31. 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 seen any indications that something has gone seriously wrong. We will explain how we came to this conclusion.
Consideration of symptoms 32. Mr A says the Trust failed to acknowledge his ill health and take any action. As a result, he suffered cardiac issues and Mr A says this could have serious or even fatal consequences.
33. The Trust has stated it has not found any evidence that incorrect treatment has been provided. Cardiac investigations have been conducted, and no significant abnormality has been found.
34. Mr A attended the Trust ED on three occasions between April 2023 and September 2024. Each time a blood test was conducted and an ECG.
35. When Mr A attended the ED on 5 April 2023 his ECG showed bradycardia with some arrythmias (irregular heartbeat). On the last two occasions he was recorded as having a normal heart rate. Mr A was discharged from the ED with no follow up on each occasion.
36. Mr A’s GP received information about Mr A’s visits to the ED and discussed them with him at subsequent consultations.
37. Mr A attended a private cardiac clinic on 12 July 2023. The private cardiologist requested Mr A’s GP arrange a number of investigations, including checking if his pain was linked to any undiagnosed digestive issue, and for Mr A to be reviewed by endocrinology.
38. The referral to the Trust endocrinology team was completed the next day.
39. We can see from the records Mr A should have had his regular two year appointment with the endocrinology team in August 2023. However, this did not take place because of capacity issues at the Trust.
40. In a letter dated 1 August 2023 to Mr A’s GP, the Trust explained Mr A’s usual consultant was not available and it could not expedite Mr A’s appointment. The Trust reiterated this in its complaint response. Mr A was seen by the endocrinology team in February 2024.
41. We considered what should have happened with the input of our clinical adviser.
42. Our adviser explained when Mr A attended the ED, his TSH (thyroid-stimulating hormone) should have been checked to see if it was in the target range. If this is the case, then there would be no further cause for endocrinological input.
43. When the GP was made aware of the blood results in April 2023 arrangements were made for him to be seen in the GP endocrine clinic on 30 May 2023. The blood results had shown Mr A’s TSH was in the lower range and his fT4 (free thyroxine) was high. This can mean his levothyroxine dose was too high.
44. The levels on 5 April 2023 are in line with being hyperthyroid which is more likely to cause a fast heart rate such as AF, not a slow heart rate. Mr A was experiencing a slow heart rate.
45. By 13 April 2023 blood tests showed his levels were returning to normal. From the records it is unclear when Mr A changed his dosage of levothyroxine, but it is recorded that at some point he reduced his dosage from 125mcg to 100mcg.
46. There is no record of the TSH being tested by the ED on 22 June 2023. Mr A arranged a private blood test through the Trust laboratory. The results showed his TSH was in normal range. His fT4 was slightly raised and this is expected when treated with levothyroxine only. Mr A’s fT3 (free triiodothyronine) was in normal range. Therefore, unlikely to have had any impact on his symptoms experienced.
47. Our adviser explained palpitations are common in the general population and, as in Mr A’s case, are not typically associated with any cardiac disease. Usually, the GP, with or without cardiology involvement, conducts the assessments and management of palpitations or cardiac disease.
48. The article from Frontiers of Endocrinology states the risk of cardiac arrhythmias in people being treated for hypothyroidism increases with excessive doses of levothyroxine or the combinations of levothyroxine and liothyronine.
49. Levothyroxine, when used at the correct dosage, should not be linked to cardiac issues. If anything, a combination of using both levothyroxine and liothyronine are more likely to cause those sorts of symptoms.
50. From the records and taking account of our clinical advice, we consider the features and symptoms Mr A has experienced are unlikely to be related to his hypothyroid or its treatment with levothyroxine, with or without liothyronine.
51. Although Mr A should have had an appointment with endocrinology in August 2023 the Trust explained this appointment could not be fulfilled due to there being a lack of capacity. We recognise the delay was not ideal and note the Trust advised Mr A’s GP in its letter dated 1 August, it did not think treatment for his hypothyroid would be causing the cardiac issues experienced.
52. We can see the Trust checked Mr A’s medication and blood results when coming to this conclusion.
53. We understand this is not Mr A’s lived experience and we are not trying to detract from what Mr A says happened to him.
54. We base our decisions on appropriate standards and guidelines. GMC guidelines section 7 state: ‘in providing good clinical care you must:
• adequately assess a patient’s condition(s), taking account of their history, including • symptoms • relevant psychological, spiritual, social, economic, and cultural factors • the patient’s views, needs, and values.
• carry out a physical examination where necessary • promptly provide (or arrange) suitable advice investigation or treatment where necessary propose • provide or 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 will meet their needs’.
55. Investigations were conducted promptly during the ED visits. The Trust made appropriate referrals, and the endocrinology team reviewed his case when capacity allowed.
56. There is no evidence that thyroid treatment provided was inappropriate or that it contributed to the cardiac arrythmias Mr A experienced. We consider the Trust actions were in line with the GMC guidelines and we have not seen evidence of failings in the care provided by the Trust.
Monitor bloods appropriately 57. Mr A says the Trust has not been monitoring his bloods often enough and only monitoring his TSH. By doing this Mr A believes the Trust has ignored what he has been telling them and feels it has not provided patient centred care.
58. Mr A sought private blood tests to obtain full biological monitoring and has been doing that monthly from April 2023 onwards. Mr A says the Trust should be doing this for him, and he should not have to pay. Particularly as the laboratory is part of the Trust.
59. The Trust explained the monitoring it had provided was in line with evidence-based research and guidelines. The Trust said it sometimes conducted testing more often for Mr A, after listening to his concerns.
60. The Trust further explained Mr A could obtain thyroid function tests via his GP. It acknowledges this might not be as frequent as Mr A would like but it would be in line with research evidence-based guidance. The GP would seek advice from the Trust if results were abnormal.
61. According to NICE and BTA guidelines the appropriate monitoring of hypothyroidism is to check TSH levels. This should be checked every three months at the start of using levothyroxine as a thyroxine replacement and then once a year. There can be the consideration of monitoring fT4 if there are still symptoms of hypothyroidism.
62. BTA guidelines say if liothyronine is taken the measurement of fT4 is of no value and the monitoring of fT3 is of limited value due to the differences after taking the dose. This is further explained in paragraph 68.
63. From the records, we can see the Trust has monitored Mr A in line with this guideline, including tests for fT4. It looks to have stopped taking tests for fT4 when Mr A was no longer taking combination therapy.
64. Further blood tests and monitoring by the GP can be done if symptoms persist or for more serious issues such as heart palpitations then monitoring can be conducted in ED.
65. The GP would otherwise monitor and make changes to medication unless it required specialist advice from a consultant endocrinologist.
66. Our adviser said monitoring people taking liothyronine is difficult. This is because it acts very quickly in the body. After taking it, the triiodothyronine level in the blood rises fast, which lowers other hormone levels (TSH and free thyroxine (fT4)). But then, triiodothyronine drops quickly within a few hours. Other hormones such as TSH and fT4 do not adjust as quickly, so it is hard to get a clear picture of thyroid hormone levels from blood tests.
67. Liothyronine works so fast, blood test results can change a lot depending on when the patient takes the blood test after taking the medication. There is no clear agreement on the best way to measure or track it. This is different from levothyroxine which turns into triiodothyronine slowly in the body and keeps hormone levels more stable.
68. This is further supported by an article by Thyroid and how the current preparations of liothyronine make it difficult to monitor.
69. NICE guidelines and the BTA statement say liothyronine should not be routinely offered due to there not being enough evidence that it offers benefits over levothyroxine used on its own and the long-term adverse effects are uncertain.
70. The NICE guideline committee has made a recommendation for further research. This research is needed to investigate the cost and clinical effectiveness of combination therapy (levothyroxine and liothyronine). The committee also mentioned research surrounding gene mutations and the response to combination therapy such as Mr A’s.
71. Within the BTA statement (table 9) it says gene mutations may only have a minor effect on thyroid hormone levels and at the moment it may be other unknown factors that may play a bigger role.
72. We are aware Mr A feels the Trust has coerced him into taking cheaper medication. We have looked at the Thyroid UK website and its’ view that liothyronine should be more readily available.
73. We appreciate this view. In our work we must use the recognised standards and guidelines clinicians are expected to adhere to. Our decision has been made based on the appropriate guidelines as set out by NICE and BTA guidance applicable at the time of events. Having done so, we have not seen any indications of failings in the monitoring of Mr A’s bloods, and we would therefore not expect the Trust to reimburse the costs of the private tests he has sought.
Medication plan 74. Mr A says since obtaining full biological monitoring monthly, he has been able to manage his medication more appropriately in line with his symptoms. Mr A has felt unsupported with this by the Trust.
75. Mr A says the Trust has not provided patient centred care because it has stuck to the guidelines and not used their own clinical expertise to fully consider his symptoms. Therefore, he has produced his own treatment and medication plan to relieve his symptoms.
76. Mr A complains the Trust has not given enough time for him to go through his symptoms and research on the matter and therefore has not fully considered or collaborated with him to find the best course of treatment. Due to this he has gone to seek a second opinion from a different hospital and consultant who he feels has given opposite advice.
77. The Trust responded to Mr A’s complaint. It acknowledged his symptoms might have had a greater impact than it first realised. During a consultation in February 2024 it was noted Mr A was managing his medication and treatment well. His symptoms had improved.
78. The Trust said clinicians strive to be patient-centred, and feedback shows it succeeds in most cases. However, it cannot always meet every patient request, as it must apply professional judgement and expertise.
79. Our adviser and NICE guidelines explain the standard care for hypothyroidism is usually levothyroxine, with a replacement dose being 1.6 x bodyweight in kg, to work out the dose in micrograms. This dose is taken once a day.
80. The BNF indicates levothyroxine should be taken on an empty stomach and suggests this should be thirty minutes before breakfast.
81. The aim for the treatment is to bring the TSH level between 0.5 and 2.0. Our adviser explains some people feel better outside this target range and the aim is for the clinician to consider the clinical picture and the biochemical result carefully. However, there is an important and ethical consideration to not indulge in experimental or unproven treatments.
82. The BTA statement says although some people will feel better outside the reference ranges this does not mean necessarily, they should be treated with liothyronine.
83. Further to this GMC guidance states doctors are to make clinical decisions that are in the best interests of the patient. This means clinicians should make decisions in line with BTA guidance, and if they decide to deviate from those guidelines, they should clearly document why they have done so.
84. From the research articles provided, NICE guidelines, BTA statement and information from our adviser, there is limited evidence to show liothyronine is beneficial or safe. This makes it difficult for the Trust to recommend or treat patients with liothyronine. As discussed earlier there are also issues with monitoring liothyronine effectively.
85. Mr A splits his levothyroxine dose. Based on what we know about how levothyroxine works; a single dose would be more appropriate as it has such a long duration of action. Our adviser could not link Mr A’s health improvements to splitting his dose.
86. Our adviser again highlighted the way Mr A is taking liothyronine (against the Trust advice) is not safe and can cause high levels of thyroid hormones within the heart and brain and have effects on his metabolism.
87. From the advice provided, BTA guidelines and BTA statement relating to levothyroxine and combining this with liothyronine, there is limited evidence to support the use of irregular doses of levothyroxine (such as higher than replacement doses) or combining this with liothyronine.
88. Mr A received a letter from the second opinion consultant on 19 June 2024. The consultant recommended a stable dose of levothyroxine. They mentioned if Mr A chooses to vary his dose, liothyronine would be more suitable. This is because liothyronine acts more quickly. The consultant recommended not exceeding 10 mcg of liothyronine at any time.
89. In line with the research and GMC guidance, prescribers should not be indulging in unethical experiments using unregulated and unapproved therapies. Further research and randomised tests are needed before using liothyronine.
90. In addition, the BTA statement says while certain gene mutations may slightly influence thyroid hormone levels, their overall impact appears to be minimal. Therefore, more research is needed to understand how combination therapy works, as other factors likely play a more significant role in how individuals respond to treatment.
91. From the medical records we can see evidence of extensive consultations with Mr A regarding his hypothyroidism care.
92. From the research we have seen and NICE guidelines, combination therapy is not well enough researched to be considered safe. The medication treatment and monitoring by the Trust was in line with current guidelines and research at the time.
93. We consider the Trust has tried to reach a consensus with Mr A and his treatment but unfortunately has not been successful. There is a distinct mismatch of expectation between Mr A and clinical team in this case.
94. We can see Mr A sought further specialist opinions and this has introduced further doubt for him, whether the Trust is providing the correct care.
95. We are aware Mr A has not felt supported by the Trust and his decisions in how to medicate his hypothyroidism.
96. While Mr A’s desire for a more tailored approach is understandable, the Trust’s medication planning was consistent with NICE guidelines and BTA guidelines.
97. We have not seen anything went wrong with the service provided by the Trust and therefore we are taking no further action on the complaint. We hope our decision provides some reassurance to Mr A that the Trust treated him in line with relevant guidance and it was not appropriate for it to support the combination of liothyronine and levothyroxine at this time.