1318
eyesight. It gives workers the entitlement to an appropriate eye and eyesight test to be carried out by a person with the necessary capabilities. Such a test is to be applied before the start of display screen work (when this takes place on a regular and habitual basis), at regular intervals subsequently, and ad hoc if the eyes and
difficulties. An forms of the ophthalmological investigation part entitlement if the preceding test indicates it. "Corrective appliances appropriate for the work concerned" have to be provided at no cost to the worker if the preceding examinations have found this necessary and "normal corrective appliances cannot be used". This brief summary should indicate that Brussels has provided a seed-bed for legal, medical, and social complications for all the pious hope of having made a practical contribution to the social dimension. In Britain, it is a Common Law requirement that no one shall hire himself out for work that he cannot do. Use of visual display units is becoming more and more widespread, and whether or not such a unit is going to be used in a particular job is ascertainable at a first interview. The putative need for the first test proposed by the Directive therefore conflicts with British law and may similarly conflict with prevailing laws of other EC member states. Although Article 2 contains definitions there is no defmition of an eye test. It has not so far been an employer’s task to work
causes
any
visual
provide an ophthalmological screening service. Not only has it transpired in the past that screening tests--eg, for glaucoma-are not cost-effective, it is also plain that if Parliament, even the European Parliament, wanted such tests to be made available they would say so. Alternatively, we are owed an explanation as to why tests are unnecessary for the rest of us, and why users of display screens should be privileged. In any case, since such tests are essentially preventive and relate to public health, it can be argued that they are the concern of national health systems; the Directive admits as much in an afterthought. Eyesight tests that do not involve refraction are not very demanding, and, given suitable prompted automated equipment, can be self-administered. Their installation should not break the bank; small establishments could share facilities. So far so good. But what sort of eye tests does the Council envisage? A glance at the external eye? A peep inside with an ophthalmoscope? An examination with a slit-lamp or perhaps an ultrasonic scan? To be followed by an electroretinogram, an electro-oculogram, and visual evoked potentials? Or will the test be confined to measurement of the intraocular pressure followed by checks on the visual fields? The point is not only that doctors are not interested when there is nothing to be interested in, but also where are all the required personnel to be found, no matter what testing of eyes is to be done?. In Britain, the number of display units in use will be in six or seven figures. Some are shared, but the number
pairs of eyes that will need "regular" (how frequent?) tests, probably quite unnecessarily, is going to be large. There is not an unlimited number of eye specialists and opticians to be tapped in any country.
of
The Council has ensured that market forces-the care of the pocket rather than the care of the patient-shall prevail. For the easy and comparatively remunerative work done on healthy eyes will delay the attention that should be given to those who need it. As a practical contribution to the formation of a social fabric the
Council’s prescription seems unimpressive. However, long before the Council will have come to see, let alone acknowledge, the error of their ways, their Directive will have to be made to work by the Members of the Community. Is it possible that the Directive contains its own salvation? Although the document vouchsafes entitlements to workers who habitually use display screen units, at no point does it say that it is concerned with all of them. Thus it may be possible to make a stab at rationalisation by suggesting that the Directive shall apply essentially to workers at some risk, perhaps to those aged 55 years and over. Medical notes would contain information about conditions liable to run in families, lead to eye tests on the basis of commonsense preventive medicine rather than on a bureaucratic edict, and so fulfil the laudable spirit of the Directive. Whatever the views ultimately to be enshrined in our laws, prudence seems to counsel that ministers in various EC countries should harmonise their policies. In this way 90/270/EEC might benefit the populace and not prove to be a social albatross around member states’ necks. 1. Council Directive of May 29, 1990. L 156/14-18.
90/270/EEC. Official J Eur Commun
Radiotherapy or surgery for squamous cell oesophageal carcinoma? The optimum management of oesophageal cancer remains controversial for several reasons. First, oesophageal cancer is not a single disease. In strict pathological terms it comprises the relatively more common squamous cell carcinoma and the much less common adenocarcinoma; the latter arises in metaplastic (Barrett’s) epithelium or, occasionally, de novo in mucus-secreting glands. However, in practice adenocarcinoma of the gastric cardia with involvement of the lower oesophagus has become at least as frequent as a cause of malignant oesophageal obstruction and poses a very similar therapeutic challenge. Second, management largely depends on the apparent stage of the disease at presentation. Although subtle symptoms may develop before the tumour has penetrated into the muscular wall of the
oesophagus,1 presentation is usually delayed until the onset of dysphagia, by which time the tumour is often at a very late stage of its natural history when
1319
palliation rather than cure may be the more appropriate aim of treatment. Third, patients get oesophageal malignancy at different stages of their history-variations in chronological and biological age as well as comorbidity will affect their fitness for some of the options. A last consideration is the combined philosophy of the individual clinician and each of his patients. Insufficient recognition has hitherto been given to this determinant of treatment own
natural
selection. For these reasons, it is inappropriate to debate the "best treatment for oesophageal cancer", but responsible clinicians should nevertheless weigh carefully the options available for a particular clinical situation, based on critical assessment of valid data, and contribute to establishing data where none exist. One such situation is operable squamous cell carcinoma of the non-cervical oesophagus, but there are no strictly comparable data on which to base a choice between radical surgery and radical radiotherapy. Earlam, backed by the Medical Research Council, designed a trial2 based on extensive groundwork and consultation to resolve this issue. 100 randomised patients were required annually for 5 years: this figure represented twice the number promised by supporters of the trial and equated with just 5 patients per year from each of 20 surgeons. After 16 months only 31 patients had been entered, representing one-quarter of the number required, and the trial was aborted. What went wrong? Earlam suggests that causes include delay in starting the trial (with resultant loss of impetus) and exclusion of a much higher proportion of patients than expected by the strict inclusion criteria of operability. In the accompanying invited commentary on the demise of this trial, Cuschieri3 expresses the view that lack of determined motivation, of time, and of financial and physical support were to blame. These factors were coupled with pig-headed dogmatism that surgery must be best. No doubt all these reasons contributed to the failure of this trial, but perhaps there is an additional, less culpable reason, to which Cuschieri refers obliquely when voicing his personal reservations regarding morbidity, quality of life, and recurrence of dysphagia after radical radiotherapyie, individual philosophy of approach. Philosophy may be dismissed as an excuse for avoiding a difficult decision-but the term philosophy of approach is used here to denote recognition of the concept that, for example, the same glass may be regarded by different individuals as being half empty or half full. Thus it is not appropriate to decree the relative importance of quality of swallowing versus treatment-related morbidity or mortality, or even to apply the concept of "acceptable mortality" at all, without considering the patient’s viewpoint. Different patients will have different attitudes to being informed of a 10, 30, or 50 % risk of dying as a result of treatment when they weigh that risk against the quality of life in
general and of swallowing in particular if they survive
the treatment. Some patients do want a chance of life at any cost and express a wish for a do-or-die approach, whereas for others avoidance of risk is paramount. What is unacceptable to many-patients or medical professionals-may be the deliberate, informed choice of others. This is not to condone unrealistic expectations by either patients or their medical advisers, nor to justify surgeons performing heroic surgery on hopeless cases or operating occasionally on the oesophagus if they have a high technical complication rate and consequent mortality. But it is naive to believe that failure to keep below an "approved" operability or mortality rate is indictable. Perhaps this is the reasoning that underlies clinicians’ reluctance to involve in randomly chosen treatment patients who, they feel, cannot be regarded as a homogeneous group because so many factors are involved. Many of these factors are peculiar to the individual patient. Such issues are all the more important when the stakes (for morbidity, mortality, and quality of life) are as high as they are for this disease. 1. Froelicher P, Miller G. The European experience with oesophageal cancer limited to the mucosa and submucosa. Gastrointest Endosc 1986; 32: 88-90. 2. Earlam R. An MRC prospective randomised trial of radiotherapy versus surgery for operable squamous cell carcinoma of the oesophagus. Ann R Coll Surg Engl 1991; 73: 8-12. 3. Cuschieri A. Invited introduction: Treatment of carcinoma of the oesophagus. Ann R Coll Surg Engl 1991; 73: 1-3.
Dangers of anti-Kell in
pregnancy
Severe haemolytic disease of the newborn (HDN) is largely an avoidable catastrophe. Successful preventative management of rhesus (Rh) HDN relies on serological screening during pregnancy. The aim is to identify clinically significant antibodies and therefore introduce measures to protect the health of both mother and baby. Antibodies other than Rh D also cause HDN; the potential dangers associated with anti-c, anti-E, and anti-K (the most important antigen of the Kell system) are especially well recognised.12 Concern about the importance of anti-K is sustained by occasional case-reports and by anecdotal evidence of severe morbidity. How seriously should obstetricians and serologists take such antibodies? We need to have more information about the risks associated with these antibodies to give firm advice to patients about outcome and management. The most pressing question is whether there is any need for invasive intervention before the natural end of pregnancy.
With respect to anti-K, Leggat and colleagues from the Royal Victoria Infirmary, Newcastle,3have now analysed 194 pregnancies over 25 years in which this antibody was detected. There were 16 affected babies but only 3 (1-5%) were severely affected and there were no deaths. As Leggat et al point out, husbands will be K-positive in only 10% of pregnancies and because of heterozygosity only about half of these
eyesight. It gives workers the entitlement to an appropriate eye and eyesight test to be carried out by a person with the necessary capabilities. Such a test is to be applied before the start of display screen work (when this takes place on a regular and habitual basis), at regular intervals subsequently, and ad hoc if the eyes and
difficulties. An forms of the ophthalmological investigation part entitlement if the preceding test indicates it. "Corrective appliances appropriate for the work concerned" have to be provided at no cost to the worker if the preceding examinations have found this necessary and "normal corrective appliances cannot be used". This brief summary should indicate that Brussels has provided a seed-bed for legal, medical, and social complications for all the pious hope of having made a practical contribution to the social dimension. In Britain, it is a Common Law requirement that no one shall hire himself out for work that he cannot do. Use of visual display units is becoming more and more widespread, and whether or not such a unit is going to be used in a particular job is ascertainable at a first interview. The putative need for the first test proposed by the Directive therefore conflicts with British law and may similarly conflict with prevailing laws of other EC member states. Although Article 2 contains definitions there is no defmition of an eye test. It has not so far been an employer’s task to work
causes
any
visual
provide an ophthalmological screening service. Not only has it transpired in the past that screening tests--eg, for glaucoma-are not cost-effective, it is also plain that if Parliament, even the European Parliament, wanted such tests to be made available they would say so. Alternatively, we are owed an explanation as to why tests are unnecessary for the rest of us, and why users of display screens should be privileged. In any case, since such tests are essentially preventive and relate to public health, it can be argued that they are the concern of national health systems; the Directive admits as much in an afterthought. Eyesight tests that do not involve refraction are not very demanding, and, given suitable prompted automated equipment, can be self-administered. Their installation should not break the bank; small establishments could share facilities. So far so good. But what sort of eye tests does the Council envisage? A glance at the external eye? A peep inside with an ophthalmoscope? An examination with a slit-lamp or perhaps an ultrasonic scan? To be followed by an electroretinogram, an electro-oculogram, and visual evoked potentials? Or will the test be confined to measurement of the intraocular pressure followed by checks on the visual fields? The point is not only that doctors are not interested when there is nothing to be interested in, but also where are all the required personnel to be found, no matter what testing of eyes is to be done?. In Britain, the number of display units in use will be in six or seven figures. Some are shared, but the number
pairs of eyes that will need "regular" (how frequent?) tests, probably quite unnecessarily, is going to be large. There is not an unlimited number of eye specialists and opticians to be tapped in any country.
of
The Council has ensured that market forces-the care of the pocket rather than the care of the patient-shall prevail. For the easy and comparatively remunerative work done on healthy eyes will delay the attention that should be given to those who need it. As a practical contribution to the formation of a social fabric the
Council’s prescription seems unimpressive. However, long before the Council will have come to see, let alone acknowledge, the error of their ways, their Directive will have to be made to work by the Members of the Community. Is it possible that the Directive contains its own salvation? Although the document vouchsafes entitlements to workers who habitually use display screen units, at no point does it say that it is concerned with all of them. Thus it may be possible to make a stab at rationalisation by suggesting that the Directive shall apply essentially to workers at some risk, perhaps to those aged 55 years and over. Medical notes would contain information about conditions liable to run in families, lead to eye tests on the basis of commonsense preventive medicine rather than on a bureaucratic edict, and so fulfil the laudable spirit of the Directive. Whatever the views ultimately to be enshrined in our laws, prudence seems to counsel that ministers in various EC countries should harmonise their policies. In this way 90/270/EEC might benefit the populace and not prove to be a social albatross around member states’ necks. 1. Council Directive of May 29, 1990. L 156/14-18.
90/270/EEC. Official J Eur Commun
Radiotherapy or surgery for squamous cell oesophageal carcinoma? The optimum management of oesophageal cancer remains controversial for several reasons. First, oesophageal cancer is not a single disease. In strict pathological terms it comprises the relatively more common squamous cell carcinoma and the much less common adenocarcinoma; the latter arises in metaplastic (Barrett’s) epithelium or, occasionally, de novo in mucus-secreting glands. However, in practice adenocarcinoma of the gastric cardia with involvement of the lower oesophagus has become at least as frequent as a cause of malignant oesophageal obstruction and poses a very similar therapeutic challenge. Second, management largely depends on the apparent stage of the disease at presentation. Although subtle symptoms may develop before the tumour has penetrated into the muscular wall of the
oesophagus,1 presentation is usually delayed until the onset of dysphagia, by which time the tumour is often at a very late stage of its natural history when
1319
palliation rather than cure may be the more appropriate aim of treatment. Third, patients get oesophageal malignancy at different stages of their history-variations in chronological and biological age as well as comorbidity will affect their fitness for some of the options. A last consideration is the combined philosophy of the individual clinician and each of his patients. Insufficient recognition has hitherto been given to this determinant of treatment own
natural
selection. For these reasons, it is inappropriate to debate the "best treatment for oesophageal cancer", but responsible clinicians should nevertheless weigh carefully the options available for a particular clinical situation, based on critical assessment of valid data, and contribute to establishing data where none exist. One such situation is operable squamous cell carcinoma of the non-cervical oesophagus, but there are no strictly comparable data on which to base a choice between radical surgery and radical radiotherapy. Earlam, backed by the Medical Research Council, designed a trial2 based on extensive groundwork and consultation to resolve this issue. 100 randomised patients were required annually for 5 years: this figure represented twice the number promised by supporters of the trial and equated with just 5 patients per year from each of 20 surgeons. After 16 months only 31 patients had been entered, representing one-quarter of the number required, and the trial was aborted. What went wrong? Earlam suggests that causes include delay in starting the trial (with resultant loss of impetus) and exclusion of a much higher proportion of patients than expected by the strict inclusion criteria of operability. In the accompanying invited commentary on the demise of this trial, Cuschieri3 expresses the view that lack of determined motivation, of time, and of financial and physical support were to blame. These factors were coupled with pig-headed dogmatism that surgery must be best. No doubt all these reasons contributed to the failure of this trial, but perhaps there is an additional, less culpable reason, to which Cuschieri refers obliquely when voicing his personal reservations regarding morbidity, quality of life, and recurrence of dysphagia after radical radiotherapyie, individual philosophy of approach. Philosophy may be dismissed as an excuse for avoiding a difficult decision-but the term philosophy of approach is used here to denote recognition of the concept that, for example, the same glass may be regarded by different individuals as being half empty or half full. Thus it is not appropriate to decree the relative importance of quality of swallowing versus treatment-related morbidity or mortality, or even to apply the concept of "acceptable mortality" at all, without considering the patient’s viewpoint. Different patients will have different attitudes to being informed of a 10, 30, or 50 % risk of dying as a result of treatment when they weigh that risk against the quality of life in
general and of swallowing in particular if they survive
the treatment. Some patients do want a chance of life at any cost and express a wish for a do-or-die approach, whereas for others avoidance of risk is paramount. What is unacceptable to many-patients or medical professionals-may be the deliberate, informed choice of others. This is not to condone unrealistic expectations by either patients or their medical advisers, nor to justify surgeons performing heroic surgery on hopeless cases or operating occasionally on the oesophagus if they have a high technical complication rate and consequent mortality. But it is naive to believe that failure to keep below an "approved" operability or mortality rate is indictable. Perhaps this is the reasoning that underlies clinicians’ reluctance to involve in randomly chosen treatment patients who, they feel, cannot be regarded as a homogeneous group because so many factors are involved. Many of these factors are peculiar to the individual patient. Such issues are all the more important when the stakes (for morbidity, mortality, and quality of life) are as high as they are for this disease. 1. Froelicher P, Miller G. The European experience with oesophageal cancer limited to the mucosa and submucosa. Gastrointest Endosc 1986; 32: 88-90. 2. Earlam R. An MRC prospective randomised trial of radiotherapy versus surgery for operable squamous cell carcinoma of the oesophagus. Ann R Coll Surg Engl 1991; 73: 8-12. 3. Cuschieri A. Invited introduction: Treatment of carcinoma of the oesophagus. Ann R Coll Surg Engl 1991; 73: 1-3.
Dangers of anti-Kell in
pregnancy
Severe haemolytic disease of the newborn (HDN) is largely an avoidable catastrophe. Successful preventative management of rhesus (Rh) HDN relies on serological screening during pregnancy. The aim is to identify clinically significant antibodies and therefore introduce measures to protect the health of both mother and baby. Antibodies other than Rh D also cause HDN; the potential dangers associated with anti-c, anti-E, and anti-K (the most important antigen of the Kell system) are especially well recognised.12 Concern about the importance of anti-K is sustained by occasional case-reports and by anecdotal evidence of severe morbidity. How seriously should obstetricians and serologists take such antibodies? We need to have more information about the risks associated with these antibodies to give firm advice to patients about outcome and management. The most pressing question is whether there is any need for invasive intervention before the natural end of pregnancy.
With respect to anti-K, Leggat and colleagues from the Royal Victoria Infirmary, Newcastle,3have now analysed 194 pregnancies over 25 years in which this antibody was detected. There were 16 affected babies but only 3 (1-5%) were severely affected and there were no deaths. As Leggat et al point out, husbands will be K-positive in only 10% of pregnancies and because of heterozygosity only about half of these
