2
814 THE FLINDERS EXPERIMENT Prof. G. J. Fraenkel 1 has described the principles underlying the proposed curriculum for the school of medicine at the Flinders University, in South Australia. Neither the hospital nor the medical school exist at this moment, and that both should be developed simultaneously is an exciting and appealing concept. Professor Fraenkel, dean of the new faculty, says that the main objective of medical education in his school is to produce graduates " equipped in every way for the further specialised education and training which will enable them to practise their chosen specialities including general practice ". He goes further by explaining that the undergraduate cur- riculum will be " relevant to patient care " and will take " full account of the involvement of medicine in the community ". Undergraduate students will have early contact with patients from their first years. The students themselves will be selected from a wider group than usual, and entry qualifica- tions will be very flexible. There is to be vertical and horizontal integration of both clinical and basic-science teaching. Artificial departmental boundaries are to be abolished, so that duplication of teaching will be reduced to a minimum. A quarter of the student’s learning time in each year will be reserved for options and electives. From the first to the last year of the six-year course there will be continued emphasis on community and social medicine. A chair of clinical chemistry will take the place of individual chairs of biochemistry and pharmacology. Liaison with general practitioners in the local area will be fostered. An attempt will be made to teach students to adopt a relaxed and appropriate attitude to suffering and distress (a most worthy aim neglected by many current medical curricula). Medical students will assume increasing responsibility in their later years and there will be decreasing supervision of their work. Students are to be taught to participate in patient management as members of a team with allied health professions. Professor Fraenkel sensibly insists that the medical course, rather than being comprehen- sive, will emphasise self-learning and problem-solving. There is a widespread feeling that medicine has lost its strategic function and that it is increasingly failing to meet community needs. Professor Fraenkel remarks that, for over a century in Great Britain, Australia, and New Zealand, relevance to patient care has not been a central policy in medical education. Any attempt to return medicine to its grass roots must begin with patient care. The Flinders University Medical School certainly has exciting opportunities to experiment with its curriculum, to integrate with a major hospital, and to record and influence the health of a community. But however exciting the new- ness of the sociological concepts may be and however beguiling it may be to think in terms of community care, health centres, and social medicine (terms often used but seldom defined), the need remains to learn the basic clinical medicine that makes for good practice of health care in the community. It is mar- vellous that students will be taught to recognise and 1. Fraenkel, G. J. A. V.C.C Education Newsletter, 1972, no. 3/72. to manipulate the social issues that are so often important in human illness. But a knowledge of clinical medicine is irreplaceable. 2 INSTANT EXPERIENCE IN CLINICAL TRIALS SIMULATION and gaming techniques 3 have been applied in military training (war games), in management courses (business games), and in teaching of history, sociology, geography, and politics. The possibilities are now being explored in medical education. Simu- lation techniques based on careful analysis of clinical method have produced patient-management-problem tests 4 which can teach and assess the student at the same time, and which stimulate him to elicit, order, and interpret data, plan treatment, and react suit- ably to problem situations. There are more elaborate systems, such as the computer-aided simulation of the clinical encounter (C.A.S.E.)."’ 7 Maxwell, at the annual scientific meeting of the Association for the Study of Medical Education, described the development and use of a novel clinical- trials game in the form of a computerised simulation exercise. The game, known as instant experience in clinical trials, and made available under the auspices of the Trust for Education and Research in Thera- peutics,9 has been successfully used in six workshops. During the game, students are provided with a realis- tically limited amount of information about a promising new drug, and, working in groups, they are asked to design a protocol for a clinical trial. This provides an opportunity for the students to discuss with their tutors the advantages and disadvantages of various forms of trial design. The organisers have already invented a population of patients, each described in terms of characteristics which can influence response to treatment, and they have decided on the true drug efficacies for each type of patient. As the game pro- ceeds, drug treatments are allocated to the patients according to proper clinical-trial methods, influenced by the students’ own trial protocols. Thus stratified randomisation is possible. The computer programme then generates full and detailed results for each group of students, according to their own experimental design and the ground rules chosen by the organisers and replete with drug defaulters, deaths, and with- drawals due to side-effects. If the students have chosen the correct factors and an appropriate trial design they will be able to derive the true results. Faults in trial design will generate figures from which the correct results may or may not be derivable by statistical examination. The students are thus given a chance to practise simple statistical analysis of typical trial results, and, by comparing the results obtained by the different groups, can examine the 2. Feinstein, A. R. Clinical Judgement; p. 385. Baltimore, 1967. 3. Taylor, J. L., Walford, R. Simulation in the Classroom. Harmonds- worth, 1972. 4. Andrew, B. J. J. med. Educ. 1972, 47, 952. 5. McCarthy, W. H., Gonella, J. S. Br. J. med. Educ. 1967, 1, 348. 6. De Dombal, F. T., Hartly, I. R., Sleeman, D. H. Lancet, 1969, i, 145. 7. Harless, W. G., Drennan, G. G., Marxer, J. J., Root, J. A., Miller, G. E. J. med. Educ. 1971, 46, 443. 8. Maxwell, C., Domenet, J. G., Joyce, C. R. B. J. clin. Pharm. 1971, 11, 323. 9. Maxwell, C., Smith, F. R., Shing, L. K. Instant Experience in Clinical Trials—A Computerized Teaching Aid. Trust for Education and Research in Therapeutics (c/o CIBA, Horsham, Sussex), 1972.

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Page 1: INSTANT EXPERIENCE IN CLINICAL TRIALS

814

THE FLINDERS EXPERIMENT

Prof. G. J. Fraenkel 1 has described the principlesunderlying the proposed curriculum for the schoolof medicine at the Flinders University, in SouthAustralia. Neither the hospital nor the medicalschool exist at this moment, and that both should bedeveloped simultaneously is an exciting and appealingconcept.

Professor Fraenkel, dean of the new faculty, saysthat the main objective of medical education in hisschool is to produce graduates " equipped in everyway for the further specialised education and trainingwhich will enable them to practise their chosen

specialities including general practice ". He goesfurther by explaining that the undergraduate cur-

riculum will be " relevant to patient care " and willtake " full account of the involvement of medicinein the community ". Undergraduate students willhave early contact with patients from their first

years. The students themselves will be selectedfrom a wider group than usual, and entry qualifica-tions will be very flexible. There is to be verticaland horizontal integration of both clinical andbasic-science teaching. Artificial departmentalboundaries are to be abolished, so that duplication ofteaching will be reduced to a minimum. A quarterof the student’s learning time in each year will bereserved for options and electives. From the first tothe last year of the six-year course there will becontinued emphasis on community and social medicine.A chair of clinical chemistry will take the place ofindividual chairs of biochemistry and pharmacology.Liaison with general practitioners in the local area willbe fostered. An attempt will be made to teach studentsto adopt a relaxed and appropriate attitude to sufferingand distress (a most worthy aim neglected by manycurrent medical curricula). Medical students willassume increasing responsibility in their later yearsand there will be decreasing supervision of theirwork. Students are to be taught to participate inpatient management as members of a team with alliedhealth professions. Professor Fraenkel sensibly insiststhat the medical course, rather than being comprehen-sive, will emphasise self-learning and problem-solving.There is a widespread feeling that medicine has

lost its strategic function and that it is increasinglyfailing to meet community needs. Professor Fraenkelremarks that, for over a century in Great Britain,Australia, and New Zealand, relevance to patientcare has not been a central policy in medical education.Any attempt to return medicine to its grass roots

must begin with patient care. The Flinders UniversityMedical School certainly has exciting opportunitiesto experiment with its curriculum, to integrate witha major hospital, and to record and influence thehealth of a community. But however exciting the new-ness of the sociological concepts may be and howeverbeguiling it may be to think in terms of communitycare, health centres, and social medicine (terms oftenused but seldom defined), the need remains to learnthe basic clinical medicine that makes for goodpractice of health care in the community. It is mar-vellous that students will be taught to recognise and

1. Fraenkel, G. J. A. V.C.C Education Newsletter, 1972, no. 3/72.

to manipulate the social issues that are so often

important in human illness. But a knowledge ofclinical medicine is irreplaceable. 2

INSTANT EXPERIENCE IN CLINICAL TRIALS

SIMULATION and gaming techniques 3 have beenapplied in military training (war games), in managementcourses (business games), and in teaching of history,sociology, geography, and politics. The possibilitiesare now being explored in medical education. Simu-lation techniques based on careful analysis of clinicalmethod have produced patient-management-problemtests 4 which can teach and assess the student at thesame time, and which stimulate him to elicit, order,and interpret data, plan treatment, and react suit-

ably to problem situations. There are more elaboratesystems, such as the computer-aided simulation of theclinical encounter (C.A.S.E.)."’ 7

Maxwell, at the annual scientific meeting of theAssociation for the Study of Medical Education,described the development and use of a novel clinical-trials game in the form of a computerised simulationexercise. The game, known as instant experience inclinical trials, and made available under the auspicesof the Trust for Education and Research in Thera-

peutics,9 has been successfully used in six workshops.During the game, students are provided with a realis-tically limited amount of information about a promisingnew drug, and, working in groups, they are asked todesign a protocol for a clinical trial. This provides anopportunity for the students to discuss with theirtutors the advantages and disadvantages of variousforms of trial design. The organisers have alreadyinvented a population of patients, each described interms of characteristics which can influence responseto treatment, and they have decided on the true drugefficacies for each type of patient. As the game pro-ceeds, drug treatments are allocated to the patientsaccording to proper clinical-trial methods, influencedby the students’ own trial protocols. Thus stratifiedrandomisation is possible. The computer programmethen generates full and detailed results for each

group of students, according to their own experimentaldesign and the ground rules chosen by the organisersand replete with drug defaulters, deaths, and with-drawals due to side-effects. If the students havechosen the correct factors and an appropriate trial

design they will be able to derive the true results.Faults in trial design will generate figures from whichthe correct results may or may not be derivable bystatistical examination. The students are thus givena chance to practise simple statistical analysis oftypical trial results, and, by comparing the resultsobtained by the different groups, can examine the

2. Feinstein, A. R. Clinical Judgement; p. 385. Baltimore, 1967.3. Taylor, J. L., Walford, R. Simulation in the Classroom. Harmonds-

worth, 1972.4. Andrew, B. J. J. med. Educ. 1972, 47, 952.5. McCarthy, W. H., Gonella, J. S. Br. J. med. Educ. 1967, 1, 348.6. De Dombal, F. T., Hartly, I. R., Sleeman, D. H. Lancet, 1969, i, 145.7. Harless, W. G., Drennan, G. G., Marxer, J. J., Root, J. A., Miller,

G. E. J. med. Educ. 1971, 46, 443.8. Maxwell, C., Domenet, J. G., Joyce, C. R. B. J. clin. Pharm. 1971,

11, 323.9. Maxwell, C., Smith, F. R., Shing, L. K. Instant Experience in

Clinical Trials—A Computerized Teaching Aid. Trust forEducation and Research in Therapeutics (c/o CIBA, Horsham,Sussex), 1972.

Page 2: INSTANT EXPERIENCE IN CLINICAL TRIALS

815

effects of varying trial designs on the results obtain-able from the same population. Since the organisershave chosen the relevant factors and drug responses,it is possible to demonstrate how some faulty trial

protocols can appear to show effects which the drugis known not to possess.

Statistical methods are more easily learned when theyare used to examine data which have real meaningfor the students. Experience with groups of under-graduates, postgraduates, and academic and industrialdoctors has shown that the game generates greatenthusiasm and excitement. It is theoretically,practically, and emotionally realistic. It is sufficientlyflexible to allow specific teaching goals to be achieved.There are a wide range of possibilities for making thegame more sophisticated and for varying the students’chances of deriving correct results. Conceivably, too,further elaborations of the system will provide a usefulresearch tool for examining clinical-trials methodology.Finally, it is important for medical graduates, even ifthey are never to design or conduct clinical trials, tobe able to interpret research data-to make sense ofresearch papers and reports of drug trials, and, indeed,to evaluate pharmaceutical company documents.This is an area where these imaginative computertechniques may be especially useful.

TAXING FOR HEALTH

TAXATION could be used quite often to assist indisease prevention, but it seldom is. Governmentsmay be right to be cautious. The effects cannot alwaysbe predicted, and if a man is wedded to a habit notdangerous enough to be banned outright but whichwill almost certainly harm him, should he be askedto pay in cash as well and to pay, in proportion to hisincome, more if he is poor than if he is rich ? How-ever, Governments can avoid backward steps. Valueadded tax, for example, will bring down the price ofsweets and raise the price of toothbrushes. These

changes may not affect the numbers of children whobrush their teeth regularly-they may not even affectcaries incidence-but they must make the preventiveefforts of dentists and others sound rather hollow.For many years there have been strong argumentsfor using tobacco duty as a means of helping peoplecut down on their smoking, but the Treasury hasalways resisted such suggestions quite unashamedlyon the ground that its coffers would be depleted as aresult. 1 An economic analysis by Russell throwsnew light on this objection. 2 Russell found that thedemand for cigarettes is inelastic, at least for the pricesprevailing in the years 1946 to 1971. This meansthat if prices rise by 1 % demand falls, but by anamount less than 1 %; total revenue from taxationwould then increase just as long as demand remainedinelastic. Cigarettes behave in this respect like food- a measure, perhaps, of the dependence they induce.

Russell believes that cigarette sales by weight oftobacco is an unsatisfactory measure of the amountsmoked, and he used number of cigarettes smoked peradult male as his consumption variable and the cost

1. Royal College of Physicians of London. Smoking and Health Now;p. 21. London, 1971.

2. Russell, M. A. H. Br. J. prev. soc. Med. 1973, 27, 1.

of twenty plain cigarettes as his price basis. In theearlier years of his survey period this may not havemattered much-indeed until 1966 weight and numberwent hand in hand. But in that year they parted com-pany, and since 1960 numbers have continued to

fluctuate while pounds of cigarette tobacco per headhave fallen steadily. This is largely because filter-tipcigarettes, almost unheard of in 1946, caught up withplain varieties in 1965 and now outnumber them fourto one. Whatever the reasons for this decline-andBritain is one of the few countries to have succeededin this sphere 4-the lower consumption by weight isan encouraging sign. Unfortunately an index ofcigarette prices which takes into account all typessmoked is not, apparently, available. Unfortunately,too, two of the years which almost exactly fit Russell’selasticity figure of 0-6 for the whole period saw whatseems to have been an elasticity of more than 1 if

weight (the basis for tobacco duty) not number wasthe consumption variable. The Treasury argumentmay not yet have been invalidated economically, evenif it is objectionable on other grounds.

ASBESTOS→LUNG CANCER→ MESOTHELIOMA

IT is interesting to follow a group of diseases overthe years and to see the irregular way in which researchfindings are applied to preventive and clinical medicine.In 1930, Merewether and Price 5 showed that inhala-tion of asbestos dust caused lung fibrosis (asbestosis),as exemplified by the experience of asbestos-textileworkers in England. Regulations, based on their

findings, and applied to asbestos-textile factories andsome parts of asbestos-cement factories, came intoforce in 1933. In these factory situations, applicationof the regulations led to a striking reduction in theincidence of asbestosis in workers employed onlyafter 1933, and a precise standard for chrysotile dusthas been put forward by the British OccupationalHygiene Society. 6 This standard was based on thedust levels and health records of factory workersexposed to chrysotile asbestos: cumulative exposureto an average concentration of 2 fibres per ml. for 50working years produced asbestosis in approximately 1 %of cases, which was regarded as a satisfactory safe limit.But asbestos is used in other industries, and papers

still appear describing groups of workers developingasbestosis under existing conditions. Murphy et al.,’ 7two years ago, described shipyard workers withevidence of asbestosis after 15 years’ exposure, theprevalence being 48% in men with 20-35 years’exposure to a "low concentration of asbestos".These investigators scarcely mention the hazard ofmalignant disease. It was Merewether who firstshowed a clearcut association between asbestosis and

3. Todd, G. F. (editor). Statistics of Smoking in the United Kingdom;table III. Tobacco Research Council, 1972.

4. Beese, D. H. (editor). Tobacco Consumption in Various Countries.Tobacco Research Council, London, 1972.

5. Merewether, E. R. A., Price, C. W. Report on the Effects of AsbestosDust on the Lungs and Dust Suppression in the Asbestos Industry.H.M. Stationery Office, 1930.

6. British Occupational Hygiene Society. Hygiene Standards for

Chrysotile Asbestos Dust. Oxford, 1968.7. Murphy, R. L. H., Ferris, B. G., Jr., Burgess, W. A., Worcester, J.,

Gaensler, E. A. New Engl. J. Med. 1971, 285, 1271.8. Merewether, E. R. A. Annual Report of the Chief Inspector of

Factories for the Year 1947; p. 79. H.M. Stationery Office, 1949.