Diagnosis of achalasia
25. Before we decide if we should conduct a detailed investigation of a complaint, we look at whether there are signs the organisation has got something wrong. We do this by comparing what should have happened with what did happen. We have done this and have not found any indications that something has gone wrong.
26. Mr O complains there was a delay by the Trust in diagnosing Mrs O with achalasia.
27. The Trust has explained it did not miss or delay Mrs O’s diagnosis of achalasia. The Trust confirmed that several tests are required for diagnosing the condition.
28. Our adviser has referred us to The BSG guidelines for oesophageal manometry and oesophageal reflux monitoring.
29. This states at section 1.5 Patients with dysphagia should preferably have an endoscopy with oesophageal biopsies to rule out and treat mucosal and structural disorders before manometry. Barium swallow should be considered where endoscopy is not possible and/or where structural disorders require further scrutiny.
30. We have also considered GMC guidance of good medical practice, this states at section 15, a doctor should promptly provide or arrange suitable advice, investigations, or treatment where necessary, and refer a patient to another practitioner when this serves the patient’s needs.
31. From the complaint to the Trust, Mr O detailed around August 2021, Mrs O started with a horrendous cough, and she was attending her GP practice due to this.
32. On 3 June 2022 Mrs O attended at the Trusts emergency department due to circulation/chest pains. The Trust diagnosed her with a suspected lower respiratory tract infection.
33. The records show on 15 September 2022, Mrs O had a gastroscopy. (This is a test to check inside your throat, food pipe (oesophagus) and stomach, known as the upper part of your digestive system).
34. The report showed the Trust diagnosed her with an hiatus hernia and oesophagitis. (A hiatus hernia is when part of the stomach squeezes up into the chest through an opening ('hiatus') in the diaphragm. Oesophagitis is the inflammation of the lining of the oesophagus).
35. On 21 January 2023 Mrs O attended at the Trust’s emergency department due to head, neck, and sore throat symptoms. The discharge summary details the Trust diagnosed her with a suspected upper respiratory infection. The Trust requested the GP consider a referral to the respiratory team.
36. On 18 February 2023 Mrs O had a further gastroscopy. This appears to be under the two-week wait referral cancer pathway, to rule out cancer. (The two week wait referral system allows a patient with symptoms that may indicate an underlying cancer to be seen as quickly as possible.)
37. The symptoms listed in the gastroscopy report were dysphagia, (where you have problems swallowing), nausea and/or vomiting and reflux symptoms. Within the report the previous gastroscopy is noted. The report details Mrs O is better after proton Pump Inhibitors (PPI) treatment (PPIs are a type of medicine which reduce the amount of acid your stomach makes). However it went on to say she is now getting reflux, nausea and vomiting. The report details following the test she has a hiatus hernia. The notes show there was no evidence of cancer. The Trust referred Mrs O back to her GP, for them to review her.
38. On 3 April 2023, Mrs O’s GP made a referral to gastroenterology at the Trust. The Trust informed Mrs O there was 12 months wait for a gastro outpatient appointment.
39. Due to the waiting times Mrs O’s GP made a private referral to a gastroenterologist, at the family’s request. On 12 May 2023, Mrs O paid privately to see a consultant gastroenterologist.
40. On 1 June 2023, Mrs O saw Mr M (consultant upper GI) through the NHS. The clinic letter from this appointment, showed the consultant recorded a queried diagnosis of symptomatic GORD-causing micro aspiration leading to chest symptoms.
41. The consultant detailed they had a detailed discussion about Gastro-oesophageal reflux disease (GORD) and Mrs O’s symptoms. The consultant recorded that it is important to rule out a possibility of micro aspiration (aspiration of small volumes of oropharyngeal secretions or gastric fluid into the lungs) causing her symptoms. They stated their feeling is her symptoms are very non typical for GORD disease. The consultant referred Mrs O for further tests of oesophageal manometry, 24 hour pH studies and water-soluble contrast swallow (barium swallow test) in order to assess her symptoms.
42. The records show on 21 July 2023, Mrs O completed a barium swallow test (water soluble contrast swallow). (This is an examination of the oesophagus (food pipe) and the stomach. The procedure uses a type of X-ray, called fluoroscopy, to view images in real time. The images are taken as the patient swallows a white liquid (called barium) down into their stomach).
43. The conclusion noted from this test was the appearances are indicative of achalasia, rather than GORD. Mrs O says the radiologist said she needed another appointment with Mr M urgently.
44. Mrs O attended at the respiratory clinic on 3 August 2023. Within the clinic letter following her attendance it detailed Mrs O had stated she was awaiting a review with the upper GI consultant, to see what they can do to help with the achalasia. The consultant physician recorded they considered this would be the most important management for her symptoms.
45. The records show on 18 August 2023, Mrs O went to A&E, due to chest pain, upper back pain and due to continuing to vomit. The Trust admitted Mrs O. The notes throughout Mrs O’s admission refer to the conclusion of suggested achalasia following the barium swallow test. The Trust completed a CT and chest x-ray. The Trust had concerns about Mrs O being at risk of aspiration. The Trust inserted a NG tube. The notes detail the Trust used this to clear the oesophagus contents.
46. The notes show on 21 August the ward clinicians discussed Mrs O’s case with the Trust gastro team. On 22 August, the clinician explained to Mrs O and her husband that achalasia is not a straightforward diagnosis, and she will need multiple investigations. On the same day the Trust completed a High-Resolution Manometry procedure on Mrs O. (This is a test to measure the pressures in a patient’s oesophagus when they are resting and when they swallow). The records show the plan was for Dr R (consultant gastroenterologist) to review Mrs O as an outpatient for achalasia.
47. On 24 August, the Trust discharged Mrs O. The discharge notice refers to her having a very severe degree of achalasia. It details the Trust has emailed Dr R as instructed by the consultant to see her as soon as possible. The discharge notice confirmed the Trust are still awaiting the results of the manometry.
48. The records show Mrs O further attended the emergency department further on 31 August 2023 due to Pyrexia (high temperature/fever). The Trust discharged her on the same day.
49. On 4 September 2023, Mrs O attended at Dr R clinic. The clinic letter from this appointment, detailed Dr R noted Mrs O has symptoms of achalasia and the barium swallow test points towards achalasia. The high-resolution manometry is not typical but on the whole points towards achalasia rather than absent motility (the pace and ease of the food movement).
50. We have considered evidence from our adviser. They have explained achalasia is a condition that everyone in upper GI would know about. It is probably the most severe form of dysmotility (a condition in which muscles of the digestive system become impaired and changes in the speed, strength or coordination in the digestive organs occurs) of the oesophagus.
51. Our adviser confirmed achalasia is diagnosed by two possible tests. The best test is an oesophageal manometry. This is where a tube is placed down the oesophagus, and it measures pressure waves at different sites of the oesophagus. This is often combined with a 24hour pH manometry test.
52. The other test is a Barium swallow, it is not as accurate. But it does quickly say whether there is pooling of barium in the oesophagus and can indicate achalasia.
53. Our adviser has explained following the second gastroscopy in February 2023 Mrs O was experiencing difficulties swallowing, with concerns of dysphagia raised. They confirm the gastroscopy had come back normal, she had lots of aspiration, and treatments she had tried has not worked. They explained therefore ideally the Trust should have considered further tests. Our adviser explained there should have been further consideration as to the motility issue she was suffering.
54. Regarding the gastroscopy in February 2023, our adviser confirmed the Trust appears to be to ruling out cancer, as such the Trust would not be looking for anything else.
55. For Mrs O to get the further tests she required, it would be correct for the Trust to refer her back to the GP, for them to decide what next needed to happen, i.e. a further referral to secondary care for treatment. Our adviser confirmed in Mrs O’s case, a referral to a gastroenterologist. They explained it is normal for Trusts to refer patients back to the GP after a cancer exclusion.
56. Our adviser stated it would be normal practice for the Trust to do this. They confirmed there is no guidance to state that the Trust should have referred Mrs O on to a gastroenterologist after the gastroscopy in February 2023.
57. Achalasia is an uncommon condition, and our adviser confirmed Mrs O presented in a slightly atypical way for it. (Not normal. Describes a state, condition, or behaviour that is unusual or different from what is considered normal). Our adviser confirmed this potentially resulted in some delays at the start, with the Trusts completing the appropriate tests to determine the diagnosis of achalasia.
58. Our adviser explained achalasia is very difficult to diagnose with a gastroscopy. This is because you can put a scope through the oesophagus and not realise it is tight.
59. They explained it was only after the February 2023 gastroscopy, there was an indication the Trust should complete further tests on Mrs O, to determine what was causing her problems, i.e. the barium swallow and manometry tests.
60. Our adviser has explained there is no specific guidance as to the time scales as to when a Trust should have completed the tests Mrs O required. Our adviser confirmed post covid-19, it is usual to wait up to six months for these types of tests.
61. Due to the length of time it takes to do the tests, our adviser has explained this is likely why the Trust has done the barium swallow test first, to speed up the process.
62. Our adviser has confirmed once Mrs O is in the NHS pathway under the gastroenterology department, the tests, diagnosis and procedure all happen reasonably quickly.
63. Our adviser explained from the appointments Mrs O has had with the Trust, there is no indications that someone has done something inappropriate. The Trust appears to have followed its obligations.
64. We are very sorry to hear of Mrs O’s experience. We appreciate this would have been a very difficult time, with the problems she experienced because of the achalasia. We recognise how long she had the problems.
65. We consider that on the basis of the evidence from our adviser the first occasion when the Trust could have considered the tests of barium swallow and manometry for identifying achalasia, was following the gastroscopy in February 2023. We acknowledge ideally, the Trust should have referred Mrs O on for the further tests following the gastroscopy in February 2023.
66. As Mrs O was not under gastroenterology or on a gastroenterology pathway at the Trust at this time. The Trust would not be expected to refer her for these tests. Considering evidence from our adviser it is usual for a Trust to refer a patient back to the GP, for them to make the necessary referral to secondary care, i.e. gastroenterology. This is what the Trust did here.
67. The evidence from the records shows once Mrs O’s GP has made the referral to gastroenterology, she is seen by the consultant on 1 June. Following this appointment the consultant recommends the tests that would be expected in line with the BSG guidelines. This is also in line with GMC guidance of promptly arranging investigations. The Trust completed these tests on 21 July and 22 August.
68. The maximum delay in the Trust completing the tests, from when they potentially could have been first is four to six months (ie February 2023 to June/July/August 2023. Our adviser has explained this is a usual wait time for these types of tests to be completed. They stated post covid this is the normal time scale of when a Trust would likely be able to complete the test. We are aware from the Trust’s initial letter, there was a long wait for Mrs O to initially see a consultant.
69. Even if the Trust had referred Mrs O onwards to a gastroenterologist after the February 2023 gastroscopy, it is likely she would not have had the tests any earlier, than she did in July and August, due to the long waiting times in this area.
70. We appreciate the wait time Mrs O had for the tests. We can appreciate how frustrating this would have been. Unfortunately, as our adviser confirmed it can be a long wait for these types of tests.
71. We also recognise all the contacting and chasing Mr O did on behalf of his wife to try and get an appointment with the consultant after the barium swallow test. We note Mr O went to the PALs team on 11 August, as he was unable to speak with anyone on the phone at the gastro outpatient department. We appreciate how annoying and frustrating this would be. We note while Mrs O was waiting to see the consultant, she had a further hospital admission, which appears to have escalated the manometry test.
72. The records show following Mrs O having the manometry test, the Trust arranged an appointment with a consultant, where they confirmed the diagnosis of achalasia.
73. Based on the above and taking into account evidence from our adviser we consider the Trust has acted in line with the guidance to arrange the suitable tests and confirmed the diagnosis. We appreciate the waiting times for the tests will have been stressful and frustrating for Mr and Mrs O.
74. We have seen no indication that the time taken for Mrs O to receive her diagnosis was a result of the Trust not doing what they should have done, but due to demand on resources and availability. This is beyond the Trusts control and not something we could require the Trust to make changes to.
75. As such there does not appear to be any indications of failings by the Trust with this issue.
Knowledge of the condition
76. Mr O says the Trust had a lack of knowledge of the condition of achalasia.
77. The Trust has explained it did not miss the diagnosis of achalasia.
78. We have considered GMC guidance. This states at section seven, a doctor must be competent in all aspects of their work, including management, research and teaching. It also states at section eight a doctor must keep their professional knowledge and skills up to date.
79. Section 15 also states a doctor must refer a patient to another practitioner when this serves the patient’s needs.
80. We have considered evidence from our adviser. They have explained they did not find any evidence of a lack of knowledge about achalasia.
81. Our adviser confirmed achalasia is an uncommon condition, with an incidence of 1.6 cases per I00,000 people each year. They confirm it is a condition that gastroenterologists and surgeons with an interest in upper GI disorders would be expected to be confident in diagnosing and understanding the main treatment options.
82. We appreciate due to the length of time Mrs O was experience symptoms, and problems, it would have been frustrating. We acknowledge it may have felt as if the clinicians did not know about the condition.
83. We acknowledge prior to the referral to gastroenterology, when Mrs O was attending the Trusts emergency department, the Trust had not mentioned achalasia or ordered the required test. While we can see Mrs O was reviewed by several different doctors within the emergency department team. We cannot say they should have had specific knowledge that would have been required for them to suspect achalasia during her attendance.
84. The GP first made the referral to the Trust on 3 April. Mrs O initially had a private appointment. A gastroenterologist at the Trust then saw her on 1 June, through the NHS. Following this they ordered the relevant tests. The Trust also referred Mrs O to Dr R (Consultant Gastroenterologist and Endoscopist) for a further assessment.
85. Based on the evidence we have seen, considering the evidence from our adviser there is no indication that the Trust or clinicians involved had a lack of knowledge about achalasia. We consider the Trust has acted in accordance with the GMC guidance of ensuring their knowledge is up to date. Also referring Mrs O on when required. Given this we see no indication of failing by the Trust in relation to this issue.
Treatment for achalasia
86. Mr O says there was a delay with the Trust providing treatment to Mrs O for achalasia and that it did not treat her symptoms and condition urgently.
87. The Trust has explained its Dr R, was made aware of Mrs O on 21 August 2023. The Trust confirmed Dr R organised for an urgent high-resolution manometry on 22 August. Also, for a clinic review at their next available clinic on 4 September. The Trust has explained due to clinical commitments Dr R is not able to visit patients in various wards unless he is a ward consultant/gastroenterologist of the week for the ward.
88. The Trust has stated Dr R explained they do not believe any of the team members could have organised the treatment quicker for Mrs O. It confirmed it had fitted Mrs O in at the earliest available endoscopy list with general anaesthesia support for the POEM procedure.
89. We have considered GMC guidance. This states at section 15 a doctor should promptly provide or arrange suitable advice, investigations, or treatment where necessary.
90. Also at section 16, which states a doctor when providing clinical care must: prescribe drugs or treatment, including repeat prescriptions, only when they have adequate knowledge of the patient’s health and are satisfied that the drugs or treatment serve the patient’s needs.
91. As referred to above the records show on 21 July, Mrs O had the barium swallow test, which indicated achalasia. She had the High-Resolution Manometry procedure, while in hospital on 22 August.
92. On 4 September 2023, Mrs O attended at Dr R clinic, who advised her symptoms and test indicated achalasia. In the clinic letter from the appointment, Dr R recorded that they discussed the treatment options available, including a peroral endoscopic myotomy (POEM) procedure. Mrs O confirmed she would like Dr R to place her on the waiting list for the POEM procedure.
93. On 12 October 2023 Mrs O attended at the Trust to carry out the POEM procedure for the achalasia. The Trust admitted Mrs O for this procedure and discharged her on 22 October.
94. On 18 December 2023, Mrs O had a telephone consultation with Dr R. The consultant confirmed the procedure had gone well. They were to arrange a follow up in 12 months’ time.
95. We have considered evidence from our adviser. They have explained achalasia is diagnosed by two possible tests. The best test is an oesophageal manometry. This is where a tube is placed down the oesophagus, and it measures pressure waves at different sites of the oesophagus. This is often combined with a 24hour pH manometry test. The other test is a barium swallow. Our adviser confirmed this test is not as accurate. But it does quickly say whether there is pooling of barium in the oesophagus and can indicate achalasia.
96. Our adviser has explained the POEM procedure is now the gold standard therapy for the condition. Our adviser has confirmed following the diagnosis of achalasia, the Trust has treated Mrs O very quickly with the POEM procedure. They stated there was no significant delay to treatment following the diagnosis.
97. Our adviser has also confirmed Mrs O could not have the POEM procedure, until she had the diagnosis of achalasia. This is because a POEM is quite an invasive procedure, and the Trust would not perform it until there was a confirmed diagnosis, that needed treatment. There was no other treatment available to her for the achalasia.
98. We are very sorry to hear of Mrs O’s condition and the problems she suffered with because of the achalasia. We appreciate this would have been a very worrying, distressing and upsetting time for her and her family. We acknowledge as more time went on Mrs O was still suffering with the condition.
99. Taking into account evidence from our adviser, for the Trust to diagnosis achalasia it would be correct for it to do the barium swallow and manometry tests. Once the Trust has completed both these tests we can see that within two weeks it arranged an appointment with a consultant, to discuss the results, diagnosis and treatment options.
100. The Trust then arranged the POEM procedure within five weeks of the diagnosis following the appointment with the consultant. Based on the evidence from our adviser the Trust could not undertake the POEM procedure until Mrs O had the diagnosis of achalasia.
101. Based on the above the Trust has acted into accordance with GMC guidance of prescribing treatment, when they have knowledge of the patient’s health and are satisfied it would serve their needs. As such there does not appear to be any indications of failings by the Trust with this issue.
102. We realise this is unlikely to be the outcome Mr & Mrs O was looking for when they had approached us. We were sorry to hear of the circumstances which led to their complaint and we do not underestimate how difficult things have been for both of them during this time.
103. We hope this clearly explains the reasons why we will not be considering the complaint further. We would like to thank Mr O for bringing his concerns to our attention.