Gloucestershire Hospitals NHS Foundation Trust

Care and treatment

6. Mr P complains the Trust did not complete appropriate tests when his wife, Mrs P, attended a TIA clinic and then the ED on 10 February 2017. He says had the Trust scanned his wife on either occasion it would have admitted her and offered her treatment.

7. Mr P also complains the advice given by the ED on discharge was inappropriate, inadequate, and potentially life-threatening. He says it contradicted what his wife had said to the doctor, and this exacerbated the anguish he and his wife experienced when his wife was refused admission and a scan.

8. Mr P says the discharge left him and his wife distraught and extremely concerned about her health. He says witnessing the Trust discharge his wife against her wishes was very distressing. He says this also left his family severely distressed for the five days between Mrs P’s discharge and later haemorrhage and admission.

9. Mr P says an admission on 10 February would have avoided the severe trauma his children experienced when his wife collapsed in their presence. He also says it would have avoided subsequent paralysis, and emergency surgery. Mr P says this would have enabled his wife to start cancer treatment sooner, given her a much greater chance of survival, and given the whole family a better quality of life.

10. Mr P says his wife’s death was avoidable, and had the failings not happened, she and the family would have had a better outcome. Mr P says she suffered more than she needed to in her final months and knowing this has caused the family a huge amount of ongoing distress.

Complaint handling

11. Mr P also complains about the Trust’s complaint handling.

12. He says there were several factual inaccuracies in the Trust’s complaint response, it did not provide enough explanation to justify its rationale, and it has not acknowledged failings in his wife’s care.

13. Mr P complains the Trust’s complaint investigation did not address his comments about the out of hours GP’s opinion, the incomplete diagnosis by the TIA clinic, or accurately consider the likelihood of timely steroid treatment allowing surgery to take place before major haemorrhage occurred. He also says the Trust’s investigation did not fairly represent, evaluate, or weigh up evidence provided by Dr O.

14. Mr P also complains the Trust withheld information from him it considered could have been the cause of his wife’s catastrophic haemorrhage, about her intending to take aspirin, but then highlighted the information to the Ombudsman. Mr P says the Trust has attempted to deflect attention away from its own failings, onto his wife.

15. Mr P says the lack of honesty and transparency in the Trust’s complaint handling has made him question all aspects of the Trust’s response and worsened the impact of the grief for the whole family.

16. To resolve his complaint Mr P wants an acknowledgement of failings, an apology, service improvements across both departments and the complaints team to prevent similar failings happening again and a financial remedy in recognition of the family’s distress.

17. Mrs P attended the Trust’s TIA clinic and then the ED on 10 February 2017 after being referred by her GP. A TIA is similar to a stroke and is often referred to as a ‘mini-stroke’. It occurs when the blood supply to part of the brain is briefly or temporarily blocked (this is different to a permanent blockage which is called a stroke). The symptoms of a TIA are like those of a stroke.

18. Mrs P’s GP referred her because for several days and weeks prior she experienced episodes where she lost the ability to speak and control some parts of her body on one side. In one instance this happened at work, and she reported dropping the phone in the middle of a conversation. She also experienced other symptoms which included a ‘fizzing’ and tingling sensation, and metallic taste, in her mouth. Mr P says Mrs P also experienced headaches and confusion that would persist even after her loss of speech and control had stopped. He also told us that during one episode he witnessed, Mrs P’s face also appeared to be drooping.

19. Staff in the TIA clinic and the ED thought Mrs P’s symptoms were migraine related. She was not offered any imaging and was sent home. On 15 February, Mrs P suffered a catastrophic bleed to the brain at home in front of her young children which was caused by a brain tumour. She was taken to hospital and emergency surgery was carried out. Emergency surgery is performed to address an acute threat to a patient’s life, organ, limb, or tissue. While this surgery saved Mrs P’s life, she was left paralysed in her left leg and left arm. Mr P took care of her daily needs such as managing her personal care, and pushing her wheelchair.

20. Over subsequent months Mrs P received some cancer treatment, and she slowly regained some ability to walk again, albeit not a great distance and with a lot of effort. However, in October she experienced another bleed and sadly died in November 2017.

26. We have set out the reasons for our decision under a series of sub-headings below, for clarity.

Care and treatment

27. Mr P says the Trust did not undertake appropriate tests. In particular, he believes the Trust should have undertaken scans, either when Mrs P attended the TIA clinic or the ED on 10 February 2017. He says if this had happened, Mrs P would have been admitted to hospital and offered treatment. He also says his wife was not given advice that was appropriate for her condition and because of this, she was at more risk of life-threatening harm.

TIA Clinic

28. The records show Mrs P was seen at the TIA clinic on 10 February 2017, and she told Dr O about three neurological episodes and symptoms. These symptoms included describing a ‘fizzing’ and tingling sensation in her mouth, and a metallic taste, shortly before each episode. The TIA clinic notes recorded that Mrs P had previously been treated for malignant melanoma. Malignant melanoma is a malignant tumour that originates in melanocytes, which are cells that produce pigment in a person’s skin.

29. Dr O booked a magnetic resonance imaging (MRI) scan for three weeks’ time and did not offer Mrs P a computed tomography (CT) scan. An MRI scan is a type of scan that uses strong magnets and radio waves to see bones, tissues and organs inside the body. A CT scan uses X-rays and a computer to create pictures of organs, bones, and other tissues inside the body.

30. Dr O decided there was no evidence of cerebrovascular disease (a disease that affects the blood flow in the brain, such as a TIA) and suspected her episodes and symptoms may have been migraine related. Dr O told Mrs P to go home.

31. We think the relevant standards are the RCP’s ‘National clinical guideline for stroke’, GMC’s ‘Good Medical Practice’, and DVLA’s ‘Neurological disorders: assessing fitness to drive’.

32. The RCP’s ‘National clinical guideline for stroke’ includes recommendations for patients with a suspected TIA. This guidance says patients with a suspected TIA should be assessed by a specialist physician before a decision on brain imaging is made. Imaging should be restricted to patients where the result of the imaging is likely to influence the management of the patient. It also says acute stroke services should have continuous access to brain imaging including CT angiography (a procedure that uses CT scanning and contrast material to examine blood vessels). The service should be capable of undertaking immediate brain imaging when it is clinically necessary.

33. The GMC’s ‘Good Medical Practice’ says when clinicians make documents, including clinical records, they must be clear, accurate and legible. They should be made at the same time as the events being recorded or as soon as possible afterwards.

34. The DVLA’s ‘Neurological disorders: assessing fitness to drive’ guidance says a person should not drive after experiencing multiple neurological episodes, such as seizures, and should only resume if there have been no more. The timeframes for how long a person should stop driving for depends on the seizure experienced (including if there is a loss of consciousness and/or an underlying causative factor that may increase risk), the outcomes of any diagnostic investigations and, ultimately, the DVLA’s decision.

35. In Mrs P’s case, her seizures would have likely been classified as unprovoked seizures because there was not an identifiable trigger or cause at the time of events. In line with the DVLA’s ‘Neurological disorders: assessing fitness to drive’ guidance, Mrs P would have had to stop driving for a period of up to 12 months and would have to tell the DVLA, who would have made the final decision about the length of time.

36. Our stroke adviser told us MRI scans are the first choice for imaging because they are better than CT scans for establishing differential diagnoses and are more detailed. That said, while CT scans will not pick up everything they can be used if an MRI scan is not readily accessible. Stroke and TIA clinics should be a ‘one-stop shop’ so MRI scanning should be available on the same day and, if not, CT scans should be considered.

37. Mrs P had experienced three short neurological episodes, lasting a few minutes each time, in the days before her referral to the TIA clinic. Our stroke adviser says because of this, if Dr O thought Mrs P had experienced a TIA then it would be recognised clinical practice not to offer imaging because the episodes were of a short duration. However, Mrs P’s symptoms were not typical for TIA. She reported changes in the sensation and taste in her mouth ahead of her episodes and this is not consistent with TIA.

38. From the clinical records we can see Dr O documented there was no evidence of cerebrovascular disease. That is, they did not suspect TIA. The records indicate the diagnosis was unclear, and they were considering if the symptoms were migraine related. However, the Trust told Mr P in its complaint responses that Dr O had considered whether Mrs P’s neurological episodes were partial seizures as a differential diagnosis (process of ruling out possible causes of the symptoms). The significance of this is that seizures can be an indication of a brain tumour. However, the differential diagnosis the Trust described in its complaint response was not documented in the Trust’s records, although the symptoms documented (as described by Mrs P) are suggestive of partial seizures.

39. We consider Dr O should have arranged an immediate CT scan for Mrs P if an MRI scan was not available. This is because of her history of malignant melanoma (which is well-recognised to spread to the brain) and her atypical symptoms of TIA which were suggestive of partial seizures. If they considered partial seizures as a differential diagnosis, this should have been documented clearly in Mrs P’s clinical records. Further, we consider Mrs P should have been advised not to drive. This is because the cause of her symptoms was unclear and a cautious approach to driving should have been advised.

40. We therefore consider the Trust did not act in line with the RCP, GMC, or DVLA guidance and consider these to be failings. We will revisit the impact of these later.

ED

41. Mrs P attended the ED later that night after experiencing two more episodes at home following her discharge from the TIA clinic. Mr P took Mrs P to the ED at one of the Trust’s hospitals. Staff told Mr and Mrs P the wait in the ED was so significant it would be better to see an out of hours GP whose clinic was operating within the hospital. They saw the out of hours GP (this was coincidentally also Mrs P’s normal GP) at 9.30pm and Mrs P started to experience a tingling sensation in the fingers of one hand.

42. The GP was concerned and gave Mr and Mrs P some information they had written down and placed in a sealed envelope at around 9.55pm. They were told to go to the ED of another of the Trust’s hospitals (because the ED in the hospital where they were located at that time was closing at 10pm) and to pass the envelope to a member of staff. Mr and Mrs P later found out that, amongst other things, the note said:

‘Diagnosis: ? TIA ? Convulsion (Previous Melanoma)…Treatment: Admit [hospital name]…P [patient] needs urgent MRI scan.’

43. This means the GP had identified a possible link (which later turned out to be the case) between Mrs P’s history of melanoma and the symptoms she was experiencing. It also shows that the GP thought Mrs P needed to be admitted to hospital and that she needed an MRI scan.

44. Mr and Mrs P waited in the ED for around four hours. When they were seen, her blood pressure was taken, and she was advised to go home. Mr P said this was despite Mrs P trying to insist staff give her a scan because she knew something was seriously wrong. Mr P says Mrs P specifically said to staff, ‘I know something terrible is going to happen’. He thinks it was particularly important that staff gave serious consideration to the GP’s advice, given the circumstances.

45. He also says Mrs P told a nurse she was scared she had a brain tumour (because she had family history of this) or that she may be close to having a stroke or some other serious event. Mrs P told the nurse she would take aspirin until she had her MRI scan to try and give herself some protection. This is because aspirin can reduce a person’s chances of having a stroke.

46. We have considered NICE’s ‘Epilepsies: diagnosis and management’. This is because Mrs P presented with seizures, and epilepsy is one of the possible causes of seizures. This says, ‘in an acute situation, CT may be used to determine whether a seizure has been caused by an acute neurological lesion or illness’. We also think the GMC’s ‘Good Medical Practice’ is relevant to this aspect of Mr P’s complaint. This guidance says doctors should promptly provide or arrange suitable advice, investigations, or treatment where necessary. It also says patients should be referred to another practitioner when it serves their needs.

47. We considered whether ED staff should have done more with the information the GP gave Mr and Mrs P in writing to pass to staff. That is, the GP’s advice to consider performing a scan on Mrs P. We recognise GPs are generalists and usually have limited time to assess a patient. It is not uncommon for them to refer patients to ED with initial working diagnoses and recommended management plans. However, with further assessments and initial investigations carried out in ED, a different working diagnosis may become apparent.

48. Therefore, we think that while doctors working in the ED should take into consideration information provided by referring GPs, they should reach their own decision about what needs to be done based on their own clinical assessment and investigations. Therefore, we cannot say ED staff should have followed the GPs advice, simply because this is what the GP requested. However, we have considered whether the assessment carried out by staff was appropriate.

49. We can see from the clinical records that staff in the ED were not able to make a definitive diagnosis for the cause of Mrs P’s symptoms. The clinician who assessed Mrs P documented three possible diagnoses. These were migraine, TIA, and partial seizures. Staff noted that Mrs P had been seen by Dr O in the TIA clinic earlier and they had not suspected a TIA. The Trust confirmed this influenced the decision making in the ED.

50. Our ED adviser told us in two of these three possible diagnoses there was an indication to order a CT scan for Mrs P to be performed that night. We think this was particularly important given the increasing frequency of Mrs P’s episodes and her history of malignant melanoma, which were known to the ED and documented.

51. In not carrying out a CT scan, we consider staff in the ED did not act in line with NICE’s ‘Epilepsies: diagnosis and management’ or the GMC’s ‘Good Medical Practice’. We therefore consider this to be a failing. We will revisit the impact of this later.

52. We have also considered the advice given by staff to Mrs P ahead of her discharge. We can see from the evidence available to us that staff told Mrs P she could return to the ED if she had several more episodes at an increasing frequency. Staff also did not tell Mrs P not to take aspirin when she told them she would do so to try and protect herself.

53. We consider this advice to have been inappropriate. Our ED adviser says ‘safety netting’ advice given about when to return to ED was unhelpful and lacked clarity. They told us it made sense to advise Mrs P to return if she experienced symptoms again that did not go away, but that the advice about the frequency of those symptoms or further episodes was inappropriate. This is because the episodes and symptoms Mrs P was experiencing were already frequent. Our ED adviser told us the ‘safety netting’ discharge advice given was essentially not wholly relevant because if the Trust had acted as it should, then Mrs P would not have been in the situation to receive poor advice.

54. With regard to the aspirin issue, our ED adviser said because staff had not suspected that Mrs P had any bleeding and based on the suspected diagnoses documented in her records, there was no reason for staff to advise her against taking aspirin. That said, our neurosurgery adviser told us it would only have been appropriate for Mrs P to take aspirin if she had suffered a TIA or stroke, and that staff were not sure what was causing Mrs P’s episodes and symptoms. They told us Mrs P’s history of malignant melanoma meant a brain tumour was another possible diagnosis, and this comes with bleeding.

55. We think staff should have been alert to other diagnoses, and the implications taking aspirin would have. We also recognise that during the complaints process the Trust told Mr P its staff should have told Mrs P not to take aspirin. Having considered this, we agree Mrs P should have been advised against taking aspirin. It also said the reason Dr O did not prescribe aspirin is because they did not think Mrs P had experienced a TIA.

56. While we recognise our ED adviser says staff had no reason to advise against taking aspirin, we consider it was a failing for staff not to do so. This is because the GMC’s ‘Good Medical Practice’ says appropriate advice should be given, and our neurosurgery adviser (and the Trust) have both said given Mrs P’s history, they should have been alert to other diagnoses. Given the fact staff did not know what was causing Mrs P’s symptoms, we think it is reasonable to expect staff to have advised her against taking aspirin when they did not know if it would be appropriate, or safe, for her condition. We will revisit the impact of this later.

Complaint handling

57. Mr P complains about the Trust’s complaint handling. He is concerned there were several factual inaccuracies in the Trust’s complaint response, and it did not provide enough explanation to justify its rationale. He says the Trust did not acknowledge the failings in Mrs P’s care and a lot of its assertions were contradictory, particularly between what was in its written responses and what was said during a meeting.

58. We think the standard that applies here is our ‘NHS Complaint Standards’. These say organisations should welcome complaints and make sure people are listened to and treated with empathy, courtesy, and respect. They should be thorough and fair in their investigation which includes providing a clear and balanced account of what happened based on established facts. They also say we expect organisations to be open and honest when things have gone wrong, or where improvements can be made.

59. Our ‘NHS Complaint Standards’ also say if things have gone wrong, it should be explained where possible why things went wrong. Organisations should identify suitable ways to put things right for people, including providing meaningful and sincere apologies and explanations.

60. We do not consider the Trust handled Mr P’s complaint in line with our ‘NHS Complaint Standards’. This is because in its written complaint response (29 January 2018), and the minutes from the meeting between Mr P and the Trust (1 May 2018), it provided several contradictory statements, assertions that are not based on established facts, and was not open and honest about all the failings that occurred. Therefore, by extension, we do not think the Trust did enough to put things right for Mr P when it handled and responded to his complaint.

61. We have set out some examples from each of the Trust’s responses, under headings below.

Complaint response: 29 January 2018

62. In this letter, the Trust said the TIA clinic’s differential diagnosis (a medical process used to identify a disease or condition by comparing and contrasting the symptoms presented) considered partial seizures, and it praised Dr O for doing so. However, we consider the Trust’s statement is inaccurate. This is because the report produced by Dr O does not include any reference to a differential diagnosis of partial seizures, and there is no other evidence we have seen that shows this was a differential diagnosis at the time of events.

63. The Trust was also contradictory in its consideration of this point. Having praised Dr O for considering seizures, the Trust response also acknowledged Dr O ‘did not explicitly mention the possibility of seizures’. Seizures are not mentioned in the report Dr O produced at the time, and they were not mentioned during the consultation itself (based on the evidence). They are only referred to in the complaint letters sent to Mr P by the Trust.

64. The Trust’s view was not balanced. The Trust said while the TIA clinic could have done a CT scan on the day, it was ‘quite possible’ the CT scan may not have shown anything. Based on the evidence available, and the advice we have received (as we explain later), we are satisfied the CT scan would likely have shown something. While it was not incorrect for the Trust to highlight the possibility a CT scan may not have shown something, it should have weighed up the possibility of the likelihood of it doing so.

65. The Trust’s response also added unnecessary ambiguity. The Trust said if Mrs P been scanned, tumours found, and admitted to hospital, ‘it is possible’ she would have been given steroids and anti-epileptic drugs, and referred to another local trust. We consider these things are more likely than not to have happened had Mrs P been scanned. Therefore, the Trust should have been clearer in its response.

66. Finally, there was a further contradiction. The Trust said, ‘it is impossible to know whether this [a CT scan] would have demonstrated any abnormality’ but later in the letter said, ‘A CT scan that night, or an MRI scan the next morning, would likely have shown a metastatic tumour’.

Letter sent following the meeting on 1 May 2018: 18 June 2018

67. The Trust did not directly address the point made to it by Mr P. In this letter, the Trust said a CT scan could have been done but was not deemed urgent, and that it is ‘not routine’ to scan all patients with transient symptoms, and that an MRI scan was often the most appropriate. However, the complaint made to the Trust was that Mrs P should have received a scan given her symptoms and clinical history. While all parties agree an MRI scan is most preferable, a CT scan is a good second option and it was possible to be carried out. The advice we have received (as referred to earlier), and our decision (as explained in more detail later), is that Mrs P should have been scanned and had she been, this would have likely escalated the urgency in Mrs P’s case.

68. The Trust were not open and transparent with Mr P. It said Dr O told it they could not have predicted or foreseen a bleed on the brain would have happened so quickly. However, the type of tumour Mrs P had is common in people with a history of malignant melanoma (as Mrs P had) and they are well known to have a high propensity to bleed. However, Mrs P’s GP’s advice (provided in the sealed envelope mentioned earlier) at the time of events, and the advice we have received, suggests that Dr O should have been aware of this very possible risk.

69. We consider paragraphs 62 to 68 above show the Trust’s responses to Mr P’s complaint were not in line with our ‘NHS Complaint Standards’. We therefore consider this to be a failing. We discuss the impact of this below.

Impact

70. We have found the Trust failed to:

• carry out a CT scan on two occasions, in the TIA clinic and ED.

• provide appropriate advice, in the TIA clinic and ED.

• provide an open and transparent response to the complaint.

71. Below, we have considered the likely impact of these failings.

Mr P’s view

72. Mr P says the impact of the Trust’s mistakes were devastating. He says if Mrs P had been scanned in either the TIA clinic, or the ED, her outcome would have been better (including avoiding her paralysis and affecting the cancer treatments available to her). He says Mrs P would have been admitted to hospital and would have been under observation. He says her blood pressure would have been under control and Mrs P would not have been taking aspirin, which is known to prevent the body’s blood clotting mechanism.

73. He says Mrs P may have received steroids or anti-seizure medication which could have prevented the bleed or lessened its impact. Therefore, while he recognises the tumour she had does have a high propensity to bleed, he says monitoring in hospital may have meant the bleed was not as severe or may have been delayed. Mr P considers there was an opportunity for elective surgery to have been carried out under controlled conditions, rather than the emergency surgery that had to take place on 15 February. Mr P says this would have enabled Mrs P to start cancer treatment sooner, given her a much greater chance of survival, and given the whole family (including Mrs P) a better quality of life. He also says that when Mrs P was paralysed, this comorbidity would have affected how she would respond to cancer treatment.

74. Mr P has also told us about the significant emotional distress the experience had on him, Mrs P, and their children. He also explained how distressing it was for him and his family to witness what Mrs P was going through. He says they witnessed her fear, and this was equally upsetting for them. He says their children saw Mrs P collapse on 15 February and this traumatised them. He says the way the Trust responded to and handled his complaint added to the grief they felt, and caused him further anguish, and frustration.

What would have happened

75. If not for the failings identified, we think that on the balance of probabilities:

• Mrs P would have undergone scans on 10 February which would have resulted in her being admitted to hospital for observation and further investigation. Our neurosurgery adviser told us it is very likely a CT scan performed on 10 February would have shown the tumours. They told us that given the size and mass effect (pressure on the brain tissue) of the large right sided tumour deposit in Mrs P’s brain, it is very likely the on-call neurosurgical team would have been contacted for their advice. Our neurosurgery adviser told us this advice would very likely have been to admit Mrs P. She would also have been told not to drive.

• Mrs P would have been given anti-seizure and steroid medication, and a referral would have been made to the neuro-oncology MDT to consider her treatment options. Our neurosurgery adviser said at the point of admission to hospital, the Trust would likely have commenced oral anti-seizure medication and steroids to counter some of the brain swelling Mrs P was experiencing. This would also have helped prevent further seizures.

• Mrs P’s blood pressure would have been monitored in hospital, with medication administered to keep this under control. This includes telling Mrs P not to take aspirin/being unable to take aspirin.

• Mrs P would also have likely undergone an MRI scan (to show a more detailed image of the brain) and a whole-body CT scan (to check for cancer spread). Our neurosurgery adviser also said referrals would have been made to the relevant neuro-oncology MDT and neurosurgical team.

• The Trust’s responses to Mr P’s complaints would have been more transparent, accurate, and evidence based.

76. We have considered how the above actions by the Trust might have changed the outcome for Mr and Mrs P. We appreciate this is a distressing prospect for Mr P and his family given their bereavement and efforts to obtain answers to their questions. We have drawn on evidence we have seen in Mrs P’s medical records, clinical advice and evidence provided by Mr P in plotting out how events would have played out in the absence of service failure.

77. There are areas where we do not consider earlier intervention by the Trust would have made a discernible difference to what ultimately happened. One of those areas concerns the commencement of steroids and anti-seizure medication in hospital. We understand why this is a key concern for Mr P. We have explained below why we do not think it would have had any bearing on reducing the risk of, or preventing, the bleed Mrs P experienced.

78. Our neurosurgery adviser told us anti-seizure medication and steroids have no effect on tumour bleeding. Anti-seizure medication manages and controls the brain’s electrical activity, so does not influence bleeding. Steroids are used to control swelling in the brain by tightening gaps between capillary cells of the capillaries in the tumour, preventing fluid (called oedema) but not blood (due to the size of blood cells), from leaking. High or low pressure in the brain does not directly influence the risk of bleeding. In fact, our neurosurgery adviser told us higher pressure around the tumour (localised pressure) can reduce bleeding because it means the tumour is compressed. Nevertheless, steroids are required to control the overall intracranial pressure (overall pressure within the skull).

79. We agree with Mr P that his wife would have been more closely monitored in hospital, which would have included managing her blood pressure. However, we cannot establish, on the balance of probability, if this would have prevented Mrs P’s bleed. We know she had diagnosed high blood pressure and was on medication. On 10 February, her blood pressure was slightly elevated at the TIA clinic (149/92) and later rose to 170/88 in the ED. Mr P told us his wife was very worried about her condition on 10 February and would have likely caused stress and anxiety. Stress can raise blood pressure, and the brain normally regulates its own blood flow (autoregulation). However, areas of the brain affected by a tumour lose this ability, increasing the risk of bleeding.

80. After Mrs P collapsed on 15 February, her blood pressure was extremely high (200/97). While a brain bleed itself can cause blood pressure to rise, the evidence suggests her blood pressure was likely not well controlled beforehand and, while we do not know what Mrs P’s blood pressure was before she suffered the bleed, her blood pressure was likely high and this likely contributed to the bleed.

81. Our neurosurgery adviser told us uncontrolled high blood pressure can cause bleeding in the brain. If Mrs P had been in hospital with better blood pressure control, the risk of bleeding might have been reduced. However, our neurosurgery adviser said due to the tumour’s nature and tendency to bleed, it is not possible to say for certain whether the bleed could have been prevented or delayed.

82. We think Mrs P would not have been taking aspirin if she had been admitted to hospital on 10 February and that this had a crucial bearing on Mrs P’s short-term outcome. The presence of aspirin would have reduced Mrs P’s body’s ability to clot her blood once a bleed started, even though the presence of it would not have caused a bleed to start. The Trust’s discharge summary of 10 February said Mrs P ‘has decided to take low dose aspirin until her MRI scan results are back’. Mr P also told us Mrs P had not mentioned taking aspirin before this date. Therefore, on the balance of probabilities, we consider Mrs P only started taking aspirin after she attended the ED.

83. Our neurosurgery adviser told us the anti-platelet effects of aspirin stay in the body for around 7 to 10 days. With this in mind, we think on the balance of probabilities it is more likely than not that Mrs P continued to take aspirin and the concentration of it increased over subsequent days. Our neurosurgery adviser said in such a scenario it likely made the bleed she experienced worse than it otherwise would have been. This is because Mrs P’s blood would not have clotted as quickly, leading to a longer period of bleeding.

84. On the balance of probabilities, we consider the aspirin contributed to a more severe bleed. If the bleed had not been as severe, we consider it is unlikely Mrs P would have been paralysed. This is because the extra volume and mass effect within the skull puts pressure on the brain and interferes with its blood supply. It can quickly cause brain and nerve damage resulting in paralysis.

85. Mr P’s key concern is whether discovery of Mrs P’s tumour earlier, would have meant she could have received treatment for her cancer which could have positively impacted her. We understand why he has those questions given the failings we have identified.

86. Our oncology adviser told us that before Mrs P experienced her catastrophic bleed on 15 February, there were several cancer treatment options available to her. They referred to Clinical Study A, Clinical Study B, Clinical Study C, and Clinical Study D to help support their advice about these options and their response rates (how effective the treatment is).

87. Only one of these treatment options remained available to Mrs P after her catastrophic bleed. Even in the absence of a bleed, these treatment options, however, were conditional and the decision-making on which option (or combination of options) to take would have been influenced by information and factors we simply do not have available to us. Factors affecting treatment options included:

• The size of Mrs P’s tumour.

• Mrs P’s performance score (a measure of fitness and activity levels in a person).

• Whether steroids would be needed as part of the treatment option and, if so, how long it would take to wean Mrs P off these before starting any second line treatments.

• The level of bleeding observed in Mrs P over time.

• Mrs P’s general health and well-being while undergoing treatment, and the progression of other cancers elsewhere in her body.

88. Sadly, in addition to not knowing if the bleed would have occurred, we also do not have sufficient information about Mrs P’s condition to be able to reach a view on the viability of any of the treatment options for Mrs P. We recognise that much of the information we are missing flows from the failings we have identified. For example, we do not know the original size of Mrs P’s tumour before her bleed because she was not scanned on 10 February. We understand the size of Mrs P’s tumour (that is, whether it was larger than 4cm or not) would have removed some of the options from the outset.

89. We know from the clinical studies (paragraph 24) that in the worst-case scenario, the treatment option would have likely brought Mrs P’s symptoms under control. However, it is possible it would not have prevented her death, and the same events would have unfolded and within the same, or similar, timeframe.

90. Our oncology adviser told us this treatment option in cases such as these control symptoms well but, once disease progression occurs (usually within six to 12 months), it usually results in the patient’s death around three to six months later. This is what we can see happened in this case. However, as we set out in paragraph 87 (fifth bullet point), Mr P is correct to say that Mrs P’s paralysis in itself may also have impacted how well she reacted to, and tolerated, the cancer treatment she received. If she was not paralysed, our oncology adviser told us it is possible she would have been offered more intensive treatment options which, in turn, she would have been more likely to be able to tolerate from a toxicity and side effect perspective.

91. In the best-case scenario (but also the most challenging treatment pathway to complete and therefore the most difficult) Mrs P may have been alive today. There are a range of options with a range of outcomes. Sadly, given the multifactorial nature of Mrs P’s condition, it is not possible to say how her cancer treatment could have been different.

92. As such, while we can say there were options available to Mrs P before she suffered a catastrophic bleed on 15 February, we simply do not know if the bleed would have proceeded to occur before treatment was selected, or which treatment option would have been chosen or been successful, had the bleed not occurred.

93. If the Trust had acted without failings, the outcome for Mrs P and the rest of the family might have been better than the outcome they received in actual events. This is because Mrs P would have been unlikely to have been paralysed which would have meant a better quality of life. In addition, had her care been managed differently, steps would have been taken which could have prevented the severity of the bleed she experienced, and she might have had multiple cancer treatment options available to her.

Impact on Mr and Mrs P and their family

94. We recognise Mrs P’s death has had a profound impact on Mr P and his family. While the events in this case are very sad in their own right, Mr P has explained to us his family’s experience with cancer over the years has meant it was particularly distressing and challenging. We think the failings identified led to a significantly reduced quality of life for Mrs P amounting to avoidable harm, significant uncertainty and distress for the family, and lost opportunities for a better outcome. This experience has been, and will continue to be, extremely distressing for Mr P and his family.

95. While we cannot say on the balance of probabilities whether the bleed Mrs P suffered on 15 February would have been delayed (or prevented) if she had been admitted to hospital on 10 February, we are satisfied that it is likely her uncontrolled blood pressure increased her chances of the bleed occurring. We are also satisfied that once that bleed started, the presence of aspirin worsened it significantly and likely led to her paralysis. This led to a reduced quality of life for Mrs P. Not only did this effect Mrs P physically, but also emotionally. Mr P says Mrs P thought something tragic was going to happen and it did. This was devastating for her.

96. Mr and Mrs P’s children were present when she collapsed on 15 February. This was traumatic for them and will continue to cause them distress - he has told us the image in their minds will not be forgotten. While Mr P was not present when Mrs P collapsed, it is distressing for him to know that his children witnessed this unnecessarily and they will all continue to be affected by this.

97. Seeing Mrs P living with her paralysis and her condition was equally distressing for all the family. Mrs P was unable to carry out everyday tasks unaided such as going to the toilet or turning over in bed. Early on in her recovery she needed to be hoisted which Mr P says was uncomfortable and undignified for her. Mrs P never regained the use of her left arm, and as it was only shortly before her death that she managed to regain some movement in her left leg, allowing her to walk short distances, albeit with significant effort. This paralysis impacted Mrs P’s ability to create good lasting memories with her children in what turned out to be the last nine months of her life. In other words, all the family’s memories were affected after the bleed.

98. It was also the case that given their family circumstances at the time, Mr P gave up work to care for his wife and their young children. While Mr P is not claiming a direct financial loss, this had a direct impact on how the family lived their life at this time. Furthermore, during the events of this complaint, Mr P was recovering from surgical treatment for his own cancer, which added to the distress and uncertainty of the time.

99. We cannot say whether Mrs P’s bleed would still have happened or been prevented. We do not know the condition of her tumour before the bleed happened and how that might or might not have affected her being able to access all or some of the six treatment options. We also do not know if, or how much, this would have extended her life. We appreciate Mr P will believe a curative option was available and he will sadly never know if that is true. This is particularly acute for the family because Mr and Mrs P’s own daughter was sadly diagnosed with cancer at the age of two and was given a 25% chance of survival. Thankfully, their daughter is now nineteen and healthy. This means their own lived experience of ‘beating the odds’ would reasonably create a belief that the same could have happened again, which adds to their distress.

100. That belief will stay with him for the rest of his life. This represents a significant uncertainty for Mr P and his family, and this is a serious injustice to them that is ongoing.

101. We consider the Trust’s complaint handling compounded matters. It caused Mr P further distress, frustration, anger, and anguish. We also think it caused him to lose trust and faith in the Trust and ultimately added to the grief he and his family feel. The relationship between Mr P and the Trust broke down, and his experience will stay with him for a long time. We set out recommendations below to put this right.

1. Mr P complains Gloucestershire Hospitals NHS Foundation Trust (the Trust) did not complete appropriate tests when his wife, Mrs P, attended a transient ischemic attack (TIA – an episode of stroke-like symptoms that completely resolve) clinic and then the emergency department (ED) on 10 February 2017, and gave her inappropriate advice. He also complains the Trust’s complaint handling was poor because it did not balance the evidence appropriately and contained inaccuracies. We recognise how distressing, traumatizing, and drawn out this experience has been for Mr P and his family.

2. We have found:

• A failure to carry out brain imaging on two occasions, in the TIA clinic and ED.

• A failure to provide appropriate advice, in the TIA clinic and ED.

• A failure in complaint handling.

3. We consider the impact of these failings to be significant. We consider there was a loss of opportunity for a better clinical outcome for Mrs P, and that her quality of life was significantly reduced in her last few months of life because of avoidable harm. We also consider Mr P, and his family, suffered significant distress. We also think they will be left with uncertainty that will continue beyond the conclusion of our investigation.

4. We therefore uphold this complaint.

5. We recommend the Trust takes action to put things right. We recommend the Trust write to Mr P to acknowledge the failings identified and apologise for the impact arising from them. The Trust should also make a payment of £12,500 to Mr P in recognition of the impact of its failings. We also recommend the Trust creates an action plan setting out what action it will take, or has already taken, to prevent a repeat of these mistakes and share this with the parties set out at the end of this report.