CLINICAL CHEMISTRY REPORTING

951 located in the most unpleasant, poorly paid jobs which offer little future or prospect of self-advancement. The cost of seizure disorders to the community must be enormous. Many who have died were chronic invalids for years before their death. Their care had involved considerable human and medical resources, not to mention anguish and hardship to parents. This may be equally true of the group placed in institutional care. Often parents wrestled with the considerable burden of a severely retarded, hyperkinetic child for many years before the child was removed. The cost of this group, while partly hidden from the community, still remains. Special education is expensive. The need for such provision within our sample was, at its peak, seven times greater than that currently required for the schoolchildren of England and Wales. Those who remain in the community with chronic epilepsy probably will be required to remain on anticonvulsants for life. Added to this must be a considerable loss of human potential. In the 25 years since the first patients in our sample were identified, there have been many advances in prophylaxis, in early treatment, and in long-term care. We know that in our own area prognosis for neonatal convulsions has vastly improved. However, there are serious lessons to be learnt from our study. Not the least is the fallacy that those seizure disorders visible to the community represent the outcome of childhood seizure disorders. A sizeable part of the outcome is concealed in remote institutions and in the grave. It is often argued that the seriously handicapped patients suffer not from epilepsy but from brain disease. This may well be correct; but to the layman it is the epilepsy which is evident, and it is as "epileptics" that the sufferers are identified. The statement that 80% of people with epilepsy lead useful normal lives2 is an artefact of the viewer’s location. It is true for those who live and remain in the community, but this study shows it is a partial truth. It is not surprising, therefore, that parents are not reassured by such statements. While two-thirds of our group suffered minimal or no ill-effects, the consequences for the remaining third are so serious as to explain why "epilepsy" frightens so much. We acknowledge with gratitude the support of the Department of Education and Science. The entire project depended upon the foresight and dedication of Dr Victoria Smallpeice and Dr Christopher Ounsted. We owe Ms Jane Barlas, Ms Faith Barbour, and Ms Marilyn Smith a debt of gratitude for their invaluable efforts. We thank all those people in the sample who kindly gave us their time and their con-

fidence.

Requests

for

reprints should be addressed

Department of Psychiatry, Hospital for Children, Old

to D.C.T., University Development Research Unit, Park Road, Headington, Oxford OX3 7LQ.

Human

REFERENCES

1. Silanpaa, M. Acta neurol. scand. 1973, suppl. 237. 2. Lord Cohen Br. med. J. 1958, ii, 672. 3 Ounsted, C. Proc. R. Soc. Med. 1952, 45, 857. 4 Ounsted, C. J. Neurol. Neurosurg. Psychia. 1953, 16, 267. 5. Taylor, D. C., Ounsted, C. Epilepsia, 1971, 12, 33. 6. Taylor, D C., Harrison, R. M. Paper read to the Turkish League Against Epilepsy: Symposium on Febrile Convulsions, June, 1975. 7. Advisory Committee on the Health and Welfare of Handicapped Persons. People with Epilepsy. H.M. Stationery Office, 1969. 8. Harrison, R. M., West, P. A Survey of Public Images of Epilepsy. Unpublished. 9. Rodin, E., Rennick, P., Dennerll, R., Lin, Y. Epilepsia, 1972, 13, 149.

Hospital Practice CLINICAL CHEMISTRY REPORTING Problems and

Proposals

ALAN M. BOLD

Department of Clinical Chemistry, Queen Elizabeth Hospital, Birmingham B15 2TH The completed report is the most obvious interface between the laboratory and the clinician. An unattractive, uninformative, or confusing report may fail to do justice to an excellent analytical service. Unfortunately, relatively little effort has been expended on achieving the best possible report, and individual enthusiasm and initiative has led to widely diverse practices in reporting. There is an urgent need for standardisation of report formats and it is suggested that all reports should include guidance on abnormality, be in cumulative format, and contain a realistic statement of analytical reliability.

Summary

INTRODUCTION

DURING the past

two

decades there has been

an

exponential growth in clinical chemistry, in the volume of tests requested, in the scope and complexity of investigations available, and generally in the speed and reliability of the analytical service provided. The journal Current Clinical Chemistry compiles titles of over 500 articles every month. Unfortunately, the completed report, which for the doctor represents the finished product of the clinical chemistry laboratory, has in many instances not been comparably improved; and the clinician might argue that many laboratory reports are now less informative than they were, say, in the 1950s. Then, from many laboratories, tests were reported on neatly typed forms, often with an interpretative comment. Now the clinician may receive a battery of test results, the value of which, for all but the very biochemically oriented clinician, is diminished by the absence of any indication of abnormality; and very large workloads are leading to the virtual disappearance of informed comments on routine tests by laboratory staff. NEED FOR STANDARDISATION

The Tunbridge report stressed -the importance of basic uniformity in documents comprising the medical record. Little reference was made to pathology reports apart from the desirability of distinct colour codes for the separate laboratory departments, and the use of standard report sizes-A4 or A6. The great variety of laboratory request and report documents is a tribute to the independence and originality of laboratory directors. There is a price to pay. Clinicians who work in different hospitals can readily become confused by the variety of forms. There is also an increasing tendency to use computers to generate laboratory reports; the computer makes more sophisticated reporting techniques feasible, but at considerable time and cost if every laboratory designs its own system and writes its own programmes. Also, more and more analytical machines, some

952 such as Radiometer’s ABL 1 blood-gas analyser and the Coulter Electronics model S automatic blood-counter, are likely to come on the market capable of generating their own reports. This could save much time and eliminate transcription error. However, the laboratory has no control over the format or content of the automatically generated reports. These may be the wrong size or shape for a final report, and may lack units or other desirable features. In consequence the laboratory may have to produce a final report. Ideally, manufacturers should design instruments capable of producing a printed report satisfactory for direct insertion in the medical record. A prerequisite would be a consensus on the format and requirements of the final report. GENERAL

INDICATION OF ABNORMALITY

REQUIREMENTS

There is no universal agreement on minimum requireof a clinical chemistry report. I suggest that no laboratory, or clinician, should be satisfied with less than the following items: ments

(1) Patient-identification data, sex, age/date of birth. (2) Colour coded, green. (3) Date, time specimen taken (preferably 24h clock). (4) Nature of specimen. (5) Analytical result, units. (6 Size suitable for incorporating in medical records. (7) Indication of "abnormality". At least desirable:

some

of the

following additional

features

are

(8) Cumulative format. (9) Analytical confidence limits. (10) Relevant conditions (e.g. fasting). (11) Warning of any drug interference. (12) Space for interpretative comment. (13) Attractive uncluttered appearance.

Requirements (1) to (5) though the pros and cons

are

of

ticularly useful in reports on the very young, so preferably the report form should permit a choice by containing a combined age/date of birth box. Whereas the Tunbridge Committee recommended a standard size of reports (either A4 or A6), some laboratories use strip reports 6-10 cm deep; with preprinted headings and careful design these can be attractive and informative and have positive advantages in saving paper and permitting at least a limited cumulative format by careful mounting on a patient’s case-record. It is important that the report should not be wider than the standard A4 mount sheet, but the depth of the report should be varied according to need, though "microstrips" should be avoided.

I

hope, uncontroversial, printing age rather than

date of birth may be debated. The date of birth must be recorded as part of the basic patient-identification data. Age is shorter and simpler, but date of birth may be par-

Portion of routine cumulative report used at the

I firmly believe that whenever feasible the report should indicate in some way those tests that are "abnormal". The variety of analytical methods employed, particularly in clinical enzymology and some immunoassays where different procedures may produce results differing by 100% or more, makes interpretation for clinicians difficult without guidance from the laboratory. The introduction of SI units increases the need for guidance. Each laboratory should offer guidance appropriate to its own methods. The use of general purpose plastic cards distributed by certain drug companies is to be deprecated since the data on these cards are often obsolete and may refer to methods not used by the local laboratory. The information two assist interpretation should preferably be on the report form itself, to obviate the need for repeatedly consulting booklets or cards giving reference intervals (the term "reference interval" is preferred to the traditional "normal values"2). Reference interval is generally used to imply the range of values found in 95% of the reference population-i.e., between the 2.5 and 97.5 percentiles. This is arbitrary, and, whilst it seems to work well enough for hospital patients, may be unacceptably narrow for

Queen Elizabeth Hospital, Birmingham,

to

show

typical

cumulatlB torntat.

Abnormalit is indicated by punting the number of standard deviations (s D. difference) by which the last result diners from the tor the reference population. A.C.!.. indicates 95’( analytical confidence limits (i.e., result f A.c.i .

mean

I’alue

953

screening purposes.3 There are strong arguments for re-4 placing reference intervals by discrimination values.2 The discrimination values, based on the application of Bayes’ theorem for conditional probability, would take account of the clinical sensitivity and specificity of the test, the clinical

cost

of misclassification, and the relative

distribution of individuals in reference and disease subgroups. Routine use of discrimination values would require much further thought and data, and there seems no feasible alternative for the foreseeable future to using reference intervals. Possible ways of indicating "abnormality" include the

following: (1) Pre-printed or stamped reference interval. (2) Underlining or ringing of "abnormal results". (3) Computer printout of age/sex related reference interval. (4) Semiquantitative guide--e.g. underline with + + or (the more symbols the more abnormal). (5) Calculated number of standard deviations from age/sex adjusted mean. (6) Use of percentiles. (7) Reporting the factor by which a value is above the upper (or below the lower) limit of the reference interval. (8) Use of a "fudge factor" to adjust all reference intervals --

to a

standard one-say 10 + 2

or

100 ± 20.

The reference interval can be printed or typed on the report form; for some tests, however, a single reference interval may be misleading, since the concentration of some plasma or urinary constituents is affected by age and/or sex56 or time of day (plasma creatinine, albumin, iron, and cortisol are examples). As a compromise, attention may be drawn to such tests by placing an asterisk .after the printed reference interval. More sophisticated methods are made practicable by the use of

computers, and in some hospitals are already used routinely. In the Queen Elizabeth Hospital, Birmingham, for the common routine tests, in addition to the analytical result, we report the number of standard deviations’7 by which the latest test reported differs from the mean for that test, allowing for any known differences due to age or sex, and for any non-gaussian distribution of values in the reference population. For results considered to be within the reference interval, we omit the statistical comment so that attention is concentrated on those tests with values considered abnormal (see accompanying figure). The procedure is flexible, and can be readily updated as more data become available or analytical methods change. After routine use for several months it seems to be liked by our medical staff. A method based on percentiles or fractiles could be used as an alternative way of indicating abnormality. From time to time more radical changes are proposed, such as replacing the analytical value with a statistical comment,8 adjusting all reference intervals to a convenient arbitrary figure9 such as 10±2 or, at least for serum enzymes, adjusting the upper limit of normal to 100.10 Whatever superficial attraction such proposals might have, it is vital that any statistical comment or

fudged value are additional to,9 " not a replacement for, the reporting of the actual analytical result; otherwise they would destroy any hope of increasing our insight into relationships between plasma constituents at a molar level (e.g., between electrolytes, urea, glucose, &c., and total osmolality). The main arguments for these proposals are nullified if adequate statistical interpretation is provided in addition to the basic analytical result.

CUMULATIVE REPORTING

of a result does not depend only on its reference population. Even though results may not fall outside the reference interval, a significant change from a series of a patient’s previous results may be an early warning of disease or relapse-e.g., serial serum-caeruloplasmin determinations have been suggested as a sensitive sign of relapse in patients with treated leukaemia.12 More commonly in hospital practice, serial values of plasma or serum glucose, potassium, calcium, &c., are used to assess response to treatment. For these reasons, and for the sheer convenience of haying the most commonly requested tests reported on one sheet, reporting cumulatively has been advocated. Prof.

Interpretation

relation

to a

F. V.

Flynn (personal communication) at University College Hospital, London, found that the use of cumulative reports for clinical chemistry significantly reduced the time spent by clinical staff in perusing laboratory reports. (Cumulative reports, however, have little or no value for the majority of hospital patients who have a limited range of clinical chemistry tests performed with few or no repeats.) Most laboratories use a computer to produce cumulative reports. The drawback is that cumulative reporting may call for a larger computer than would otherwise be needed. Our own experience is that, whilst several clinicians are enthusiastic about cumulative reports, and indeed require their junior staff to prepare their own cumulative reports, when these were offered on demand relatively few requests were received. However, if the capability of producing cumulative reports is required, whether these are produced routinely or only on demand has little influence on the size of computer required. Amongst those laboratories that do produce cumulative reports routinely, practice differs. Some laboratories, including our own, report vertically, with the latest result lowest (see figure), others report vertically with the latest result uppermost, others report sequential results horizontally, with the latest result on the right. Doubtless even outside China there is a laboratory that completes the picture by reporting horizontally, right to left. ANALYTICAL CONFIDENCE LIMITS

All

laboratory tests are subject to analytical error. For tests for example, serum-sodium concentration-precision may be excellent (95% analytical confidence limits of +1 to 2% are attainable). For others, including some serum enzymes and radioimmunoassays at low levels, realistic 95% analytical confidence limits may be of the order of +25 to 50%. Laboratories may spend much money on quality-control programmes enabling self-assessment of performance, but rarely communicate some

this information to clinicians. Few clinicians, I suspect, have more than a rough notion of the reliability of tests. As scientists and seekers after truth, laboratory workers ought to be entirely frank about their analytical performance. Understandably perhaps, there is frequently reluctance to admit how imprecise some methods are: many published papers describing analytical methods cite data about precision which may reflect what a dedicated research worker can achieve under ideal conditions, but bear little relation to what can be achieved routinely. I believe all laboratories should, on the report state realistic analytical confidence limits. In too

954

the

this is now stated for the most common routine tests. While a single percentage figure could be pre-printed on the report form, this cannot readily be changed, nor does one figure always reliably indicate precision since for some tests this is worse at low concentrations than at normal or high concentrations. We use the computer to calculate the 95% analytical confidence limits (A.C.I..), illustrated in the figure, rather than leave clinical staff to do the calculation themselves from a percentage figure. Thus for bilirubin at a concentration of 61 11MOV1, A.C.L. is _+7 7 so that the 95% confidence limits for this result are 54 to 68 mol/1. The computer programme can easily be adjusted to reflect current performance, and for some tests a different precision at low, normal, or high concentrations is allowed for.

Queen Elizabeth Hospital,

TEST CONDITIONS

Some tests, such as plasma glucose or triglycerides and arterial blood oxygen tension, are much affected by conditions under which the blood is taken-for glucose or triglycerides, whether the patient is fasting, or, for blood-oxygen tension, what percentage of oxygen the patient is inspiring. Other tests, such as plasma-cortisol, are much affected by time of day. It is desirable that the report indicates these factors where known, or at least warns the clinician that an assumption (e.g., fasting) has been made. DRUG INTERFERENCE

The effects of drug

therapy on laboratory tests, either by physiological pharmacological action, or interference in the analytical method, are increasingly recogor

nised.13 The

of

the clinician since laboratory cannot regularly undertake the task of ascertaining what treatment each patient is having, apart from special tests-for example, certain endocrine tests. However, the complexity of drug interference poses an impossible burden on the memory. The introduction of computerised recording of all drugs administered to each patient could enable laboratory and clinical staff to be automatically alerted to the possibility of drug treatment interfering with tests requested. onus

awareness

is

on

the

decide on the content of the report form, since this determines the data that should be provided on the request form. Here there is a weakness since the best-organised laboratory depends on the cooperation of the doctor completing the request form; important details such as the time the specimen was taken and whether the patient was fasting are frequently omitted. This problem can only be solved by long-term education and drawing the attention of clinical staff to the fact that certain data were not given. Forms that serve both for requesting and reporting tests are used in some hospitals. Results are usually filled in manually by laboratory staff, and the form may incorporate a no-carbon-required duplicate which is retained as the laboratory record. This practice can save clerical time required for typing separate reports. Economically it is attractive, particularly for the smaller hospital lacking data-processing equipment, though it is difficult to ensure that hand-written reports are always legible and even more difficult to make them attractive. My own experience has been that it is exceptionally difficult to reconcile the requirements of requesting and reporting without resorting to an unacceptably large number of forms or having to accept an unsatisfactory report form. to

TO SIGN OR NOT TO

Whether reports should be signed by a senior member of the laboratory staff is debatable. McGowan" argues that this is highly desirable, and in principle this is surely correct. In practice the argument for signing is less clear. Apart from any possible medicolegal implication 15, the sheer number of reports, which can daily be 500 or even more in a large laboratory, makes signing a time-consuming and fatiguing process, making any considered comment difficult. I prefer not to go through the motions of signing reports, but use the computer to call attention to all unusual results (unusual being personally and arbitrarily defined as clinically important, unlikely, or interesting results, or ones which have shown a notable change from any previously determined value). This concentrates attention on to a relatively small number of reports, allowing some time for thought, or going to see the patient. CONCLUSIONS

INTERPRETATIVE COMMENT

any report should allow space for interpretative comment; but it is often not realistic to offer comment on the common routine tests, and in our own reports we have had to forego space for such a facility, though the facility for a free text comment is available on all tests other than the "top 30". Any report is a com-

Ideally,

promise between providing enough useful information, and cluttering up the report with the irrelevant. While diagnosis by discriminant-function analysis and similar techniques is still a research procedure, the technique seems to have considerable promise, and in the design of the ultimate report form allowance should be made for the possible application of computers in providing inter-

pretative comment. RELATION BETWEEN

In

REQUEST

designing laboratory forms,

AND REPORT FORMS

the first

SIGN?

requirement

is

I have not yet

seen

an

"ideal" clinical

chemistry

impressive systems have been though directors seem so concerned with Laboratory test data and producing efficiently reliably that the quaof form the has often been report lity neglected. Regrettably, published contributions by the user (the clinician) on this topic are rare. It is high time that laboratory workers and clinicians agreed on general principles governing good laboratory reports. We should also coreport, devised.

some

operate with manufacturers to ensure that machines producing reports automatically do so acceptably. Clinicians and laboratory workers should contribute nationally and internationally to discussion on standardised laboratory request and report forms, with optimal format. The need is urgent, for though computerbased reporting systems make feasible the production of more informative reports, they are less flexible than manual systems, and major changes can be expensive.

955 I am grateful for the advice of several colleagues, particularly Miss L. 0. Morris, Prof. T. P. Whitehead, and Dr P. Wilding, who all assisted in the design of the reporting system in the Queen Elizabeth

Hospital. REFERENCES

1. The Standardisation of Hospital Medical Records. H.M. Stationery Office, 1965. 2. Sunderman, F. W. Clin Chem. 1975, 21, 1873. 3. Hems, G. Lancet, 1969, i, 267. 4. Murphy, E A., Abbey, H. J. chron. Dis. 1967, 20, 79. 5. Flynn, F. V. Ann. Clin. Biochem. 1969, 6, 1. 6. Bold, A. M., Wilding, P. Clinical Chemistry: Conversion Scales with Adult Normal (Reference) Values. Oxford, 1975. 7. Grasbeck, R., Fellman, J Scand. J. clin. Lab. Invest. 1968, 21, 193. 8. Lennox, B., Lancet, 1975, ii, 1085. 9. Wright, B. M. ibid. p. 1261. 10. Gerbstem, W. H., Ledener, H. L. J. Am. med. Ass 1974, 227, 325. 11. Gräsbeck, R. Lancet, 1976, i, 244. 12. Hrgovciv, M., Tessmer, C. F., Brown, B. W., Wilbur, J. R., Mumford, D. M., Thomas, F. B., Shullenberger, C. C., Taylor, G. Prog. Clin. Cancer, 1973, 5, 121. 13 Young, D. S., Pestaner, L. C., Gibberman, V. Clin Chem. 1975, 21, 1D. 14. McGowan, G. K. J. clin Path. 1974, 27, 427 15. Memorandum Concerning the Signing of Pathology Reports. Medical Defence Union, 1971.

Occasional Book

ferent. The student is the one who suffers-but the signs of his illness will not be manifest immediately; he will become a doctor who is unable to modify his practice in relation to advances in knowledge, if his training has been anti-academic or if a non-intellectual and non-critical approach has been engendered. Professor Greene makes other points which will be echoed by many British academics. The demands of clinical service are such that if they are not resisted academic growth is strangled. He also, somewhat as an aside, fires a broadside at curriculum committees by asking the fundamental, and always unanswered, question "What is the ultimate objective of medical education and how does it relate to the future needs of the community"? and he states how amateur, non-scientific, and conjectural is the scrutiny currently applied to both old and new teaching methods. These are matters for all medical and dental academics to consider. They will learn from reading this book something about modern anaesthesia which itself is a valuable benefit; but, more importantly, they may question themselves about their own specialties. Clinicians practising in university hospitals should also read it in order to reassess their ideas about their own position and, furthermore, they will perhaps come to understand those who have misgivings about the extension of the involvement of district general hospitals in undergraduate medical education and desire to see this carefully regu-

lated. UNIVERSITY MEDICINE

j. N. LUNN 1

RECENT publication, Anesthesiology and the University, unlikely to be noticed by many academic or non-academic general practitioners, gastroenterologists, surgeons, or pathologists. This is a pity because the contents of this monograph bear examination by any doctor and also because, if its general message is ignored, the whole of the British medical profession

A

is

is doomed. It is directed to the anaesthesiologists of America and, in summary, the author, himself an academic, argues persuasively’for the place of academic doctors within the university. Academics are different from clinicians even though both may work in university hospitals; academics are, or should be, appointed because they possess evidence of academic ability in teaching and research. They should not be appointed on the basis of administrative ability, political skill, or clinical prowess though it is likely that these estimable qualities may also be present. The high level of scholarship which is a feature of Western civilisation stems from the academic activity predominantly found in the universities. It is clear that academics in medicine must not only themselves be trained in the discipline of scholarship but must also be able to foster scholarship in the young. Governmental, not to say public, pressure is now operative in Britain to remove or reduce the influence of the university in the education of our doctors. The opinion is sometimes expressed that "X is a good physician" and the non-sequitur "I am confident he can teach our students" follows. No doubt such a person can teach the technology of medicine, because that is what he does superbly, but will the lessons of scientific thought, hypothesis, experiment, observation, deduction, be carefully and conscientiously demonstrated so that the student learns in a manner which will last him throughout his professional career? Clinical decisions must often, in the best interests of the patient, be prompt, and even to some extent, empiric, whereas the academic approach in instruction must be slower and may involve more investigation. We are in danger of forgetting that consultants are appointed to consult; if they happen to teach or conduct clinical research, they do so as a sideline to their main activity which is clinical work. Those whose primary function is an academic one are likely to be better at that than those whose primary function is something difN. M. GRFENE. Oxford: Blackwell. 1975. Pp. 164. £7.

1. Anesthesiology and the University.

Commentary from Westminster Preventive Medicine and Health Education FROM A CORRESPONDENT

FOR

spheres

country which is a world leader in so many of medicine Britain is disappointingly low in the

a

international league in preventive medicine. Prevention has received little of the resources and not much attention. But now at least part of this is changing. Prevention still may not be due for the resources it deserves, but it is beginning to get the attention. In Marchwe had the Government’s consultative document, Prevention and Health: Everybody’s Business, which was meant to stimulate public discussion on the issues. If the national debate seems sluggish in getting under way, then another document due later this year may stir up something. This is the report of the inquiry into preventive medicine which a subcommittee of the all-Party Commons Expenditure Committee has been conducting for the past few months. The nine-member committee, under the chairmanship of Mrs Renee Short, has been collecting evidence, both oral and written, from a wide range of medical and nonmedical experts. The result is expected to be a number of recommendations designed to correct the imbalance between cure and prevention; and the controversial issues involved may be just what is needed to get the public debate going. For what the committee has been investigating goes to the very heart of many of the most divisive problems which face a democratic country. How far should we rely solely on education and persuasion and how far on measures of compulsion through legislation ?

Philadelphia: Lippincott. 1. See Lancet, March

20, 1976, p. 621.