The Trust should have completed a biopsy sooner than it did on 18 June 2019
20. Mrs A said they were told by a doctor at the Trust as early as 11 September 2018 that tests had indicated Mr A had possible mesothelioma cancer likely due to his background of working with asbestos. Mrs A says despite this the Trust did not conduct a biopsy to confirm this possible diagnosis until 18 June 2019.
21. NICE NG12 says for suspected mesothelioma, to offer a chest and urgent X-ray (to be done within two weeks) in people aged 40 and over, if:
• (1.1.5) they have one or more of the following unexplained symptoms and have been exposed to asbestos:
• cough • fatigue • shortness of breath • chest pain • weight loss, or • appetite loss.
NICE NG12 goes on to say (1.16.2) ‘Discussion with a specialist […] should be considered if there is uncertainty about the interpretation of symptoms and signs, and whether a referral is needed’.
22. Mr A was admitted to the Trust between 6 and 14 September 2018 with chest pain when walking, dull right flank pain and shortness of breath.
23. The Trust conducted an ultrasound scan of Mr A’s abdomen and a right-side chest Xray. The Trust admitted Mr A and treated him with antibiotics for a working diagnosis of pneumonia and pleural effusion (the body naturally produces a small amount of pleural fluid that lubricates the space between the lung and chest wall, the build-up of fluid in the space between the lung and chest wall is known as an effusion).
24. There are several tests to help doctors determine malignancy. These include a physical examination, blood tests, X-ray, CT scan (computer tomography scan), removing and testing individual cells by extracting some of the fluid in the cavity between the lung and chest (cytology), or by removing and testing a block of tissue (histology) from the same area through a biopsy.
25. The Trust inserted a chest drain to start removing excess fluid that had collected around Mr A’s lung. It sent this fluid for testing.
26. The fluid tested negative for malignancy (the presence of cancer). The Trust said there were high infection markers and the CT scan had shown Mr A had calcified right side pleural plaques (deposits in the lungs that are often asymptomatic (no symptoms) but are signs of asbestos exposure, over time they can lead to asbestos-related malignancies) and a shallow pneumothorax.
27. The Trust conducted further tests on 10 September 2018. A CT thorax, abdomen and pelvis (an imaging method that uses X-rays to create cross-sectional pictures of the chest and upper abdomen) reported pleural plaques, atelectasis (scarring), and no effusion (possibly because this was removed via the drain).
28. The Trust diagnosed Mr A with empyema and a right-sided pleural effusion. The most common causes for pleural effusion are congestive heart failure, cancer, pneumonia and pulmonary embolism.
29. On 11 September 2018 the Trust removed the chest drain and said initial cytology was negative for malignancy but suspicious of it. The Trust noted it discussed this with Mr A and Mrs A before his discharge on 14 September 2018. The Trust said it would hold a lung multidisciplinary team meeting (MDT) to discuss Mr A’s management.
30. The Trust MDT on 17 September 2018 agreed initial cytology was suspicious and possibly indicated a malignant pleural effusion, however Mr A did not have enough pleural fluid for a biopsy at that time. The Trust requested repeat imaging in six weeks to see if the pleural fluid had reaccumulated enough for a VATS biopsy (video assisted thorascopic surgery to remove some tissue for histology testing from the concerned area).
31. The BTS ‘Pleural disease guideline’ says that in many cases where patients have a pleural effusion no specific diagnosis can be made, and not all of these turn into malignancy. Watchful waiting may be the appropriate management. This is what the Trust was doing in its early management of Mr A’s pleural effusion.
32. This guidance also talks about benign asbestos pleural effusions. It says ‘the effusion is usually small and asymptomatic […] There is a propensity for the effusion to resolve itself within 6 months, leaving behind residual diffuse pleural thickening. As there are no definitive tests, the diagnosis can only be made with certainty after a prolonged period of follow-up and consideration should be given to early thoracoscopy with pleural biopsy in any patient with a pleural effusion and a history of asbestos exposure, particularly in the presence of chest pain’.
33. On 21 September 2018 Mr A attended a respiratory clinic at the Trust. It requested a repeat CT scan as per the MDT care plan discussed on 17 September 2018.
34. Our respiratory adviser said the Trust’s actions thus far were in line with the guidance identified above. Diagnostic pleural aspiration, CT scan and cytology were appropriate tests to try to diagnose Mr A’s symptoms. When the fluid sample collected did not provide a diagnosis, and was suggestive of empyema, the Trust discussed Mr A’s case with specialists and decided to bring Mr A back in three months time for a review.
35. To summarise the Trust’s actions so far, it did consider a biopsy after early suspicions of malignancy but there was not enough fluid to test. It planned to bring Mr A back in six weeks to reassess him. It began a period of following-up Mr A in line with the guidance above. We find no failings up to this point.
36. On 28 September 2018 the Trust got some further results from the cytology testing which also suggested Mr A had empyema.
37. Between 4 October 2018 and 17 October 2018 Mr A was admitted to the Trust with chest pain. The Trust diagnosed Mr A with, and treated him for, acute myocardial infarction (a heart attack).
38. The Trust conducted a CT scan of his heart during Mr A’s admission which showed he had a stable right pleural effusion with adjacent pleural thickening (when scar tissue thickens the lining around the lungs) and pleural plaques.
39. On 29 October 2018 Mr A returned to the Trust for his follow-up scan as per the Trust MDT instructions from September 2018. On 12 November 2018 Mr A attended a respiratory clinic at the Trust for a further scan. On 14 November 2018 the Trust held an MDT meeting to review the further investigations.
40. The repeat scans showed no significant change in Mr A’s right-sided minimal pleural effusion. The Trust said Mr A’s weight was stable, he reported no new symptoms, and there was no other evidence of unwellness. The Trust said there was no new evidence of disease activity, and it made no recommendation for a biopsy. The Trust arranged for a further follow up review for Mr A in three months’ time (by February 2019).
41. Our respiratory adviser said a biopsy was not indicated after the October scans or November respiratory clinic review. The supplementary fluid cytology report was reassuring and there were no progressive changes on the CT scans. The pleural thickening was present going back to July and the MDT had already deemed that it was too small to safely biopsy. The plan for ongoing radiological follow-up was appropriate.
42. On 11 February 2019 Mr A returned to the Trust for a chest X-ray. The Trust reviewed the results on 15 February 2019 and said that, compared to Mr A’s 2018 scans, the pleural effusion remained stable, Mr A’s weight had gone up and, though he was occasionally breathless, this was likely due to a recent increase in his weight. The Trust said in there were still no signs to indicate disease activity. The Trust said it would review Mr A in three months’ time (around May 2019).
43. At this stage the Trust was still ‘watchful waiting’. There had been no change in Mr A’s pleural effusion and his weight had increased. Given the broadly unchanged position the Trust was still acting in line with the guidance set out above. There is no indication the Trust needed to make a referral for a biopsy here.
44. On 2 April 2019 Mr A returned to the Trust for a chest X-ray. The Trust reported findings on 3 April 2019 and said the results correlated with the X-ray taken in February 2019 and there were no significant changes.
45. On 10 April 2019 Mr A returned to the Trust with chest pain. The Trust performed a CT scan. The Trust diagnosed Mr A with a right medium-sized pneumothorax and trapped lung (the inability of the lung to expand and fill because of a fibrinous pleural layer that stops normal movement between the lung and chest wall) with no malignancy seen. The CT scan, compared to previous scans, showed no new changes to Mr A’s pleural effusion.
46. That said, the Trust arranged to see Mr A on 25 April 2019 for a discussion about his recent presentation. The Trust said Mr A had shown additional worrying signs in his most recent attendance on 10 April 2019. It said the pneumothorax and a trapped lung, and reported weight loss, was different to his prior presentations.
47. The Trust said that although there remained no significant change in Mr A’s pleural effusion from his most recent scans compared with his previous scans, it would refer him for a biopsy and lung decortication (a surgical procedure to cut away the fibrinous pleural layer to allow the lung to expand).
48. NICE Guideline ‘Diagnosis and treatment of lung cancer’ is relevant here. The guidance says to offer urgent referral for chest radiography when a patient presents with:
• any of the following unexplained or persistent (lasting more than three weeks) symptoms or signs: cough, chest or shoulder pain, dyspnoea, hoarseness, weight loss, chest signs, finger clubbing.
49. When Mr A presented with some of these features previously from September 2018 to February 2019 (shortness of breath and chest pain) the Trust arranged for chest scans and repeat follow-ups (as described above).
50. BTS Guidance on the Investigation and Management of Pleural Mesothelioma says that when a patient presents with a malignant pleural effusion breathlessness is a common symptom. It says that other symptoms, such as fever, chills, fatigue, weakness and weight loss may be prominent.
51. When Mr A presented with new features in April 2019 (the trapped lung and weight loss) the Trust began considering a malignant pleural effusion and started the biopsy referral process at Mr A’s clinic follow-up on 25 April 2019.
52. On 8 May 2019 the Trust referred Mr A for a lung function test. On 13 May 2019 the Trust respiratory team referred Mr A for a VATS biopsy due to persistent chronic right pleural effusion with a trapped lung.
53. On 17 May 2019 the Trust performed a lung function test on Mr A. The results showed a reduction in his lung function compared to tests in September 2018.
54. On 3 June 2019 Mr A went to the Trust for a pre-biopsy admission assessment. The Trust performed the biopsy and decortication on Mr A on 18 June 2019. The Trust sent samples for histopathology (testing of blocks of tissue taken from the affected area).
55. The test results were reported on 17 July 2019. The histopathology results sadly revealed Mr A had mesothelioma.
56. Sadly, Mr A was not well and had to attend hospital on many occasions between September 2018 and June 2019. When we looked at each of these, the evidence showed the Trust appropriately assessed and investigated Mr A’s presentations and his need for a biopsy in line with guidance. When Mr A’s clinical picture suggested the need for a biopsy, the Trust arranged this. We find no failing here. We hope Mrs A takes some reassurance from knowing the Trust did not delay arranging a biopsy.
The Trust should have told the family Mr A had mesothelioma, and about his prognosis, sooner than it did on 19 July 2019
57. The GMC guidance says doctors must give patients the information they want or need to know in a way they can understand.
58. The NHS website says for biopsies ‘Results are often available within a few days. But this is difficult to predict, because further tests may be needed after the first examination of the sample’.
59. Mr A had his biopsy on 18 June 2019. The results were available on 17 July 2019. Before the Trust could confirm a diagnosis, it held a lung MDT on 19 July 2019 (Mrs A said this was postponed from 12 July 2019) where clinicians agreed Mr A’s diagnosis and prognosis. The Trust told Mr and Mrs A the same day.
60. Sadly, Mr A died on 29 July 2019, ten days later. We acknowledge Mrs A was incredibly upset by the very quick way these devastating events unfolded. There was clearly very little time between learning of Mr A’s prognosis and him dying. This would have left Mr A and his family very little time to prepare. We are sorry to hear how quickly Mr A declined.
61. We find no delay in telling Mr A his diagnosis and prognosis. The Trust told Mr A and Mrs A about his diagnosis and prognosis the same day that it confirmed this at the MDT on 19 July 2019. That was in line with the GMC guidance. We do not think the Trust could have told Mr A and Mrs A results of the biopsy any sooner than it did.
The Trust did not appropriately address Michael’s shoulder pain, despite making nurses aware of this from admission on 17 June to 23 July 2019
62. Mrs A said Mr A had excruciating pain in his shoulder and the Trust did nothing about it despite she and Mr A often complaining about it during his admission.
63. Mr A’s clinical records for his admission show only two recordings of shoulder pain.
64. The first time the Trust noted shoulder pain was on 20 June 2019. The medical note says, ‘Oral analgesia was prescribed as indicated’. The Trust gave Mr A codeine (a strong painkiller).
65. The second time, on 29 June 2019, the nursing and ward round noted Mr A complained of shoulder pain at night. The note said no pain relief prescribed yet, but that the nurses were waiting for a doctor to prescribe pain relief.
66. The drug charts show Mr A received paracetamol and codeine between 30 June and 3 July 2019. The Trust also gave him two doses of liquid morphine on 1 July 2019.
67. The notes refer to neck pain on several occasions but there is no further note of shoulder pain or shoulder pain management in Mr A’s records.
68. We have conflicting evidence here. Mrs A says Mr A complained often of shoulder pain. The clinical records show Mr A was being regularly assessed and observed by the Trust (daily physiotherapy assessments and ward rounds). We can see no other specific complaints of shoulder pain or details of this in Mr A’s clinical records. There were no spikes in his pain charts or drug charts which would indicate treatment of a problem. The drug charts do not reflect high pain medication usage. The daily physiotherapy notes do not note any shoulder issues.
69. Our nurse adviser said that if Mr A was suffering consistent and persistent pain the drug charts should reflect higher amounts of pain relief. We see no evidence of this in Mr A’s pain or drug charts.
70. NICE clinical knowledge summary, ‘Analgesia – mild to moderate pain, Scenario: Choice of analgesic’ provides a stepwise approach to managing mild to moderate pain in adults. The evidence we have seen indicates the Trust’s prescribing for shoulder pain was in line with steps 1 to 5. The Trust gave Mr A paracetamol and codeine. The Trust also gave Mr A liquid morphine (a stronger opioid painkiller) on 1 July 2019.
71. In summary, the clinical record shows that when Mr A complained of shoulder pain the Trust gave him pain relief. We have no way of reconciling the conflicting account Mrs A gave that he complained of shoulder pain more often than that. The Trust did also give Mr A regular daily pain relief even where that was not specifically in response to shoulder pain. We do not find a failing here. In making that finding we are not saying Mr A was never in pain. We know that must have been extremely difficult for Mrs A at what was already a very distressing time.
The Trust did not properly meet Mr A’s nutritional needs between 17 June 2019 and 23 July 2019
72. Mrs A says Mr A had difficulty eating and swallowing during his admission, and the Trust should have done more to ensure Mr A was receiving adequate nutrition. She says this could have prevented the speed of Mr A’s deterioration whilst an inpatient at the Trust.
73. Section 1.5 of NICE CG 32 talks about monitoring of nutrition support in hospital. It says:
• ‘1.5.1 Healthcare professionals should review the indications, route, risks, benefits and goals of nutrition support at regular intervals. The time between reviews depends on the patient, care setting and duration of nutrition support. Intervals may increase as the patient is stabilised on nutrition support.
and, • 1.5.2 People having nutrition support in hospital should be monitored by healthcare professionals with the relevant skills and training in nutritional monitoring.’
74. The Trust operated on Mr A on 18 June 2019. Post-operatively Mr A’s nutritional intake declined, and he had problems swallowing and keeping his food down.
75. The Trust recorded Mr A’s weight five times during this admission. On 17 June 2019 the Trust recorded Mr A’s weight as 88.4kg, on 26 June 2019 it was 86.6kg, on 1 July it was 86.6kg, on 5 July it was 87kg, and on 17 July it had dropped significantly to 78.5kg.
76. From 26 June 2019 the Trust involved dieticians, speech and language therapists (SALT), gastroenterology specialists and nutritional clinical nurse specialists who reviewed and assessed Mr A’s eating and drinking. The Trust used a Malnutrition Universal Screening Tool (MUST - a five-step screening tool to identify adults, who are malnourished, or at risk of malnutrition, and includes management guidelines which can be used to develop a care plan) and food charts documenting Mr A’s intake.
77. On 27 June 2019 the Trust thought Mr A was suffering with achalasia (a disorder that makes it difficult for food and liquid to pass from the swallowing tube connecting mouth and stomach, it occurs when nerves in the oesophagus become damaged).
78. The Trust conducted a barium swallow and video fluoroscopy (scans and tests to assess swallowing function) on 27 June 2019. On 9 July it performed an endoscopy to review Mr A’s LES Function (the process by which food transits from the oesophagus to the stomach and prevents reflux of gastric contents back into the oesophagus).
79. The Trust gave Mr A Botox injections on 4 and 7 July 2019 (achalasia can be treated with muscle relaxants such as Botox) and it also gave Mr A throat strengthening exercises. The Trust conducted an oesophagogastro duodenoscopy on 9 July 2019 (OGD – involves looking at the upper part of the gut and the food pipe into the stomach).
80. The Trust actions between 17 June 2019 and 23 July 2019 were in line with NICE CG32 1.5. It ensured appropriate specialists regularly reviewed Mr A and monitored his nutrition. Daily ward round notes and nursing gastrointestinal care and evaluation notes demonstrate the Trust was monitoring Mr A’s post operative recovery, including daily nutritional observations.
81. The Trust monitored Mr A’s nutrition via dieticians and speech and language therapists, and when this did not work it escalated its concerns to its GE specialists. The Trust conducted several investigations and considered Mr A’s problem to be oesophageal related (achalasia).
82. NICE CG 32 also says nutrition support should be considered in people at risk of malnutrition who:
• have eaten little or nothing for more than 5 days and/or are likely to eat little or nothing for the next 5 days or longer, or, • have a poor absorptive capacity, and/or have high nutrient losses and/or have increased nutritional needs.
83. The records show the Trust tried to improve Mr A’s nutritional intake by giving him anti-sickness medication, different types of diet (soft and puree food), and oral calorific supplements. The Trust gave Mr A intravenous infusions to provide additional nutrition and vitamins.
84. The Trust gave Mr A nutritional support in line with the NICE guidance above. It tried giving Mr A different types of food, diets, nutritional supplements and IV infusions.
85. Section 1.3.3 of NICE QS24 says:
• ‘Healthcare professionals should consider using oral, enteral or parenteral nutrition support [feeding by tube], alone or in combination, for people who are either malnourished or at risk of malnutrition’.
86. The records show the Trust first considered inserting a nasogastric (NG) feeding tube on 28 June 2019 after the Trust considered it was unlikely to meet Mr A’s nutritional needs through oral intake alone.
87. The Trust considered dilation and fitting Mr A with an oesophageal stent on 11 July 2019 if his feeding issues continued up to 15 July 2019 (the Trust decided against this procedure after Mr A was given his poor prognosis on 19 July 2019).
88. The Trust inserted an NG Tube on 16 July 2019. Mr A did not tolerate the tube and pulled it out on 17 July 2019. The Trust reinserted the tube and Mr A’s NG feed was started on 20 July 2019. Mr A continued to have difficulty with the NG tube and his feed was stopped on 21 July 2019.
89. The Trust actions are in line with the guidance above. We can see it considered giving Mr A enteral feeding from 28 June 2019. The Trust did not insert the NG Tube until 16 July 2019. But Mr A’s weight did improve between 1 July 2019 and 5 July 2019. When Mr A began losing weight at a significant rate after 5 July 2019, the Trust then reconsidered and inserted the tube. This was in line with the above guidance.
90. NICE CG32, ‘Nutrition support for adults: oral nutrition support, enteral tube feeding and parenteral nutrition’ says medical professionals should assess, screen, try NG tube feed and then parenteral feeding.
91. Mrs A asked whether the Trust could have tried a PEG (Percutaneous endoscopic gastrostomy – where a small tube through the abdomen into the stomach is used to bypass the oesophagus and where a special formula is given through a vein to provide most of the nutrients the body needs).
92. The Trust said that on 22 July 2019 Mr A was not fit for a Stent, or further NG tube placement, or a PEG as a procedure, as they risked causing aspiration and infection. The dietician review on 23 July 2019 confirmed their opinion that a PEG was not appropriate for Mr A at this stage.
93. Deciding whether the Trust properly met Mr A’s nutritional needs was made more difficult by issues with the Trust’s record keeping. The NMC Code comments upon the need for nurses to keep clear and accurate records. Our nurse adviser said they could not find regular or consistent completion of tools, for example the MUST, and oral intake was not sufficiently recorded. They said the nutritional intake record charts from 4 to 23 July 2019 were poorly completed and did not fully document Mr A’s actual oral intake or comment upon his nutritional needs. Our nurse adviser said the notes show a risk of malnutrition however not enough of a screening tool has been applied to measure his intolerance to the NG tube and risk associated with that. We could see no body mass index measurements and, although Mr A’s weight is recorded and monitored, the chart is incomplete and there is no loss or gain recorded.
94. Despite incomplete records, we are satisfied we have enough evidence to make a finding. The evidence we have seen (detailed above) indicates the Trust regularly assessed Mr A’s nutritional needs, involved appropriate specialists, conducted investigations around Mr A’s swallowing problems and tried different types of diets. The Trust records of Mr A’s weight actually showed an increase in his weight between 1 and 5 July 2019. When the oral support did not work, and Mr A declined at a faster rate, it tried botox injections and then inserting a tube (enteral). This is very invasive and sadly Mr A did not tolerate it. The next step would have been a PEG (parenteral) however the Trust considered it not appropriate due to Mr A’s condition.
95. When we look at the Trust’s actions, we are satisfied, despite indications of poor recording, that it did try alternative methods to improve Mr A’s nutritional intake during his admission. Sadly, there was not sufficient time for the Trust to attempt parenteral/PEG feeding. There is no indication the Trust would not have tried this if Mr A was well enough and his prognosis was better. We find no failing here.
96. We were sorry to hear about Mr A’s difficulties with his nutrition. Sadly, he was very unwell at this time and despite Trust efforts this did not improve.
97. This concludes our investigation of Mrs A’s complaint. We know this has been a very difficult time for her, particularly given the very short time between Mr A’s diagnosis and his very sad death. We are grateful to her for the time and effort she has spent telling us about what happened to her husband. We know that cannot have been easy for her.