Risk of complications
19. Ms R complains the Trust did not provide her mother with an accurate explanation of the risks of complications her surgery might cause. She says Mrs R was told the risk of complications was 2-3%, whereas the actual risk was 8%. She told us her mother would not have gone ahead with the surgery if she had known this.
20. As explained previously, in December 2021 Mrs R had an operation to remove the upper section of her left lung. She had a scan in November 2022 which suggested the lung cancer had come back, and so her case was discussed at a Multi-Disciplinary Team (MDT) meeting on 15 November. An MDT is a group of healthcare professionals from different disciplines who collaborate to discuss and make joint decisions about a patient’s care.
21. MDT records note the scan results were consistent with lung cancer. They also note that, for technical reasons, stereotactic body radiosurgery (SABR) was not an option. SABR is a precise, high-dose radiation treatment that uses small beams to target a tumour with minimal damage to surrounding healthy tissue. The conclusion of the MDT was that Mrs R should be offered the option of wedge resection, i.e. surgery to remove tissue.
22. We considered how this was explained to Mrs R. The GMP guidance, section 32, says doctors must give patients the information they want or need to know in a way they can understand. The NICE perioperative guidance covers all phases of care, from the time patients are booked for surgery until they are discharged afterward. It says a patient’s risks and surgical options should be discussed with them to allow for informed shared decision making.
23. Mrs R had an appointment with a consultant thoracic surgeon on 22 November. The surgeon wrote to Mrs R on 23 November and confirmed the information discussed during the appointment as follows: • radiotherapy was not suitable for technical reasons, and they advised a surgical operation • a repeat operation was always more complex than the first because of anticipated adhesions of the lung within the chest wall • they would try and preserve a part of her lower lobe but might end up having to remove it completely (this is known as a complete pneumonectomy) because of the location of the tumour • Mrs R had good lung function and did not have any other major medical conditions • Mrs R was keen to proceed with surgery fully aware of increased risk complications in the form of infection, bleeding, bronchopneumonia, respiratory failure and not surviving the operation • the risk of these complications was in the range of 2% to 3%.
24. The SCTS guidance says the risk of complications of a lobectomy is 2%. The evidence shows, however, the thoracic surgeon told Mrs R they might need to do a complete pneumonectomy. The SCTS says a pneumonectomy is considered high risk surgery. Nationally, one person in 20 (5%) dies within one month of surgery. The patient’s individual risk might be higher or lower depending on their health.
25. We understand from our thoracic adviser that, because it was possible a pneumonectomy might need to be done, Mrs R should have been given a risk factor of between 8% and 10%. This is because the risk of that procedure is 5%, and Mrs R had additional factors (scar tissue from her previous lung surgery and she was taking methotrexate, which is an immunosuppressant), which needed to be taken into account.
26. In its complaint response, the Trust said the risk quoted to Mrs R was based on national, departmental and personal assessments, considering the complexity of the procedure and the patient’s medical conditions.
27. Mrs R was admitted to hospital on 5 January for her surgery later that day. She signed a consent form which explained the risks of the surgery and reiterated the mortality risk was 2% to 3%.
28. During the surgery, the thoracic surgeon decided to remove Mrs R’s left lower lobe. This meant she had undergone a completion pneumectomy.
29. The evidence we have seen shows Mrs R was not given an accurate risk factor for complete pneumectomy surgery, even though the thoracic surgeon knew it was a possibility in her case.
30. We found Mrs R was not given an accurate explanation of the risk of complications from the surgery. She was told at the appointment on 22 November, and again on 5 January, her risk of serious complications was between 2% and 3%. Taking into account that the Trust was aware Mrs R might need a pneumonectomy, she had scar tissue from previous surgery, and was taking methotrexate, she should have been told the risk of complications was at least 8%. We found the Trust did not act in line with the GMP and NICE guidance we have referred to. We looked at the impact of this below.
Impact
31. The Trust gave Mrs R an underestimated risk of complications for her surgery. Ms R told us her mother would not have gone ahead with surgery if she had been given an accurate explanation of the increased risk. This has caused Mrs R’s family distress.
32. The risk level formed part of the information the Trust gave to Mrs R to help her decide if she wanted to go ahead with surgery. This means she did not have the full facts available to her and so did not have an opportunity to make an informed decision about her treatment based on full and accurate information.
33. Our oncologist adviser told us surgery and SABR were the only potentially curative treatments for Mrs R’s lung cancer. We can see, however, SABR was not suitable in Mrs R’s case. This left surgery as the only potentially curative treatment option available to Mrs R. Our adviser says the only other treatment options available to Mrs R were chemotherapy and radiotherapy. However, these were palliative options, rather than curative, meaning they could be used only to prolong Mrs R’s life and make her more comfortable. They could not have cured her condition.
34. This means that, if Mrs R had been given accurate information, her choices would have been to have surgery knowing there was an 8% risk of serious complications, including death, or accepting her condition could not be cured, and the focus of her treatment would now be on improving the quality of the time she had left.
35. We cannot give any view as to whether or not Mrs R would have made the decision to go ahead with surgery if she had been advised the surgery had a higher risk of complications. We understand this would be an extremely difficult decision for any patient to make. Ms R is clear that she believes her mother would not have gone ahead with the surgery if she had known the increased risks. We recognise her strength of feeling here. In our independent and impartial role, we cannot give any view on the balance of probabilities as to what Mrs R would have decided. This means we cannot say the poor communication we have identified led to her sad death at that time.
36. What we can say is that the knowledge that Mrs R was not given an opportunity to make an informed decision has caused additional distress to her family at an already difficult time. They can now never know if she might have made a different decision about treatment. We cannot say the outcome would have been different but the uncertainty of not knowing what Mrs R would have decided is an injustice in itself.
37. Our complaint standards say wherever possible, staff should explain why things went wrong and identify suitable ways to put things right for people. Remedies may include: • a meaningful apology, explanation, and acceptance of responsibility • remedial action including revising policies and procedures to stop the same thing happening again and financial compensation for direct or indirect financial loss, loss of opportunity, inconvenience, distress, or any combination of these.
38. We can see in the SIR, the Trust put in place an action point which recommended the thoracic surgery team should review the relevant literature and discuss the risks of surgery and tailoring these risks for individual patients at its next meeting. In its complaint response the Trust said Mrs R’s positive attitude during consultation and her remarkable recovery from her previous surgery led the consultant thoracic surgeon to underestimate the risks in her case. It said it sincerely apologised for this.
39. Overall, the Trust’s failure to provide Mrs R with accurate information in November 2021 likely led to additional and avoidable upset, distress and frustration for her family. We found the Trust has not adequately acknowledged the full impact of this failing. This is because it has not acknowledged the family’s ongoing distress that Mrs R’s decision to go ahead with surgery might have been different if she had been in full possession of the facts, or the impact of knowing this after her death has on them. We have therefore made recommendations to the Trust to put things right.
Existing medical conditions
40. Ms R complains the Trust did not take account of her mother’s current medical conditions when it decided to go ahead with surgery on 5 January. Specifically, she tells us her mother had a recent chest infection for which she had taken antibiotics, was taking methotrexate for rheumatoid arthritis, and had a positive Covid-19 test on the day of her operation.
41. We have carefully considered the process by which doctors decided to proceed with Mrs R’s surgery on 5 January.
42. BTS guidelines make recommendations for clinicians when assessing a patient’s fitness for lung cancer surgery, including pulmonary function. Pulmonary function is measured during a spirometry test. Forced Expiratory Volume 1 (FEV1) is a measurement of lung function that indicates how much air a person can forcibly exhale from their lungs in one second. A FEV1 result of 40% or less is considered high risk for the planned procedure. Patients with a FEV1 of more than 40% are considered average risk and no further tests are required.
43. The NICE preoperative guidance says every patient requiring surgery and/or anaesthesia or anaesthesia-led sedation should undergo formal preoperative assessment before the day of admission to ensure they are fit for surgery and anaesthesia. The American Society of Anaesthesiologists (ASA) Physical Status Classification System should be used to confirm a patient’s fitness to undergo anaesthetic. The ASA system says patients undergoing major or complex surgery (including lung operations) should have the following tests prior to surgery: • full blood count • kidney function • electrocardiogram (ECG, which records the electrical activity of the heart).
44. Mrs R was referred for a pre-operative lung function test. The test was done on 4 November. Her FEV1 was recorded as 93% and it was noted she had normal spirometry and lung volumes.
45. We understand from our thoracic adviser that, in line with BTS guidelines, these results meant the Trust did not need to make further investigations outside of the formal preoperative assessment.
46. A nurse called Mrs R on 20 December to complete a pre-admission screening. They recorded Mrs R had a normal spirometry on 4 November. They scheduled a full blood count, renal (kidney) function test and ECG for 28 December. They noted Mrs R was taking methotrexate and would ask the thoracic surgeon if Mrs R needed to stop taking it before the operation. This is because methotrexate suppresses the immune system, which can increase the risk of infection.
47. The rheumatology guidance recommends withholding methotrexate for one dosing interval before surgery.
48. The nurse called Mrs R on 22 December and told her the thoracic surgeon said she needed to stop taking methotrexate a week before the operation. This is in line with the rheumatology guidance above. During the call, Mrs R told the nurse she had recently been diagnosed with a suspected chest infection and prescribed a seven-day course of antibiotics. The nurse told Mrs R to contact the clinic if she was not well enough to attend her appointment on 28 December.
49. Mrs R attended the pre-operative appointment on 28 December. She had blood count, ECG and kidney tests which were within normal levels and raised no concerns.
50. We can see from our independent thoracic advice that Mrs R’s pre-operative assessments were completed in line with NICE guidance.
51. We explored with our thoracic adviser whether the lung function test should have been repeated when the Trust became aware of Mrs R’s chest infection. There are no published standards or guidelines that would address this scenario. Our adviser explained the lung function test would normally only be repeated if Mrs R’s symptoms changed or if the chest X-ray raised any issues. This was not the case for Mrs R.
52. Mrs R was admitted to hospital on 5 January for her planned surgery later that day.
53. A nurse recorded Mrs R had: • last taken methotrexate two weeks ago • completed her course of antibiotics eight days ago • normal spirometry (which we understand refers to the test taken on 4 November) • a Covid-19 test that morning.
54. The Trust says in January 2022 it required all patients who were being electively admitted to a critical care area to have a routine Covid-19 swab at the point of admission to ensure appropriate placement of patients in the vulnerable category within the critical care environment. A decision to go ahead with surgery was not dependent on the outcome of the test and it would not be delayed pending a result.
55. We have looked at the RCA guidance, which says a thorough anaesthetic pre-assessment should be performed on all patients prior to surgery to make sure the patient is fit and optimally prepared for surgery.
56. An anaesthetist spoke to Mrs R as part of a clinical assessment before the surgery. They noted she was on methotrexate for rheumatoid arthritis had been given a seven-day course of antibiotics on 22 December following a chest X-ray. They also noted she had no cough and was now better.
57. The anaesthetist discussed Mrs R’s recent chest infection with the thoracic surgeon. They decided to do a chest X-ray prior to the operation. The X-ray was reviewed and the anaesthetist recorded it was clear.
58. The thoracic surgeon recorded during the operation they sent a section of Mrs R’s lung for analysis. It showed mixed adeno-squamous carcinoma (an aggressive type of cancer), and the surgeon completed a left lower lobectomy.
59. At 5.29pm the Trust recorded Mrs R’s Covid-19 test was positive.
60. The operation was completed at 6.40pm. Mrs R was then moved to the Enhanced Post-Operative Care unit (a specialised ward for higher-risk surgical patients who need more monitoring than a general ward but not intensive care) at 8.20pm.
61. In the early hours of 7 January Mrs R became unresponsive and records show she was in peri-arrest. This is the critical period immediately before or just after a patient goes into full cardiac arrest. It is a medical term used to describe a patient who is very unstable and exhibiting signs of severe clinical deterioration. Doctors decided to intubate her due to lack of airway protection, respiratory distress, and likely aspiration (the accidental inhalation of foreign material into the airway and lungs).
62. Mrs R was transferred to the Critical Care Unit. Despite treatment she continued to decline and sadly died at 6.30pm.
63. We understand from our thoracic adviser that an anaesthetic team makes their assessment about a patient’s suitability for anaesthesia based on the history, examination and previous records available to them. We found from our advice that in Mrs R’s case the anaesthetist’s assessment was performed and documented in line with guidance and, based on the information available, there were no contra-indications (factors that make a procedure unsafe) to surgery.
64. Following Mrs R’s death, the Trust completed an SIR into the circumstances surrounding her care. The purpose of an SIR is to investigate what (if anything) went wrong, learn from the event, and implement changes to prevent similar incidents from happening again. The SIR found the surgery should have been delayed, considering Mrs R’s recent chest infection, the fact she had been on methotrexate, and because the surgery was for a complete pneumonectomy.
65. We explored this very carefully with our thoracic adviser, as we found that the Trust acted in line with applicable guidelines and standards of care, for the reasons explained above. We understand that, with the benefit of hindsight, the SIR’s conclusion that it would have been better for the surgery to have been delayed was logical. However, this does not indicate that the care and treatment Mrs R received was outside of applicable guidelines and standards. Nor do we consider such matters with the benefit of hindsight, as it would not be fair and impartial to do so. In carrying out our work, we consider whether organisations acted in line with applicable guidelines and standards based on the information available to them at that time.
66. We can also explain that, irrespective of whether the surgery had been delayed, it still came with a high risk of mortality, and any delay would not have changed that. This means we cannot say the sad outcome would have been different. Mrs R died of aspiration pneumonia, which was unrelated to her recent chest infection or methotrexate prescription.
67. We are satisfied the Trust acted in line with the guidance we have referred to. It was aware of Mrs R’s health conditions and medications when it made the decision to proceed with surgery on 5 January 2023. It knew she recently had a chest infection, and had been taking methotrexate up until two weeks prior to the surgery. We can also see the outcome of the Covid-19 test was not relevant to whether surgery would go ahead.
68. While we found the Trust acted in line with guidance in this matter, we are pleased that as part of the SIR the Trust identified improvements it could make in cases similar to Mrs R’s.
Accessing other health care provider records
69. Ms R complains the Trust did not access Mrs R’s GP records or those from a different NHS trust before it decided to go ahead with the operation on 5 January.
70. GMP says that, in providing clinical care, doctors must check that the care or treatment they provide for each patient is compatible with any other treatments the patient is receiving and make good use of the resources available to them.
71. NHS England’s SCR guidance explains SCR is a national database that holds electronic records of important patient information for anyone born in England or who has registered for NHS care there. A patient’s SCR is created automatically when they are registered with a GP practice in England. At a minimum it contains information about current medication, allergies and details of any previous bad reactions to medicines. The SCR can be seen and used by authorised staff involved in the patient’s direct care. The original scope of SCR was to provide access to key information in urgent and emergency care settings, although other care settings, including ‘scheduled care’, are approved to view it. A ‘scheduled care’ setting refers to non-emergency medical services that are planned in advance, including outpatient appointments, diagnostic tests, and scheduled surgeries.
72. Unless trusts use compatible clinical records system, they are not able to access a patient’s records from another trust directly.
73. We have looked at Mrs R’s GP records, which show she was prescribed methotrexate for rheumatoid arthritis from June 2019. The last prescription prior to her surgery was issued on 2 December 2022.
74. Records also show Mrs R went to her GP on 21 December. She said she had a flu-like illness for one week which was getting worse. The GP referred her to a hospital in a different NHS trust for assessment.
75. Mrs R went to that hospital the same day. She was diagnosed with a suspected lower respiratory tract infection, and prescribed antibiotics. This information was available on her GP record.
76. We cannot see Mrs R’s SCR was accessed by Trust staff prior to her surgery. There are no guidelines or standards that say this is a requirement for elective surgery. As such, we have not seen anything to indicate it made mistakes in not doing so.
77. We have seen, however, the Trust knew in advance of Mrs R’s surgery that she was taking methotrexate and had a chest infection for which she had taken a seven-day course of antibiotics. As we explained earlier, this information was taken into account as part of the pre-operative assessment process. We have not seen anything to indicate that if Mrs R’s GP and the other hospital’s records had been accessed, they would have given any additional information that might have impacted on the clinical decision-making process. We hope this provides reassurance to Mrs R’s family.
78. With the above in mind, we find the Trust acted in line with GMP guidance, which says doctors must check that the care or treatment they provide for each patient is compatible with any other treatments the patient is receiving and make good use of the resources available to them, and so we have not seen any indications of failings here.
Coroner referral
79. Ms R complains the Trust did not tell the coroner it was undertaking an SIR into Mrs R’s unexpected death.
80. Mrs R died on 7 January 2023. The Trust reported an incident relating to her death on its internal reporting system on 8 January. It said there was an ‘unexpected deterioration of patient’.
81. NHS Serious Incident guidance says serious incidents are events in health care where the potential for learning is so great, or the consequences to patients, families and carers, staff or organisations are so significant, that they warrant using additional resources to mount a comprehensive response. Serious incidents include acts and/or omissions that result in unexpected or avoidable death. Serious incidents or suspected serious incidents must be declared no longer than two working days after the incident is identified. An initial incident review should be undertaken to confirm whether a serious incident had occurred and, if applicable, the level of investigation required.
82. A cause of death is always set out in the following format on the Medical Certificate of Cause of Death (MCCD): • 1a the disease or condition immediately causing death • 1b the underlying cause of 1a • 1c the underlying cause of 1b • 2 any disease that did not cause death but contributed in some way.
It is not always necessary for sections 1b, 1c or 2 to be completed.
83. The Notification of Deaths Regulations impose a duty on a medical practitioner to notify the senior coroner of a person’s death in circumstances including ‘death due to a person undergoing a treatment or procedure of a medical or similar nature’ or where the cause of death is unknown. This applies if the death was related to surgical, diagnostic or therapeutic procedures or investigations, anaesthetics, nursing or any other kind of medical care. This includes scenarios such as death that occurs unexpectedly, given the clinical condition of the deceased person prior to receiving medical care. An MCCD, which is typically completed by a doctor and states the cause of death, will not be issued until the coroner agrees.
84. The regulations require the notification to the coroner to be made as soon as is reasonably practicable after the registered medical practitioner has determined that the death should be notified. The registered medical practitioner is required to indicate the reason why it is deemed that the death should be notified. We understand that in most cases, the notifying registered medical practitioner will provide a detailed explanation of the likely cause of death in narrative form. Where possible, this should include the proposed medical cause of death. The registered medical practitioner is required to provide the coroner with any further information that they consider to be relevant.
85. In line with this guidance the Trust reported Mrs R’s death to the coroner on 9 January. It said the reason for the referral was ‘the person undergoing a treatment or procedure of a medical or similar nature’ and the cause of death was: • 1a unascertained • 1b aspiration pneumonia • 2 carcinoma of the lung The referral also included the following information: • Mrs R tested positive for Covid-19 on 5 January • a chest X-ray showed she had an acute lung injury related to aspiration • she passed away due to multi-organ failure.
86. We can see that on the date the Trust referred Mrs R’s case to the coroner, it had not made a decision to undertake an SIR. It was therefore not possible to include this information in the referral.
87. MOJ guidance says the coroner’s staff will make enquiries to help the coroner decide whether to investigate the death. If this confirms that the death was due to a natural illness or condition and that there are no unusual circumstances, the coroner will not need to investigate, and early discussions will mean the doctor can sign a MCCD. The coroner may decide that an investigation is needed where they believe the death was not from natural causes, or that it was natural but the cause cannot be determined. They will ask a specialist doctor (usually a pathologist), to carry out a post-mortem to help find out the cause of death.
88. On 17 January the assistant coroner recorded they were not under a duty to investigate Mrs R’s death, and so they had not requested a postmortem. They recorded Mrs R’s cause of death as: • 1a aspiration pneumonia • 2 carcinoma of the lung.
89. On 9 February, following a review of the report made on 8 January, the Trust commissioned an SIR. We can see the decision to carry out an SIR was made after the coroner had confirmed Mrs R’s cause of death was aspiration pneumonia.
90. The SIR was completed on 7 September 2023. It said in the absence of a postmortem the Trust could not be certain of Mrs R’s cause of death. If the cause of death was linked to the previous chest infection, it was likely she would not have died as quickly, and the signs of infection would have been more apparent.
91. NHS Serious Incident guidance says an SIR must be shared with key interested bodies including patients, victims and their families. It does not, however, make any specific reference to the coroner being a key interested body.
92. The coroner wrote to the Trust’s Chief Executive on 17 November 2023. They had seen a news report (we understand this refers to a local news report about the SIR outcome) which said Mrs R died following surgery that should have been postponed due to Covid-19. They said her death had been referred to their office but there was no mention of Covid-19 in the referral. They asked the Trust to send a copy of its investigation report so they could review the contents to determine if they had reason to suspect an unnatural death. They said any investigation reports which established deficiencies in care which likely caused or contributed to the death should be sent to them irrespective as to whether the death had previously been referred. We can see the Trust sent a copy of the SIR to the coroner later that month.
93. We have seen the referral the Trust had made to the coroner on 9 January. We can confirm it did include information about Mrs R’s positive Covid-19 test on 5 January, so we have not seen there was any omission on the Trust’s part.
94. The coroner wrote to Ms R on 22 August 2025 and said the Trust had sent it a copy of the SIR. Given the cause of death provided and the contents of the investigation report, they advised there was no reason to suspect an unnatural death, and so the coroner had no jurisdiction and no inquest was required.
95. We found the Trust gave all relevant information available to it at the time in its referral to the coroner. A decision to carry out an SIR had not yet been made and so could not have been included in the referral. We are satisfied the Trust acted in line with its obligations as set out in the Notification of Death regulations at the time the referral was made on 9 January.
96. We can see the coroner’s view is an SIR should be shared with them once completed. We have seen no guidance to support that the Trust was required to do so, although we recognise an SIR may be helpful to the coroner in completing their work. As such, we found the Trust failed to act in line with applicable guidelines and standards in its handling of the SIR.
97. We can also see that, when the SIR was completed, the coroner found no reason to suspect an unnatural death. We have therefore not seen anything to indicate the coroner would have made any different decision about a postmortem before it confirmed Mrs R’s cause of death, even if it had been made aware of the SIR, which we hope reassures her family.