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Selected Investigations Completed August 2001November 2001 > Part II, Case no. E.699/00-01 and E.2527/99-00
Complaint against:
Complaint as put by Mr X
1. The account of the complaint provided by Mr X was that in 1994 his wife, Mrs X was diagnosed as suffering with breast cancer and underwent a mastectomy at St Bartholomew’s Hospital in Rochester. Mrs X underwent a course of chemotherapy at Guy’s Hospital, which is managed by Guy’s & St Thomas’ NHS Trust. Subsequently she attended regular follow-up clinics at Guy’s Hospital, and at the Medway Maritime Hospital (Medway Hospital) which is managed by the Medway NHS Trust. In March 1997 a consultant surgeon at Medway Hospital became concerned that Mrs X’s tumour marker score had increased, and arranged for some further tests. The tests showed an abnormal bone scan and an increased tumour marker score. On 21 April the consultant surgeon at Medway Hospital wrote to the clinical oncology unit at Guy’s Hospital. He pointed out the increased tumour marker score, and asked for advice on Mrs X’s further clinical management. The clinical oncology unit at Guy’s Hospital reviewed Mrs X in May. On examination her chest was found to be clear and they found no evidence of disease recurrence. In view of this it was decided not to undertake any further investigations, and that Mrs X would be reviewed in four months time
2. On 15 June 1998, Mrs X saw her general practitioner (the GP) complaining of right-sided lower back pain. He referred her to Medway Hospital for an X-ray. Medway Hospital told the GP that the X-ray showed only degenerative changes. On 27 July the GP concluded that Mrs X’s symptoms required further investigation. He telephoned the orthopaedic department at Medway Hospital and arranged for Mrs X to be admitted immediately. Further tests revealed that Mrs X was suffering with secondary cancer. Mrs X died on 24 September 1998.
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3. The matters investigated were that Medway Hospital and Guy’s Hospital failed to diagnose the recurrence of Mrs X’s cancer and arrange appropriate management.
Investigation
4. Separate statements of complaint were issued to Guy’s & St Thomas’ NHS Trust and to the Medway NHS Trust on 23 June and 20 July 2000 respectively. Subsequently, I proposed to both Trusts that I conduct a joint investigation, and issue a joint report: one of the central issues was the continuity of care received by Mrs X from both Trusts, her ‘patient journey’ and it was considered that a joint report would facilitate the presentation and assessment of that. A new statement of complaint was issued to both Trusts on 14 November 2000. The comments of the Trusts were obtained, and relevant papers, including the clinical records, were examined. Evidence was taken from a consultant surgeon at St Bartholomew’s Hospital, Rochester (the first consultant), and a consultant radiologist at Medway Hospital (the consultant radiologist), both of whom worked for the Medway NHS Trust, and a medical oncologist at the clinical oncology unit at Guy’s Hospital, (the second consultant) who worked for Guy’s & St Thomas’ NHS Trust. Two professional assessorsa consultant surgeon and a consultant radiotherapist – were appointed to provide clinical advice. Their report is included, in its entirety, at paragraph 30 below. I have not put into this report every detail investigated; but I am satisfied that no matter of significance has been overlooked. At Annex A is a schedule of abbreviations used in this report and at Annex B is a glossary of the medical terms used. Before her marriage in 1998, Mrs X was known as Mrs W but for ease of reference, I have called her Mrs X throughout the report.
5. Mr X also complained to the Ombudsman about the GP; and the report of the Ombudsman’s investigation into that complaint was issued on 3 October 2000 (E.526/99-00).
Guidance
6. The following guidance is relevant:
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The British Association of Surgical Oncology and Breast Speciality Group’s ‘Guidelines for Surgeons in the Management of Symptomatic Breast Disease in the United Kingdom’ (1998 revision)
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West Kent Health Authority’s ‘Review of Breast Care Services’, issued in February 1997
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Medway Symptomatic Breast Unit’s draft protocol for management of patients with early breast cancer.
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Clinical Outcome Group’s guidelines on the management of breast cancer (provided by Guy’s Hospital).
Mr X’s evidence
7. Mr X wrote to the chief executive of Guy’s & St Thomas’ NHS Trust on 18 November 1998, having obtained Mrs X’s records. He noted that the first consultant had referred her to Guy’s Hospital for an opinion following an abnormal CA15-3 tumour marker test in April 1997 and an abnormal bone scan. Mr X wrote:
‘…. I note that my wife was subsequently seen by [a registrar to the second consultant (the registrar)] and that, following a consultation with the registrar, her problems were put down to a previously fractured rib and, although the bone scan had shown a slightly increased uptake in the sacro-iliac joint, following a clinical examination, the conclusion was that nothing sinister was going on and my wife was discharged with a follow up review in four months’ time.
‘I am alarmed that my wife’s referral by a consultant, what I believe to be a tertiary referral, warranted nothing more than an assessment by a junior doctor. [Another consultant at Guy’s Hospital] or [the second consultant] would have known from [the first consultant’s] referral letter that the reason he was seeking further advice, apart from the abnormal test results, was that he was suspicious that my wife did have a recurrence from her breast cancer, which did not surprise him as her original cancer was aggressive and 13 out of some 21 lymph nodes were originally involved.
‘I would welcome your investigation into the appropriateness of my wife’s treatment at Guy’s hospital in this respect. Your explanation as to why my wife was not offered further tests to exclude the recurrence of her cancer, such as with the benefit of a CAT scan, MRI scan or other appropriate examinations ….’.
8. On 13 April 1999 Mr X met the second consultant at Guy’s Hospital. In a letter to Guy’s & St Thomas’ NHS Trust on 5 May 1999, Mr X wrote expressing concern that as a result of that meeting, it was clear that Guy’s Hospital did not use the CA15-3 tumour marker as a predictor of the likelihood of the spread of breast cancer. This appeared to indicate a need for a unified approach to the treatment of patients such as Mrs X, with specialist centres like Guy’s Hospital agreeing an approach to the methods of detection of cancer recurrence. He added that in his wife’s case, although she was quite ill, she was denied any appropriate intervention until the disease was at an advanced stage, leading to unnecessary pain and suffering.
9. Mr X wrote to the Medway NHS Trust on a number of occasions from 16 June 1999. In his letter of that date he asked why the X-ray that had been taken at Medway NHS Trust on 16 June 1998 had been reported on as showing ‘degenerative changes’ only, when a month later a CT scan had revealed that his wife had extensive metastatic secondaries. He also asked for an independent person (someone not employed by the Medway NHS Trust) with expertise in this field to review the X-ray and report. He further complained that if a correct diagnosis had been made, palliative radiotherapy treatment could have been given earlier to alleviate his wife’s symptoms.
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10. On 28 March 2000 Mr X wrote to the Ombudsman asking if the investigation of his complaint then underway (against the GP) could include his complaints against Guy’s Hospital and Medway Hospital. His letter said:
‘The convenor’s response, in which he encloses literature on the subject, gives the impression that patients and their GPs (and other specialists such as [the first consultant]) fully understand Guy’s (and presumably other cancer centres) approach to treating/following up patients following primary treatment for breast cancer. Just to briefly summarise what happened in my wife’s case:
· ‘April 1997, [the first consultant], correctly suspects that an abnormal tumour marker score and bone scan signified that my wife had a “recurrence somewhere”. He had earlier drawn Guy’s attention to the increasing tumour marker scores.
· ‘May 1997, because of the minimalist approach to follow-up, Guy’s & St Thomas’ rationalised my wife’s symptoms as non-significantin spite of her complaining of back pain, the progressive increase in tumour marker score from 29 to 53 to 67 and the abnormal bone scan report reported by [the first consultant]. This view was taken on the basis of a clinical examination. They were not in possession of the bone scan films and conducted no tests on their own account to further investigate [the first consultant’s] suspicions.
· ‘June 1998, Medway Maritime Hospital misread X-ray showing abnormality in spine.
· ‘On the basis of the reassurance received from Guy’s & St Thomas’, GP treats wife for sciatica despite her being in excruciating and unremitting pain.
· ‘I find it quite astonishing that Guy’s (and perhaps other centres throughout the country who may be following the guidance) appear to be operating in isolation from their patients, the patients’ family doctors and their supporting hospitals. The simple truth (perhaps miscalled simplicity by the Guy’s convenor who seems satisfied by what he has been told) is that:
· ‘My wife was misled into believing that Guy’s had excluded the possibility of recurrence when in fact we now know that they do not investigate beyond the primary treatment stage unless tumour recurrence appears at the operation site. This led to failure to offer appropriate palliative treatment to my wife leading to her acute distress and discomfort.
· ‘Local surgeons who are having regard to tumour marker scores and suspicious bone scans are wasting their time in conveying such information to the cancer centres because of the minimalist intervention policy.
‘….
‘For these reasons, I would urge you to consider either instructing Guy’s & St Thomas’ to institute an Independent Review into my complaint or for you to include this aspect of my complaint in your already constituted investigation into other matters related to my wife’s care and treatment by [the GP], and also, as previously indicated, it would be helpful, I believe, to include the failure of Medway [Hospital] in regard to [the] misreading of the X-ray results when reporting to [the GP]. I feel that there are benefits in dealing with this matter in a comprehensive fashion rather than piece-meal.’
11. I interviewed Mr X and he confirmed the chronology at paragraph 12. Mr X told me that he found Guy’s Hospital’s policy on dealing with referrals of possible cancer recurrence following breast cancer unacceptable. It was at odds with that of Medway Hospital, who seemed keen to detect cancer recurrence, even if no symptoms were apparent. He said that at the meeting with the second consultant (see paragraph 12, 13 April 1999) he was told that there was an inability to prevent the secondary spread of breast cancer and that their approach was to take note only if any symptoms occurred and when they did, address the question of prognosis, although there was no chance of a cure. Mr X found this ‘a policy of despair’. He wanted to know when recurrence could have been detected; and, if it had been detected, how this might have affected the management of Mrs X and the overall outcome. Finally, Mr X said that his main purpose in complaining was to find out what had gone wrong and why, and to prevent it happening to anyone else.
Chronology of main events
12. The following is a chronology of the main events:
March 1994Mrs X was referred to the first consultant with a lump in her right breast and was seen by him on 9 March. Subsequent investigations confirmed the malignant nature of the lump and Mrs X underwent a modified radical mastectomy at St Bartholomew’s Hospital, Rochester on 29 March. Analysis of the removed tissue showed a particularly aggressive form of breast cancer that had spread to involve 13 lymph nodes.
1994-1997After surgery Mrs X attended regular follow-up clinics at Guy’s Hospital, Medway Hospital and, until November 1996, the Mid-Kent Oncology Centre, Maidstone. She received chemotherapy, radiotherapy and the anti-cancer drug Tamoxifen.
1 April 1997A bone scan showed increased uptake in the 5th through to the 9th ribs antero-laterally and in the left sacro iliac joint while the CA15-3 tumour marker score was higher than normal. An X-ray of the pelvic area and chest was normal. The bone scan report included the comment ‘(represents fractures)’ after the reference to the uptake in the ribs. Mrs X had had a previous bone scan prior to her mastectomy in March 1994, which showed no abnormalities.
21 April 1997The first consultant referred Mrs X to Guy’s Hospital. His letter to them said that he had detected an increase in CA 15-3 and remarked on the abnormal bone scan. (A full schedule of the CA15-3 scores is set out in the professional assessors’ report at paragraph 30). He said that he suspected a recurrence somewhere as Mrs X had had an aggressive cancer with many of the lymph nodes involved. He sent the report of the bone scan, but not the plain films or scans themselves. No mention was made in this referral to the normal bone scan taken in March 1994 (which was mentioned in a letter to Guy’s Hospital on 11 April 1994).
25 April 1997X-rays of chest and pelvis taken at Medway Hospital. No rib fractures or secondaries in chest; early old-age changes in the hips, no secondaries seen. There is no evidence to show that neither this report, nor the X-rays themselves were sent to Guy’s Hospital (and this omission was mentioned by the registrar in her letter of 15 May 1997 – see above).
13 May 1997 Mrs X attended the Medical Oncology Unit at Guy’s Hospital. Mrs X was seen by the registrar who noted the increased uptake in the ribs on the report of the bone scan and also the comment on the report that this represented fractures. There was an additional comment on the uptake in the sacro iliac joint, but the registrar noted that the plain films and scans were not available at the consultation. Mrs X was deemed to be asymptomatic. In a letter to Mrs X’s then GP, dated 15 May 1997, the registrar said that although the bone scan was slightly abnormal, she did not consider it sinister and concluded that there was no evidence of disease recurrence. The letter was not copied to the first consultant.
8 September 1997Mrs X was again seen by the registrar at Guy’s Hospital. Medical notes state no evidence of disease recurrence.
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12 January 1998Mrs X was seen by the second consultant at Guy’s Hospital. He reported that there was no evidence of recurrent disease. His letter was copied to the first consultant at Medway Hospital.
13 February 1998Clinical note at Medway Hospital recorded Mrs X as being well, and asymptomatic. However, from a blood test taken on that day and result notified on 25 February 1998, her CA15-3 score had risen to 707 and the report of this was ringed in red by the first consultant.
10 March 1998The first consultant wrote to Mrs X requesting she attend a follow up mammogram. No mention was made of the increased CA15-3.
25 March 1998 – An X-ray taken at Medway Hospital was reported as ‘Heart and lungs are clear’. No rib abnormality was reported.
17 April 1998 Mrs X attended Medway Hospital for a mammogram, which showed no mammographic evidence of disease recurrence.
12 June 1998Mrs X registered with a new general practitioner (the GP).
15 June 1998Mrs X visited the GP complaining of right sided lower back pain. He referred her to Medway Hospital for an X-ray.
16 June 1998The consultant radiologist looked at an X-ray of Mrs X’s lower back and reported that it showed degenerative changes only.
24 June 1998 Mrs X returned to her GP and he told her the results of the X-ray.
3 July 1998The GP visited Mrs X at home. He undertook a physical examination and decided to refer her to a consultant rheumatologist to assess her arthritis.
6 July 1998Mrs X went to Medway Hospital’s accident centre with back pains and other symptoms. A diagnosis of sciatica was made. Mrs X was discharged and prescribed Voltarol. On a form for her to give to her GP the accident centre suggested a bone scan to exclude metastatic disease, an ultrasound, and referral to the first consultant. The following day a doctor from the GP’s on-call service visited Mrs X at home. He diagnosed back pain and prescribed painkillers.
21 July 1998The GP made another visit to Mrs X at her home and a further examination revealed a small peanut-sized nodule in the mastectomy scar of her right breast. He planned to refer Mrs X to the first consultant.
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27 July 1998The GP made a third visit to Mrs X at her home and concluded that her symptoms required urgent investigation. He rang the orthopaedic department at the Medway Hospital and arranged for Mrs X to be admitted immediately.
28 July 1998A CT scan showed extensive involvement of vertebral bodies of L3, L4 and L5, and some encroachment of tumour into the spinal canal. The report of the scan said ‘Conclusion. Findings compatible with bone secondaries. There is progression as compared to study of 1/4/97’.
3 August 1998Mrs X was admitted to Maidstone Hospital for urgent radiotherapy to the lumbar spine and SIJs, both to improve the pain control and to pre-empt cauda equina compression. X-rays, a bone scan and a CT scan revealed that this was due to extensive metastatic disease, especially in the lumbar spine and the sacrum. There was also evidence of imminent cauda equina compression. Further tests showed that Mrs X also had liver metastases.
24 September 1998Mrs X died from secondary cancer.
18 November 1998 Mr X wrote to Guy’s & St Thomas’ NHS Trust (see paragraph 7).
30 November 1998A consultant at the Guy’s Hospital Breast Cancer Biology Group (the third consultant) wrote in response to a request from Guy’s & St Thomas’ NHS Trust for him to comment on Mr X’s complaint. In his letter he commented:
‘I think the crucial point is that while it seems counter-intuitive, even if further investigations by way of CT and MRI scan had been done in 1997 in view of [Mrs X’s] apparent lack of symptoms no treatment would have been initiated at that point. Since there is a great emphasis on early diagnosis of primary breast cancer, it is tempting to believe that early diagnosis of metastatic disease will necessarily improve outcome. There is no evidence that early treatment of advanced disease influences outcome and indeed in someone who is otherwise well and asymptomatic, it is likely that the side effects of treatment would outweigh any benefit. As stated previously, in a setting where the disease cannot be eradicated, treatment is directed at symptom control and palliation.’
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25 February 1999In reply to Mr X’s letter of 18 November 1998 (see paragraph 6), Guy’s & St Thomas’ NHS Trust wrote stating that the CA15-3 tumour marker test was occasionally used to monitor treatment, but that its use in the early diagnosis of recurrent disease was not established. They added that the films of the bone scan and the plain films taken as a result were not made available to them when they received the referral from the first consultant. On the issue of the increased uptake in the 5th through to the 9th ribs, the Trust said:
‘Your wife had a history of fracture on that side, and indeed the report from the Nuclear Medicine Department of Medway Health Authority commented that these “represent fractures” (see entry for 1 April 1997).’
Turning to the issue of Mrs X being seen by a junior doctor, the Trust said:
‘Whilst your wife was not seen initially by [the second consultant], registrars discuss plans for treatment and management with senior clinicians. On the basis of the information that was available to her at the time [the registrar] found no evidence of disease recurrence. ….. Mrs X was subsequently reviewed by [the registrar] and [the second consultant] who both noted that there was no clinical evidence of disease recurrence. There was no indication for a change of treatment.’
Later in the same letter the Trust said:
‘Further tests would have been carried out if symptoms had developed’.
13 April 1999Mr X met the second consultant at Guy’s Hospital to discuss his concerns.
16 June 1999Mr X wrote to the Medway NHS Trust, asking about the X-ray taken on 16 June 1998, and for an independent review of the X-ray. There were subsequent exchanges of correspondence.
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29 November 1999A consultant medical oncologist acting as clinical adviser to the convenor of Guy’s & St Thomas’ NHS Trust who was considering Mr X’s request for an independent review panel (the clinical adviser), wrote to the Trust setting out his views on the complaint. In that letter he gave the following information:
‘In terms of evidence for doing CA15-3 routinely, despite several studies having been published, the sensitivity of CA15-3 alone in detecting tumour recurrence is only 60%. I do not think that it should be recommended as a routine marker for detection of breast cancer recurrence in previously treated patients with breast cancer. The Clinical Outcomes Group which has given guidelines on the management of breast cancer, which is advice mainly to purchasers and is an expert and peer reviewed document, would back this statement up and will have evidence to suggest that tumour markers are not required in monitoring patients with breast cancer ….
‘However, the abnormal bone scan meant that the patient at the very least should have had another bone scan if she had continuing symptoms to rule out the possibility that there was further increase in disease in the bones. This was clearly not performed by the doctors at Guy’s Breast Unit. I think this would be an error of omission.
‘There are clear guidelines in terms of management of patients once bone metastases occur and as the patient was not referred back to Guy’s in the interim having developed other problems it is difficult to evaluate how they were managed. However, early detection of bone metastases does not necessarily change the long term outcome of the patient, although there are drugs now in the form of biphosphonates and there is a randomised trial showing improved survival in patients with clear-cut bone metastases. This is on the basis of one study.
‘My overall view in this case is that the doctors at Guy’s Hospital should have taken note having been given the result of a CA15-3 test and the bone scan by repeating them at an appropriate interval and assessing whether there was indeed any progression of the disease in the bones. The results at that time, in terms of using biphosphonates was not mature so it would be reasonable not to give any treatment but to observe the patient protem until she developed symptoms before instituting further therapy. In terms of guidelines as I mentioned earlier, the Clinical Outcome Group have published guidelines on the management of breast cancer which [the second consultant] knows and would have adopted in his Unit. I do not think doing markers in a routine way to detect early recurrence is the right way to go about it until one has evidence, but certainly if symptoms become apparent and bone scan is abnormal then further investigation is clearly necessary.
‘In my view the only error of omission was not repeating the bone scan at Guy’s Hospital and taking further notice of the elevated tumour marker and the abnormality in the bone scans. I think the Trust will have to apologise for not doing a repeat bone scan after an interval as the first bone scan was positive.’
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20 January 2000Following the meeting on 13 April 1999 (see above) the second consultant made the following written statement of what he had explained to Mr X at that meeting.
‘I met [Mr X] on 13th April 1999 at Guy’s Hospital ....
‘I explained that advanced breast cancer was a disease that could not be eradicated with currently available treatments. Nevertheless, it could follow a prolonged course and may remain asymptomatic for long periods of time. The aim of treatment, therefore, is to enable life to be as active and as free from symptoms for as long as possible with a minimum of adverse effects from treatment. Hence, when the disease is either apparently static or progressing slowly without significant symptoms, anti-tumour treatment is not needed and should be kept in reserve until such time as symptoms need to be relieved. This approach ensures that a patient is not subjected to side-effects of treatment at a time when it cannot symptomatically be helpful and that resistance of the disease to drugs, which could be useful at a future date, is not induced.
‘CA15-3 is a molecule, the level of which in the blood has a certain correlation with the amount of the tumour present in the body. However, it is not a specific marker for breast cancer and there is no evidence whatsoever that monitoring it can usefully guide treatment to improve the prognosis of this disease. Therefore, we do not use this marker in the management of breast cancer at the Guy’s Breast Unit.’
2 February 2000The convenor for Guy’s & St Thomas NHS Trust refused Mr X’s request for an independent review, because the Trust believed it had given answers to all of Mr X’s complaints, and that no further information would be brought out in a panel.
7 February 2000Mr X made a formal complaint to the Medway NHS Trust.
1 June 2000The chief executive of the Medway NHS Trust wrote to Mr X:
‘At the outset I would like to formally apologise for the reporting error [of 16 June 1998, see above]. [The Medway Trust Secretary] in his correspondence acknowledged that your wife’s X-ray had been incorrectly reported, and attempted to explain how this occurred. He also commented that the Trust viewed it as a serious matter and that your wife’s X-rays would be used at one of the Radiology Audit sessions held to discuss difficult cases that have arisen. The radiologist concerned had also been advised of the matter.
‘As part of the complaint process the individuals who are the subject of any complaint are given the opportunity to give an explanation. In your wife’s case [the consultant radiologist] has been asked how he arrived at the conclusion that the film showed only degenerative changes.
‘[The consultant radiologist] has looked again at your wife’s X-rays for 16 June 1998. He advises that because of the history given by [the GP], when he studied your wife’s film he was looking for metastases. There were two films, one taken of the spine from the front to the back (AP) view, and another taken from side to side (lateral) view. As explained previously, reporting is based on clinical interpretation of shadows of different light intensity. Normally metastases form in the pedicles of the spine first, but in your wife’s case they did not. The metastases (lesions) were at the bottom of the spine only where the spine joins the pelvis, and where the bones are thicker. On the lateral view the X-ray beam has to penetrate through the pelvis before getting to the spine, and this made diagnosis from that view difficult.
‘On the AP view, there was some gas in your wife’s gut, which gave a shadow of a darker intensity. On this view, the X-ray beam has to look beyond the gut before getting to the spine. [The consultant radiologist] believes that what he thought was some of the gas he saw in the gut was, in fact, a discrete lesion which was not readily apparent because of the area in which it was located. [The consultant radiologist] is very concerned that this happened, and wishes to join me in the apology offered.
‘The second part of your complaint was that your wife was denied treatment opportunities because of the misreporting of that X-ray film. Comparison of that film with films taken on 28 July [1998] show that there was a rapid spread and I am sure it has already been explained that even if the earlier diagnosis had been made, it would sadly not have been possible to have provided curative treatment. It is accepted, however, that more palliative care could have been provided sooner.
‘In conclusion I would repeat my apology and, particularly, for the additional pain and suffering caused to your wife and yourself.’
Evidence from Guy’s & St Thomas’ NHS Trust
13. In their response to the complaint, Guy’s & St Thomas’ NHS Trust made the following observations:
‘…. The important point at that consultation [on 13 May 1997, when Mrs X was first seen by the registrar] was that Mrs X was asymptomatic and [the registrar] advised in her letter to [the first consultant] that Mrs X be kept under observation and review. [Note: the registrar wrote to the GP, not to the first consultant, nor was the letter copied to the first consultant.] Mrs X was seen again by [the registrar] on the 8th September 1997 and by [the second consultant] on 12th January 1998 who both noted that she was asymptomatic from her breast cancer. There was no indication for a change in treatment’.
The letter went on to quote the last paragraph from [the second consultant’s] note of his meeting with Mr X (see 20 January 2000 in chronology above, paragraph 12) and from the third consultant’s advice (see 30 November 1998 in chronology. It concluded:
‘…. The development of metastatic disease was not detected at the appointments on May 1997 to January 1998, and the Trust have tried to give explanations for this which are set out above.
‘The Trust has given these same explanations both in correspondence and at the meeting with [the second consultant] in April 1999. Nevertheless I have every sympathy with Mr X and can understand why he cannot accept the explanations. The Trust welcomes the involvement of the Health Service Commissioner at this point and I hope that by his involvement will be able to help resolve Mr X’s complaint, which has been protracted over a very distressing time for Mr X and his family.’
14. The second consultant, told me that he had only met Mrs X on one occasion (12 January 1998). He could not recall that meeting. (He recalled the meeting with Mr X on 13 April 1999). He said that there was no written protocol or pro-forma for referrals from hospitals such as the Medway Hospital; the onus was on the referring consultant or doctor to provide the relevant information for Guy’s Hospital to respond to and provide advice. The second consultant did not know the first consultant personally, but was aware that he did refer patients to Guy’s Hospital from time to time, but fewer recently. The first consultant had never been a major breast cancer referrer to Guy’s Hospital.
15. The second consultant said that the first consultant’s referral letter was ‘not untypical’. It was the second consultant’s view that there seemed little point for the first consultant to have taken CA15-3 tests, for the reasons set out in his letter of 20 January 2000 (see chronology above). He added that once a patient had received radical treatment for breast cancer (eg a mastectomy) there was no point hunting for recurrence with tests such as CA15-3 that lack specificity, and where the patient was asymptomatic. He added that the tests could do more harm than good and that one should not go looking for trouble. If Mrs X had displayed symptoms, then he would have taken action. This was accepted practice, certainly in Guy’s and St Thomas’ NHS Trust, except where clinical trials were taking place. The second consultant said that it was known in 1994 that Mrs X had a poor prognosis: this is why she was given post-operative adjuvant treatment.
16. The second consultant said that the increasing CA15-3, the tone of the first consultant’s letter, and the abnormal bone scan, when seen with no symptoms in the patient, did not cause him to have any reason to disagree with the conclusions of the registrarher examinations, tests conducted and conclusions were perfectly reasonable. He said that he could not specifically remember the registrar discussing the case with himthere were many discussions with junior clinicians on most days. He noted that there was no record of the registrar discussing the case with him, but said that that did not indicate that a discussion had not taken place. He said that even if the bone scan film (and not just the report of the scan) had been made available, it would not have made any difference to the conclusions. He said that the reference to rib fractures in the registrar’s assessment was taken from the bone scan report. He did not know whether Mrs X had in fact suffered from broken ribs.
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17. The second consultant accepted that the registrar’s letter of 15 May 1997 had only been sent to Mrs X’s then GP and not to the referring consultant, (the first consultant). That was an omission and he could not explain why it had occurred- it may have been an administrative error: there was certainly no reason not to let the first consultant know Guy’s Hospital response to his referral, indeed the next examination report by Guy’s Hospital was copied to him.
Evidence obtained from Medway Trust and its staff
18. The Medway Trust, in responding to the first statement of complaint (see paragraph 4) said:
‘Mr X first wrote to the Trust on 16 June 1999 advising he was pursuing a complaint involving Guy’s Hospital and his GP. He requested that X-rays taken at the request of [the GP] on 16 June 1998 be reviewed by an independent consultant radiologist as no mention had been made in the X-ray report of his wife’s extensive metastatic secondaries.
‘The X-rays were originally reported by [the consultant radiologist] and were reviewed by [the director of imaging]. It was explained to Mr X by way of letter dated 4 August 1999 that on closer examination there was a lesion visible on the films, although it was not readily apparent. Further correspondence was then exchanged with Mr X, about the way the reporting error occurred and the quality of reporting, and he raised the matter formally as a complaint by way of letter dated 7 February 2000. A formal response was issued…on 1 June 2000.
‘As will be noted …. the Radiologist and the Trust have accepted that the X-ray taken on 16 June 1998 was incorrectly reported and apologies have been offered. The Trust accepts that the complaint is justified and as a consequence of the incorrect reporting, Mrs X suffered further pain. Had an earlier diagnosis been made, care would have been provided sooner.’
19. In response to my request, the Medway NHS Trust provided a letter from the clinical director of breast screening for N W Kent (the clinical director) dated 30 January 2001 describing the arrangements for multi-disciplinary meetings in respect of breast cancer patients both in 1997 and currently. The letter from the clinical director said:
‘In 1997 two multi-disciplinary meetings were held each week. In attendance were a consultant pathologist, a consultant radiologist, a breast care nurse specialist, the consultant surgeon, and various junior doctors. At one of the two weekly meetings a consultant medical oncologist was present. Any decisions taken were documented by the surgeon.’
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The letter went on to say:
‘Presently there is one meeting a week, attended by both consultant surgeons, a consultant pathologist, a consultant radiologist, a breast care nurse specialist and a consultant clinical oncologist (radiotherapy). Minutes are taken by a clinical co-ordinator onto a specially designed form, which is then filed in the patient’s notes. Each new case of breast cancer is discussed at the meeting. Most cases are discussed twice, once when the initial diagnosis is made, and again after surgery when more detailed pathology is available. Patients may be discussed again if they require a second operation or if they suffer local recurrence. Patients presenting with metastatic disease after treatment for the local disease has finished are not usually discussed at this meeting.’
20. In his oral evidence, the first consultant said that Mrs X was referred to him in 1994. He had used the CA15-3 tumour marker blood test since 1994, on his own initiative. He requested the test routinely, but accepted that it did not appear in any protocol for the treatment of cancer, and that it was not used at Guy’s Hospital.
21. The first consultant said that where CA15-3 appeared to be rising, he did not have a set action plan. It depended on any other test results, but where he was concerned, the patient could be sent to see an oncologist at either Maidstone Oncology Unit or Guy’s Hospital. Patients were usually given a choice.
22. The first consultant confirmed that he did not send the actual bone scan plain film, or any X-rays to Guy’s Hospital when he first referred Mrs X to them in 1997. All he sent was the report of the bone scan. Guy’s Hospital did not subsequently ask for them, and it was the first consultant’s normal practice to only send X-rays or plain films if and when Guy’s Hospital asked for them (usually by telephone). There was and is no protocol between Medway Hospital and Guy’s Hospital for referrals such as Mrs X’s, although he saw the onus on Guy’s Hospital to request X-rays or more information from him if they thought it necessary. The same system operates now as it did in 1997 although at Medway Hospital they now have multi-disciplinary meetings to discuss patients.
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23. The first consultant had not seen the registrar’s letter of 15 May 1997 to Mrs X’s original GP saying that in her view there was nothing sinister in the abnormal bone scan or raised CA15-3 score. According to Mrs X’s clinical file the first time the first consultant became aware of that diagnosis was in September 1997 when he received a copy of Guy’s Hospital clinical notes on Mrs X which contained an entry for the registrar’s examination of Mrs X on 13 May 1997.
24. The first consultant referred to a CA15-3 test result from Mrs X’s clinical file. It showed a CA15-3 score of 707 in February 1998 which he had circled with a red pen. He said that he had circled the result because it was significant and because he wanted to get in touch with Mrs X. He wrote to Mrs X on 10 March 1998 to ask her to come in for a mammogram. He said that he would have repeated the CA15-3 blood test, if she had come in for the mammogram, but accepted that he should have copied his letter to her GP to try to contact her (Mrs X had moved home around this time) and possibly copied it to the second consultant at Guy’s Hospital.
25. On consulting Mrs X’s medical records the first consultant established that as a result of an assault she had attended accident and emergency (A&E) at Medway Hospital on 3 April 1995 with a fractured wrist. However, there was no evidence in her records to indicate that she had ever suffered from fractured ribs.
26. The first consultant said that the note of 30 January 2001 from the clinical director to the Trust secretary (see paragraph 19 above) was not quite correct; it was not right to say that patients presenting with metastatic disease after treatment for the local disease has finished are not usually discussed at this meeting. Such patients were usually discussed. The first consultant said that the palliative care discipline should also be present at the meetings. In response to a request for further clarification on this matter the Medway NHS Trust subsequently wrote to the Ombudsman’s office:
‘Patients with metastatic disease after treatment for the local disease has finished are not routinely discussed at the meetings referred to. Some are, but not all. As an example, if there is recurrence in the breast with metastatic disease which needs multi-disciplinary treatment then they would be. If the patient is already under the oncologist and develops cancer, say in the bone or lung then they would not be.
‘Routinely there is no palliative care representative at these meetings. They do have access to a representative, but these staff are very busy and the vast majority of patients do not require palliative input.’
27. The consultant radiologist said that he had been employed as a locum consultant radiologist at Medway Hospital for five years. His line manager was the director of imaging. He confirmed that he saw and interpreted the X-ray of 16 June 1998 without the benefit of seeing earlier films. Upon re-examining the X-ray he commented that it was quite clear that there was something abnormal with the X-ray and that the gas in the gut was distinct from the metastases. He apologised for the mistake and said that as a consequence of his mis-reporting, the director of imaging had spoken to him. He was now a lot more careful and wary when reporting X-rays.
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28. The consultant radiologist said that he did not do ultrasound scans and that in an average session (of two-three hours) he would do between 50-150 reports depending on the type of X-ray. He said he was very dependent upon what the X-ray request card said, but that he was fully aware of the possibility of metastases in Mrs X’s X-ray. Even if the GP had put a specific query regarding metastases on the request card, it would not have made any difference to his report of the X-ray, as he was aware of the possibility of metastases. However, he said that had he seen the bone scan or the previous X-rays, that might have made a difference.
29. The consultant radiologist then viewed the most recent X-ray of Mrs X (shortly before she died). He said that from that X-ray it did not appear to him that Mrs X had ever suffered from broken ribs.
Report of the Ombudsman’s independent professional assessors
30. I set out below the report of the professional assessors.
Report by the Professional Assessors.
(i) The matter subject to investigation was that Medway Hospital and Guy’s Hospital failed to diagnose the recurrence of Mrs X’s cancer and arrange for appropriate management. From Mr X’s letters to the two Trusts it is clear that he had two primary complaints:
§ that Guy’s Hospital took insufficient note of Mrs X’s raised CA15-3 Tumour Marker levels and abnormal bone scan when referred to them by the first consultant, and that there was a lack of a unified approach to the follow-up of cancer patients managed jointly between Guy’s Hospital and Medway Hospital; and
§ that the misreporting of Mrs X’s spinal X-rays in June 1998 by the Medway Hospital led to a delay in her receiving appropriate palliative care.
(ii) In producing this report information from the following sources has been utilised:
1. Copies of Mrs X’s clinical notes from:
a) Guy’s Hospital
b) Medway Hospital.
2. The interview with the first consultant 7 February 2001.
3. The interview with the second consultant 20 February 2001.
4. The interview with the consultant radiologist 7 February 2001.
5. Report of the West Kent Breast Cancer Review Group, issued by West Kent Health Authority, February 1997.
6. Clinical Outcome Group: guidelines on the management of breast cancer.
7. Medway Symptomatic Breast Unit; draft protocol for the management of patients with early breast cancer.
8. Correspondence between the Ombudsman’s Office and the two Trusts, and the complainant.
Outline of the medical history
(iii) Mrs X was referred to the first consultant with a lump in her right breast and seen by him on 9 March 1994. Subsequent investigations confirmed the malignant nature of the lump and surgery was advised. On 29 March 1994 Mrs X was admitted for and underwent a modified radical mastectomy (removal of the breast, and the lymph nodes beneath her right arm). Analysis of the removed tissue showed a particularly aggressive form of breast cancer that had spread to involve 13 lymph nodes.
(iv) After surgery Mrs X received chemotherapy, radiotherapy and the anti cancer drug Tamoxifen. Her care was managed by three hospitals; Medway Hospital, Rochester, Kent; Guy’s Hospital, London; and, until November 1996, The Mid-Kent Oncology Centre, Maidstone.
(v) Mrs X remained symptomatically well until June 1998 at which time she developed and was investigated for low back pain. These investigations culminated in July and August 1998 with the demonstration of extensive deposits of tumour in the lower portion of her spine and liver. Mrs X underwent further chemotherapy and radiotherapy but died on 28 September 1998.
(vi) At intervals during her illness (detailed below) Mrs X underwent a variety of tests in a bid to detect any spread of her breast cancer to more distant tissues and in particular to her skeleton, a favoured site for tumour metastases. The tests performed included bone scans; X-rays of her spine and chest; and measurements of the tumour marker CA15-3. The interpretation of and response to these tests, and communications between the various clinicians involved in Mrs X’s care are key to understanding her management.
(vii)The first consultant regularly used measurements of the tumour marker CA15-3 to inform his management of patients with breast cancer. There was no set protocol as to how patients with abnormal measurements were to be dealt with either at Medway Hospital, or at Guy’s Hospital to where some patients were referred.
(viii) Mrs X had the following measurements of CA15-3 made:
Date Concentration (U/ml)*
17/03/94 55
24/11/95 29
14/02/97 53
26/03/97 67
13/02/98 707
03/08/98 6919
* Normal level 0 –29 U/ml
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(ix) The first measurement was made on the 17 March 1994 before Mrs X underwent a mastectomy; the concentration of CA15-3 was raised and probably reflected the extent of the cancer within Mrs X’s breast and axillary lymph nodes. Following the surgical removal of her tumour and after receiving chemotherapy and radiotherapy a measurement, made on the 24 November 1995, showed that Mrs X’s CA15-3 level had returned to normal.
(x)The next two measurements of CA15-3 were made early in 1997 at a time when Mrs X was still asymptomatic. On both occasions abnormal levels of CA15-3 were detected. These results prompted the first consultant to investigate the possibility that Mrs X’s breast cancer had returned albeit without causing symptoms. A chest X-ray was normal, but a bone scan, performed to detect the presence of tumour deposits in the skeleton, on 1 April 1997 was reported as follows:
‘Increased uptake at the left 5th to 9th ribs anterolaterally (represent fractures). Focally increased uptake at superior aspect of left SI joint, which needs X-ray comparisons. Rest of the scan appears normal.’
(xi) In other words abnormalities in the ribs and pelvis were present which were consistent with the presence of tumour deposits.
(xii)The subsequently performed X-ray of the pelvis was reported as showing no evidence of cancer deposits in the bones.
(xiii) As a result of the abnormal bone scan and the elevated level of CA15-3 the first consultant sought help from the Oncology unit at Guy’s Hospital. In his letter of referral dated 21st April 1997 the first consultant made known his concern that Mrs X could have recurrent breast cancer and asked for oncological assistance.
(xiv) The registrar to the second consultant saw Mrs X at Guy’s Hospital on 13 May 1997. She concluded that the chest abnormality seen on the bone scan could be explained by previous rib fractures (mentioned in the bone scan report) and that the changes in the pelvis did not warrant further investigation as Mrs X was asymptomatic. The following however may have influenced these conclusions:
· The registrar did not have available to her either the bone scan pictures or the chest and pelvic X-rays. She was instead working from the faxed reports of the results, and in the case of the pelvic X-rays even these were not available. There was thus no opportunity to check the veracity of the reports against the original films. The first consultant said when interviewed that he would only send the actual X-rays if specifically requested to do so by Guy’s Hospital, whilst the second consultant at Guy’s Hospital said that it is the responsibility of the referring Consultant to provide all the relevant information.
· No mention was made by the first consultant in his referral letter that Mrs X had previously had a normal bone scan just prior to her mastectomy in March 1994 and that the changes observed on her most recent scan (1 April 1997) were therefore new.
· Had the chest X-ray been available to the registrar she would have seen that there were no fractured ribs to explain the abnormal bone scan and she might well have concluded that there was a possibility that metastases were present.
·We have been unable to confirm that Mrs X ever sustained an injury to her chest. Mrs X did suffer an assault in April of 1995 for which she attended the A&E Department at Medway Hospital. However, there is no mention in her records of fractured ribs, and the Breast Care Nurse assigned to her care at the time confirmed that whilst Mrs X had fractured her wrist she had no injuries to her chest. Mr X said that he was unaware of any injury to his wife’s chest and the report of the X-ray taken on 25 April 1997 includes the comment; ‘no rib fractures …’ Finally the consultant radiologist looked at the most recent X-ray of Mrs X’s chest and said that in his opinion she had never suffered rib fractures.
· There is no record of the registrar having discussed the case with the second consultant during Mrs X’s clinic visit and therefore no firm evidence of Mrs X’s case having been considered by a senior clinician. The second consultant said that he could not specifically recall his registrar having discussed the case with him, but that that was what normally happened.
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(xv)No further investigations were organised by the registrar, but arrangements were made to see Mrs X again in 4 months time. A copy of the letter, which the registrar wrote to Mrs X’s GP at the time, regarding the clinic visit was not sent to the first consultant at Medway Hospital. The second consultant has accepted that that was an omission for which he cannot offer an explanation, except oversight.
· The effect of this omission was that the first consultant was denied the opportunity to further investigate Mrs X’s abnormal bone scan and CA15-3 results himself. Had he received the registrar’s letter the first consultant assured us that he would have arranged a further bone scan for three months hence. In doing so he would have been able to check if the abnormalities observed on the bone scan in May had become more definite or widespread; had such observations been made they would have strengthened his view that bone metastases were present.
· We note, however, that no such investigations were organised by the first consultant after receipt of the registrar’s letter relating to Mrs X’s next visit to Guy’s Hospital on 8 September 1997.
(xvi) The next time Mrs X’s CA15-3 level was measured was in February 1998. A registrar to the first consultant requested the test, at a time when Mrs X was still symptomatically well. The result, 707U/ml was markedly elevated and more than 25 times the normal level. This result was received and acknowledged by the first consultant who ringed the result in red, which was his way of denoting something of significance. However, no follow up action was taken either by way of further tests or by contact with Mrs X’s GP. No specific reason for this was evident in our enquiry other than it being an oversight. The first consultant did write to Mrs X on 10 March 1998 requesting that she attend for a follow up mammogram, but no mention was made of the abnormal CA15-3 result. The first consultant had made a number of unsuccessful earlier requests for Mrs X to have a mammogram.
· Had a further bone scan been performed at this stage it would almost certainly have shown the spinal metastases that subsequently produced Mrs X’s severe back pain.
Spinal X-rays of June 1998
(xvii) Mrs X became symptomatic in June 1998 and presented to the GP complaining of back pain. The GP correctly referred Mrs X for plain X-rays of her spine. His request card for the X-ray records that Mrs X had breast cancer, back pain and restricted movement, and asks if ’any bony pathology’ could be present. The X-rays were carried out on 16 June and reported by the consultant radiologist at Medway Hospital. His report reads:
‘Degenerative changes only’
(xviii) In retrospect the report proved to be wrong. On re-examination the X-rays clearly show an area of bone thinning in the pelvis consistent with the presence of a metastasis. The consultant radiologist told us at interview, when reviewing the X-rays, that the abnormality was clearly visible and should have been reported at the time.
(xix) As a consequence of this report the GP was falsely reassured that Mrs X did not have metastatic breast cancer and he pursued alternative diagnoses. Mrs X’s symptoms worsened and she was eventually admitted as an emergency to the Medway Hospital on 27 July 1998 at which time further X-rays revealed multiple metastases in her spine.
(xx) Although the consultant radiologist admits and apologises for his error in misreporting the pelvic X-rays there were a number of other factors operating at the time which militated against the correct diagnosis being reached :
· At the time he referred Mrs X for her X-rays, the GP had been her doctor for just 3 days as she had only just registered with him. He did not therefore have access to Mrs X’s previous general practice notes, and he would not therefore have been aware either of the abnormalities on her bone scan of 1 April 1997 or the raised CA15-3 levels. Had those notes been available he might well have emphasised the findings on his X-ray request form, which could have led to the consultant radiologist looking more closely at the x-rays. | 
