2018 management
23. We have carefully considered the evidence from Mr E’s consultations in 2018. The Trust has provided us with very limited medical records for these consultations. Mr E has told us he saw the consultant numerous times throughout 2018.
24. We understand there are some missing medical records from the file we have received. In the Trust’s complaint response dated 1 October 2019 it refers to the consultants ‘handwritten records’ and ‘iportal’ records. We have asked for these records, but the Trust has confirmed it does not have these. Due to the lack of records, unfortunately it is not clear exactly what was happening during these appointments.
25. The records we have seen evidence Mr E had gastroenterology appointments at the Trust in 2018 on:
8 January 2018 – Mr E was reviewed by the IBD nurse 30 April 2018 – Mr E attended for an anti TNF blood test 27 July 2018 – Mr E was reviewed by the gastroenterology consultant 2 9 August 2018 - Mr E attended for an anti TNF blood test 29 November 2018 - Mr E attended for an anti TNF blood test
26. Mr E says from early 2018 he was feeling unwell and experiencing symptoms such as fatigue, loss of appetite, shortness of breath, and weight loss. He says he told his consultant at his gastroenterology appointments about these symptoms and how unwell he felt. He thinks the Trust should have acted on these symptoms at these appointments.
27. The Trust says Mr E’s blood tests going back to 2017 were largely unremarkable. The Trust has not commented more specifically on Mr E’s consultations in 2018. It has acknowledged it is unclear from the records what happened at these consultations. The Trust says the consultant has now left the Trust so it cannot add further information.
28. We will first set out what should have happened in Mr E’s case. The NHS website says the main symptoms of ulcerative colitis are recurring diarrhoea, tummy pain and needing to empty your bowels frequently. It says you may also experience extreme tiredness (fatigue), loss of appetite and weight loss.
29. The severity of these symptoms can vary in each patient depending on how much of the rectum and colon are inflamed, and how severe the inflammation is. Patients may go through weeks or months with mild symptoms followed by flare ups when symptoms are worse.
30. Treatment for ulcerative colitis aims to relieve symptoms during a flare up and stop symptoms from returning. Generally, this requires close monitoring and treatment with medication.
31. The NICE guideline for managing ulcerative colitis says clinicians should:
‘1.1.1 Discuss the disease and associated symptoms, treatment options and monitoring: • with the person with ulcerative colitis and their family members or carers (as appropriate) and • within the multidisciplinary team (the composition of which should be appropriate for the age of the person) at every opportunity. 1.1.2 Discuss the possible nature, frequency and severity of side effects of drug treatment for ulcerative colitis with the person, and their family members or carers (as appropriate)’.
32. We have reviewed each of Mr E’s appointments in 2018. We will set out if we consider what happened was in line with what should have happened.
33. The medical records indicate that Mr E’s first review with the gastroenterology consultant in 2018 was on 27 July for an ulcerative colitis review. His previous appointment with the consultant appears to have been in 2017.
34. At the appointment on the 27 July 2018, the consultant reviewed Mr E’s latest blood test from 30 April 2018 and said the results were satisfactory.
35. The consultant said Mr E’s calprotectin levels were markedly elevated. These are protein levels in the stool indicating inflammation. He was also symptomatic for ulcerative colitis, particularly in the morning.
36. Mr E’s ulcerative colitis was being treated with a drug called Humira to control his symptoms. Occasionally people who are treated with Humira can develop antibodies to the drug. This means it does not work properly. A blood test can be taken which is called anti TNF monitoring. This will measure if the Humira is working properly and if a person has developed antibodies.
37. We can see Mr E was presenting with symptoms of ulcerative colitis at his appointment in July 2018. Because of this, the consultant said they were going to check Mr E’s anti TNF for antibodies to see if his dose or type of medication needed to be changed. The records say Mr E’s physical exam was ‘otherwise unchanged’.
38. The consultant wrote to Mr E’s GP following the appointment to say they were trying to manage Mr E’s poor control of his symptoms. The Trust carried out anti TNF monitoring on 27 July 2018, 29 August 2018, and 29 November 2018.
39. We have reviewed these blood test results. Our gastroenterology adviser did not identify any signs of concern. The tests did not show that Mr E had antibodies present.
40. The Trust carried out regular anti TNF testing for Mr E in 2018 and the records support there was a regular input from the consultant. There was also an appropriate follow up in place, as Mr E received monitoring and drug treatment with the inflammatory bowel disease nurses. This is in line with the BSG guidelines.
41. It is worth acknowledging that at Mr E’s appointment on 27 July the consultant said it would discuss Mr E’s blood test results and come up with a plan in an MDT (multidisciplinary team). We have seen no evidence the MDT took place. However, the Trust have acknowledged the consultant told Mr E he would discuss his care at an MDT.
42. We asked our gastroenterology adviser to comment on this. They say as Mr E’s antibody tests came back negative, from a colitis perspective, an MDT discussion was no longer clinically required. This is because the tests indicated Mr E’s Humira and treatment for ulcerative colitis was working as it should and his condition was under control.
43. While the Trust did not do what it said it would, the overall clinical treatment picture for 2018 was in line with the relevant guidance. We recognise there is a shortfall here. We do not think this falls so far short of what the guidance says should have happened to amount to a failing. However, we recognise the Trust should have communicated better with Mr E and told him if it was not going to do what it said it would. We can understand how this would have been confusing and distressing for Mr E.
44. There are no records of the consultant reviewing Mr E in clinic again until March 2019.
45. Based on the information we have seen so far, Mr E’s consultations in 2018 were appropriately managed and the test results from 2018 were satisfactory. The results did not show that Mr E had significant antibodies, indicating Humira was still an appropriate treatment for him. The management and treatment were in line with the BSG and NICE guidance. We have not seen a failing here.
2019 management
46. Mr E complains he was reporting worsening symptoms such as fatigue, weight loss, and night sweats to his consultant at his gastroenterology appointments at the Trust in 2019. Specifically, he is concerned that the Trust did not appropriately follow up on his blood test results from February and March 2019. Mr E says his symptoms and blood test results were worrying indicators that the Trust ignored.
47. The Trust says it has considered Mr E’s blood test results from February and March 2019. It says the results do not necessarily point to any major abnormality. The Trust does not think it needed take further action following these tests. Furthermore, the Trust says it is not clear from Mr E’s records if the consultant reviewed Mr E’s weight, but his weight loss would be a worrying sign. The Trust has not commented on the other symptoms Mr E says he presented with.
48. The NICE guideline ‘Suspected cancer: recognition and referral’, applies here. The guideline lists the nonspecific symptoms of cancer. This includes unexplained weight and appetite loss, fatigue, and night sweats.
49. Some symptoms or symptom combinations may be features of several different cancers. The guidance says if a patient presents with nonspecific symptoms clinicians should:
50. ‘Symptoms of concern in adults
'1.13.2 For people with unexplained weight loss, which is a symptom of several cancers including colorectal, gastro-oesophageal, lung, prostate, pancreatic and urological cancer: • carry out an assessment for additional symptoms, signs or findings that may help to clarify which cancer is most likely and • offer urgent investigation or a suspected cancer pathway referral (for an appointment within 2 weeks). [2015] 1.13.3 For people with unexplained appetite loss, which is a symptom of several cancers including lung, oesophageal, stomach, colorectal, pancreatic, bladder and renal cancer: • carry out an assessment for additional symptoms, signs or findings that may help to clarify which cancer is most likely and • offer urgent investigation or a suspected cancer pathway referral (for an appointment within 2 weeks). [2015]’.
51. The specific pathway for Hodgkin’s lymphoma also lists associated symptoms to consider. The guidance says clinicians should:
‘1.10.10 Consider a suspected cancer pathway referral (for an appointment within 2 weeks) for Hodgkin's lymphoma in adults presenting with unexplained lymphadenopathy. When considering referral, take into account any associated symptoms, particularly fever, night sweats, shortness of breath, pruritus, weight loss or alcohol-induced lymph node pain’.
52. We have reviewed what happened at Mr E’s appointments in 2019. We will set out if we consider what happened was in line with what should have happened. It is worth noting the records from 2019 are also sparse. We will go on to consider the Trust’s record keeping later in the report.
53. We have reviewed the results of Mr E’s blood test on 22 February 2019. Our gastroenterology adviser says the test indicated minor changes and minor nonspecific abnormalities. This means the test did not point to a specific diagnosis or issue and was not necessarily a cause for concern. If this test was viewed in isolation, it did not indicate the Trust needed to take further action. However, a trend in multiple blood tests can be a more significant source of information and will often explain more than a single test.
54. Mr E’s GP arranged for him to have a second blood test because of his symptoms on 15 March 2019. This showed similar changes to the previous test. These were also nonspecific changes not necessarily pointing to any serious issue. However, when this test is viewed alongside the earlier test, clear changes can be seen in the results in only three weeks. This indicated further investigation was needed.
55. Mr E went on to have a gastroenterology review on 18 March 2019. We have looked at what happened, and if the Trust’s management of Mr E at this appointment was in line with the guidance.
56. At this review, the consultant said, from a colitis perspective, things seemed to be under relatively good control. The consultant recorded Mr E’s biggest problem was neck pain, head pain, and that he had low B12 levels (fewer red blood cells than normal). This can be an indication of iron deficiency, otherwise known as anaemia.
57. The Trust says it cannot see any evidence from the consultants handwritten notes (which we do not have) whether they had recorded Mr E’s physical condition at his appointments. However, it says the iPortal system shows on 4 February 2019 Mr E weighed 75kg, and by his clinic appointment on 18 March 2019 he weighed 71.9kg. This shows he was losing weight at quite a significant rate.
58. The consultant planned to review Mr E six weeks later. The records show the consultant did not contact or review Mr E after six weeks. He did not hear from the consultant again.
59. Our gastroenterology adviser says the threshold for referring patients with non-specific symptoms (such as the ones listed in the NICE guidelines), and weight loss should be low. This is because there is a possible connection between both long standing colitis and lymphoma. There is also a risk of lymphoma associated with biological therapy such as Humira.
60. The combination of Mr E’s symptoms and documented weight loss in a patient with ulcerative colitis should have been a trigger for further investigations, in line with the NICE guidelines.
61. Our gastroenterology adviser says although it is difficult to pinpoint an exact date the Trust should have taken further action; we can see at Mr E’s appointment on 18 March 2019 that his colitis was doing well.
62. At the appointment on 18 March the consultant should have taken into account Mr E’s history and considered if he had any symptoms that were not attributable to his colitis. They should have asked questions or thought about arranging further investigations to explain Mr E’s symptoms, in line with the NICE guidelines set out above.
63. The consultant should have then considered arranging blood tests and the appropriate scans.
64. If Mr E’s colitis had not been under control, symptoms such as weight loss may have been less worrying. The information the Trust had on 18 March 2019 suggested there was another cause for Mr E’s symptoms.
65. As the Trust knew Mr E’s colitis was under control on 18 March 2019, alongside the changes in his blood results, it should have investigated his symptoms further at this stage. We have not seen any evidence that the Trust acted on Mr E’s blood tests or nonspecific symptoms, and we have found a failing here.
Impact
66. We have considered Mr E’s blood tests and consultations in 2019 and consider there to be a failing as set out above. We think the Trust should have identified the blood results and clinical picture on 18 March 2019 which suggested Mr E needed further investigations and potentially treatment.
67. We have looked at the impact this had on Mr E and what would have been different if the failing had not occurred.
68. Mr E says he was at a very low point when he was telling the consultant about his symptoms, but the Trust was not taking action. He says he developed malnutrition and was very poorly.
69. Mr E feels the Trust caused him unnecessary delay, stress, and suffering. He says it caused him a delay in getting his diagnosis. Mr E says if he had received an earlier diagnosis, he could have started treatment sooner. This may have impacted on his overall prognosis and condition.
70. Mr E has been told the earlier someone is diagnosed, the better the chances are of remission. He says this has been a distressing experience for him and his family physically and emotionally.
71. Generally, an earlier cancer diagnosis means there is awareness of a malignant condition at an early stage. This may mean there is a lesser risk of the cancer spreading to other organs and a person has a better overall prognosis. We have considered whether Mr E’s cancer would have been diagnosed sooner if the Trust had taken the right action following the appointment on 18 March 2019.
72. If the Trust had acted on the results on 18 March 2019, the next step would be to put Mr E on the 2 week cancer pathway in line with the NICE guidelines. The guidelines indicate this Mr E would have been seen on the pathway approximately at the start of April 2019.
73. Mr E would then have had a CT scan and further investigations within two weeks, in line with the guidelines. It is likely this would have been in April 2019. Mr E did not receive his CT scan results until 24 June 2019. He was given a diagnosis in July 2019.
74. Now we know that Mr E would have been referred onto a cancer pathway sooner, we took advice from a haematologist to understand what impact the delay in investigations had on Mr E.
75. Our haematology adviser says this is a difficult case as it is not possible to say with certainty what would or would not have happened on exact dates. There is very limited information from the Trust and sparse medical notes, which makes it hard to understand exactly what was happening and when.
76. If the Trust had started investigations in March 2019, there is a possibility the outcome could have been different for Mr E, as there are factors that can impact on the stage of the lymphoma. Some of these factors would not have changed anything, such as a person’s age or gender. However, some factors can make a difference, such as the characteristics of the disease, how advanced the disease is, and an overall prognosis.
77. This means an earlier diagnosis can result in treatment which is more effective, leading to a better chance of remission and overall survival.
78. Our haematology adviser could not quantify at what stage things might or might not have been different. There is a possibility that Mr E’s disease would have been less advanced if investigations had been started sooner. If a disease is less advanced a person may need less advanced, and fewer cycles of, treatment and a person’s chances of going into remission are better.
79. Equally, an earlier diagnosis may not have made a difference to Mr E’s overall prognosis and treatment. It is not possible to determine how long Mr E had lymphoma for or how quickly it did or did not progress.
80. Ultimately, as the Trust did not follow the NICE guidelines, we will never know what the outcome would have been if it started its investigations sooner.
81. Mr E was complaining about his symptoms, but the Trust did not pick this up at the earliest opportunity. It is clear this was a worry for him and his family when he felt the Trust was not treating or supporting him properly. Although we can never know if Mr E could have had a better prognosis, we recognise he was left not knowing if the outcome might have been different.
82. We have found a failing linking to an injustice.
83. The Trust has not acknowledged that it got this wrong. We uphold this part of the complaint. This is something we will ask the Trust to address in our recommendations section.
Communication
84. Mr E says the Trust ignored him and his GP when he was asking for help, advice, and support. As set out above, it is unclear from the records when Mr E first raised his symptoms with the Trust.
85. We recognise Mr E’s account and that he has told us he was telling the Trust from 2018 onwards about his symptoms. We cannot see anything in the gastroenterology consultations from 2018 to support this. However, the records do appear to be sparse.
86. Although the records do not note that Mr E was telling his consultant about his symptoms in 2018, we acknowledge that does not necessarily mean this did not happen.
87. On 3 June 2019, Mr E told the colorectal clinic he had lost one stone over the past nine months and felt tired with increased shortness of breath. This would date back to his concerns starting around September 2018.
88. At his review with a new gastroenterology consultant on 24 June 2019, Mr E explained that for the past 12 months or so, he had been unwell with significant weight loss, nausea, and tiredness. This would indicate Mr E’s concerns dated back to mid-2018 also.
89. Mr E went to his GP on 13 March 2019. The GP records show Mr E told his GP his weight was decreasing, and he felt like he was losing muscle mass. The records say Mr E had mentioned it to his gastroenterology consultant, but they had not done anything.
90. On the balance of probabilities, looking at the above evidence, it seems likely Mr E was mentioning his symptoms in mid to late 2018. It does not appear the consultant acknowledged or documented these concerns.
91. The General Medical Council’s (GMC) guidance, Good Medical Practice, says:
‘31 You must listen to patients, take account of their views, and respond honestly to their questions.
32 You must give patients the information they want or need to know in a way they can understand. You should make sure that arrangements are made, wherever possible, to meet patients’ language and communication needs.
33 You must be considerate to those close to the patient and be sensitive and responsive in giving them information and support.
34 When you are on duty you must be readily accessible to patients and colleagues seeking information, advice or support’.
92. We recognise it seems the Trust clinically acted within the standards and guidance during Mr E’s consultations in 2018. We have set this out in the first part of the report. However, the Trust did not act in line with the GMC guidance when communicating with Mr E.
93. We have not seen any evidence to support that the Trust was listening to Mr E’s views or were responsive to his concerns. We acknowledge it would have been frustrating and upsetting for Mr E to feel like he wasn’t being listened to when he was unwell. We have found a failing here.
94. Mr E felt like the Trust were ignoring his symptoms. Because of this he contacted his GP with his concerns. His GP wrote the Trust to ask for advice and support on Mr E’s symptoms and blood test results on 1 April 2019.
95. The GP explained Mr E presented with neck pain, feeling tired, loss of body mass and feeling generally unwell. The GP asked Mr E’s consultant at the Trust for advice on the next steps for Mr E’s lower gastrointestinal investigations. The GP asked if Mr E’s deranged (abnormal) blood tests could be accounted for by his colitis.
96. The records show the GP also faxed a letter to the consultant on 5 April 2019. The GP telephoned the consultant’s secretary on 12 April 2019 to chase it up. The evidence shows the secretary confirmed the Trust received the fax.
97. Mr E went back to his GP on 26 April 2019. The records show neither Mr E nor his GP had a response from the Trust. The GP assessed Mr E and decided to wait for the Trust’s input, as he was already under their service in secondary care. The GP planned to wait for the consultant’s review for their advice and next steps.
98. The GP called the consultant’s secretary again on 7 and 14 May 2019 and left a message asking for a call back. The secretary returned the call on 17 May 2019 to confirm the consultant was leaving and Mr E was on a waiting list.
99. Mr E attended his GP again on 24 May 2019. He was very concerned about his health and had still not heard from the Trust. The records show Mr E told the GP he felt his health was getting steadily worse.
100. As the GP could not get a response from the Trust via the normal routes, and given Mr E’s symptoms, he referred Mr E to the two-week wait (suspected cancer) colorectal clinic. He also arranged for urgent repeat blood tests and a follow up GP review.
101. Mr E and his GP did not hear anything from the Trust following the GP’s correspondence. In its complaint response, the Trust said it received the fax and printed it out for the consultant to review. The Trust cannot confirm when the consultant reviewed the GP’s letter. However, the Trust says this review happened prior to the consultant leaving the Trust on 17 May 2019.
102. The Trust says the consultant had ticked the GP’s letter and written ‘OK’ on it. It says this means Mr E’s results were seen to be satisfactory and the Trust didn’t need to take any further action.
103. We have not seen any evidence to show the Trust communicated this information with Mr E or his GP. Mr E and his GP sought advice from the Trust, and it did not respond.
104. The GMC guidance says:
‘15 You must provide a good standard of practice and care. If you assess, diagnose or treat patients, you must: a) adequately assess the patient’s conditions, taking account of their history (including the symptoms and psychological, spiritual, social and cultural factors), their views and values; where necessary, examine the patient b) promptly provide or arrange suitable advice, investigations or treatment where necessary c) refer a patient to another practitioner when this serves the patient’s needs’.
105. The evidence shows Mr E’s history and symptoms were not documented, or listened to, from approximately the middle of September 2018. The Trust also did not respond to when Mr E’s GP sought advice and support. This is not line with the GMC guidance and there is a failing here.
Impact
106. Mr E has told us how difficult it was for him and his family when he was reaching out for support, and he felt ignored. Mr E says he felt like he was dying but he could not get help from anyone.
107. On a balance of probabilities, it appears Mr E was reaching out about his symptoms for around one year before he was acknowledged. He says this was a year of physical and mental distress as he did not know what to do.
108. Mr E had to continually return to his GP in early 2019 and his GP considered admitting him to hospital. This has clearly been an extremely difficult time for Mr E and his family.
109. The Trust said it offers its apologies for the lack of contact. We can see the Trust has acknowledged that it did not correspond with Mr E’s GP in April 2019. However, the Trust has not acknowledged and apologised for the impact this had on Mr E.
110. We have found that the Trust’s actions had an emotional impact on Mr E for around one year. We uphold this part of the complaint. This is something we will ask the Trust to address in our recommendations section.
Record keeping
111. Mr E has concerns about the Trust’s record keeping. He says he was not provided with all the available records. He said he had a lot of trouble trying to access information from the Trust and feels it has been uncooperative. He is concerned the Trust has been reluctant to provide the relevant evidence throughout his complaint.
112. We also had difficulty in obtaining the records from the Trust. The Trust has accepted some of the records are missing, and we had to proceed without this information. Both clinical advisers have commented that the Trust’s record keeping was poor in this case. The advisers have said the missing records made it difficult to understand what was happening at different points.
113. The GMC guidance says:
‘Documents you 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.’ It also says that clinical records should include:
• relevant clinical findings • the decisions made and actions agreed, and who is making the decisions and agreeing the actions • the information given to patients • any drugs prescribed or other investigation or treatment • who is making the record and when.
114. The documents the Trust provided us with were sparse. There are limited records available from Mr E’s consultations. The Trust has acknowledged there are missing records it cannot provide us with. This is not in line with the GMC’s guidance, and we have found a failing with the Trust’s record keeping.
Impact
115. Mr E has told us how concerned he is that the records are poor, and that some records are missing. He says he feels like the Trust have not wanted to help him with his requests and this has been stressful.
116. We recognise the lack of documentation about Mr E’s consultations will have caused him to have concerns. If the appropriate documentation had been available, our advisers may have known more about the consultations. We uphold this part of the complaint. We will ask the Trust to address this below.