Research trials 15. Ms B complains the Trust did not gain her family’s consent when it enrolled her sister onto the UK ROX and EXAKT research trials during her admission to the intensive care unit (the ICU) in June 2023. She says this is a serious breach of the published research protocol.
16. We were sorry to hear Ms B’s concerns about how the Trust managed her sister’s involvement in the trials during her admission. From what she told us, it was clearly an extremely difficult time for her and her family, and it is understandable that this concern caused them additional distress at an already distressing time.
17. UK ROX is an ICU research trial that compares two approaches to oxygen therapy. It is a large-scale clinical trial looking at patients who are admitted to ICU requiring oxygen therapy via mechanical ventilation and seeing whether a lower target oxygen (conservative oxygen therapy) level may lead to better patient outcomes compared to the standard level of oxygen given.
18. To be eligible to take part in the trial, patients must be over 18, receiving mechanical ventilation in the ICU following an unplanned admission (so not after an elective procedure) or invasive mechanical ventilation that was started in the ICU, and receiving supplemental oxygen.
19. UK-ROX trial guidance says that once enrolled onto the trial, patients will be randomised to receive lower target oxygen therapy or standard oxygen therapy. It says it uses a deferred consent which means patients will be randomised to receive the assigned treatment as soon as possible without prior consent. By doing this it aims to minimise the distress and burden on families during a distressing time. Following randomisation, the Trust will then approach the patient if they have capacity to give consent.
20. However, it is generally not possible to gain consent from patients who are eligible for this trial early in the process, as they are critically unwell and mechanically ventilated. The used of sedatives and analgesic drugs mean that patients may lack capacity or the ability to communicate effectively.
21. Therefore, the guidance says the Trust should approach the personal consultee (a friend or close relative) instead and ideally this should be done within 24-48 hours of randomisation, and once the patient’s medical situation is no longer considered an emergency. The personal consultee should sign the opinion form to give consent. If the personal consultee advises that the patient would choose not to participate in the trial, this decision will be respected and will be abided by, and the trial treatment will be stopped.
22. If the participant sadly dies or there is no personal consultee available (or they do not want to be consulted), the Trust is able to approach an independent person such as a doctor not involved in the trial for their opinion. This is a nominated consultee, and they are also eligible to give or decline consent and sign the opinion form.
23. EXAKT stands for ‘Exploring pulse oXimeter Accuracy across sKin Tones’ and is a sub study of UK-ROX meaning it runs alongside it. The aim of this trial is to find out whether skin tone affects the accuracy of pulse oximeters. A pulse oximeter is a probe/clip on a patient’s finger that measures their oxygen levels. This trial involves various measurements from the patient, some of which are part of standard care on the ICU, however, it does include additional oxygen measurements from finger-tip pulse oximeters.
24. Our adviser explained that in intensive care, there are two main methods to find out a patient’s oxygen levels and these are: Pulse oximetry which is a non-invasive measurement of oxygen levels using a probe on the finger which gives a percentage of blood oxygen saturations, and arterial blood gas sampling where around 1ml of blood is taken regularly and analysed using a machine on the ICU.
25. There is increasing evidence that pulse oximeters may overestimate true oxygen levels for people with darker pigmented skin which can lead to underestimating the severity of a person’s condition. The Exakt study uses several pulse oximeters and for each patient, two of these are usually placed on the fingers. The oxygen level is then compared to the oxygen level in a routine blood sample (arterial blood gas sample). Our adviser explained that these blood samples are part of routine care on ICU regardless of research trials.
26. Ms C was admitted to the Trust in late June after she had been found unresponsive at home. The Trust diagnosed an intracranial bleed (bleeding within the head) following a CT scan on the same date. It then intubated Ms C (inserted a tube to help her breathe) and enrolled her onto the UK-ROX / EXAKT study the same day.
27. Following randomisation, the Trust provided Ms C with usual oxygen therapy. This means she received the same oxygen she would have received without enrolment onto the trial.
28. Five days later, the Trust decided to remove Ms C from the trial. From what we have seen, the Trust felt unable to inform the family about the trials due to miscommunication between it and the family. Ms C sadly died the next day. The Trust informed the family about Ms C’s involvement in the trials by email two weeks after her sad death.
29. From what we have seen, the Trust followed UK-ROX trial guidance when it initially enrolled Ms C onto the trials. This is because it identified that Ms C was eligible to take part in the trial as she met the criteria above which states patients must be over 18, and receiving mechanical ventilation in the ICU following an unplanned admission. It then followed the process to randomise her onto the trials. As the Trust uses deferred consent for these trials in line with the UK-ROX guidance, it is not necessary for it to gain this consent before enrolling a patient onto it.
30. Our adviser explained that if a patient is not able to give consent due to being sedated or unconscious, as in Ms C’s case, the Trust should have found a family member or someone to advocate for the patient. It should have then given this person information about recruitment onto the trial, given them information about the trial itself, and asked if the patient would have wanted to continue with their enrolment.
31. However, we cannot see any evidence that the Trust sought consent from Ms C’s family in a timely manner for her to continue on the trial after the initial enrolment, in line with the UK-ROX guidance that says the Trust should approach a personal consultee (a friend or close relative), ideally within 24-48 hours of randomisation. As we cannot see any evidence the Trust followed the UK-ROX guidance and gained consent, this is a failing. We will consider the impact of this later in our report.
32. Ms B is also concerned with how the Trust removed her sister from the trials. She does not think it has been truthful and believes it removed her due to her sad death rather than the Trust’s concerns that it’s communication with the family was causing them additional distress.
33. From the evidence we have seen in the medical records, the Trust decided to remove Ms C from the trials as it was unable to communicate with the family in view of miscommunication problems between it and Ms C’s relatives. The Trust told us it contacted the study sponsor on the same day for advice on how to formally remove her from the trials.
34. From what we have seen, it completed the nominated consultee opinion form in early July (after Ms C’s sad death) when it received advice from the sponsor. A doctor who was not involved in the trials completed the nominated consultee opinion form.
35. We consider this action is in line with the UK-ROX guidance above as the Trust approached a nominated consultee (a doctor not involved in the trials) to complete the opinion form to remove Ms C from the trials, after her sad death.
36. However, the Trust used her admission date as the date on the consultee form rather than the date it decided to remove her from the trial. It is understandable that this fact has concerned her family.
37. Our adviser explained that while the Trust did backdate the consultee form to Ms C’s admission date, we can see that it did complete the necessary form to remove her from the trial after it decided to do so, five days after her admission.
38. We cannot see any documentation in the medical records to explain why the Trust used Ms C’s admission date when it completed the form to remove her from the trials, and it is understandable that this fact may have led to confusion for the family. The UK-ROX guidance does not explain what to do in this situation either, which means we cannot say what the Trust did here was wrong.
39. The Trust decided to remove Ms C from the trials five days after her admission and one day before her sad death. Therefore, we consider it did this as it did not get consent from the family rather than because Ms C sadly died.
40. Based on this information, we do not consider it did this as a reaction to Ms C’s sad death as Ms S suspects. We hope this information reassures Ms C’s family and clarifies anything they are unsure about.
41. As we have seen that something went wrong when the Trust did not get the family’s consent for their sister to take part in the trials within 24-48 hours, we have gone on to consider how this impacted Ms C and in turn, her family.
42. Ms B told us that her and the family were most distressed and angry when the Trust informed them by email two weeks after her sad death, that their sister had taken part in the research trials. She explained that words cannot convey how the family felt at that time when they received the news following her sister’s sad death.
43. She told us the family has not grieved her sister’s sad death, and she is concerned the Trust did not respect her sister which causes her distress. We were sorry to hear how the Trust’s actions around consent caused the family additional distress at an already significantly upsetting time.
44. Our adviser explained that although the Trust did not gain consent from Ms C’s family to enrol her onto the research trials, her involvement in the trial did not impact or make a clinical difference to her sad outcome. This is because the trial did not involve any interventions that could have impacted her care as she received the same level of oxygen she would have otherwise.
45. However, the Trust’s actions around consent and lack of communication about this, is likely to have caused the family anger and distress. We can see evidence that the Trust had at least eight conversations with Ms C’s family about her condition during her admission and these are missed opportunities to inform them about her enrolment in the trials.
46. Our Principles of Remedy say that to put things right, organisations should provide an apology, explanation, and an acknowledgement of responsibility.
47. In its responses to the complaint, the Trust acknowledged its poor communication and recognised it should have communicated Ms C’s involvement in the trials much sooner than it did. It apologised for its poor communication and recognised this added to the distress and upset Ms B and her family experienced. This action is in line with our Principles.
48. Although we do not consider the Trust’s actions had any clinical impact on Ms C, we can see how finding out she was on the trials after the event, would have caused her family the confusion, distress, and upset they told us about. We imagine it made an already distressing situation more stressful.
49. Ms B wants an acknowledgement of failings and a financial remedy. We have seen the Trust has acknowledged the distress this experience had on Ms B and attempted to remedy this by apologising.
50. We considered our Severity of Injustice scale as Ms B requested a financial remedy to resolve her complaint. The impact of the failings we found, fall into the lower levels of our Severity of Injustice scale and we would expect an apology and service improvements to remedy the impact that flowed from the failings, which in this case, is distress, anger, and frustration.
51. Based on this, we consider the Trust should implement service improvements regarding consent to prevent the same thing from happening again, and we cannot see any evidence in its responses that it has considered this. Therefore, we will make recommendations at the end of our report.
Communication and complaint handling 52. Ms B is understandably concerned with how the Trust managed her complaint. She complains the Trust did not address her concerns when it investigated her complaint, and this prolonged the complaints process. She is also concerned the Trust took additional oxygen measurements from her sister whilst she was on the research trials, and it did not disclose this in its response to her complaint. She told us she later found out this information from another organisation.
53. We were sorry to hear how the Trust’s management of Ms B’s complaint caused her distress and that she feels it did not provide her with the correct information during the complaints process. We can imagine this was incredibly frustrating for her and her family as they were still in the grieving process following the sad death of their sister.
54. The NHS complaints standards say an effective complaint system makes sure staff take a thorough, proportionate and balanced look into the issues raised by a complaint. It goes on to say organisations should give people a clear, balanced account of what happened based on established facts and be open and honest when things have gone wrong or had an unfair impact and take accountability for this.
55. The NHS Complaints Regulations say that organisations must provide a response within six months from the day the official complaint was made.
56. The Trust initially told Ms B her sister had been involved in the trials during her admission, by email two weeks after her sad death. It explained that it uses deferred consent to enrol patients onto the trials and because it recognised the stress her family faced during her sister’s admission, it made the decision to remove her from the trial as it did not feel her participation on it was appropriate. It reassured the family that the trial did not impact or alter the care her sister received.
57. In early August, Ms B raised her concerns to the Trust about her sister’s involvement in the trials and how this then escalated the family’s concerns about her sister’s overall care during her admission. She requested the full details of the trials, all correspondence and material relating to her sister’s involvement in it, and all reports relating to his sister’s care in relation to it.
58. The Trust responded to the complaint approximately two weeks later. In this response, it gave further details about the trial, how Ms C was randomised onto it, and the reason it made the decision to remove her from it (as it felt further communication with the family at the time would have led to more distress for them).
59. It reassured Ms C that any data collected during the trial would not be used for analysis and that the trial did not alter her sister’s treatment. It included the trial screening and randomisation form, the consultee opinion form to withdraw her from the trial, and the details of the research trials as per Ms B’s request.
60. We have seen this first response from the Trust answered Ms B’s initial concerns and provided her with the information she requested when she complained to it. Therefore, the Trust followed the NHS complaints standards here when it responded to the complaint as it gave a clear, balanced account of what happened based on established facts.
61. In early September, Ms B raised further concerns that the Trust missed opportunities to seek her family’s consent for her sister to take part in the trials. She told the Trust that it had breached the research trial protocol because of this and requested an explanation as to why it did this. She complained that her sister’s involvement in the Exakt trial meant that she was subjected to additional measurements that would have not taken place if she had not been on the trial.
62. She says the Trust’s statement that the trial did not change the treatment her sister received, was not true. The family requested further information which included their concerns about what data from their sister’s care was used in relation to the trials and requested that the Trust removed this from the national research electronic system. She also reminded the Trust she had requested all information relating to her sister’s involvement in the trial.
63. A month later, the Trust confirmed that Ms B’s concerns had been logged for a formal investigation. We can see she reiterated her main concerns to the Trust later in October. These main concerns were that the Trust did not inform the family that her sister had been enrolled onto the research trials during her admission, it removed her sister from the trials as she had sadly died rather than the Trust not getting consent from the family, it backdated the nominated consultee form to her admission date incorrectly, it had not reassured the family that her sister’s data from the trial would not be used, she felt her sister’s treatment had changed because of the trials, and she wanted the name of the ICU consultant the family had met with during her sister’s admission.
64. At the end of October, she shared additional concerns about a wound on her sister’s neck. The Trust acknowledged these letters 11 days later. She contacted the Trust again in early December as it had not provided a response to her complaint within 40 days, and she raised further concerns which included the conduct of two doctors.
65. In mid-January 2024, the Trust wrote to Ms B with its initial review of her complaint. It acknowledged that Ms B had made repeated attempts to get answers to her concerns, and the Trust had failed to appropriately address and answer the concerns she raised. It recognised that Ms B had outstanding concerns or concerns that it had not fully addressed.
66. It apologised for the delays and poor communication and acknowledged this added to the distress and anger the family experienced. It said that it planned to address all her concerns in one comprehensive response. It offered to provide Ms B and her family with a face-to-face meeting prior to providing this full response and suggested it could organise someone independent to investigate the complaint. It acknowledged flaws in its complaint handling to this point and planned to address the core concerns she had raised.
67. Eight days later, Ms B wrote to the Trust. She explained that its previous letter was not a full response to her complaint, failed to address her concerns, and requested it urgently address all her concerns. She explained that the complaints process had caused her and her family great distress. She set out her detailed outstanding concerns in her letter for the Trust to consider which included her concerns about the trial and the data relating to this, additional oxygen measurements taken by the Trust during her sister’s admission, a wound on her sister’s neck, and the Trust’s handling of her complaint.
68. In early February, the Trust provided Ms B with a final response to her complaint. We can see that it addressed all her concerns from her previous correspondence, in this response. It also explained that as no additional diagnostic tests are required for the trials it enrolled Ms C onto, it therefore did not take additional readings from her due to this. However, based on the guidance above about the Exakt trial, we can see the trial involves additional oxygen measurements from finger-tip pulse oximeters. Therefore, we do not consider this information to be factually correct.
69. From what we have seen in the final response, the Trust partially followed the NHS complaint standards as we can see it answered Ms B’s questions in a fair and balanced way. However, as we consider the information about the additional readings to be factually incorrect, the Trust did not follow the NHS complaint standards here as it did not appear give a clear, balanced account of what happened based on established facts and be open and honest when things have gone wrong.
70. As the Trust did not follow the NHS complaint standards consistently, this is a failing and we will consider the impact of this later in our report.
71. After considering the timeline above, we can see the Trust took four months to provide Ms B with a final response to her complaint. We can see that the Trust provided a final response within the six months timeframe specified in the NHS Complaints Regulations, therefore the Trust followed relevant guidance here when it responded to the complaint within this timeframe.
72. It is clear from the information and correspondence that we have seen, this was a difficult process for both Ms B and the Trust. It is understandable that Ms B became frustrated with the complaint process as she was trying to gather information about what happened during her sister’s care. We can see that she requested additional information from the Trust during the complaints process and shared further concerns with it when she contacted it on at least three occasions following its confirmation of its formal investigation of her complaint.
73. We recognise that these additional requests would have prolonged the Trust’s ability to provide a comprehensive final response, however, it still did this within the relevant time frame in the NHS complaints regulations guidance. Therefore, we consider that nothing went wrong here.
74. As we have seen that something went wrong when the Trust informed Ms B that it did not take any additional readings from her sister during her admission due to the trial, we have gone on to consider the impact of this.
75. Ms B explained that the whole complaint process has taken a massive amount of time and has been awful for the family. She says the misinformation from the Trust about the additional measurements caused them distress. We can imagine getting this information from another organisation caused Ms B some of the distress she told us about.
76. We cannot not see any evidence in the medical records to suggest that the Trust carried out any extra invasive procedures for example additional blood samples, because of Ms C’s enrolment onto the trials.
77. Our adviser confirmed that an additional pulse oximetry probe was used due to the trial, but this is non-invasive. We recognise that this may have led to some confusion between the Trust and Ms B about the actual meaning of additional measurements. It is possible that the Trust interpreted this question to mean additional invasive readings and based its answer on the fact that no additional diagnostic tests were required for the trials.
78. Although this lack of communication did not impact the care Ms C received, we do consider it caused Ms B some level of distress, especially as she found this information out from another organisation.
79. Our Principles of Remedy say that to put things right, organisations should provide an apology, explanation, and an acknowledgement of responsibility.
80. We cannot see any evidence to suggest the Trust has acknowledged this statement may be factually incorrect or recognised Ms B’s interpretation of it may not be how it intended it to come across, in line with our Principles.
81. Ms B told us she wants an acknowledgement of failings and a financial remedy to resolve her complaint, so we considered our Severity of Injustice scale. The impact of the failings we found relating to communication, fall into the lower levels of our Severity of Injustice scale and we would expect an apology to remedy the impact that flowed from the failings, which in this case, is distress and frustration.
82. We cannot see the Trust has fully acknowledged or fully remedied this part of Ms B’s complaint or the distress and frustration this information may have caused her. Therefore, we will make recommendations at the end of our report.
Conclusion 83. Based on the available evidence and the clinical advice, we consider the Trust followed UK-ROX guidance when it removed Ms B’s sister from the research trials, and the NHS complaints regulations when it responded to her complaint. Therefore, we will take no further action on these aspects of the complaint.
84. However, the Trust did not follow guidance from UK-ROX when it did not get deferred consent from Ms B and her family to enrol their sister onto the trials. We also think some information in its final response in February 2024 is factually incorrect and therefore does not follow NHS complaint standards which say organisations should give people a clear, balanced account of what happened based on established facts. We consider this led to some of the distress Ms B told us about.
85. Therefore, based on our Principles, we consider it is reasonable the Trust does some further work to remedy this complaint, and the distress its actions caused Ms B. Overall, we partly uphold this complaint and make recommendations.