologist adviser, the information in Mr R’s records, the Trust’s investigation report and the account provided by Mrs R. It is not possible for us to say with any degree of certainty how successful chemotherapy would have been if it had been provided in line with the NHS cancer waiting time guidance. It is clear that Mr R had a very aggressive form of cancer and his condition deteriorated very quickly as a result.
24. We think the delay in providing chemotherapy and the failure to refer Mr R to an alternate provider was a missed opportunity on the part of the Trust to provide treatment which may have benefitted him.
25. In its investigation report the Trust has acknowledged the capacity issues it was experiencing in its chemotherapy unit at this time, and it has set out the action it has taken to improve this service. We think these improvements are appropriate to reduce the risk of similar capacity issues happening in future.
26. However we do not think this action addresses the failure to refer Mr R to an alternate provider. We also do not think it addresses the doubt that now remains about how successful chemotherapy may have been for Mr R if it was provided in line with the NHS cancer waiting time guidance. For this reason, we have decided to uphold this point of complaint.
The Trust clinicians failed to manage his oesophageal stent
27. The records indicate Mr R’s first stent was inserted on 13 December 2019. Our gastroenterology adviser said the note from this procedure confirms that, in accordance with the BSG and ESGE guidelines, a fully covered stent was inserted into Mr R’s oesophagus using endoscope (a long, thin tube with a small camera inside) and radiological (scan imaging) guidance to confirm it was correctly placed.
28. The records indicate that following insertion of the stent, Mr R was reviewed by the Trust’s medical team and dietitian. The entries in the records at this time state Mr R was still experiencing vomiting with certain food but was able to tolerate soft foods and liquids.
29. Our gastroenterology adviser said this is not unexpected after a patient has a stent inserted, as after it is inserted the stent expands to widen the passageway and can continue to expand over the days after it has been inserted. However, even a fully expanded stent does not guarantee a patient’s swallowing will return to normal. Patients will need to change their diet to ensure optimal performance of the stent. This includes a soft diet, careful use of fluids and if necessary, liquid nutritional supplements.
30. The records show Mr R was reviewed by the Trust dietitian on 16 and 17 December 2019. The entry for 16 December 2019 states Mr R was struggling with his diet but managing drinks including Fresubin (a supplement drink). The entry for 17 December 2019 states Mr R was managing some soft foods and continuing to take the supplement drinks. On both occasions it is recorded that Trust dietitian discussed with him the dietary implications of eating with a stent before he was discharged on 17 December 2019.
31. The records indicate Mr R was reviewed on 10 January 2020 by the Trust’s specialist nurse who noted that he was managing a soft diet. Our gastroenterologist adviser said this would not be unusual for a patient with a stent, yet the specialist nurse arranged an X-ray to check the position of the stent. The records indicate the stent had fallen into Mr R’s stomach and the Trust clinicians removed it on 21 January 2020.
32. Our gastroenterology adviser said the fact the stent had fallen into Mr R’s stomach does not mean if had failed to work. He said that generally a stent is inserted into a narrowed oesophagus to allow food to pass more easily and a stent will only remain in place while there is narrowing within the oesophagus.
33. The records indicate that when Mr R’s stent was first inserted, he had a large tumour obstructing his oesophagus. The stent was inserted and expanded which pushed the tumour aside, opening up the passage. Our gastroenterology adviser said it is likely that over the weeks that followed, the compression effect of the stent on the tumour would have caused a degree of necrosis within the tumour (where the cells of the tumour die). This would have resulted in the narrowing effect of the tumour being lessened by the presence of the stent.
34. Our gastroenterology adviser said at some point the stent slipped into Mr R’s stomach because the degree of narrowing from the tumour was no longer sufficient to hold the stent in place. This phenomenon is discussed in the ESGE guidelines and is a recognised complication from stent insertion. Our gastroenterology adviser said this is an indication the stent worked effectively to reduce the narrowing of Mr R’s oesophagus.
35. The records indicate Mr R was tolerating a soft diet on 10 January 2020, despite the fact the stent was no longer in place and had fallen into his stomach. Our gastroenterologist adviser said this is because his oesophagus had been widened by the pressure effects of the stent. The records support this view as the note of the removal of the stent states that it was easily brought up through his oesophagus as it was wide enough to allow the stent to pass.
36. The Trust clinicians decided not to replace the stent at this time. Our gastroenterologist adviser said this decision can be supported and if a second stent had been inserted at this time it would almost certainly have slipped into Mr R’s stomach as the first one did.
37. Mr R was readmitted to hospital on 17 February 2020 as his condition had deteriorated and he had again experienced difficulty swallowing. The Trust clinicians provided intravenous nutrition and scans showed a regrowth of the tumour which had again blocked his oesophagus. The Trust clinicians inserted a second stent on 25 February 2020, using endoscope and radiological guidance, to confirm it was correctly placed.
38. We carefully considered the advice from our gastroenterologist adviser, the information in Mr R’s records and the account provided by Mrs R. It seems the first stent was inserted to help Mr R with the swallowing problems he had experienced at the time. Following the insertion of the stent, he was reviewed by the Trust dietitians and specialist nurses. The stent was removed promptly when it was found to have dropped into his stomach. It seems the decision not to reinsert the stent at that point was reasonable as there was insufficient narrowing in his oesophagus to hold a stent in place.
39. It seems when Mr R experienced further difficulties swallowing, due to the progression of his disease, the Trust clinicians treated him with intravenous nutritional support and arranged for a second stent to be inserted. The second stent was inserted and the difficulties he had experienced in swallowing improved.
40. We have not seen any evidence to indicate the Trust clinicians failed to manage Mr R’s stent and we think the Trust acted in line with the NICE guidelines and the BSG and ESGE guidelines. For this reason we have decided to not uphold this point of complaint.
Mr R contracted COVID-19 while in hospital
41. The final stages of Mr R’s care and treatment coincides with the start of the COVID-19 pandemic in the UK and the resulting difficulties this placed on all NHS organisations. His death certificate states the cause of death as pneumonia resulting from COVID-19, and advanced oesophageal cancer. It is not possible for us to say with any degree of certainty precisely when or how Mr R contracted COVID-19 or whether he contracted it due to circumstances at the Trust, or conditions on its wards, or in its departments at this time.
42. Our oncologist adviser said the COVID-19 infection did not directly cause Mr R’s death as he was already suffering from an aggressive incurable cancer, but it is reasonable to conclude that it contributed to the deterioration of his condition. Our oncologist adviser said there is no evidence in the records to indicate that the care provided to Mr R was reduced or that any care he needed was declined as a result of his COVID-19 infection.
43. We carefully considered the advice from our oncologist adviser and the information in Mr R’s records. We acknowledge Mrs R’s account of this incident and we can understand why she thinks her husband may have contracted COVID-19 as a result of failings at the Trust.
44. The pandemic was in the early stages at this time and many of the measures which were incorporated to safeguard patients and healthcare professionals were not yet in place. There were no official guidelines in place at this early stage of the pandemic to instruct NHS organisations on how to provide care and treatment and reduce the spread of infection. The scale of the pandemic and the action required to safeguard people and limit the transmission of the virus was not yet known and only became apparent as the pandemic developed.
45. We have seen no evidence to indicate Mr R contracted COVID-19 due to failings on the part of the Trust. We have seen no evidence to indicate Mr R’s care was reduced or restricted in any way, or that he was denied treatment as a result of his COVID-19 infection. For this reason, we have decided to not uphold this point of complaint.
The Trust clinicians failed to keep adequate medical records
46. The GMC guidelines state:
‘Documents you (clinicians) make (including clinical records) to formally record your work must be clear, accurate and legible. You should make records at the same time as the events you are recording or as soon as possible afterwards.’
47. For our investigation we requested a full copy of Mr R’s medical records from the Trust and we have reviewed these records so that we can see precisely what care was provided to Mr R and when. The records we received from the Trust contained over 1000 pages of medical notes which covered the period of Mr R’s care between November 2019 and March 2020.
48. By using the information contained in the records we have been able to conduct a thorough investigation of Mr R’s care, and we have not encountered any significant difficulties as a result of the Trust’s record keeping. The records contain all of the information we would expect to see when conducting an investigation into such a serious incident.
49. Both of our advisers said that this level of recording does not suggest that there were inadequacies in the Trust’s note taking and record keeping. We have seen that the records and the notes they contain are appropriately detailed and cover all the important aspects of Mr R’s care.
50. We have not seen any evidence to indicate the quality of the information noted in the records or the quality of the record keeping was inadequate or had a detrimental impact on the Trust’s ability to provide care for Mr R or the effectiveness of this care. The evidence we have seen supports the view the Trust’s record keeping was consistent with the recommendations set out in the GMC guidelines. For this reason we have decided to not uphold this point of complaint.
The Trust failed to maintain adequate communication between the different departments involved in Mr R’s care
51. Treatment of patients with cancer involves a wide range of healthcare professionals. The NICE guidelines set out how organisations should take a multidisciplinary approach to treating cancer patients and multidisciplinary team meetings play an important role in ensuring good lines of communication across all of the teams.
52. The records indicate the Trust’s gastroenterology clinic started Mr R’s investigations, care and treatment following his referral in November 2019 and the Trust oncologist was responsible for overseeing his care from 23 December 2019 onwards. The records also indicate the Trust gastroenterology clinic and oncologist were supported by a multidisciplinary team including surgery, nursing, physiotherapy and dietician.
53. The records indicate Mr R’s care and treatment was discussed at various multidisciplinary team meetings during this period and the outcomes of these meetings were communicated to Mr and Mrs R and shared with his GP. We have seen no evidence to indicate care and treatment was not provided or was delayed as a result of the communication between the different departments within the Trust.
54. The main areas of care Mrs R is complaining about relate to the management of Mr R’s stent, not replacing the stent when it was removed in January 2019, as well as the delay in providing his chemotherapy.
55. We consider the Trust clinicians managed Mr R’s stent appropriately. The stent was not replaced. This was due to the clinical decision made at the time and the opinion that it would not provide any benefit, not because of poor communication across the departments.
56. As we have also said earlier in our report, we think not seeking an alternate provider for Mr R’s chemotherapy is a failing. However the delay, which meant the Trust could not provide this chemotherapy itself, was due to known capacity issues in its chemotherapy unit and not as a result of poor communication across the departments.
57. We accept this was a very difficult time for Mr and Mrs R and we acknowledge her account of the Trust’s communication and her view of the difficulties it posed. Based on the information we have seen we have found no evidence the communication between the various healthcare professionals involved in Mr R’s care during this period was inadequate or detrimental to his treatment.
58. In response, Mrs R said the lack of urgency and the lack of treatment the poor communication caused contributed to her husband’s death. She said she felt the Trust let her husband die as he had cancer and then COVID-19 and she said he was not really treated for either. We acknowledge Mrs R’s view and we can understand why she has made this point in her complaint. This must have been an extremely distressing incident for her.
59. Mr R had advanced oesophageal cancer. At the time of his presentation in November 2019 the records indicate his cancer had spread to the lymph nodes in his chest and to his bones, indicative of stage IV oesophageal cancer. The UK Cancer Research guidelines state that 80% of patients with stage IV oesophageal cancer die within twelve months of diagnosis. It is clear that this is a terrible disease with an awful prognosis.
60. Our gastroenterologist adviser said the records indicate the Trust made all reasonable attempts to prolong Mr R’s life as much as possible. A stent was inserted to try and improve his swallowing difficulties and to try and optimise his condition so that he could receive some palliative chemotherapy. Unfortunately his cancer continued to progress and he was not well enough to receive chemotherapy by the time the Trust was able to provide it.
61. Our gastroenterologist adviser said the records indicate that, as well as providing treatment for his cancer, the Trust clinicians also treated his COVID-19 infection and pneumonia with antibiotics, oxygen and nebulisers (a machine that turns liquid medicine into a fine mist which can be breathed in through a mask or mouthpiece). The records indicate that it was only by 29 March 2020, as it was becoming apparent Mr R would not recover, that the Trust considered embarking on an end-of-life care pathway if he continued to deteriorate.
62. We carefully considered the advice from our gastroenterologist adviser, the information in Mr R’s records and the account provided by Mrs R. We have seen no evidence to indicate the Trust failed to maintain adequate communication between the different departments involved in Mr R’s care.
63. We have seen no evidence to indicate the Trust held back treatment or that Mr R was left to die. The information we have seen in the records supports the view that the Trust clinicians continued to provide active treatment right up to the time of his death. It seems Mr R died as a result of his rapidly spreading cancer despite efforts to treat him. For this reason we have decided to not uphold this point of complaint.