- Email: [email protected]
The business of mental illness
170
THE LANCET
Medicine and the Law surgery with fatal complications An operation in a private hospital might be expected to go
"Keyhole"
wrong less often if anything than one in the public sector but accidents still happen. The way surgical complications in
private practice are handled is one issue raised by an inquest in London last month. On May 22, 1992, a 49-year-old woman was admitted to the Portland Hospital, London, for vaginal hysterectomy (large fibroids) to be performed by Mr Albert Singer. The surgeon encountered problems and concluded the procedure abdominally. Abdominal problems ensued and her condition deteriorated. At the inquest Mr Singer said that his patient had not been keen on further open abdominal surgery, and a laparoscopy was done on June 12. Both Mr Peter Hawley, a specialist in colorectal surgery, and Dr Russell McDonald, an NHS registrar in obstetrics and gynaecology, were retained by Singer, who ended up assisting McDonald with a "keyhole" bowel exploration, with Hawley watching the monitor (a videorecording was retained). Singer denied that his patient was frightened and confused when he suggested keyhole surgery and that he had overruled Hawley, who had advised open surgery. Laparoscopy revealed a kinked and swollen bowel. This was repaired. Soon afterwards, septicaemia set in and the patient had to be moved to intensive care at the Harley Street Clinic and later to University College Hospital, where she died on June 22 from a brain haemorrhage brought on by
septicaemia. At St Pancras Coroner’s Court, the coroner, Dr Douglas a verdict of accidental death. He refused to find that the death was "aggravated by neglect or lack of care". However, he held that a combination of missed opportunities had led to the patient’s death. Hawley testified that Singer, who had called him in, had not discussed keyhole surgery. When he found himself scrubbing up with McDonald he told him that he was to perform open surgery, with Singer assisting. He then learned that McDonald’s operation was to proceed and that his was not. Hawley said in evidence that McDonald had remarked, lightheartedly, "We don’t need your sort of surgeon, we can handle all these procedures ourselves. We have done you out of a fee". Yet McDonald admitted that he had no experience of the bowel operation-indeed, he had been concerned about the prospect. He said that he had been told that Hawley would be there to supervise and that he "would have been most reluctant to operate had he not been there". On June 13, Singer had rejected a nurse’s test result showing an abnormal white-blood-cell count. He agreed in evidence that if the result were correct it would have indicated septicaemia caused by leakage from the bowel. He told the inquest that he thought the nurse had made a mistake or that the test sample had been taken at the wrong time. The result did not fit in with the patient’s "general clinical picture". A pulmonary embolism seemed the likely cause. Septicaemia was his second diagnosis but he wanted to exclude a clot. By June 15, the patient had deteriorated further and he accepted that septicaemia was likely. On June 14 the patient was moved to the Harley Street Clinic but was too ill for exploratory bowel surgery. Hawley criticised the care given at that clinic; he had arrived early on June 15 to find the patient unventilated when it was clear to him that this was necessary. Tests confirmed septicaemia. Open
Chambers, brought in
on June 15 revealed that the ileum had been cut, Hawley thought to have been caused by scissors during the keyhole surgery. A further operation was done on June 16. The coroner noted apparent lack of clarity among four consultants (which included the anaesthetist Dr Raja Jayaweera) about who was in charge of the patient on the night of June 14. It was Dr Raphael Balcon, a physician and cardiologist, who had secured her admission to the Harley Street Clinic and subsequently Dr Rodney Armstrong and Dr Leon Kaufman were also retained. Jayaweera, contacted during the night of June 14 by the resident medical officer at the Harley Street Clinic, was told that the patient’s blood pressure was low. When he saw her nearly 5 hours later he was horrified to learn that she had not been given antibiotics. Armstrong, head of the intensive care unit at University College Hospital, said that early prescription of antibiotics significantly increased chances of survival. It also emerged at the inquest that Singer had asked Hawley not to tell the patient’s husband that McDonald had been brought in. Hawley said he felt "uncomfortable" about that. The widower intends to sue the doctors responsible for his wife’s care in the two private hospitals. He considers that the inquest has raised general issues such as the relation between state and private health provision-notably, the quality of intensive care in the private sector and the availability of transfer from private to NHS intensive care units-and the merits and risks of keyhole surgery. Hawley had testified that, had he been allowed to perform open bowel surgery on June 12, the patient would have made a full recovery. Was keyhole bowel surgery indicated in these circumstances, let alone by a doctor with no experience of it? Other key questions relate to overall responsibility when complications develop and to the duty to patient or family of a specialist who is called in but disagrees with the decisions of the clinician the patient first went to. On Armstrong’s evidence it can be difficult to transfer a patient from the private sector into an NHS intensive care unit because they are usually full. While he praised the unit at the Harley Street Clinic, Armstrong felt that the patient would have been better off in an NHS hospital. Her condition required the panoply of intensive care services available there.
surgery
which
Diana Brahams
Noticeboard The business of mental illness A junior hospital doctor is suing his regional health authority over his nervous breakdown, which he claims was caused by excessively long working hours. If he is successful, the case will set a precedent in the UK and follow a trend in the USA, where increasing numbers of people are suing their employers because of the ill-effects of work-related stress. Such a situation might take some time to develop in the UK, but British industry is already losing out heavily because of the workforce’s mental illness. Addressing a conference on mental health at work held by the departments of health and employment and six public bodies last week, Secretary of State for Health Virginia Bottomley quantified the problem. Each year, 80 million working days are lost through mental illness (35 million days through coronary heart disease and stroke) at an estimated cost of at least C3.7 billion. The cost to the NHS is about 20% of the total bill. As Prof Cary Cooper (Manchester) put it, "... employers can create intolerable levels of stress on their employees, and it is the tax payer who picks up the bill ...". Together with the other speakers, Cooper said that the most important work-related issue that research shows is responsible for mental ill-health and related absenteeism is how
171
THE LANCET
much autonomy and control people feel they have in their work and
development. The second biggest negative influence on an employee’s mental health is a poor relation with one’s immediate superior, especially in an organisation where progress is based on career
punishment rather than reward. But there are many other harmful business practices, such as rewarding technically qualified workers
by promotion into positions that require management skills that they do not possess and for which they may have no aptitude; general practitioners who are expected to be effective managers face this type of pressure. Clearly these and the numerous other practices that contribute to mental ill-health are ripe targets for primary
prevention. But what if it is too late for primary prevention? Prof David Shapiro (Sheffield) suggested that counselling and employee assistance programmes (EAPs) have great potential to prevent serious mental-health problems at work. EAPs, which are policies and procedures that a company uses to identify or respond to employees’ emotional difficulties that interfere with job
performance, were first used to deal with alcohol-related health and behavioural problems in the US workforce in the 1940s. Shapiro emphasised two caveats about these programmes. First, although there are indications that these techniques could yield substantial benefits, there is a need for more rigorous evaluation. Second, the American model of EAPs is likely to require substantial modification if it is
to be appropriate for British culture. This noted a member of the audience, is likely to be the greatest culture, to impediment progress-ie, until the entrenched stigmatisation of such common illnesses as depression and anxiety is tackled, British industry will continue to lose out.
Thames Cancer
Registry
About 60 000 new cases of cancer (or 55 000 if skin cancers other than melanoma are excluded) are registered with the Thames Cancer Registry every year. The Registry’s data for 1987-89, released last week, show a similarity in the broad pattern of cancer occurrence in the four Thames health regions. What differences there were seem to reflect real differences in cancer risk rather than underregistration; for example, cancers associated with lower socioeconomic status were commoner in poorer districts. The Registry data are expected to differ from those held by the Office of Population Censuses and Surveys, largely because of faulty data transmission procedures, which are being addressed. These faulty procedures are thought to explain why incidence rates published by the OPCS for the Thames regions for 1985 and 1986 have been several per cent lower than those obtainable from the Registry’s database. Conscious of the importance of quality of data, the Registry, which has been recording cancer in the South Thames regions since 1960 and which extended coverage to the North Thames regions in 1985, invited a peer review committee last year to scrutinise all its activities. A programme to supplement the recommendations has been developed and peer review is to be conducted regularly. The time-lag between year of diagnosis and publication of incidence data is going to be shortened. The Registry’s report discusses two indicators of data qualitythe percentage of registered cancers histologically verified (HV%), and the percentage registered on the basis of a death certificate only (DCO%). Other measures of data quality will be introduced in future reports. Some 60% of the registrations were histologically verified, over 20% were based on death certificates only, and about 10% were based solely on clinical opinion. Usually a high DCO% is an indication of incomplete registration. In the Thames regions, the high rate can be attributed to the decision, since 1983, not to trace back records for confirmation of diagnosis for cases first brought to the Registry’s attention by a certificate for a death occurring outside hospital, because of financial constraints. However, since 1992, cases first registered because of a death outside hospital are being checked back through the Family Health Services Authorities, and this move should reduce the DCO% for 1989 onwards. 1. Cancer in South East Thames, South West Thames, North East Thames, and North West Thames, 1978-89 (one volume for each of the regions). London Thames Cancer Registry (15 Cotswold Road, Sutton, Surrey SM2 5PY). 1992.
Home
testing
Home testing, whether for monitoring therapy, as in diabetes, or for diagnosis, as for pregnancy, is on the increase, so it is important that kits give accurate results when used by the layman. However, false-negative results were obtained for about half the 478 positive urine samples in a French study’ in which over 600 laywomen were asked to test coded urine samples containing human gonadotropin or no hormone. Eleven pregnancy and diagnosis kits were selected for the survey, out of the twenty-seven on the market in France. Fifteen were rejected because, when used by qualified clinical chemistry technicians, they were not 100% specific or sensitive; the other was withdrawn at the request of the manufacturer. The main reason for the poor results was difficulty in understanding the explanatory leaflets, which was not related to the woman’s socioeconomic status. An accompanying editorial2 draws attention to a US survey3 in which false-negative results were also obtained, albeit to a lesser extent (10%), possibly because the subjects were hospital employees and because kits in the USA have to satisfy strict Food and Drug Administration rules, whereas in France manufacturers have only to follow general guidelines published by the Ministry of Health (although there are plans to subject home-test kits to the same requirements as those for laboratory kits). The editorial recommends that manufacturers should develop one-step methods; provide short, clear instructions with pictorial examples (pregnancy kits have to be understood by inner-city teenagers, for example); include positive and negative controls (perferably built in); use colour to represent positive reactions and lack of colour to represent negative reactions (rather than the other way round); and develop methods that are free from interference (for example, by drugs that the patient is taking or by proteinuria or haematuria). 1 Daviaud
J, Foumet D, Ballonge C, et al. Reliability and feasibility of pregnancy home-use tests: laboratory validation and diagnostic evaluation by 638 volunteers. Clin Chem 1993; 39: 53-59. 2. Hicks JM. Home testing: to do or not to do? Clin Chem 1993; 39: 7-8. 3 Hicks JM, Iosefson M. Reliability of home pregnancy kits in the hands of lay persons. N Engl J Med 1989; 320: 320-21.
Immunotherapy for HIV infection Treatment of HIV-infected patients with cultures of their own HIV-specific cytotoxic cells is to be assessed in a pilot trial under the US National Institute of Allergy and Infectious Diseases DATRI programme. Started in October, 1991, DATRI (Division of AIDS Treatment Research Initiative) is a means for rapidly conducting
clinical trials of new treatments for HIV infection and disorders related to it. Therapies found to be promising may then be considered for larger-scale trials by the Institute’s other AIDS networks-the AIDS Clinical Trial Group (ACTG) and the Terry Beirn Community Programs for Clinical Research on AIDS
(CPCRA). Between 15 and 24 patients with CD4 count of 100--MO/UL will be enrolled for the trial (DATRI 006), to be conducted at the New England Medical Center in Boston, Massachusetts (principal investigator Dr Judy Lieberman). Patients will receive 1 billion, 5 billion, or 25 billion cytotoxic T cells and be followed up for 24 weeks. Only 1 patient can be enrolled per month, so the trial could take 2 years to complete.
International Association of Bioethics Interest in bioethics heightened in the past year. That year saw the Council of Europe working towards the completion of its European Bioethics Convention and towards the creation of an international (see p 169) ethics body. It also saw the formation of the International Association of Bioethics, initiated by a group of bioethics philosophers. The association, which is open to people from all disciplines who share an interest in free, open, and reasoned discussion of bioethics, plans to meet every 2-3 years. Further information is obtainable from Kay Boyle, Centre for Human Bioethics, Monash University, Clayton, Victoria 3168, Australia.
THE LANCET
Medicine and the Law surgery with fatal complications An operation in a private hospital might be expected to go
"Keyhole"
wrong less often if anything than one in the public sector but accidents still happen. The way surgical complications in
private practice are handled is one issue raised by an inquest in London last month. On May 22, 1992, a 49-year-old woman was admitted to the Portland Hospital, London, for vaginal hysterectomy (large fibroids) to be performed by Mr Albert Singer. The surgeon encountered problems and concluded the procedure abdominally. Abdominal problems ensued and her condition deteriorated. At the inquest Mr Singer said that his patient had not been keen on further open abdominal surgery, and a laparoscopy was done on June 12. Both Mr Peter Hawley, a specialist in colorectal surgery, and Dr Russell McDonald, an NHS registrar in obstetrics and gynaecology, were retained by Singer, who ended up assisting McDonald with a "keyhole" bowel exploration, with Hawley watching the monitor (a videorecording was retained). Singer denied that his patient was frightened and confused when he suggested keyhole surgery and that he had overruled Hawley, who had advised open surgery. Laparoscopy revealed a kinked and swollen bowel. This was repaired. Soon afterwards, septicaemia set in and the patient had to be moved to intensive care at the Harley Street Clinic and later to University College Hospital, where she died on June 22 from a brain haemorrhage brought on by
septicaemia. At St Pancras Coroner’s Court, the coroner, Dr Douglas a verdict of accidental death. He refused to find that the death was "aggravated by neglect or lack of care". However, he held that a combination of missed opportunities had led to the patient’s death. Hawley testified that Singer, who had called him in, had not discussed keyhole surgery. When he found himself scrubbing up with McDonald he told him that he was to perform open surgery, with Singer assisting. He then learned that McDonald’s operation was to proceed and that his was not. Hawley said in evidence that McDonald had remarked, lightheartedly, "We don’t need your sort of surgeon, we can handle all these procedures ourselves. We have done you out of a fee". Yet McDonald admitted that he had no experience of the bowel operation-indeed, he had been concerned about the prospect. He said that he had been told that Hawley would be there to supervise and that he "would have been most reluctant to operate had he not been there". On June 13, Singer had rejected a nurse’s test result showing an abnormal white-blood-cell count. He agreed in evidence that if the result were correct it would have indicated septicaemia caused by leakage from the bowel. He told the inquest that he thought the nurse had made a mistake or that the test sample had been taken at the wrong time. The result did not fit in with the patient’s "general clinical picture". A pulmonary embolism seemed the likely cause. Septicaemia was his second diagnosis but he wanted to exclude a clot. By June 15, the patient had deteriorated further and he accepted that septicaemia was likely. On June 14 the patient was moved to the Harley Street Clinic but was too ill for exploratory bowel surgery. Hawley criticised the care given at that clinic; he had arrived early on June 15 to find the patient unventilated when it was clear to him that this was necessary. Tests confirmed septicaemia. Open
Chambers, brought in
on June 15 revealed that the ileum had been cut, Hawley thought to have been caused by scissors during the keyhole surgery. A further operation was done on June 16. The coroner noted apparent lack of clarity among four consultants (which included the anaesthetist Dr Raja Jayaweera) about who was in charge of the patient on the night of June 14. It was Dr Raphael Balcon, a physician and cardiologist, who had secured her admission to the Harley Street Clinic and subsequently Dr Rodney Armstrong and Dr Leon Kaufman were also retained. Jayaweera, contacted during the night of June 14 by the resident medical officer at the Harley Street Clinic, was told that the patient’s blood pressure was low. When he saw her nearly 5 hours later he was horrified to learn that she had not been given antibiotics. Armstrong, head of the intensive care unit at University College Hospital, said that early prescription of antibiotics significantly increased chances of survival. It also emerged at the inquest that Singer had asked Hawley not to tell the patient’s husband that McDonald had been brought in. Hawley said he felt "uncomfortable" about that. The widower intends to sue the doctors responsible for his wife’s care in the two private hospitals. He considers that the inquest has raised general issues such as the relation between state and private health provision-notably, the quality of intensive care in the private sector and the availability of transfer from private to NHS intensive care units-and the merits and risks of keyhole surgery. Hawley had testified that, had he been allowed to perform open bowel surgery on June 12, the patient would have made a full recovery. Was keyhole bowel surgery indicated in these circumstances, let alone by a doctor with no experience of it? Other key questions relate to overall responsibility when complications develop and to the duty to patient or family of a specialist who is called in but disagrees with the decisions of the clinician the patient first went to. On Armstrong’s evidence it can be difficult to transfer a patient from the private sector into an NHS intensive care unit because they are usually full. While he praised the unit at the Harley Street Clinic, Armstrong felt that the patient would have been better off in an NHS hospital. Her condition required the panoply of intensive care services available there.
surgery
which
Diana Brahams
Noticeboard The business of mental illness A junior hospital doctor is suing his regional health authority over his nervous breakdown, which he claims was caused by excessively long working hours. If he is successful, the case will set a precedent in the UK and follow a trend in the USA, where increasing numbers of people are suing their employers because of the ill-effects of work-related stress. Such a situation might take some time to develop in the UK, but British industry is already losing out heavily because of the workforce’s mental illness. Addressing a conference on mental health at work held by the departments of health and employment and six public bodies last week, Secretary of State for Health Virginia Bottomley quantified the problem. Each year, 80 million working days are lost through mental illness (35 million days through coronary heart disease and stroke) at an estimated cost of at least C3.7 billion. The cost to the NHS is about 20% of the total bill. As Prof Cary Cooper (Manchester) put it, "... employers can create intolerable levels of stress on their employees, and it is the tax payer who picks up the bill ...". Together with the other speakers, Cooper said that the most important work-related issue that research shows is responsible for mental ill-health and related absenteeism is how
171
THE LANCET
much autonomy and control people feel they have in their work and
development. The second biggest negative influence on an employee’s mental health is a poor relation with one’s immediate superior, especially in an organisation where progress is based on career
punishment rather than reward. But there are many other harmful business practices, such as rewarding technically qualified workers
by promotion into positions that require management skills that they do not possess and for which they may have no aptitude; general practitioners who are expected to be effective managers face this type of pressure. Clearly these and the numerous other practices that contribute to mental ill-health are ripe targets for primary
prevention. But what if it is too late for primary prevention? Prof David Shapiro (Sheffield) suggested that counselling and employee assistance programmes (EAPs) have great potential to prevent serious mental-health problems at work. EAPs, which are policies and procedures that a company uses to identify or respond to employees’ emotional difficulties that interfere with job
performance, were first used to deal with alcohol-related health and behavioural problems in the US workforce in the 1940s. Shapiro emphasised two caveats about these programmes. First, although there are indications that these techniques could yield substantial benefits, there is a need for more rigorous evaluation. Second, the American model of EAPs is likely to require substantial modification if it is
to be appropriate for British culture. This noted a member of the audience, is likely to be the greatest culture, to impediment progress-ie, until the entrenched stigmatisation of such common illnesses as depression and anxiety is tackled, British industry will continue to lose out.
Thames Cancer
Registry
About 60 000 new cases of cancer (or 55 000 if skin cancers other than melanoma are excluded) are registered with the Thames Cancer Registry every year. The Registry’s data for 1987-89, released last week, show a similarity in the broad pattern of cancer occurrence in the four Thames health regions. What differences there were seem to reflect real differences in cancer risk rather than underregistration; for example, cancers associated with lower socioeconomic status were commoner in poorer districts. The Registry data are expected to differ from those held by the Office of Population Censuses and Surveys, largely because of faulty data transmission procedures, which are being addressed. These faulty procedures are thought to explain why incidence rates published by the OPCS for the Thames regions for 1985 and 1986 have been several per cent lower than those obtainable from the Registry’s database. Conscious of the importance of quality of data, the Registry, which has been recording cancer in the South Thames regions since 1960 and which extended coverage to the North Thames regions in 1985, invited a peer review committee last year to scrutinise all its activities. A programme to supplement the recommendations has been developed and peer review is to be conducted regularly. The time-lag between year of diagnosis and publication of incidence data is going to be shortened. The Registry’s report discusses two indicators of data qualitythe percentage of registered cancers histologically verified (HV%), and the percentage registered on the basis of a death certificate only (DCO%). Other measures of data quality will be introduced in future reports. Some 60% of the registrations were histologically verified, over 20% were based on death certificates only, and about 10% were based solely on clinical opinion. Usually a high DCO% is an indication of incomplete registration. In the Thames regions, the high rate can be attributed to the decision, since 1983, not to trace back records for confirmation of diagnosis for cases first brought to the Registry’s attention by a certificate for a death occurring outside hospital, because of financial constraints. However, since 1992, cases first registered because of a death outside hospital are being checked back through the Family Health Services Authorities, and this move should reduce the DCO% for 1989 onwards. 1. Cancer in South East Thames, South West Thames, North East Thames, and North West Thames, 1978-89 (one volume for each of the regions). London Thames Cancer Registry (15 Cotswold Road, Sutton, Surrey SM2 5PY). 1992.
Home
testing
Home testing, whether for monitoring therapy, as in diabetes, or for diagnosis, as for pregnancy, is on the increase, so it is important that kits give accurate results when used by the layman. However, false-negative results were obtained for about half the 478 positive urine samples in a French study’ in which over 600 laywomen were asked to test coded urine samples containing human gonadotropin or no hormone. Eleven pregnancy and diagnosis kits were selected for the survey, out of the twenty-seven on the market in France. Fifteen were rejected because, when used by qualified clinical chemistry technicians, they were not 100% specific or sensitive; the other was withdrawn at the request of the manufacturer. The main reason for the poor results was difficulty in understanding the explanatory leaflets, which was not related to the woman’s socioeconomic status. An accompanying editorial2 draws attention to a US survey3 in which false-negative results were also obtained, albeit to a lesser extent (10%), possibly because the subjects were hospital employees and because kits in the USA have to satisfy strict Food and Drug Administration rules, whereas in France manufacturers have only to follow general guidelines published by the Ministry of Health (although there are plans to subject home-test kits to the same requirements as those for laboratory kits). The editorial recommends that manufacturers should develop one-step methods; provide short, clear instructions with pictorial examples (pregnancy kits have to be understood by inner-city teenagers, for example); include positive and negative controls (perferably built in); use colour to represent positive reactions and lack of colour to represent negative reactions (rather than the other way round); and develop methods that are free from interference (for example, by drugs that the patient is taking or by proteinuria or haematuria). 1 Daviaud
J, Foumet D, Ballonge C, et al. Reliability and feasibility of pregnancy home-use tests: laboratory validation and diagnostic evaluation by 638 volunteers. Clin Chem 1993; 39: 53-59. 2. Hicks JM. Home testing: to do or not to do? Clin Chem 1993; 39: 7-8. 3 Hicks JM, Iosefson M. Reliability of home pregnancy kits in the hands of lay persons. N Engl J Med 1989; 320: 320-21.
Immunotherapy for HIV infection Treatment of HIV-infected patients with cultures of their own HIV-specific cytotoxic cells is to be assessed in a pilot trial under the US National Institute of Allergy and Infectious Diseases DATRI programme. Started in October, 1991, DATRI (Division of AIDS Treatment Research Initiative) is a means for rapidly conducting
clinical trials of new treatments for HIV infection and disorders related to it. Therapies found to be promising may then be considered for larger-scale trials by the Institute’s other AIDS networks-the AIDS Clinical Trial Group (ACTG) and the Terry Beirn Community Programs for Clinical Research on AIDS
(CPCRA). Between 15 and 24 patients with CD4 count of 100--MO/UL will be enrolled for the trial (DATRI 006), to be conducted at the New England Medical Center in Boston, Massachusetts (principal investigator Dr Judy Lieberman). Patients will receive 1 billion, 5 billion, or 25 billion cytotoxic T cells and be followed up for 24 weeks. Only 1 patient can be enrolled per month, so the trial could take 2 years to complete.
International Association of Bioethics Interest in bioethics heightened in the past year. That year saw the Council of Europe working towards the completion of its European Bioethics Convention and towards the creation of an international (see p 169) ethics body. It also saw the formation of the International Association of Bioethics, initiated by a group of bioethics philosophers. The association, which is open to people from all disciplines who share an interest in free, open, and reasoned discussion of bioethics, plans to meet every 2-3 years. Further information is obtainable from Kay Boyle, Centre for Human Bioethics, Monash University, Clayton, Victoria 3168, Australia.