21. The initial assessment the Trust carried out on 1 November 2017 was in line with the GMC guidance. This says:
‘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 […); 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.
In providing clinical care you must: a prescribe drugs or treatment, including repeat prescriptions, only when you have adequate knowledge of the patient’s health and are satisfied that the drugs or treatment serve the patient’s needs b provide effective treatments based on the best available evidence c take all possible steps to alleviate pain and distress whether or not a cure may be possible d consult colleagues where appropriate e respect the patient’s right to seek a second opinion f check that the care or treatment you provide for each patient is compatible with any other treatments the patient is receiving […].’
22. The records show the Trust took a history of Mr H’s symptoms, carried out an examination of his lungs, and made a suggested diagnosis of postnasal drip (where mucus drips down from the back of the nose into the throat producing a cough). The Trust planned a CT scan of Mr H’s lungs and performed a lung function test.
23. The referral letter from the GP for this appointment had outlined Mr H was referred because of recurrent chest infections and a wheeze. It mentioned that an earlier scan and lung function test were normal. In light of this history and the reported symptoms, our adviser said the assessments and clinical care were all in line with the quoted GMC GMP.
24. However, the care and treatment after this point was not in line with the guidance. The CT results were reported on 26 November, and the Trust failed on several occasions to act on this.
25. The CT report outlined that there were changes of ILD within Mr H’s lung tissue. There is nothing in the records from this point on to show anyone looked at this scan report, or acted on it. The Trust appears to have overlooked the report completely and has not acknowledged this. This is not in line with the GMC guidance to ‘promptly provide or arrange suitable advice, investigations or treatment’ and ‘provide effective treatments based on the best available evidence’.
26. We would have expected the consultant to have carried out a review of all Mr H’s results (including the scan) in clinic, and to have written to the GP and Mr H with the outcome of this scan. The clinic appointment on 1 November states the consultant intended to carry out a review in three months, but this did not happen. For this reason, the care and treatment fell short of the guidance in paragraph 21.
27. The Trust next saw Mr H on 13 July 2018. This was another missed opportunity to act on the scan of November 2017. The consultant made no mention of the CT scan, but instead focused on a different CT report relating to Mr H’s sinuses. This was not in line with GMC guidance as the Trust did not take into account the history or ‘best available evidence’.
28. The consultant requested the GP arrange a barium swallow to ‘make sure there is no reflux’. A barium swallow is a test to assess swallowing ability and look for any blockages or abnormalities in the oesophagus, and reflux is the regurgitation of acid stomach contents back into the oesophagus.
29. The clinic letter of this appointment contains inaccurate information. It states Mr H’s ‘PFTs are completely normal’. This was not the case. The test results ordered by the consultant, that were completed on 3 January 2018 showed Mr H’s lungs’ ability to absorb oxygen was reduced to 70% of normal. The Trust did not assess or treat Mr H in line with the GMC guidance and did not properly interpret his lung function tests.
30. Our adviser explained that if the Trust had acted as it should have, it would have suspected Mr H had pulmonary fibrosis. There were missed opportunities to action this in November 2017 when the CT scan was reported, 3 January 2018 when the PFTs were carried out, then again on 13 July 2018 at the clinic review. Instead the respiratory service noted it would not bring him back to chest clinic, recommending the GP make a referral to the Ear Nose and Throat Clinic.
31. If the Trust had properly recognised pulmonary fibrosis it would have applied the NICE guidance CG163 to his ongoing assessment and care and treatment. This guidance says:
‘1.2.2 Diagnose idiopathic pulmonary fibrosis only with the consensus of the multidisciplinary team […] based on: • the clinical features, lung function and radiological findings […] • pathology when indicated […].’
32. CG163 also recommends regular follow up, dependent on the speed of disease progression:
‘1.6.2 Consider follow-up of people with idiopathic pulmonary fibrosis: • every 3 months or sooner if they are showing rapid disease progression or rapid deterioration of symptoms or • every 6 months or sooner if they have steadily progressing disease or • initially every 6 months if they have stable disease and then annually if they have stable disease after 1 year.’
33. We do not know how often Mr H would have been reviewed, as the Trust failed to carry out the required multidisciplinary team (MDT) meeting to diagnose the severity of his condition. This caused a missed opportunity for regular reviews.
34. Mr H attended the department of respiratory medicine again on 14 September 2018. The clinic letter gives incorrect information. It states Mr H had chronic obstructive pulmonary disease (COPD), the name for a group of lung conditions that cause breathing difficulties. Our adviser told us the PFTs had shown this to not be the case.
35. The Trust again failed to review the scan from November 2017 at this appointment. The review concentrated only on the CT scan of Mr H’s sinuses. The doctor prescribed an inhaler, which was not in line with his condition. This was not in line with the guidance outlined in paragraph 21.
36. The care and treatment at this appointment was incorrect and not relevant for Mr H’s condition. This was another missed opportunity to follow the recommended assessment and reviews of CG163.
37. The Trust wrote the next clinic letter on 30 October 2018, following a normal barium swallow result on 12 October. This letter discharged Mr H back to the care of his GP. Again, there was no mention or consideration of the CT scan of his lungs.
38. To summarise, the department of respiratory medicine took early steps to properly assess Mr H’s condition on 1 November 2017. It then failed to follow up the investigations it had carried out, and between 26 November 2017 and his discharge from the service on 30 October 2018 it gave incorrect information in the clinic letters and failed to act in line with the guidance quoted in paragraphs 21, 31 and 32.
39. Miss G told us about her concerns that the Trust did not notify Mr H’s brothers about possible risks to them. We were sorry to hear they have since found out they are affected by the condition and that one brother has sadly died.
40. Our adviser explained there is no clear cause of this condition. It is not normally inherited, although some people can have a genetic predisposition to it. They explained there is no guidance to say trusts should offer screening for ILD to the family of a patient with the condition. For this reason we did not find this was a failing. We have looked at how the delay in diagnosis has impacted Miss G in relation to this point in paragraphs 48 and 49.
41. The GP referred Mr H back to the department of respiratory medicine on 24 May 2022 and the Trust saw him in clinic on 16 July. This appointment was arranged within a reasonable timeframe, in line with the NHS constitution which says patients should wait no longer than 18 weeks from GP referral to treatment.
42. The consultation notes show the consultant noted the progression of ILD. He noted raised eosinophils (a type of white blood cell, raised levels can cause asthma). He arranged blood tests and full lung function tests, with the plan to refer Mr H to the ILD clinic if necessary, when these tests were completed.
43. Our adviser said the consultant had concerns that Mr H may have asthma or COPD, as well as ILD. They explained this was a reasonable conclusion to reach because in addition to the raised eosinophils, the lung function results from December 2021 (carried out by the GP) showed an obstructive result (this can mean the patient has a lung condition that narrows the airways, such as COPD or asthma).
44. The care and treatment from this point was in line with the guidance in paragraph 21. The Trust also acted in line with the NICE guidance CG163 (albeit this should have happened in 2017), which says:
‘Assess everyone with suspected idiopathic pulmonary fibrosis by: • taking a detailed history, carrying out a clinical examination […] and performing blood tests to help exclude alternative diagnoses, including lung diseases associated with environmental and occupational exposure, with connective tissue diseases and with drugs and • performing lung function testing (spirometry and gas transfer) and • reviewing results of chest X-ray and • performing CT of the thorax (including high-resolution images).’
45. The Trust correctly began the process for referring Mr H to the ILD clinic as outlined in paragraph 31. Our adviser explained it often takes six to eight weeks to arrange the tests outlined in the clinic letter of July 2022 and there is no guidance to say how quickly this should happen. Mr H deteriorated and was admitted to hospital in August before this could happen. He sadly died a few days later.
Impact 46. If the Trust had acted in line with the GMC guidance it would have reviewed the scan report from 26 November 2017 and the lung function tests from 3 January 2018. The Trust would then have considered Mr H’s case at an ILD MDT, as required by NICE guidance CG163.
47. Our adviser told us it is likely, based on Mr H’s assessment, tests results, history and presentation at that time that the MDT would have made a diagnosis of pulmonary fibrosis and identified this as usual interstitial pneumonia (UIP). The term ‘usual’ refers to the fact that UIP is the most common form of fibrosis. ‘Pneumonia’ indicates ‘lung abnormality’, which includes fibrosis and inflammation. With this condition the tiny air sacs in the lungs (alveoli) become damaged and increasingly scarred. This causes the lungs to become stiff and makes it difficult to breathe and for oxygen to get into the blood.
48. As outlined in paragraph 33, we do not know how often Mr H would have been reviewed. We do know he would have had the information he needed to discuss his condition with Miss G and his family, to understand his prognosis, and to make plans.
49. We are aware this information may have led to family discussions about ILD. We do not know if this would have led to any family members seeking advice, and we consider this was a missed opportunity. We understand the thought of this continues to cause distress for Miss G. Miss G also told us about the plans she and Mr H had to marry, and we are sorry to hear how upsetting it is to her that they missed the chance to do this.
50. Our adviser considered whether there were missed opportunities for treatment, and pointed to NICE CG163. This notes ‘There is no conclusive evidence to support the use of any drugs to increase the survival of people with idiopathic pulmonary fibrosis.’ Sadly, there is no treatment that can cure this condition.
51. NICE guidance TA379 and TA540 both outline the circumstances doctors should consider giving the medications nintedanib and pirfenidone, which can slow down the progression of the disease. Both sets of guidance recommend the drugs only be considered as an option if ‘the person has a forced vital capacity (FVC) between 50% and 80% predicted’. This means the patient can breathe out less than 50% to 80% of the inhaled air in their lungs in one second.
52. If the Trust had followed guidance, our adviser said it is likely the MDT meeting in January 2018 would have concluded Mr H was not eligible for the drugs, as his lung function tests showed his lung function was too good. The MDT would have reviewed Mr H in line with the guidance as outlined in paragraph 32. We cannot know if he would have been reviewed every 3, 6 or 12 months as the Trust did not complete the assessment by the specialist MDT to see if Mr H had rapid disease progression, steadily progressing disease, or stable disease.
53. It is likely these reviews, however often, would include clinical assessment, full lung function testing and thoracic imaging (scans of the chest). We cannot know at what point Mr H’s condition deteriorated to the extent he would have been considered to start the medication to slow progression. Our adviser said it is likely, on the balance of probabilities, he would have met the criteria at some point.
54. We cannot know whether or what difference this would have made to the outcome, as patients with ILD have a poor prognosis. NICE CG163 explains the average survival rate is approximately three years from the time of diagnosis.
55. We can see Mr H and his family missed the opportunity to be fully aware of his condition, to better prepare for his end of life, and to access the support outlined in 1.6.1 of CG163.
‘• consider psychosocial needs and referral to relevant services as appropriate • consider referral to palliative care services • assess for comorbidities (which may include anxiety, bronchiectasis, depression, diabetes, dyspepsia, ischaemic heart disease, lung cancer and pulmonary hypertension).’
56. We do not know what led to the failings, as the Trust has not acknowledged these, and so we cannot be reassured it has taken steps to prevent a recurrence. The complaint responses are based on incorrect information. The notes of the complaint meeting the Trust had with Miss G say:
‘As you are aware, [Mr H] had a computerised tomography (CT) scan completed in 2017 and Dr A advised that [Mr H] did not have any respiratory symptoms that indicated any clinical concern at the time therefore [Mr H] care was discharged back to the care of his general practitioner and clinical advice was provided to him to speak with his general practitioner should his symptoms progress or worsen and a further appointment could be arranged with a member of the Respiratory Team to review his condition.’
57. This is incorrect and is not supported by the medical records. It is clearly documented in the clinic records of 1 November 2017 that Mr H had a cough and recurrent chest infection, and these are respiratory symptoms.
58. Additionally, it is misleading for the response to say there were no clinical concerns at that time, when ILD was noted on the CT. This should have raised clinical concerns. This has never been recognised and there is no evidence the CT result was reviewed at the time, meaning the failure to follow this up was not in line with the guidance.
59. The first complaint response said ‘It is noted that [Mr H] had a further CT scan in May 2021 and Dr A reviewed the imaging results and noticed that his condition appeared to have progressed.’ The scan was taken in May 2022. The response has given the wrong date, meaning the explanations about disease progression were misleading.
60. The first response also said ‘A lung function test was previously performed on 3 January 2022 and the results of this were satisfactory showing no signs of obstruction or restriction. Unfortunately, [Mr H’s] condition appeared to have progressively gotten worse over time’. There was no lung function test in January 2022. This also gives a misleading picture of disease progression.
61. The notes of the meeting with Miss G also said ‘On reviewing [Mr H's] previous lung function test in January 2022, it is documented that the results of these were satisfactory showing no signs of obstruction or restriction.’
62. Again this gives an inaccurate picture, and suggests Mr H had not deteriorated by January 2022. The Trust has not provided evidence of any lung function tests to support this opinion about Mr H’s condition at this point.
63. The complaint investigation missed the opportunity to give an accurate picture of what happened, and to identify and remedy the failings. We have made recommendations from paragraph 64 onwards.