Shropshire Community Health NHS Trust

Mrs J D complains on behalf of her wife, Mrs M D. She claims, following chest imaging requested by the rheumatology department at the Trust that took place on 9 May and 16 August 2022:

• the consultant rheumatologist failed to communicate the details of her lung condition to Mrs M D or her GP • the consultant rheumatologist failed to make a referral for appropriate care and treatment (this would include whether rituximab was suitable or not and if separate treatment should have been sought for the lung condition) • the Trust failed to address Mrs J D’s complaint during the complaints handling.

5.Mrs J D says, if her wife had known about her lung condition, she would not have undergone immunosuppressing treatment. She says her wife had a good quality of life with her previous medication to manage her condition and the only improvement in receiving the immunosuppressing therapy would be medication management from weekly injections to bi-annual infusions. She says her wife was shocked to learn of her condition on admission to hospital.

6.Mrs J D says the lack of knowledge of the lung condition meant they did not seek appropriate treatment from the GP when Mrs M D first became ill shortly after her immunosuppressing treatment. They were also unable to relay the condition to the ambulance crew which meant there was a delay in paramedics attending and suitable treatment being started on admission to hospital. She believes earlier treatment at the first signs of LW becoming unwell could have meant a different outcome.

7.She says with appropriate treatment for the lung condition at the point of its discovery, she and her wife could have had more quality time together as a family and made plans for her care. Instead they had to deal with the shock of her diagnosis and manage her end of life care and death over a period of 11 days.

8.Mrs J D says she has struggled to grieve for her wife while the question of her knowledge of her condition and accepting treatment remains in question. She says through the complaints process she felt the rheumatology department were being dishonest as their version of events changed and ultimately could not be supported by evidence.

9.Mrs JD seeks: • an apology from the rheumatology department; and • financial compensation for the impact of the failings on Mrs J D

10.Mrs M D suffered from rheumatoid arthritis and had been using the drug tocilizumab, once weekly, to treat this. On 16 March 2022 the consultant rheumatologist offered Mrs M D rituximab instead of tocilizumab as a way to manage her medications and pain. Rituximab is an infusion therapy. It would be given once every year and so could be easier for her to manage than weekly injections.

11. Mrs M D had a chest x-ray in May 2022 and a follow up CT scan in August 2022 which was reported in October 2022. These showed the development of a lung condition when compared to scans carried out previously in 2017.

12.On 3 and 17 November 2022 respectively Mrs M D received two infusions of Rituximab. The family has told us within a week of the second infusion Mrs M D developed a chest infection. She received antibiotics, then was later prescribed further antibiotics and an inhaler when the first course of treatment didn’t work. On 11 December 2022 Mrs M D was admitted to hospital with breathing difficulties and she died on 22 December 2022.

Issue one - The Consultant Rheumatologist failed to communicate the details of her lung condition to Mrs M D or her GP

16.Mrs J D and her family say they do not believe Mrs M D was told about the progression of any underlying lung condition. They say they first learnt about the condition when Mrs M D was admitted to hospital in December 2022 with breathing difficulties. They have told us Mrs M D was shocked at the news of the lung condition at this time. The consultant rheumatologist has said throughout the complaints process they did tell Mrs M D about her lung condition. They have said this conversation took place as a telephone appointment, face to face appointment or via a short notice appointment in an ‘extra clinic’.

17.We have considered Good Medical Practice where it says: 32 ‘You must give patients the information they want or need to know in a way they can understand’. This sets the standard that the consultant rheumatologist should have told Mrs M D about her test results and the development of her lung condition.

18.Based on the evidence we have seen, on the balance of probabilities we find the consultant rheumatologist failed to communicate Mrs M D’s lung condition to her. In the absence of records, and clear dates from the consultant on when they told her about her condition - which Good Medical Practice says staff should make a record of, we find Mrs J D’s account that the consultant did not tell Mrs M D more compelling. Our reasoning is set out below.

19.To investigate this part of the complaint, we have explored each scenario of possible interaction with Mrs M D from the consultant rheumatologist’s statements. The consultant rheumatologist has not provided dates for when they believe these appointments could have likely happened. We have considered all appointments from when Rituximab was first considered by the consultant rheumatologist on 9 March 2022 to when Mrs M D received her first infusion on 3 November 2022. We have also looked at how the appointment system works for each of these types of consultations and how outcomes are communicated to patients and their GPs. The appointment system for rheumatology was run by Telford Musculoskeletal Services (TeMS) and so we have received the appointment records from them.

The appointment system 20.The Trust use a system called RIO to make and log patient appointments; which is part of the electronic patient records. This includes telephone, face to face, and ‘extra’ clinics at Euston House appointments. The requests for appointments come through the medical teams to the administration team who then make the appointment and generate the letters to be sent to the patient. Once a consultation is complete, the administration team will receive a dictation from the consultant about what was discussed, they will then type this in a letter and send it to the patient and their GP.

21.We have seen a screenshot of the RIO system for Mrs M D showing all appointments with the consultant rheumatologist between 14 November 2017 to 18 January 2023 (this was the last scheduled appointment before Mrs M D died). It shows the last appointment Mrs M D had with the consultant rheumatologist before her death was 9 March 2022. From the clinic outcome letter sent to the GP, we know this is the consultation where starting rituximab therapy was discussed. As the testing was only requested at this time, no results would have been available to discuss with Mrs M D.

22.There is no evidence on the appointment system to show the consultant rheumatologist held a face to face, telephone or ‘extra clinic’ appointment with Mrs M D after her results were available to tell her about her lung condition.

Telephone call to the patient not captured by the appointment system 23.We considered whether an ad hoc call could have been made by the consultant rheumatologist to Mrs M D which was not covered by the RIO appointment system. The calls from Trust phones to a patient are logged and recorded using the RIO appointment system. The Trust has told us the call records for this period no longer exist. They said their systems hold the information for one to two years before it is deleted and they have sent us a screen shot of the relevant period which confirms this. We note as part of the complaints process a manager at the Trust considered the telephone records. In their email, they say they had checked both the RIO appointment system and the telephone data but could find no record of a call from the consultant rheumatologist to Mrs M D.

24.As discussed at paragraph 19, all patient appointments should be processed through the RIO system. We also note Good Medical Practice says: 19 ‘You should make records at the same time as the events you are recording or as soon as possible afterwards’. For this version of events to have happened, the consultant rheumatologist will have needed to access the patient record for contact details but then act outside of the appointment system to make the call and not record it. We believe this is unlikely as the consultant rheumatologist would have needed to go against the appointment system and the GMC’s guidance. We find it more likely the call did not take place rather than a series of errors.

GP’s access to the CT scan results 25.We looked at whether Mrs M D’s GP could have had access to the results of the CT and could have told her about the lung condition it showed. The Trust has said in their meeting with the family that Mrs M D’s GP should have known the results of the CT scan through the Trust’s imaging system called Xero Review. Mrs J D told us she spoke to Mrs M D’s GP shortly after her death to try and understand whether her wife knew about her lung condition. Mrs J D told us the GP was not aware and said they had not received notification from TeMS that a CT was to take place or its results.

26.We have considered section 44a of Good Medical Practice which says doctors must share all relevant information with all colleagues involved in your patients’ care within and outside the team. From the evidence we have seen, we do not think this took place.

27.As set out in paragraph 19, the appointment system RIO records the letters sent to patients and their GP. We have seen the consultation letters sent to Mrs M D’s GP. For the period we are considering, we have found a letter following the consultation on 9 March 2022 about starting Rituximab therapy and the outcome of the rheumatology nurse’s medication education telephone appointment with Mrs M D on 24 August 2022. The latter mentions a chest x-ray, but not the results or the fact a further chest CT has been carried out and not yet reported on.

28.We understand from speaking to TeMS that GPs do have access to Xero Review. However, without notification that the CT scan was undertaken, or there were any concerns raised by the earlier chest X-ray; we cannot reasonably see why the GP would have had reason to access the imaging results. We therefore do not find it appropriate to conclude Mrs M D’s GP was sufficiently informed of the lung condition.

Our consideration on the balance of probabilities 29.After considering the information above, we have not seen evidence which supports the consultant rheumatologist’s version of events. We have asked the consultant rheumatologist for comments for us to explore in any more detail why they believe the conversation with Mrs M D happened. We have explored each possibility they have offered through the complaints process and to us (telephone, face to face or last minute appointment) to fully investigate their recollection. As explored above, there would have needed to be a series of errors for any appointment to have taken place without it being recorded on the RIO system. We find on a balance of probabilities Mrs M D was not told about the progress of her lung condition.

Issue two - The consultant rheumatologist failed to make a referral for appropriate care and treatment

30.Mrs J D says she questions whether Mrs M D was a suitable patient for Rituximab. She says because the CT scan showed the development of a lung condition, her wife should have been referred for treatment for this. The consultant rheumatologist says Mrs M D remained suitable for Rituximab. We have seen an email between them and the rheumatology nurse saying the same before treatment started.

31.We consider section 44a of Good Medical Practice again here as the reasonable standard for transferring care and sharing relevant information with medical colleagues. We have looked at what clinical information was available to the consultant rheumatologist and whether secondary care was required.

What is Rituximab?

32.Rituximab is a drug used for the treatment of moderate to severe rheumatoid arthritis – it is also used as a treatment for several other autoimmune conditions. It is an intravenous treatment provided by 2 infusions, 14 days apart and usually at intervals of 6 months or greater. A schedule of screening tests pre-treatment is outlined in the British Society of Rheumatology (BSR) guidelines. These include screening tests for infection – Hepatitis serology, human immunodeficiency virus (HIV), varicella zoster virus (VZV) and tuberculosis (TB). A review of other medical conditions is also required to ensure that there are no contraindications (either relative or absolute) to the administration of Rituximab. Cardiac, respiratory and neurological conditions can influence a decision to prescribe Rituximab. Regarding lung disease the guideline states that “Pre-existing Interstitial Lung Disease (ILD) is not a specific contraindication to biologic therapy; however, caution is advised in patients with poor respiratory reserve.”

Before testing 33.We consider it was appropriate to refer Mrs M D for Rituximab treatment before testing. We have considered Good Medical Practice which says at section 15 ‘you must adequately assess the patient's conditions, taking into account their history’.

34.Mrs J D and family say they understood the change in treatment would help with medication management (having treatment every few months rather than weekly injections). They say they understood there would be no better pain management of Mrs M D’s symptoms.

35.We have seen the outcome letter from the consultation on 9 March 2022 where Rituximab therapy is discussed. This letter says Mrs M D had been experiencing more frequent flares of her arthritis and her weekly injections were not as effective. It says the plan was to switch to Rituximab therapy if the screening tests were satisfactory.

36.We have considered her treatment history and note Mrs M D had previously taken immunosuppressant medications and was taking tociluzimab as a weekly injection. Our clinical advisor told us tociluzimab and Rituximab work in different ways rather than one being a stronger anti-inflammatory than the other. They said, because individuals will respond to medications differently, it is sometimes beneficial to try different medications.

37.Whether the purpose of considering rituximab was for medication management or better pain management, they both appear to be reasonable reasons to consider changing to Rituximab. Based on the evidence we have seen, this appears to have been a suitable treatment option for Mrs Wilde prior to testing and there was no indication to refer for further treatment at this stage.

After testing 38.We have set out at paragraph 31 the BSR guidelines for pre-treatment testing. Further to this, the guidelines note ILD is common in patients with rheumatoid arthritis. It also says there is little evidence of the impact of both rituximab and tociluzimab specifically on ILD. The guidelines say those with poor respiratory reserve should have decisions to start medications like rituximab made on an individualised basis in conjunction with a respiratory physician, and with full appreciation of the evidence base. The consultant rheumatologist told us they did not refer Mrs M D for a review by respiratory medicine because she was asymptomatic.

39.Mrs M D’s chest X-ray on 9 May 2022 showed changes to her lungs since a previous X-ray in 2017. At the time of reporting, the radiologist recommended further investigation for an atypical infection like TB and said the changes could have been caused by either the progression of the rheumatoid disease or drug reaction. Our clinical advisor told us Mrs M D had satisfactory infection screening results for Hepatitis serology, HIV, VZV and TB. The results of Mrs M D’s further CT scan carried out in August 2022 showed there was evidence of chronic lung disease and the radiographer believed it to be a known progression of rheumatoid arthritis.

40.The BSR guidelines say a respiratory specialist should be sought for those with poor reserve. We have already established on the balance of probabilities Mrs M D was not told about her lung condition. On the same basis, we cannot find evidence she was asked by the consultant rheumatologist about any difficulties breathing or episodes of breathlessness or that a referral was made to respiratory specialist to request pulmonary function testing to ascertain lung performance. There is no evidence to support any interaction between Mrs M D and the consultant rheumatologist about the CT scan results. Having considered the medical records and the clinical advice we have received, we find this amounts to a service failure.

Issue three - The Trust failed to address Mrs J D’s complaint during the complaints handling

41. We have considered our complaint standards to measure whether the complaints handling was effective for Mrs J D’s complaint. These standards say, wherever possible, staff should explain why things went wrong and identify suitable ways to put things right for people. Staff should give meaningful and sincere apologies and explanations that openly reflect the impact on the people concerned. We uphold this part of the complaint.

42. To consider this part of the complaint we have looked at an exchange of emails between Mrs J D, her son and the Trust. We have also reviewed the meeting notes between these parties and the consultant rheumatologists at the Trust.

43. We have seen Mrs J D and her son repeatedly ask for evidence to support the consultant rheumatologist’s version of events. On 17 October 2023, the Trust emailed Mrs J D setting out the investigation which had been carried out by TeMS and that no appointment records could be found which showed when the results of the CT scan were discussed. This is in line with our own investigation of Issue one above. When Mrs J D was no evidence to support the consultant’s statements. She asked the Trust what she should do. The Trust response directed her to contact PHSO.

44.While our consideration of Issue one above is in more detail, we consider the email sent to Mrs J D by the Trust on 17 October 2023 already established there was no evidence to support the consultant rheumatologist’s version of events. We have seen no further communication from the Trust which apologised for the lack of evidence, recognised the impact this information had on the family or tried to ‘put it right’ for them. The Trust’s consideration of the complaint is effectively left incomplete and is not in line with our complaint standards. We find maladministration in the complaint handling.

Impact 45. It is the Ombudsman’s role to explore the injustice caused by any failings we have found. In Mrs J D’s case we have found:

• Mrs M D was not told, and should have been told, the results of her CT scan • The consultant rheumatologist should have made enquiries with Mrs M D about any breathlessness to make an informed decision about her suitability for Rituximab or referral to respiratory medicine • The Trust has not made findings or addressed any injustice to Mrs J D from the complaint they investigated.

46. We have considered what would have happened if Mrs M D had been told the results of the CT scan and questioned on any symptoms associated with ILD. This should have led to an additional consultation where the results of the scan were explained to her, a possible referral to respiratory medicine and an informed decision on whether she was suitable for receiving Rituximab.

47. We asked our clinical advisor to help us understand the differences between the imaging results between 2017 and 2022 to understand what Mrs M D might have been told. The report showed increased shadowing and pleural change in the lungs which was a development of her lung condition and was in line with ILD related to underlying rheumatoid arthritis. Arthritis.org says this is a well recognised progression of the disease with 1 in 10 patients developing the condition over time. The clinical advisor gave their opinion that the findings on the imaging themselves were not a cause for concern and the next steps in treatment would have depended on whether Mrs M D was experiencing any respiratory issues.

48. We have next considered evidence about whether Mrs M D was experiencing symptoms of breathlessness. We have seen in the meeting note on 23 January 2023 Mrs J D says her wife was active before the treatment (attending concerts and going on holidays abroad) and this has been repeated in her complaint to us. We have also seen the clinic letter from 2022 where no respiratory symptoms were mentioned. Equally, a full and thorough consultation following the discovery of the advancement of the ILD, as discovered in the scan results, with Mrs M D could have allowed the Trust to explore different symptoms she may have not routinely complained of to her wife.

49. We have considered what respiratory treatment could have been suggested for Mrs M D if she had reported any breathlessness. Our clinical advisor told us the main focus for treatment would still be on controlling the rheumatoid arthritis and then addressing any specific respiratory symptoms. They said this would have still included immunosuppressant therapy along with steroids and pulmonary rehabilitation but the presence of the ILD would make Mrs M D more susceptible to chest infections. We have not seen evidence to suggest Mrs M D was clinically unsuitable to receive rituximab, even in the presence of ILD. However, it still would have been her choice as to what care and treatment she received.

50. We cannot say with certainty what personal choice Mrs M D would have made about her care and treatment following the disclosure of the ILD. As discussed above, there is uncertainty what a consultation about any breathlessness or respiratory issues would have uncovered. Her wife and family say she would not have chosen the rituximab treatment if she had known about the ILD and the possible risks to her health. We have already seen Mrs M D was still clinically suitable for rituximab treatment. We cannot say with any certainty what she would have said in the consultation, what specific information she would have been given, and ultimately what choice she would have made about how to proceed.

51. So we have looked more generally at the effectiveness of rituximab in patients with ILD like Mrs M D. Our clinical advisor has directed us to several clinical articles on this matter which we have listed at paragraph 16. We have seen these articles give differing views on whether Rituximab contributes to ILD or can be used as a treatment of ILD. We have not seen evidence to show Mrs M D was clinically unsuitable at any time to start rituximab. The BSR guidelines support a more individual approach to the prescribing of rituximab. Our consideration of the various articles and case studies support this. We have seen from the records Mrs M D had tried a number of different immunosuppressing treatments and so her immunity would have already been lowered. We also note the ILD is a known progression of rheumatoid arthritis and Mrs M D would have been living with this condition before it was discovered in the CT scan. The timing of the rituximab treatment and Mrs M D’s chest infection does create a devastating chain of events for her wife and family. From our review of the records and research papers, we cannot say there is formal link between the rituximab treatment, the development of the chest infection leading to pneumonia and Mrs M D’s death.

52. Mrs J D says a direct impact of not knowing about the ILD meant appropriate treatment for Mrs M D’s chest infection was not given sooner. She and her family believe earlier treatment could have led to a different outcome. They told us how Mrs M D had received two lots of antibiotics in the community but still have severe shortness of breath. Her son told us he called for an ambulance because of the severity of the symptoms. The family said it took doctors a little while to find the right treatment for Mrs M D because, Mrs M D and her family could not tell them about the ILD as they had no prior knowledge of it spreading. They also told us Mrs M D’s decline was rapid and they were only given short notice Mrs M D would be placed in an induced coma and she died shortly after this. The family has told us how they question whether there could have been a better outcome for Mrs M D if they could have given doctors an accurate medical history of ILD both in the community and at the hospital. Our clinical advisor told us the treatment in the community with two rounds of antibiotics was appropriate and would have been the first line of treatment. They also told us Mrs M D received appropriate treatment once she was in hospital. Any change in the course of treatment would have been to respond to respiratory issues. We have established above we cannot say with confidence whether these were present or not as this was not explored with Mrs M D at the appropriate time. We recognise this is another uncertainty for Mrs J D and the continued upset this will cause. We hope her and her family can take some comfort in knowing they did everything in their control at the time.

53. Through exploring what would have happened differently, we are left with a number of different possibilities • Mrs M D may have shared concerns of breathlessness and been referred to respiratory medicine for investigation and treatment • She may not have reported respiratory concerns which meant no further referral was necessary • She may have decided not to proceed with rituximab and continue with her previous immunosuppressing treatment • She may have decided to try rituximab as a different immunosuppressing treatment

54. We cannot say on the balance of probabilities one scenario is more likely than the others – this is because the Trust did not undertake the relevant exploratory work with Mrs M D and we do not know what this would have revealed. We cannot say any scenario would have made it less likely Mrs M D would have deteriorated from a chest infection the way in which she did and died. We instead recognise this ongoing level of uncertainty and questions we cannot provide answers to as a significant injustice to the family. We note this uncertainty will continue to have a profound impact on Mrs J D and her family – they will feel Mrs M D would have made a different decision about her treatment and things might have been different. This was a serious injustice to them which occurred as a result of the service failure we found. Consequently, we partly uphold this aspect of the complaint.

55. We also find there is a further impact to the family as a result of the poor complaints handling in this case. By not drawing conclusions and addressing the family’s impact when they could have, the Trust has added to the family’s grief and prevented them being able to explore some closure to this distressing series of events for them. This was an injustice to them which occurred as a result of the maladministration we found. In light of this, we uphold this aspect of the complaint.

1. Mrs M D, was treated by the Trust for rheumatoid arthritis. While undergoing testing for a new treatment option, a CT scan identified an underlying lung condition. Mrs M D was not told about this. She underwent immunosuppressant treatment for arthritis. Sadly, shortly after this treatment she developed pneumonia and died 10 days later. Her wife, Mrs J D, believes Mrs M D would not have chosen to have immunosuppressant treatment had she been told about the underlying lung condition. Mrs J D believes her wife would still be alive today had she been fully informed about her health. She also believes the Trust and the consultant rheumatologist did not provide an open and honest response to her complaint.

2. We find failings in the communication of the CT scan results, the lack of decision to refer Mrs M D for further appropriate care and the Trust’s complaints handling. While we find these failings, we have been unable to say on the balance of probabilities that if the correct information and treatment had been provided, it would have led to a different outcome for Mrs M D. This is because the lack of exploration of her lung condition with her at the time means we are unable to say exactly what the correct course of action should have been for the ongoing treatment of her rheumatoid arthritis and her lung condition. It is therefore likely that we will partly uphold the complaint. We recognise the significant uncertainty this will continue to cause her wife Mrs J D and compound her and her family’s ongoing grief.

3. The Trust did not take any steps to provide a remedy to Mrs J D. We recommend the Trust pays £3700 and issues an apology to her in recognition of the ongoing uncertainty as to whether the events leading up to her wife’s death could have happened differently or been prevented altogether. We also recommend they report back to us addressing what steps they have or will take to ensure the failings we have found are not repeated for future patients receiving test or imaging results and using the complaints process.