23. We have carefully considered the evidence from Mrs I’s chest X-rays from 2016 onwards alongside the relevant standards. We will first set out what should have happened in Mrs I’s case.
24. Our radiology adviser says abnormalities that turn out to be cancerous can be very faint and hard to read on a chest X-ray. An X-ray is not as sensitive as a CT scan when detecting small abnormalities. Some areas, such as the lung behind a rib, are difficult to assess because of overlapping density.
25. It is possible that a lung density looks to be cancerous because of its outline, but other lung densities may look like they are benign. Because of this, radiologists must use other factors than just appearance alone when considering if a lesion is suspicious for cancer. A radiologist must also consider things such as rapid growth, a history of smoking and coughing up blood.
26. The Royal College of Radiologists standards for interpretation and reporting set out the kinds of clinical information radiologists should keep in mind when reporting on a scan and assessing abnormalities.
27. The standards explain when an abnormality is seen a radiologist should evaluate its characteristics such as shape, contour, density, pattern, and intensity. This enables them to formulate an opinion on whether there is an active pathological process present, or if the scan is within the range of normal appearances.
28. The standards say: ‘Imaging abnormalities should be correlated with other factors, for example age, sex, past medical history, current clinical presentation and medication, to determine the significance of the imaging findings’.
29. If a patient has a chest X-ray finding that suggests lung cancer or are aged 40 or over with unexplained haematosis (coughing up blood), the NICE guidance recommends a patient is referred using a suspected cancer pathway referral for an appointment for lung cancer within two weeks.
30. The NICE guidance says:
‘1.1 Lung and pleural cancers
Lung cancer
1.1.1 Refer people using a suspected cancer pathway referral (for an appointment within 2 weeks) for lung cancer if they: · have chest X-ray findings that suggest lung cancer or · are aged 40 and over with unexplained haemoptysis. [2015] 1.1.2 Offer an urgent chest X-ray (to be performed within 2 weeks) to assess for lung cancer in people aged 40 and over if they have 2 or more of the following unexplained symptoms, or if they have ever smoked and have 1 or more of the following unexplained symptoms: · cough · fatigue · shortness of breath · chest pain · weight loss · appetite loss.
1.1.3 Consider an urgent chest X-ray (to be performed within 2 weeks) to assess for lung cancer in people aged 40 and over with any of the following: · persistent or recurrent chest infection · finger clubbing · supraclavicular lymphadenopathy or persistent cervical lymphadenopathy · chest signs consistent with lung cancer · thrombocytosis’.
31. Under the two-week pathway a patient would have a rapid assessment by a respiratory unit, a CT scan, and other diagnostic tests to confirm a cancer diagnosis.
32. Our radiology adviser says with a retrospective review of a scan, there is a hindsight bias, as you are alerted to a possible missed diagnosis and search for it. They explained this should be taken into account to make a fair and reasonable assessment.
33. We have reviewed each of Mrs I’s chest X-rays from 2016 to March 2018. We will set out if we consider whether what happened was in line with what should have happened.
Left lung
18 February 2016
34. Mrs I’s GP referred her for a chest X-ray at the Trust to check for possible rib fractures after a fall. She says there were signs of lung cancer on the X-ray at this stage, that the Trust missed.
35. The Trust did not report signs of any abnormality at the time in 2016. In its complaint response dated 16 January 2019, it says the X-ray shows a nodule in the left lung. It did not think cancer was present at this stage.
36. We reviewed the X-ray, and our radiology adviser can see there was a subtle opacity (an area that appears opaquer and darker) in Mrs I’s left lung. We think this could have represented a lung cancer nodule.
37. There was no mention of possible lung cancer at this stage, and it is not something the radiologist was looking for. Our radiology adviser told us the area of opacity was only just visible. This means the finding was not significant enough for the radiologist to mention as an incidental finding.
38. The Trust’s report of the X-ray focused on the signs of trauma and did not mention this abnormal area. It is important to note the purpose of the scan was to look for trauma after a fall, not because lung cancer was suspected. This means the report took into account Mrs I’s presenting problem, and this is in line with the Royal College of Radiologists standards.
39. Overall, we think the opacity was minor and not of great concern, and the Trust’s report appropriately focused on Mrs I’s presenting problem. This means there is no failing here.
22 December 2016
40. Mrs I’s GP referred her to the Trust for a second chest X-ray as she was presenting with a persistent cough and a history of smoking. These are symptoms the NICE guidance says could be a sign of cancer.
41. Mrs I says she was complaining of symptoms of lung cancer such as a cough, breathlessness, fatigue, and a poor appetite. Mrs I was concerned about her health and says the X-rays show her cancer was missed.
42. In its investigation of the complaint the Trust did not find that it missed cancer at this stage. It agreed there was a nodule on the left lung but that it was stable at the time. The X-ray report says Mrs I had a cough for six weeks, poor appetite and reduced breath. The Trust reported that there was no significant abnormality seen on this scan.
43. We have reviewed the evidence and have found the nodule was not stable. We compared the evidence from this X-ray with the previous one and found the same nodule was present and it had grown in size.
44. The Trust did not note this at the time, and it did not mention this in its report of the scan.
45. The purpose of the scan was to investigate the cause of Mrs I’s symptoms. Because of this and Mrs I’s clinical history of a cough and smoking, the radiologist should have been prompted to search for signs of lung cancer.
46. The radiologist should have detected the small abnormality on the X-ray as being a sign of possible cancer. The radiologist should have started a referral to the pathway in line with the NICE guidance at this point in December 2016.
47. The Trust made a mistake when it said the scan was normal. It did not act in line with the NICE and RCR guidelines. This is a failing. We will go on to consider the impact of this later in the report.
25 September 2017
48. Mrs I’s GP referred her for another chest X-ray at the Trust on this date as she presented with a cough for ten months, was tired and breathless.
49. Mrs I says she had continuing symptoms at this time and had expressed her concerns to her GP. Mrs I says the Trust contradicted itself when it reported on this X-ray. It acknowledged she had a nodule which was present since February 2016, but it had not mentioned this nodule at her X-ray in December 2016.
50. The Trust radiologist reported a 9mm nodule on the left lung which had been present since February 2016 but was new since the X-ray in 2013. The Trust radiologist said it was likely this nodule was benign and arranged a follow up for six months’ time.
51. The evidence shows us the nodule the Trust saw on 25 September was the same one that was present on the February 2016 and December 2016 X-rays. Although this had been present on previous scans, it was a new finding from 2013 that had not been followed up on yet.
52. We think the Trust made a mistake when it said the nodule was benign. This was unlikely given Mrs I’s presentation of symptoms listed in the NICE guidance.
53. Our radiology adviser says when a radiologist has seen a new abnormality in the lung in a patient with a cough and history of smoking, they should be suspicious the abnormality could be a cancer and initiate a referral to investigate further.
54. Given Mrs I’s symptoms, the Trust should have been suspicious of lung cancer at this point and made a referral for the two-week cancer pathway in line with the NICE guidance. The Trust did not do this, and we think there is a failing here.
8 March 2018
55. The Trust arranged a follow up X-ray for Mrs I on 8 March 2018. Mrs I was still complaining of symptoms of a persistent cough, breathlessness, and fatigue.
56. The Trust radiologist said there was a nodule present in the left lung. The Trust radiologist observed the nodule had grown to 14mm and that it had been present since 2016. It said the nodule was likely to be benign and there were no new lesions. The Trust did not take any further action on this X-ray.
57. Mrs I says she returned to the GP because of her breathlessness and symptoms after this X-ray. A locum GP referred her on a 2-week cancer pathway as a result. She feels the Trust should have acted on this X-ray.
58. The records show Mrs I was presenting with a cough, had a history of smoking and the nodule had grown from the previous scan. The Trust should have initiated a 2-week referral here in line with the NICE guidance. The Trust did not do this and there is a failing here.
Right lung
59. Mrs I complains that the Trust did not identify the nodule on her right lung at any of the above appointments when it should have done.
60. The Trust says the right nodule was not visible on any of the chest X-rays performed from 2016 to 2018.
61. Our review of the evidence confirms the nodule on her right lung was not visible on the X-rays. This appears to be because of the type and position of the lesion. Based on the clinical picture the Trust had at the time (which was the findings from the chest X-rays) there are no reasons to suggest it should have diagnosed the right lesion from the chest X-rays. We have not found a failing here.
62. Our radiology and cardiothoracic advisers say we cannot know when the lesion on the right lung appeared as it is not visible on the X-rays between December 2016 and March 2018.
63. Although we have not seen a failing here, we recognise that if the Trust had taken a different action in response to the nodule in Mrs I’s left lung, it might have seen the right lung nodule when carrying out the NICE cancer pathway and follow up tests. We will explore this as part of our consideration of the impact of the Trust’s failings regarding the management of Mrs I’s left lung.
Impact of the Trusts management of Mrs I’s left lung
64. Having considered Mrs I’s X-rays, we consider the Trust missed signs that she might have had cancer. It should have identified the nodule in Mrs I’s left lung from December 2016 onwards as being possible cancer, and it should have referred her onto the 2-week pathway then. There were two further opportunities for it to do this on 25 September 2017 and 8 March 2018.
65. We have looked at the impact this had on Mrs I’s overall condition and we looked at what would have been different if the failings had not occurred. As part of this we considered the possibility the Trust could have picked up the right lung nodule. We took advice from a cardiothoracic surgeon to help with this.
66. Mrs I went on to have a further X-ray on 29 March 2018. Following a lung MDT at the Trust on 31 May 2018 the Trust identified lesions on the left and right lung. Mrs I had to have her right lung lobe and lymph nodes removed, and a resection of her left lung on 3 July 2018.
67. Mrs I feels this could have been avoided if the Trust had acted on her X-ray results sooner. She feels the delays caused by the Trust may have impacted on her life expectancy and have impacted her current physical health, as she is often breathless.
68. 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 first considered whether Mrs I’s cancer would have been diagnosed sooner if the Trust had taken the right action following the X-ray on 22 December 2016.
69. If the Trust had identified the left nodule on the X-ray on 22 December 2016, the next step would have been to put Mrs I on the 2-week lung cancer pathway. She would have had a CT scan and PET scan to look at the nodule, as recommended in section 1.3.4 of the NICE lung cancer guidelines.
70. The nodule on the left side of Mrs I’s lung at the PET scan on 4 May 2018 presented as a cold nodule (this means its trace on the X-ray made it look less likely to be cancerous). Therefore, the results of Mrs I’s actual PET scan in 2018 were not suggestive of cancer at the time.
71. Our cardiothoracic adviser says if a nodule is cold on a PET scan, the suspicion of malignancy (cancer) goes down. If a cold nodule is seen a patient would undergo further investigations and an interval scan within three to six months.
72. They explained that as this nodule was cold on the scan in 2018, it is more likely than not this would have been cold on a PET scan at an earlier point in time. It is likely an earlier PET scan would indicate the lesion was unlikely to be cancer. Therefore, the Trust would next have followed up with an interval CT scan.
73. Our cardiothoracic adviser says it is more likely than not Mrs I would not have been diagnosed with cancer at this stage around January 2017. Instead, the Trust would have monitored her and carried out an interval CT scan.
74. The pulmonary nodule guidelines indicate the interval scan would have taken place three to six months from the date of Mrs I’s X-ray on 22 December 2016.
75. This means Mrs I would have likely had an interval scan between March 2017 and June 2017 in line with the timescales set out in the guidance. The evidence we have seen suggests the interval scan is likely to have shown the nodule had grown in size. This would have warranted a referral to the surgical team or a biopsy.
76. We think that if the Trust had referred her to the surgical team or done a biopsy between March and June 2017, she would have still needed surgery. Our thinking is that she would have likely had surgery approximately around September 2017 (in accordance with the timescales set out in the NICE guidance). Mrs I did not have surgery until July 2018, and this is a delay of around 10 months.
77. Now we know that Mrs I would have been able to have surgery sooner than she did (around September 2017), we have considered what type of surgery she would have needed and to what extent. To do this we have taken into account the surgery Mrs I actually had in July 2018 and that she was eventually found to have cancer both in the left and right lung.
78. As explained in paragraphs 60 – 64 of the report, we cannot know when the right lung nodule was first present as it is not visible on the X-rays due to its position. For this reason, we have considered the two potential scenarios: · Option 1 – what would have happened if Mrs I’s right lesion was not yet present at the time the left nodule was identified and removed (around September 2017) · Option 2 – what would have happened if the right lesion was present at the time the left nodule was identified and removed (around September 2017)
Option 1 – right lesion was not present
79. If Mrs I went on to have surgery on the left side around September 2017, our adviser has considered what would have happened if the right nodule was not there at that point in time.
80. Our cardiothoracic adviser says examinations would have shown Mrs I had a carcinoma (cancer) in the left upper lobe. They explained it is likely at this point in time Mrs I would have needed a left upper lobectomy. This means removing at least half (or more) of her left lung.
81. If the lesion on the right had not presented at that point when Mrs I would have had surgery, it is likely Mrs I would have had more of her lung removed on the left side than she actually did when she had surgery in July 2018.
82. This is because it is likely she would have had her left upper lobe removed based on the clinical picture at that time and in line with the NICE guidelines. In July 2018 Mrs I had a resection of the left lung. This is where a wedge is taken instead of half.
83. The Trust would then have followed up with surgery on the left side with CT scans and eventually identified the lesion on the right side at some point in time. We know this as we know the right lesion was present by July 2018. Mrs I would then have needed a second surgery on the right side of her lung.
84. If the cancers were identified at two separate times Mrs I would have needed an upper lobectomy on the left (taking out more lung/half left lung) rather than just a small wedge section.
85. This is because the Trust would not have known there was a lesion on the right. The Trust therefore would not have decided to conservatively manage the left given the picture on the right, like it did in July 2018.
86. If Mrs I had a left upper lobectomy removing half or more of her lung, this would have had a negative impact on her quality of life, as she would have been more breathless than she is now.
87. Later down the line Mrs I would also have needed a second surgery at a separate time when the right lesion appeared. She would have needed the same amount of lung removed on the right side as in July 2018. This is due to the presentation of the lesion. Mrs I would possibly have already lost more of her left lung from the earlier surgery.
88. This means that whilst we recognise there was a ten month delay in Mrs I having surgery, we cannot see this led to the clinical impact Mrs I claims. Our advice indicates she would always have needed the same if not more invasive surgery.
Option 2 – right lesion was present
89. Our adviser has considered on a balance of probabilities what type of treatment Mrs I would have needed based on if the right nodule was present if the Trust had started its investigations in December 2016.
90. If the right lesion was present, we can see Mrs I would have had earlier surgery than she did. Our cardiothoracic adviser says the clinical picture shows it is likely Mrs I would have undergone the exact same surgery she had in July 2018. However, she would have had this around September 2017. This is a delay of ten months.
91. We can see Mrs I would have been able to have the surgery at an earlier point in time, but the treatment would have remained the same.
92. Our cardiothoracic adviser says that on a balance of probabilities, the type of treatment Mrs I needed was not impacted by the Trust’s failure to identify her cancer in December 2016 or 2017. They explained she would have needed the same procedure regardless.
93. As Mrs I would have needed the same, if not more, of her lung removing, our cardiothoracic adviser says the delay in treatment would not have impacted on her physical health such as her breathlessness. However, under option 1, there is a chance Mrs I would have been left even more breathless if she had needed two surgeries and lost more of her left lung.
94. Our cardiothoracic adviser says with a wedge resection (which is what she had in 2018) there is a slightly increased risk of local reoccurrence. Lung cancer is most likely to reoccur within the first two years after surgery. It has been over two and a half years since Mrs I had her surgery. She has not seen a reoccurrence in her cancer within this timeframe. Our surgical adviser says that if a lung cancer is going to recur, it is more likely to do so in the first two years after surgery of lung cancers.
95. This is not to take away how distressing it must have been for Mrs I when she was presenting with symptoms consistent with lung cancer, but the Trust did not act on this. She says it was extremely distressing when she was presenting at the Trust unwell. It knew she had symptoms but did not act on these. Mrs I felt like she had to push for her symptoms to be taken seriously and acted on.
96. The Trust also did not correctly report on her X-rays. It is understandable this must have been a really difficult time for her. Mrs I did lose the opportunity to have her diagnosis and surgery sooner than she did.
97. Although Mrs I was fortunate to not have suffered any detriment in terms of her prognosis and treatment outcome because of the Trust’s actions, the Trust indicated failings could have had a more serious impact in a different set of circumstances.
98. The nature of Mrs I’s cancer in this case meant the delayed diagnosis gave the Trust a full clinical picture. This meant it could decide to conservatively manage the left side of her lung, as it was taking a large amount of the right. The circumstances in this case meant Mrs I needed less surgery than she may have needed otherwise. In another set of circumstances or another patient the outcome might have been different.
99. We consider this to be significant and the Trust has not acknowledged that it got anything wrong at any point. Although we think the Trust’s failings had no clinical impact on Mrs I’s outcome or prognosis, we recognise it was serious. We therefore partly uphold this part of the complaint. This is something we will ask the Trust to address in our recommendations section.