transcervical endometrial resection but also in transurethral prostatectomv. P N RAO
University Hospital of South Manchester, Manchester M20 8LR
2 3 4
5 6
Bauimann R, Magos AL, Kay JDS, Turnbull AC. Absorption of glycine irrigating solution during transcersical resection of endometrium. Br M edJ 1990;300:304-5. (3 Februarv.) Madsen PO, Kuni H, Naber KG. Various methods of determining irrigating fluid absorption during transurethral resection of prostate. Urol Res 1973;1:70-8. Sittclair JF, Hutchison A, Baraza R, Telfer ABM. Absorption of 5% glycine after percutaneous ultrasonic lithotripsy for renal stone disease. BrMedj 1985;291:691-2. Schultz RE, Hanno PM, Wein AJ, Lesin RM, Pollack HM, Arsdalen KNV. Percutaneous ultrasonic lithotripsy: choice of irrigant.J Urol 1983;130:858-60. Rao PN. Fluid absorption during urological endoscopy. Br J Urol 1987;60:93-9. Hahn R, M joberg M. Immediate detection of irrigant absorption during transurethral prostatectomy: case report. Can JAnaesth 1989;36:86-8.
SIR,-Dr Ralf Baumann and colleagues describe changes in haematological and biochemical variables in patients before, during, and after transcervical endometrial resection with a urological resectoscope.t These changes correlated with the volume of irrigating fluid absorbed. Glycine solution is commonly used as a medium in operative endoscopy and Dr Baumann and colleagues used 1-5% glycine, which is claimed to be the simplest and safest' medium and
non-haemolysing.' We measured the osmolality of 1-5% glycine with a Roebling micro-osmometer that was calibrated to 0 and 300 mmol/kg. A total of 34 samples from five batches were measured. The osmolality was found to vary between 186 and 200 mmolUkg with the exception of one sample from a batch of 15, which had an osmolality of 39 mmolUkg. Interbatch difference in osmolality was 5 mmol/kg and intrabatch variation was 14 mmolUkg. A physiologically isotonic solution would have an osmolality in the range 280-300 mmolUkg. Therefore, 1 5% glycine is considerably hypotonic and not nearly isotonic.4 We suggest that greater consideration should be given to the choice of irrigating fluid for endometrial resection and similar procedures. J WIENER L GREGORY University Hospital of Wales, Cardiff CF4 4XN I Baumann R, Magos AL, Kay JDS, Turnbull AC. Absorption of glycine irrigating solution during transcervical resection of endometrium. BrMledj 1990;300:304-5. (3 February.) 2 Chisholm GD, Fair WR. Scientific foundation of-urology. Chicago: Oxford and Year Book Medical Publishers, 1990. 3 Nesbit RM, Glickman SI. The use of glycine solution as an irrigating medium during transurethral resection. 7 Urol 1948;59: 1212-6. 4 Rao PN. Fluid absorption during urological endoscopy.
Brj Urol 1987;60:93-9.
Promotion by the British pharmaceutical industry SIR, -As pharmaceutical physicians in a company that has not been mentioned in complaints to the Association of the British Pharmaceutical Industry (ABPI) we were interested in the paper by Drs Andrew Herxheimer and Joe Collier on promotion by the British pharmaceutical industry. ' Breach of the ABPI code or the Medicines Act cannot be condoned under any circumstances. We find it difficult, however, to interpret the data in the paper and do not understand how the authors reached their conclusions. We cannot tell whether a large or small proportion of all the promotional materials in the United Kingdom are in breach of the act and whether the ABPI has been diligent in detecting 100 breaches per year or whether the problem is much more widespread. How wide is
BMJ VOLUME 300
17 MARCH 1990
the ABPI's spontaneous audit? Numerators have been identified, but not denominators. The paper contains unproved assumptions such as "we estimate in round numbers that 600 breaches were detected in six years" and "it is assumed that the incidence of breaches did not change between 1972 and 1988." Such methods for deriving conclusions would not usually pass scientific peer review. An independent audit for comparison with these data would help to investigate whether the ABPI code is being enforced more vigorously than the Medicines Act. We do not know of any data to support the hearsay quote of a Food and Drug Administration official that "the vast majority of promotional materials submitted for consideration to the FDA are false or misleading in some respect" or that the administration takes regulatory action in 5% of cases. The interpretation of this statement requires a definition of the conditions under which the materials are submitted: Were they complaints or routine audit? How can we tell whether the system in the United Kingdom is better or worse than that in the United States? There are no data in this paper that suggest that a different type of regulation would be more effective. In particular, the general public and members of the health professions may not be qualified to judge whether materials are misleading. Independent specialists in the field may be the best judges. This paper will probably be widely cited, but it is hard to interpret without suitable comparative groups. A W FOX J E GAIT
Norwich Eaton Pharmaceuticals, PO Box 191, Norwich, New York 13815, United States 1 Herxheimer A, Collier J. Promotion by the British pharmaceutical industry, 1983-8: a critical analysis of self regulation. Br MedJ 1990;300:307-1 1. (3 February.)
SIR,-In their analysis of self regulation of the promotion of prescription medicines by the British pharmaceutical industry Drs Andrew Herxheimer and Joe Collier on numerous occasions refer to the breaches of the Association of the British Pharmaceutical Industry code by Organon.' In table III they list Organon as having made misleading claims or comparisons on five occasions while in the bar chart Organon is shown as having breached the code on 32 occasions. What the authors signally failed to point out is that Organon Laboratories does not market Norcuron, which accounts for the vast majority of the breaches referred to in the article. This product belongs to the entirely independently managed company, Organon Teknika. Therefore the reference to Organon is misleading. This error is all the more regrettable as the authors note that the subsidiaries of Glaxo have been consolidated. B J BOATFIELD
Organon Laboratories,
Cambridge CB4 4FL Herxheimer A, Collier J. Promotion by the British pharmaceutical industry, 1983-8: a critical analysis of self regulation. BrMedJ 1990;300:307-11. (3 Februarv.)
AUTHORS' REPLY, - Drs A W Fox and J E Gait say that they do not understand how we reached our conclusions but do not say which conclusions they mean. Our study is essentially descriptive and based on published information that anyone can check. We also cannot tell what proportion of the promotional materials in the United Kingdom breaches the ABPI code or the Medicines Act and therefore could make no statement about the diligence of the ABPI. If they want to know how wide the ABPI's "spontaneous audit" is then they must ask the ABPI, not us.
Our estimate that around 600 breaches were detected in six years derives from the data we gave: 379 breaches were detected by the committee and 158 or more by the secretariat, totalling 537. To this must be added an undisclosed number detected by the ABPI medical consultant. We did not assume that the incidence did not change: we wrote "if it is assumed that . the incidence of breaches did not change," and in the next sentence indeed suggested that this assumption may not be justified. Drs Fox and Gait mistrust the statement by the Food and Drug Administration official that we quoted, but he was talking about his full time professional work. We do not know of any data to suggest that he was wrong. We sympathise with Mr B J Boatfield's irritation at being unwittingly lumped together with his sibling at Organon Teknika, which shares his address. We thank him for putting us right. ANDREW HERXHEIMER
Charing Cross and Westminster Medical School, London W6 8RF
JOE COLLIER St George's Hospital Medical School, London SW 17 ORE
Node negative breast cancer SIR,-In their editorial Drs S M O'Reilly and M A Richards addressed the question of adjuvant treatment in patients with node negative breast cancer. How often, though, does the clinician have information as to the state of the axillary nodes? We examined all of the patients with primary breast cancer who presented over two years in Hillingdon Health District. From January 1985 to December 1986 there were 199 new patients. In all, 111 of them underwent a conservative surgical procedure (not mastectomy), but an axillary nodal staging procedure was carried out in only 30 patients. We suspect that this finding is not exceptional and is probably representative of practice in most health districts aside from specialist centres. Thus in practice the oncologist has often to make a decision regarding adjuvant treatment without the benefit of information about the state of the axillary nodes. M D LESLIE E J MAHER
Department of Radiotherapy and Oncology, Mount Vernon Hospital, Middlesex HA6 2RN 1 O'Reilly SM, Richards MA. Node negative breast cancer. BrMtfedJ7 1990;300:346-8. (10 February.)
Open access gastroscopy SIR,-Mr G H Hutchinson is to be congratulated on his foresight in offering open access gastroscopy at Halton District General Hospital' when others have clearly felt this to be unrewarding. He and the other authors of the audit paper on open access gastroscopy tended, however, to judge the success
of the technique by the number of positive results -a criterion by which others have judged similar results to be less worth while. It is about time that hospital specialists looked a little further than positive or negative results in assessing the worth of their services. Do we chastise general practitioners for referring patients for a lengthy outpatient appointment when nothing abnormal is found? General practitioners have to diagnose and treat people with symptoms that are sufficiently severe to warrant several general practitioner consultations. Whatever the patient's age the result will be of some value to the general practitioner. Indeed a negative result in a 60 year old patient may be of more value than a positive result in a 20 year old. This-is not to condone the indiscriminate
749
use of gastroscopy when investigations are carried out with no more information than that the patient has "dyspepsia." There is also the uncertainty in any retrospective study of patients going back as far as 1986 of how many patients with normal results had gastritis due to Helicobacter pylon. Unless an antral biopsy was done this entity will have been missed as the condition is often not visible even to experienced endoscopists. Our hospital has offered open access gastroscopy to general practitioners for the past eight months through a request form that takes two to three minutes to complete and requests information on drug history, etc. We insist that forms are filled in satisfactorily, and the demand for the new service has been stable over the past four months at about 25 patients per week, gastroscopy being performed within two to three weeks of the request (the catchment population is 300 000). This workload is absorbed by six consultants and two clinical assistants, who are already performing over 4000 endoscopies per year. Most patients requiring open access gastroscopy would be referred to the outpatient department if this service was not available. Previously almost half of our clinic referrals were essentially requests for gastroscopy but initiated at least one new patient visit to the clinic. These requests have now fallen, allowing patients whose complaint is not urgent to be seen within four to six weeks instead of the three to four months it took before the open access gastroscopy service was made available to general practitioners. Thus everybody gains. The general practitioner retains clinical control of the patient and obtains accurate diagnostic information on his or her upper gastrointestinal tract. The only loser is the radiologist-is it time to do more open access ultrasound? M G BRAMBLE P A CANN
Gastrointestinal Unit, Middlesbrough General Hospital,
Middlesbrough I Kerrigan DD, Brown SR, Hutchinson GH. Open access gastroscopy: too much to swallow? Br Med J 1990;300:374-6. (10
February.)
SIR, -We would like to make several observations regarding the recent article on open access gastroscopy by Dr D D Kerrigan and colleagues.' While agreeing that open access endoscopy is desirable we feel it is important to emphasise to general practitioners that, particularly in patients under 45 who have uncomplicated dyspepsia, some sort of selection is imperative to avoid swamping the service. In a recent study in Leicester we showed that in patients under 45, 60% had no disease at endoscopy, with this figure rising to 75% after barium meal examination.2 Although we are not suggesting that all patients under 45 should be denied access to endoscopy, a more careful clinical screening is necessary to reduce numbers. The worry of having an arbitrary cut off point for endoscopy is the possibility of missing gastric carcinoma, but, of 707 histologically proved cases of gastric carcinoma over seven years in Leicester, only 1 8% of the patients were under 45. All of these patients had symptoms that were suggestive of more serious disease than simple dyspepsia. Unfortunately the article by Mr Kerrigan and colleagues does not give a breakdown of the various diseases by age or the percentage of abnormal findings, which would have been valuable. Ideally, an open access endoscopy unit for patients over 45 would be a practical proposition provided that there was a simple screening system that could be applied by general practitioners in their surgeries to decide which patients warrant referral. We are currently working on such a system to apply to patients under 45 and only time
750
will tell whether this will be practical for a busy general practitioner. With medical audit uppermost in most people's minds this probably should be the way forward. A C B WICKS T BATTCOCK
Leicester General Hospital, Leicester LE5 4PW 1 Kerrigan DD, Braun SR, Hutchinson (GH. Open access gastroscopy: too much to swallow? Br Med 1990;300:37-6. (10 February.) 2 Williams B, Luckas M, Ellingham JHM, Dain A, Wicks ACB. Do young patients with dyspepsia need investigation? Lancet 1988;ii: 1349-5 1.
Medical audit SIR,-Letters on medical audit by Dr B J Boughton' and Drs Malcolm Aylett and Pali Hungin2 yet again show the diversity of those who describe its scope and implementation. The provision of funding seems likely to dictate the scale that these studies will assume. A paper from the standing committee on postgraduate medical education is before Mr Kenneth Clarke, and a departmental circular on audit is expected soon, which will embody guidelines and, no doubt, reflect an estimate of the time and funding to be allocated. It must be recognised that introducing medical audit comprehensively across the specialties cannot be imposed on the plenum of material and must be allowed to develop from in depth investigation of chosen topics. The chief benefit to be gained in the long run may emerge as an increased willingness of health professionals to consider and accept changes in practice that are identified in the process. This will require the jettisoning of old and often favoured procedures, giving place to newer and demonstrably more effective activities. CONSTANCE E FOZZARD Royal Cornwall Hospital (Treliske) Truro, Cornwall TR1 3LJ
Increased measurement of blood pressure may result in many outcomes-for example, more patients labelled hypertensive, more patients worried about hypertension, more citizens rendered patients, fewer deaths from target organ damage, more morbidity from antihypertensive drugs, less emphasis on other aspects of the patients' health, and so on. Measure of outcome may be a holy grail that we might never attain, but measuring only process in the belief that it equals outcome suggests that we are entitled to construct our own holy grail for each of our activities. "Just because we know what we are doing is right, we need only count how often we are doing the right things" is perhaps an approach we have come to recognise in Her Majesty's government, but it is not a scientific approach which we should apply to our activities. TOM W NIMMO
Falkirk FK 1 4PG I Aylett M, Hungin P. AMedical audit. BrMed] 1990;300:463. (17
Februars.)
Anabolic steroids and infarction SIR,-As the interest in the thrombogenicity of anabolic steroids has continued' I would like to update our report on a 23 year old bodybuilder taking anabolic steroids who presented in June 1989 with an acute lateral myocardial infarction.2 Firstly, with regard to his plasma lipid concentrations, which he had had checked several times as a health screening measure at his bodybuilding club before his infarct, he exhibited the low high density lipoprotein and high low density lipoprotein concentrations that are characteristic of people taking anabolic steroids' (table). He now claims to have stopped taking anabolic steroids, and his results are greatly improved (table). Plasma lipid concentrations in a 23 year old bodybuilder
1 Boughton BJ. Medical audit. Br Med J 1990;300:463. (17
Februarv.) 2 Avlett M. Hungin P. M\edical audit. BrMedJ 1990;300:463. (17 Februarv.)
SIR,-I would like to take issue with Drs Malcolm Aylett and Pali Hungin, who state that "in general practice process is virtually synonymous with outcome" and suggest that audit of process will suffice. ' They cite frequency of measurement of blood pressure as an cxample of a basic clinical process that.could validly be audited in isolation. I suggest that process is never synonymous with outcome. I agree that setting standard clinical protocols -and measuring the percentage of adherence to these protocols is a measure of the level of adherence to the protocol. No measure of the effect of the activity is made. Previous assumptions on which the stated protocol is based have to be accepted as proved and unchangeable. Though it is useful to count the number of blood pressure measurements done in a general practice, if previously the practice has set out to measure everyone's blood pressure and later wishes to know if this has been done I am concerned that in counting the level of the defined activity the effects of that activity, for good or ill, are not considered. I am reminded of the story of the security officer who checked, as was his protocol, that all wheelbarrows leaving the building site where he worked were empty. He did this with great dedication. He never noticed over a period of a year that 50 wheelbarrows had been stolen. Unerringly he had followed the process laid down for him. He had no interest in outcome. Similarly, in general practice we cannot assume that counting the frequency of any activity does any more than count the frequency of that activity.
Total cholesterol High density lipoprotein (mmol/l) (mmol/l)
Date 1 July 1987 4 Jan 1989
9March 1989 26 Jan 1990
0-12 0-07 017 0.59
10 50 9-77 7-21
7-10
He also underwent cardiac catheterisation, which showed a large area of anterior and septal akinesis. In the left coronary artery the left main stem was normal, the left anterior descending artery was occluded after the first septal branch and filled distally from the right coronary artery, and there was atheroma in a large oblique marginal branch. There was also narrowing in the right coronary artery at the bifurcation into the posterior descending and left ventricular branches. The patient continues to exercise and has declined any further interventions. The findings on catheterisation contrast with the findings of normal coronary arteries in a previous similar case4 and add some further suggestive evidence that atherogenesis mediated through abnormal lipid concentration may at least partly explain any thrombogenic effect of anabolic steroids. SIMON BOWMAN Oldchurch Hospital, Romford RM7 OBE I Ferenchick GS. Are androgenic steroids thrombogenic? N Engl 7 Med 1990;322:476. 2 Bowman SJ, Tanna S, Fernando S, Ayodeji A, Weatherstone RN. Anabolic steroids and infarction. Br MedJ 1989;299:632. (2 September.) 3 Hurley BF, Seals DR, Hagberg JM, et al.High density lipoprotein cholesterol in bodybuilders v powerlifters. J7AMA 1984; 252:507-13. 4 McNutt RA, Ferenchick GS, Kirlin PC, Hamlin NJ. Acute myocardial infarction in a 22 year old world class weight lifter using anabolic steroids. AmJ7 Cardiology 1988;62:164.
BMJ VOLUME 300
17 MARCH 1990
University Hospital of South Manchester, Manchester M20 8LR
2 3 4
5 6
Bauimann R, Magos AL, Kay JDS, Turnbull AC. Absorption of glycine irrigating solution during transcersical resection of endometrium. Br M edJ 1990;300:304-5. (3 Februarv.) Madsen PO, Kuni H, Naber KG. Various methods of determining irrigating fluid absorption during transurethral resection of prostate. Urol Res 1973;1:70-8. Sittclair JF, Hutchison A, Baraza R, Telfer ABM. Absorption of 5% glycine after percutaneous ultrasonic lithotripsy for renal stone disease. BrMedj 1985;291:691-2. Schultz RE, Hanno PM, Wein AJ, Lesin RM, Pollack HM, Arsdalen KNV. Percutaneous ultrasonic lithotripsy: choice of irrigant.J Urol 1983;130:858-60. Rao PN. Fluid absorption during urological endoscopy. Br J Urol 1987;60:93-9. Hahn R, M joberg M. Immediate detection of irrigant absorption during transurethral prostatectomy: case report. Can JAnaesth 1989;36:86-8.
SIR,-Dr Ralf Baumann and colleagues describe changes in haematological and biochemical variables in patients before, during, and after transcervical endometrial resection with a urological resectoscope.t These changes correlated with the volume of irrigating fluid absorbed. Glycine solution is commonly used as a medium in operative endoscopy and Dr Baumann and colleagues used 1-5% glycine, which is claimed to be the simplest and safest' medium and
non-haemolysing.' We measured the osmolality of 1-5% glycine with a Roebling micro-osmometer that was calibrated to 0 and 300 mmol/kg. A total of 34 samples from five batches were measured. The osmolality was found to vary between 186 and 200 mmolUkg with the exception of one sample from a batch of 15, which had an osmolality of 39 mmolUkg. Interbatch difference in osmolality was 5 mmol/kg and intrabatch variation was 14 mmolUkg. A physiologically isotonic solution would have an osmolality in the range 280-300 mmolUkg. Therefore, 1 5% glycine is considerably hypotonic and not nearly isotonic.4 We suggest that greater consideration should be given to the choice of irrigating fluid for endometrial resection and similar procedures. J WIENER L GREGORY University Hospital of Wales, Cardiff CF4 4XN I Baumann R, Magos AL, Kay JDS, Turnbull AC. Absorption of glycine irrigating solution during transcervical resection of endometrium. BrMledj 1990;300:304-5. (3 February.) 2 Chisholm GD, Fair WR. Scientific foundation of-urology. Chicago: Oxford and Year Book Medical Publishers, 1990. 3 Nesbit RM, Glickman SI. The use of glycine solution as an irrigating medium during transurethral resection. 7 Urol 1948;59: 1212-6. 4 Rao PN. Fluid absorption during urological endoscopy.
Brj Urol 1987;60:93-9.
Promotion by the British pharmaceutical industry SIR, -As pharmaceutical physicians in a company that has not been mentioned in complaints to the Association of the British Pharmaceutical Industry (ABPI) we were interested in the paper by Drs Andrew Herxheimer and Joe Collier on promotion by the British pharmaceutical industry. ' Breach of the ABPI code or the Medicines Act cannot be condoned under any circumstances. We find it difficult, however, to interpret the data in the paper and do not understand how the authors reached their conclusions. We cannot tell whether a large or small proportion of all the promotional materials in the United Kingdom are in breach of the act and whether the ABPI has been diligent in detecting 100 breaches per year or whether the problem is much more widespread. How wide is
BMJ VOLUME 300
17 MARCH 1990
the ABPI's spontaneous audit? Numerators have been identified, but not denominators. The paper contains unproved assumptions such as "we estimate in round numbers that 600 breaches were detected in six years" and "it is assumed that the incidence of breaches did not change between 1972 and 1988." Such methods for deriving conclusions would not usually pass scientific peer review. An independent audit for comparison with these data would help to investigate whether the ABPI code is being enforced more vigorously than the Medicines Act. We do not know of any data to support the hearsay quote of a Food and Drug Administration official that "the vast majority of promotional materials submitted for consideration to the FDA are false or misleading in some respect" or that the administration takes regulatory action in 5% of cases. The interpretation of this statement requires a definition of the conditions under which the materials are submitted: Were they complaints or routine audit? How can we tell whether the system in the United Kingdom is better or worse than that in the United States? There are no data in this paper that suggest that a different type of regulation would be more effective. In particular, the general public and members of the health professions may not be qualified to judge whether materials are misleading. Independent specialists in the field may be the best judges. This paper will probably be widely cited, but it is hard to interpret without suitable comparative groups. A W FOX J E GAIT
Norwich Eaton Pharmaceuticals, PO Box 191, Norwich, New York 13815, United States 1 Herxheimer A, Collier J. Promotion by the British pharmaceutical industry, 1983-8: a critical analysis of self regulation. Br MedJ 1990;300:307-1 1. (3 February.)
SIR,-In their analysis of self regulation of the promotion of prescription medicines by the British pharmaceutical industry Drs Andrew Herxheimer and Joe Collier on numerous occasions refer to the breaches of the Association of the British Pharmaceutical Industry code by Organon.' In table III they list Organon as having made misleading claims or comparisons on five occasions while in the bar chart Organon is shown as having breached the code on 32 occasions. What the authors signally failed to point out is that Organon Laboratories does not market Norcuron, which accounts for the vast majority of the breaches referred to in the article. This product belongs to the entirely independently managed company, Organon Teknika. Therefore the reference to Organon is misleading. This error is all the more regrettable as the authors note that the subsidiaries of Glaxo have been consolidated. B J BOATFIELD
Organon Laboratories,
Cambridge CB4 4FL Herxheimer A, Collier J. Promotion by the British pharmaceutical industry, 1983-8: a critical analysis of self regulation. BrMedJ 1990;300:307-11. (3 Februarv.)
AUTHORS' REPLY, - Drs A W Fox and J E Gait say that they do not understand how we reached our conclusions but do not say which conclusions they mean. Our study is essentially descriptive and based on published information that anyone can check. We also cannot tell what proportion of the promotional materials in the United Kingdom breaches the ABPI code or the Medicines Act and therefore could make no statement about the diligence of the ABPI. If they want to know how wide the ABPI's "spontaneous audit" is then they must ask the ABPI, not us.
Our estimate that around 600 breaches were detected in six years derives from the data we gave: 379 breaches were detected by the committee and 158 or more by the secretariat, totalling 537. To this must be added an undisclosed number detected by the ABPI medical consultant. We did not assume that the incidence did not change: we wrote "if it is assumed that . the incidence of breaches did not change," and in the next sentence indeed suggested that this assumption may not be justified. Drs Fox and Gait mistrust the statement by the Food and Drug Administration official that we quoted, but he was talking about his full time professional work. We do not know of any data to suggest that he was wrong. We sympathise with Mr B J Boatfield's irritation at being unwittingly lumped together with his sibling at Organon Teknika, which shares his address. We thank him for putting us right. ANDREW HERXHEIMER
Charing Cross and Westminster Medical School, London W6 8RF
JOE COLLIER St George's Hospital Medical School, London SW 17 ORE
Node negative breast cancer SIR,-In their editorial Drs S M O'Reilly and M A Richards addressed the question of adjuvant treatment in patients with node negative breast cancer. How often, though, does the clinician have information as to the state of the axillary nodes? We examined all of the patients with primary breast cancer who presented over two years in Hillingdon Health District. From January 1985 to December 1986 there were 199 new patients. In all, 111 of them underwent a conservative surgical procedure (not mastectomy), but an axillary nodal staging procedure was carried out in only 30 patients. We suspect that this finding is not exceptional and is probably representative of practice in most health districts aside from specialist centres. Thus in practice the oncologist has often to make a decision regarding adjuvant treatment without the benefit of information about the state of the axillary nodes. M D LESLIE E J MAHER
Department of Radiotherapy and Oncology, Mount Vernon Hospital, Middlesex HA6 2RN 1 O'Reilly SM, Richards MA. Node negative breast cancer. BrMtfedJ7 1990;300:346-8. (10 February.)
Open access gastroscopy SIR,-Mr G H Hutchinson is to be congratulated on his foresight in offering open access gastroscopy at Halton District General Hospital' when others have clearly felt this to be unrewarding. He and the other authors of the audit paper on open access gastroscopy tended, however, to judge the success
of the technique by the number of positive results -a criterion by which others have judged similar results to be less worth while. It is about time that hospital specialists looked a little further than positive or negative results in assessing the worth of their services. Do we chastise general practitioners for referring patients for a lengthy outpatient appointment when nothing abnormal is found? General practitioners have to diagnose and treat people with symptoms that are sufficiently severe to warrant several general practitioner consultations. Whatever the patient's age the result will be of some value to the general practitioner. Indeed a negative result in a 60 year old patient may be of more value than a positive result in a 20 year old. This-is not to condone the indiscriminate
749
use of gastroscopy when investigations are carried out with no more information than that the patient has "dyspepsia." There is also the uncertainty in any retrospective study of patients going back as far as 1986 of how many patients with normal results had gastritis due to Helicobacter pylon. Unless an antral biopsy was done this entity will have been missed as the condition is often not visible even to experienced endoscopists. Our hospital has offered open access gastroscopy to general practitioners for the past eight months through a request form that takes two to three minutes to complete and requests information on drug history, etc. We insist that forms are filled in satisfactorily, and the demand for the new service has been stable over the past four months at about 25 patients per week, gastroscopy being performed within two to three weeks of the request (the catchment population is 300 000). This workload is absorbed by six consultants and two clinical assistants, who are already performing over 4000 endoscopies per year. Most patients requiring open access gastroscopy would be referred to the outpatient department if this service was not available. Previously almost half of our clinic referrals were essentially requests for gastroscopy but initiated at least one new patient visit to the clinic. These requests have now fallen, allowing patients whose complaint is not urgent to be seen within four to six weeks instead of the three to four months it took before the open access gastroscopy service was made available to general practitioners. Thus everybody gains. The general practitioner retains clinical control of the patient and obtains accurate diagnostic information on his or her upper gastrointestinal tract. The only loser is the radiologist-is it time to do more open access ultrasound? M G BRAMBLE P A CANN
Gastrointestinal Unit, Middlesbrough General Hospital,
Middlesbrough I Kerrigan DD, Brown SR, Hutchinson GH. Open access gastroscopy: too much to swallow? Br Med J 1990;300:374-6. (10
February.)
SIR, -We would like to make several observations regarding the recent article on open access gastroscopy by Dr D D Kerrigan and colleagues.' While agreeing that open access endoscopy is desirable we feel it is important to emphasise to general practitioners that, particularly in patients under 45 who have uncomplicated dyspepsia, some sort of selection is imperative to avoid swamping the service. In a recent study in Leicester we showed that in patients under 45, 60% had no disease at endoscopy, with this figure rising to 75% after barium meal examination.2 Although we are not suggesting that all patients under 45 should be denied access to endoscopy, a more careful clinical screening is necessary to reduce numbers. The worry of having an arbitrary cut off point for endoscopy is the possibility of missing gastric carcinoma, but, of 707 histologically proved cases of gastric carcinoma over seven years in Leicester, only 1 8% of the patients were under 45. All of these patients had symptoms that were suggestive of more serious disease than simple dyspepsia. Unfortunately the article by Mr Kerrigan and colleagues does not give a breakdown of the various diseases by age or the percentage of abnormal findings, which would have been valuable. Ideally, an open access endoscopy unit for patients over 45 would be a practical proposition provided that there was a simple screening system that could be applied by general practitioners in their surgeries to decide which patients warrant referral. We are currently working on such a system to apply to patients under 45 and only time
750
will tell whether this will be practical for a busy general practitioner. With medical audit uppermost in most people's minds this probably should be the way forward. A C B WICKS T BATTCOCK
Leicester General Hospital, Leicester LE5 4PW 1 Kerrigan DD, Braun SR, Hutchinson (GH. Open access gastroscopy: too much to swallow? Br Med 1990;300:37-6. (10 February.) 2 Williams B, Luckas M, Ellingham JHM, Dain A, Wicks ACB. Do young patients with dyspepsia need investigation? Lancet 1988;ii: 1349-5 1.
Medical audit SIR,-Letters on medical audit by Dr B J Boughton' and Drs Malcolm Aylett and Pali Hungin2 yet again show the diversity of those who describe its scope and implementation. The provision of funding seems likely to dictate the scale that these studies will assume. A paper from the standing committee on postgraduate medical education is before Mr Kenneth Clarke, and a departmental circular on audit is expected soon, which will embody guidelines and, no doubt, reflect an estimate of the time and funding to be allocated. It must be recognised that introducing medical audit comprehensively across the specialties cannot be imposed on the plenum of material and must be allowed to develop from in depth investigation of chosen topics. The chief benefit to be gained in the long run may emerge as an increased willingness of health professionals to consider and accept changes in practice that are identified in the process. This will require the jettisoning of old and often favoured procedures, giving place to newer and demonstrably more effective activities. CONSTANCE E FOZZARD Royal Cornwall Hospital (Treliske) Truro, Cornwall TR1 3LJ
Increased measurement of blood pressure may result in many outcomes-for example, more patients labelled hypertensive, more patients worried about hypertension, more citizens rendered patients, fewer deaths from target organ damage, more morbidity from antihypertensive drugs, less emphasis on other aspects of the patients' health, and so on. Measure of outcome may be a holy grail that we might never attain, but measuring only process in the belief that it equals outcome suggests that we are entitled to construct our own holy grail for each of our activities. "Just because we know what we are doing is right, we need only count how often we are doing the right things" is perhaps an approach we have come to recognise in Her Majesty's government, but it is not a scientific approach which we should apply to our activities. TOM W NIMMO
Falkirk FK 1 4PG I Aylett M, Hungin P. AMedical audit. BrMed] 1990;300:463. (17
Februars.)
Anabolic steroids and infarction SIR,-As the interest in the thrombogenicity of anabolic steroids has continued' I would like to update our report on a 23 year old bodybuilder taking anabolic steroids who presented in June 1989 with an acute lateral myocardial infarction.2 Firstly, with regard to his plasma lipid concentrations, which he had had checked several times as a health screening measure at his bodybuilding club before his infarct, he exhibited the low high density lipoprotein and high low density lipoprotein concentrations that are characteristic of people taking anabolic steroids' (table). He now claims to have stopped taking anabolic steroids, and his results are greatly improved (table). Plasma lipid concentrations in a 23 year old bodybuilder
1 Boughton BJ. Medical audit. Br Med J 1990;300:463. (17
Februarv.) 2 Avlett M. Hungin P. M\edical audit. BrMedJ 1990;300:463. (17 Februarv.)
SIR,-I would like to take issue with Drs Malcolm Aylett and Pali Hungin, who state that "in general practice process is virtually synonymous with outcome" and suggest that audit of process will suffice. ' They cite frequency of measurement of blood pressure as an cxample of a basic clinical process that.could validly be audited in isolation. I suggest that process is never synonymous with outcome. I agree that setting standard clinical protocols -and measuring the percentage of adherence to these protocols is a measure of the level of adherence to the protocol. No measure of the effect of the activity is made. Previous assumptions on which the stated protocol is based have to be accepted as proved and unchangeable. Though it is useful to count the number of blood pressure measurements done in a general practice, if previously the practice has set out to measure everyone's blood pressure and later wishes to know if this has been done I am concerned that in counting the level of the defined activity the effects of that activity, for good or ill, are not considered. I am reminded of the story of the security officer who checked, as was his protocol, that all wheelbarrows leaving the building site where he worked were empty. He did this with great dedication. He never noticed over a period of a year that 50 wheelbarrows had been stolen. Unerringly he had followed the process laid down for him. He had no interest in outcome. Similarly, in general practice we cannot assume that counting the frequency of any activity does any more than count the frequency of that activity.
Total cholesterol High density lipoprotein (mmol/l) (mmol/l)
Date 1 July 1987 4 Jan 1989
9March 1989 26 Jan 1990
0-12 0-07 017 0.59
10 50 9-77 7-21
7-10
He also underwent cardiac catheterisation, which showed a large area of anterior and septal akinesis. In the left coronary artery the left main stem was normal, the left anterior descending artery was occluded after the first septal branch and filled distally from the right coronary artery, and there was atheroma in a large oblique marginal branch. There was also narrowing in the right coronary artery at the bifurcation into the posterior descending and left ventricular branches. The patient continues to exercise and has declined any further interventions. The findings on catheterisation contrast with the findings of normal coronary arteries in a previous similar case4 and add some further suggestive evidence that atherogenesis mediated through abnormal lipid concentration may at least partly explain any thrombogenic effect of anabolic steroids. SIMON BOWMAN Oldchurch Hospital, Romford RM7 OBE I Ferenchick GS. Are androgenic steroids thrombogenic? N Engl 7 Med 1990;322:476. 2 Bowman SJ, Tanna S, Fernando S, Ayodeji A, Weatherstone RN. Anabolic steroids and infarction. Br MedJ 1989;299:632. (2 September.) 3 Hurley BF, Seals DR, Hagberg JM, et al.High density lipoprotein cholesterol in bodybuilders v powerlifters. J7AMA 1984; 252:507-13. 4 McNutt RA, Ferenchick GS, Kirlin PC, Hamlin NJ. Acute myocardial infarction in a 22 year old world class weight lifter using anabolic steroids. AmJ7 Cardiology 1988;62:164.
BMJ VOLUME 300
17 MARCH 1990
