The responsible use of the clinical laboratory

The Responsible Use of the Clinical Laboratory E L L I S S. B E N S O N Department

of Laboratory

Medicine

& Pathology,

Concern about spiralling health care costs is leading to a reexamination of the use of the clinical laboratory and other diagnostic technologies in patient care. Laboratory resources are viewed as limited and their use must be measured to meet real needs. Several observers have noted significant overutilization and inappropriate utilization of laboratory services by patient care physicians, especially at teaching hospitals. Efforts to modify physician behavior by use of educational programs, positive incentives and similar means have been largely disappointing, Several laboratory-based initiatives aimed at bringing about more responsible use of the laboratory are discussed. Improved education in the judicious use of the laboratory, beginning in medical school and carrying on through the early stages of a physician's career, is considered the most promising long-term approach. This, along with improved communication between the laboratory and the clinic, is the avenue most likely to bring about more responsible use of the clinical laboratory in health care.

KEY WORDS: laboratories; decision making; technology, assessment; technology, medical; costs and cost analysis; education, medical. edicine, in the past two and a half decades, has witnessed an immense expansion of its inventory M of technological aids in the diagnosis and m a n a g e m e n t of patients. This technological and scientific revolution has transformed the clinical laboratory from a largely m a n u a l ~'cottage" industry to a highly sophisticated, highly automated and centralized system of great analytical capacity, capable of producing large quantities of data of good quality at impressive speed. Accompartying this change has been a change in the behavior of physicians using the laboratory from one of discriminant and relatively parsimonious use to one of relatively lavish use. Recent attention to costs is leading to a re-examination of the use of the laboratory as well as t h a t of other costly facets of modern medical care. This re-examination is directed both at physician factors and laboratory factors influencing use.

The responsible physician Centralization of hospital laboratory facilities and the ability of this centralized laboratory to generate large quantities of data have had the unfortunate sideeffect of moving the laboratory to a relatively remote site from the patient, physically, conceptually, and philosophically. From the physician's standpoint, there has been a shift in emphasis to a data-gathering exhaustive approach and away from logical, hypotheticodeductive reasoning (1). Correspondence: E. S. Benson, M.D., Department of Laboratory Medicine & Pathology, Box 198, Mayo Memorial Building, University of Minnesota, 420 Delaware Street SE, Minneapolis, MN 55455, USA. This article is based upon a presentation at "Laboratory Medicine for the Next Decade" International Symposium, Hamilton, ON, October 2-3, 1985. 262

U n i v e r s i t y of M i n n e s o t a ,

Minneapolis,

Minnesota

W h a t have been the effects of these developments? As we know, one of them has been an ever-increasing use of laboratory tests. In the United States, laboratory costs to payers have expanded on a compound 15% basis yearly at least until 1984. Careful evaluation of the causes of this increased cost has shown that it is not due to increased laboratory costs. Unit costs have remained quite constant since 1971 in 1971 dollars. The increased cost is due to increased test use. The same figures hold for Canada. Morrison (2) has shown t h a t in British Columbia a 50- to 100-fold increase in tbtal laboratory costs has t a k e n place since 1971, without a significant change in unit laboratory costs. Finkelstein (3) examined the use of 20 high volume, low cost, high technology chemistry tests and 20 ~'low technology" largely manual, chiefly microbiological tests. He concluded from this study that technology (automation) alone could not explain rapidly expanding laboratory use since the same rate of change was found in both groups. He concluded that a change in style in the use of the laboratory by patient care physicians was the major factor in expanding use. Parallel conclusions were reached in a staff report of the President's Council on Wage and Price Stability (4). This staff report entitled '~The Rapid Rise of Hospital Costs" concluded that sharply escalating costs in the hospital industry were due not to inefficiency, to unjustiffed profit margins or wage rates, but to a change in product. The change in product was an increase in intensity of services rendered at all levels of care, but especially in acute and intensive care. Let me give you a few examples of how this is working with respect to the laboratory: Griner (5), whose voice was early raised in warning about overuse and misuse of laboratory tests in teaching hospitals, conducted a study of patients with pulmonary edema a year before and a year after an intensive care unit (ICU) was opened (6). After the opening of the intensive care unit, the length of stay increased by 2.3 days, the average bill increased 43%, arterial blood gas determinations increased five-fold, yet there was no difference in mortality between the two groups. Schroeder (7) has pointed out t h a t this type of experience is probably due to the use of rigid protocols in the ICU. He tells us t h a t he has ~'almost had to lie down in front of the portable x-ray unit" to prevent staff from taking two chest x-rays each day on patients in the ICU because this was ~'on the protocol". Schroeder and his associates (8), in a careful study, found a 33-fold variation in laboratory use among internists working in a University Hospital out-patient department. Case mix was standardized and no reasons for this variation could be found except practice style. They also concluded t h a t ~high user" physicians did not CLINICAL BIOCHEMISTRY, VOLUME 19, OCTOBER 1986

RESPONSIBLE LABORATORY USE provide a better level of care t h a n did low users. These observations and m a n y others support two conclusions: 1) There has been a pronounced change over the past two decades in the style of laboratory medicine brought about by a u t o m a t i o n and technological advances which are now providing rapid delivery of large quantities of laboratory data; 2) This change has been paralleled by a change in practice style of physicians towards more dependence on data accumulation and ~numbers". Lewis T h o m a s ( 9 ) h a s characterized this state of affairs in the following not too exaggerated statement: "The greatest and most expensive fad in the history of medicine is today's diagnostic laboratory. Automated, computerized, capable of emitting numerical data at a machine gun speed, ready at a tap of a finger to perform dozens of tests simultaneously, the laboratory has an irresistible charm, particularly for residents and medical students. The laboratory sheet is the centerpiece of ward rounds. It organizes straws of fact that young doctors, not yet comfortable with what they know, can clutch". Ludwig Eichna, upon his r e t i r e m e n t as Professor and Chairman of the D e p a r t m e n t of Medicine at Downstate Medical Center, Brooklyn, had the fortitude and patience to go back through medical school as a student. He recounted his experience with the new diagnostic process thusly (10): "Witness resident rounds: chart rack in the middle of the ward or out in the corridor, house staff and students crowded around it, the resident asks, ~What are the numbers?' (This is the actual word used for test results.) They are produced and reviewed; more tests are ordered. The patient may not even be visited or examined or may be seen only perfunctorily. Not often does one hear, ~How is the patient? Did you examine this or that?" Schon (11) has t e r m e d the process I have just described as "problem solving" with inadequate preliminary "problem setting." I n a d e q u a t e setting of clinical problems and emphasis on the g a t h e r i n g of ~'numbers" lead to misuse and overuse of laboratory tests. Many would say t h a t the exhaustive use of laboratory tests t h a t I have described is chiefly a characteristic of University Hospitals and major teaching hospitals and is not found in any r a m p a n t form in other practice settings. This m a y be largely true but. not entirely so since physicians carry over into practice many of the habits they have learned, especially those learned in residency training. Freeborn (12), for example, found considerable evidence of overuse of laboratory tests in a large prepaid group practice. It would certainly be wrong to suggest t h a t this state of afthirs has neither been noted nor dealt with by clinicians. Several individuals (5, 13, 14), all internists, have concluded from careful studies t h a t the major factors in overutilization and malutilization of laboratory tests are physician factors. Griner (5) and also Schroeder (14) concluded t h a t the major factors were: 1) A lack of appreciation on the p a r t of physicianusers of i m p o r t a n t test characteristics limiting or influencing their use and interpretation; and 2) an inconsistent logic of test use. CLINICALBIOCHEMISTRY, VOLUME 19, OCTOBER 1986

Percentage of pohenls havLng Prothrombln Time

bOO o CONTROL 9O 80

:EXPERIMENTAL

7O 60 5O

/(

I

l

l

I

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I

I

8/74'~12/74~5/75 6/75 9/75 12/75 5/76 6/76

DATA COLLECTION\ EDUCATIONAL PROGRAM

Figure 1 - - Effect of educational program on the request rate of admission prothrombin times requested by house staff. Month and year is on abscissa. Experimental group is house staff exposed to educational program. Control groups were not exposed to program. (From Eisenberg (18)). Reprinted by permission of the Association of American Medical Colleges. Griner (5, 13, 15), Schroeder (14, 16, 17), and Eisenberg ( 1 8 - 2 1 ) have led the way in efforts to bring about more judicious and appropriate use of laboratory tests t h r o u g h physician behavioral modification. Several approaches have been used and/or advocated. These m i g h t be classified as follows: 1) Educational programs; 2) Feedback and Audit; 3) Positive incentives; 4) Administrative m a n o e u v r e s including rationing and quotas. 1) EDUCATIONAL PROGRAMS Educational efforts have been largely concentrated on house s t a f f a n d physicians in an effort to m a k e t h e m more a w a r e of limitations and costs of tests in general, and in specific diagnostic situations. Griner (15) instituted a regular weekly s e m i n a r p r o g r a m for third y e a r residents and found a significant decrease in use of laboratory tests per patient. Eisenberg has perhaps had the most experience with this approach on a controlled basis. He investigated the effect of an educational prog r a m on the misuse of prothrombin time as an admission screen for liver disease (18) (Figure 1). The effect on those residents in the p r o g r a m compared to a control group was i m m e d i a t e and pronounced but was shortlived, illustrating the need for continual reinforcement. Eisenberg (22) later used a computer feedback of laboratory use and data on costs supplemented by educational p r o g r a m s and found no effect, no difference between control and e x p e r i m e n t a l group, in laboratory use. 2) FEEDBACK STRATEGIES Feedback strategies m a y t a k e the form of practice audits, as in the Physician Standards Review Organizations (PSRO) programs, or feedback on costs as a method of audit. 263

BENSON TABLE 1 Billing Period (10 Weeks) Number and Cost of Tests a

Intern Intern Intern Intern

mean number of tests per week mean cost per week median number of tests per week median cost per week

Mean of Experimental Group (10) (n = 172 patients)

Mean of Control Group (12) (n = 181 patients)

15.1 b $108 ¢ 11.1 $77

15.6 d $113 e 13.2 $91

aFrom Campbell and Makler (23). Reproduced by permission of University of Minnesota Press. bSD = 2.05. ~SD = $19.69. dSD = 3.49. eSD = $26.90. TABLE 2 Adjusted Number of Laboratory Determinants per Patient Hospitalization a Time Period Group All first-year residents, year before study (38, 32, 34) c Control (28, 47, 44) c Incentive (26, 48, 32) c Chart review (28, 41, 42) c

Base-Line b

Intervention

Follow-up

110

129

121

102

65 d

78

112

80 d

100

107

57 d

51 e

aFrom Martin et al. (24). Reprinted by permission of New England Journal of Medicine. bNo differences were observed between groups (p > 0.5). CFigures in parentheses denote the number of observations during the base-line, intervention, and follow-up periods, respectively. dp < 0.05 for comparison with base-line period. Control and chart-review groups had numbers significantly lower than that of the incentive group (p < 0.05). eThe chart-review group's number was significantly lower than that of the control and incentive groups or of all firstyear residents during the year before the study (p < 0.05). For example, Campbell and Makler (23) compared two groups of interns, one of which received patient bills on a weekly basis along with a questionnaire in which each participant was asked to give his reasons for ordering certain tests. The control group received no bills or questionnaires. As one can see (Table 1), the program had no effect as compared with controls. Incidentally, in this program as in other similar ones, there was quite a sharp drop in test use in the control group, sometimes more t h a n in the experimental group. Martin and associates (24) reported a study at B r i g h a m and Women's Hospital in Boston in which a chart-review group, a financial incentive group, and a control group were compared. Each group was made up of faculty, residents and medical students. The chart review group engaged in regular periodic chart-based 264

discussions on use of laboratory and x-ray tests. Members of the financial incentive group were promised a gift certificate of $150 each to be used for purchase of medical books or journals if they effected a 20% reduction in laboratory tests and radiological procedures in the test period as compared with the baseline. A significant decline in test use was found for the chart review group as compared with the control group (Table 2). No significant change was noted in the incentive group and few of this group received the promised reward. It is perhaps significant that role model faculty were engaged in the periodic discussions of the chart review group. Martin and associates concluded from this study t h a t physicians' testing behavior can be changed and t h a t restraint can be developed at least among young physicians in training by appropriate educational programs and feedback incentives, especially if they are intensively involved in them personally and if senior physician leaders (role models) take part in them with enthusiasm. Marton, Tul and Sox (25) reported results similar to those of Martin and associates (24) in an experiment in which feedback on use of tests and an educational manual were used. Feedback alone had no effect, but when supplemented by use of a ~cost-sensitizing" manual, a 42% reduction in test use was achieved. Schroeder (7), however, repeated the study of Martin et al. at the University of California, San Francisco, using a combined educational and audit feedback and groups similar to those of Martin et al. and failed to reproduce Martin's results. He found no difference between the control and experimental groups. B a r b a r a McNeil (26, also personal communication 1985) is conducting a study at three hospitals in the H a r v a r d group. In this study, one service in each hospital is included, dividing patients into diagnostic related groups (DRG's). She then studies the cost per patient for each physician and the aggregate average cost for t h a t service in each hospital. Outliers will draw special attention and reasons for their status will be reviewed. This approach requires close and committed cooperation of the service chief. It remains to be seen what the long-term effect will be, that is, how successful the program will be in modifying utilization on a long-term basis. CLINICAL BIOCHEMISTRY,VOLUME 19, OCTOBER 1986

RESPONSIBLE LABORATORY USE 3) POSITIVE INCENTIVES: REWARDS

Can physician behavior be modified by a system of positive incentives or rewards? As we have noted, Martin et al. (24) tried this method in their Brigham and Women's Hospital study without encouraging results. Eisenberg's residents rejected the idea of rewards as an option of his program (27). Health Maintenance Organizations (HMO's) might be considered a form of positive incentive since physicians ir such programs are rewarded financially for cost-saving behavior in the utilization of services. Studies performed to date, however, including those of Luft (28, 29) have not revealed any notable effect on laboratory use. The efforts for cost containment thus far have been notably concentrated on rates of surgery and on hospital admission. Incentives from service chiefs have predominantly favored higher laboratory use. Residents who have ordered many tests have been rewarded, those who failed to order tests that may have been desired by the chief are punished. No reward generally has been accorded those who ordered tests judiciously and sparingly; no punishment usually has befallen the ones who ordered tests lavishly and injudiciously. The general experience with educational programs, feed-back programs and positive incentives, at the house staff and physician level, has not been encouraging. Either the effects are short-lived, or, when success has been claimed, as in the case of Griner's study (15), they are in uncontrolled settings. The success of the Martin study (24) has not been achieved by others to the same extent (Marton et al. (25) and Schroeder (7), for example). This is not to say that this approach is entirely without merit and should not be tried. Further efforts along these three lines are certainly warranted, but it appears that the practice styles and behavior patterns that influence use are deeply ingrained and will not be easily modified. Eisenberg has recently very thoroughly reviewed the subject of physicians' practice patterns and their modifications (21). 4) ADMINISTRATIVEMANOEUVRES The three approaches I have just discussed depend on physicians voluntarily making changes in their behavior. An alternative method is to institute administrative measures that mandate change. Among such measures are rationing and quotas. A question with rationing is: Who will do the rationing? Not the physician certainly: he should not do it. The physician must place his patient's welfare first-this is an important element in the physician ethic. Calls for rationing have, by and large, not come from physicians or from patients, but from third part ies-bus'iness leaders, administration, economists and, sometimes, government officials. At any rate, such methods have rarely worked well and have sometimes backfired when, because of them, patients or their relatives have found that they were denied crucial services. Greenberg (30) imagines an individual saying to his doctor:-~You mean to say, doctor, that you think this test might help my child, but the rules don't allow it, even if I want to pay for it myself?." CLINICAL BIOCHEMISTRY, VOLUME 19, OCTOBER 1986

In an experiment in Canada, referred to by Ashley and his associates (31), a check was placed on diagnostic service requisitioning by each physician based on the average for that specialty. Unfortunately, ~high users" did not respond well while ~low users" raised their use levels towards the average. Dixon and Laszlo (32), on the other hand, at a Veterans Administration Hospital, claimed some success in lowering overall test use when physicians were limited to eight tests per day. A more promising approach is one in which protocols are examined and modified. Griner (15) used this approach in eliminating several admission tests and other protocols. He found an overall beneficial effect on utilization. Generally, this method requires the support of the service chief and/or other major authority figures. I will discuss this approach in a little more detail later. Schroeder (7) has concluded regretfully that until we have a generation of physicians who can think ofprobabilities as Rev. Thomas Bayes thought and have the computer facility to use Bayesian logic, we will not get very far with efforts at physician behavioral modification to improve the logic of test use.

The responsible clinical laboratory It may be attractive to conclude that, since patient care physicians do all the requisitioning of tests, problems of test use are entirely physician problems, and we in the laboratory are blameless and have no responsibility to overcome these problems. This conclusion is attractive, but I believe it to be wrong. The laboratory has had a hand in bringing about the problems of overuse and misuse of tests and we in laboratory medicine have a responsibility, along with clinical physicians, to help correct abuses. How do we in laboratory medicine contribute to problems of laboratory use? 1) We have provided the means of obtaining large quantities of data, much of it unsolicited. 2) We have participated in the development and use of protocols notably for monitoring. 3) We have introduced new tests often with insufficient attention to their added value. 4) We have allowed the laboratory repertoire of tests to be expanded almost endlessly both by introduction of new technology and failure to retire old and outdated technology. 5) We have often provided uninformative re p o rtsreports not containing all the relevant information needed to evaluate critically and interpret a result. 6) Our efforts to provide assistance and guidance to residents and clinical staff on the use of the laboratory have been too weak and desultory. 7) We have in large measure failed in our task of educating medical students in the effective use of the laboratory. 8) We have allowed the communication links between laboratory and clinic to become remote and impersonal. Accordingly, we too often are working at cross purposes with clinicians rather than closely in league with them. This is quite a broad indictment of a generation of laboratorians and it probably is unjust in many partic265

BENSON ulars. Many individuals in Laboratory Medicine have addressed one or more of these problems, for example, the education of medical students, more effectively t h a n I am crediting them with. But I believe my charge is justified in the aggregate. We in Laboratory Medicine have misread our role in some crucial sense. We have directed too much of our attention to providing high quality and timely results and not enough to the task of making our laboratory skills help solve actual clinical problems. Measures that we take to help solve problems of utilization should be addressed to these deficiencies. 1. DATA OVERLOAD Admission screening and well population screening are not now as popular as they have been in the recent past, but they persist. When multichannel biochemical analysis of hospitalized patients was first proposed in the 1960's, it was an exciting moment. Here was a new idea, a new prospect: if biochemical analysis can be performed rapidly, economically, and accurately, why not make a cluster of these analyses a part of the initial examination and speed up the process of arriving at a diagnosis? As we have learned, admission screening did not provide all the benefits anticipated. In careful studies, Whitehead and Wooten (33) and Leonard and associates (34) in England found no correlation between use of an admission screening battery and length of stay in hospital. Durbridge and his associates (35, 36) in Australia found a low yield of significant information on use of a routine screening battery on admission to hospital. Olsen and her associates (37) in the United States found no correlation between use of an admission screening battery and any outcome parameter, except t h a t screened patients remained longer in hospital. These and other studies found one significant difference between screened and unscreened patients: namely, a higher overall cost in the screened group; probably a result of the additional, often unnecessary, laboratory investigations the screening process generated. One of the more unfortunate results, I believe, of the use of multitest batteries is the negative effect it has had on the logic of test use. The approach has the effect of converting the logic of test use from a problemoriented to a data-oriented one. It has in part been responsible for the heavy emphasis on ~numbers" noted by Lewis Thomas (8) and Ludwig Eichna (9). One step we can take, therefore, is to examine our use of multitest batteries, including screening batteries, to see if they are really accomplishing useful clinical purposes. Accumulation of a comprehensive data base for subsequent clinical investigation is not a valid reason for such use, especially in this era of cost consciousness.

for certain tests to be performed on a specified time basis. Often the frequency of testing is set without any consideration of physiological and analytical variance. These protocols need to be examined to see if they are rational: for example, are tests ordered at too frequent intervals? Connelly and his associates (38) examined the use of the differential leukocyte count as a part of the admission hematologic profile at University of Minnesota Hospitals. This test is a labor-intensive, yet imprecise and error-prone procedure. In 2682 adult cases studied, they did not find one case in which the differential count used as a screening test provided clinically significant information not provided by some other simpler method. At no time did a differential count used in this way lead to a clinical decision of any note. This study led to a directive from the Medical Staff Hospital Council, endorsed by the department heads of Medicine and Pediatrics, deleting the differential leukocyte count from the hematologic screening battery (the CBC) and urging physicians to not include it as a part of the admission workup, except when there is a specific indication for its use. Shapiro and associates (39) recently conducted a similar study of the leukocyte differential count with similar results to those of Connelly. These authors make the important point that one might concentrate on ~laborintensive" procedures used in screening in trying to reduce overutilization. We have noted how Griner (15) was able to reduce laboratory volume by elimination or modification of protocols. It is incumbent on us to study such protocols to determine whether they are achieving the objectives sought. I firmly believe much useless laboratory testing can be eliminated by reducing the frequency of testing called for in m a n y protocols. This can only be accomplished, however, after careful study. 3. NEW TESTS New tests are too often introduced without adequate justification of their added value with respect to the problems they aim to address. That it precisely and accurately measures the constituent sought, is not sufficient reason for the introduction of a new test into use. It must have diagnostic effectiveness and be superior to alternative existing methods in reliability, simplicity or speed. We have means now of evaluating the diagnostic effectiveness of a laboratory test using predictive value theory (40). Even so, as Sackett (1) has pointed out, when a new diagnostic test comes into widespread use, its positive predictive value tends to decline from the claimed value due chiefly to misjudgments concerning its sensitivity, specificity and the prevalance of the disease sought.

2. PROTOCOLS 4. EXPANDINGREPERTOIRE A steadily increasing amount of our laboratory work, in chemistry at least, is going into monitoring: monitoring the course of an illness or the m a n a g e m e n t of a course of therapy. In my setting, more t h a n 50% of the chemistry workload is assignable to monitoring. Much of this monitoring work is based on protocols which call 266

Continuous addition of new tests and new analytes to the laboratory's repertoire has resulted in a ~menu" of clinical chemistry tests t h a t for m a n y hospital laboratories is very extensive. Old technologies replaced by new are too often retained. If the laboratory provides CLINICAL BIOCHEMISTRY, VOLUME 19, OCTOBER 1986

RESPONSIBLE LABORATORY USE

requisition forms which list all possible tests, the temptation to order more tests than necessary becomes quite irresistible. We compound the problem by providing large quantities of unsolicited data, often 12 or 20 results in a batch. In effect, the laboratory provides a lengthy and wellstudied smorgasbord of plain food and delicacies from which clinicians can select their choices. Some have larger appetites than others but choices are relatively free (a third party is paying for the spread). We servers may complicate matters by heaping several varieties of food, chiefly plain food, to be sure, on each plate, but this does not seem to abate the diners' appetites; in fact, it appears only to sharpen the appetite for more. The size of the repertoire is an advantage if a hypothetico-deductive approach to problem-solving is used, since tools can be chosen to assist in the step-bystep unravelling of a specific diagnostic problem. When the exhaustive pattern recognition method of diagnosis is used, it has the potential of providing a flood of data in which crucial pieces of evidence are lost amid the welter of data. How can we address this problem? Some have suggested that we can do so by no longer providing a test requisition form or computer format which lists all or a large number of tests, forcing the ordering physician or his agent to write out the name of each test requested. I do not particularly like this solution because it seems to me to be one in which quality of service is reduced. We know that we can control utilization to some extent by providing poor service. For example, if we take two weeks to turn around a test such as the T4, there will be many fewer T4's ordered. Another quite similar approach has been that of placing an impediment between the ordering physician and the laboratory test, such as a "gate-keeper." In some instances, the physician must go through a laboratory resident to get permission to order tests beyond a basic set. The coagulation laboratory at the University of Minnesota offers a large number of tests. The request form for coagulation lists only a few tests by name, including one battery. If tests beyond these few are ordered, they must be ordered specifically by request. The coagulation physicians (usually first a resident) screen these and in the case of ones that seem "dumb" or misguided, the laboratory physician contacts the ordering physician, usually a house officer, and in most cases talks him out of them. Sometimes a new test is popular - for example, recently Protein C was in this category. Many requests for this test may come to the laboratory, many of them in the "dumb" category. The coagulation physician has prepared a written communication in the case of this test which may be read offby the technologist by telephone to the ordering physician. The laboratory physicians also respond to written or telephoned requests from ward physicians to advise on specific cases and these requests come fairly often, especially from surgery and the surgical specialties. This approach is certainly sparing of unnecessary, misleading and useless testing, but it takes a good deal of time of the laboratory physicians and the cost benefit may be questionable. Yet, to me, it seems a more logical CLINICAL BIOCHEMISTRY,VOLUME 19, OCTOBER 1986

approach - the hypothetico-deductive problem-solving approach that one seeks. I believe it will be used increasingly in clinical chemistry as well as in other areas of laboratory medicine, since the laboratory aspects of medicine have expanded beyond the capability of most physicians to keep abreast of them except perhaps in each physician's specialty areas of interest. With the aid of computers and expert systems, laboratory physicians and other laboratory scientists will have a greater ability to provide this type of constructive guidance in the new era. Some have suggested that the problem of expanded repertoire can be addressed by revising the request forms to group and prioritize test items, sometimes in an algorithmic form. This may be helpful in some instances, as for example, tests of thyroid function, but I believe this is only a partial and perhaps stop gap measure: the problem is much greater than this. I believe the most likely road to success is the most difficult and longest. It includes: 1) better education of physicians, starting in medical school; and 2) more involvement of laboratory physicians and scientists at the interface between the laboratory and clinic, in guiding the use of the laboratory and in assisting in interpretation of laboratory data. 5. SUBOPTIMAL REPORTING SYSTEMS

Too often the laboratory report form is crowded, rich in data - especially in numbers - poorly organized, and poor in supporting information or interpretative assistance. This too can lead indirectly to suboptimal use of the laboratory. Humans, as compared to computers, are weak in attention span and in short- and long-term memory. Physicians' tasks require attention and are memory-intensive. The laboratory report form should aid in bridging the gaps in attention and memory by grouping relevant data, displaying trends, indicating significant variance (from population norms and intraindividual variance) and, when appropriate, providing the data in the form of a pattern - departures from normal are thus more easily recognized. The profile report forms associated with the various generations of Auto Analyzer (Technicon Instruments Corp., Tarrytown, NY 10591) were, I believe, a large factor in their popularity amongst physicians. Solberg (personal communication 1985) has developed a system of graphics to improve display of laboratory data. Williams (41) has developed a radial display system (Figure 2). In this display system, the magnitude of each individual variate is represented by its distance from a central point. The reference range is denoted by a shaded area. Thus, from a large number of results presented simultaneously, abnormal results and the relative magnitude of each abnormality can be quickly discerned. 6. INADEQUATE GUIDANCEIN INTERPRETATION

If a surgical pathologist included in his report only the gross and microscopic findings that he notes in a surgical specimen he examines, leaving the surgeon to make up his mind as to what these findings mean, his tenure would be short-lived indeed. Instead, his report 267

BENSON L1/77 / ~4

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ng,/, )

AP, 7."

95

g'/,

UrA, ~ X 9.6

Figure 2 - Radial plot of laboratory data on a patient. (Reproduced from Williams (43)). Reproduced by permission of the Regional Health Resource Centre, Urbana, IL. includes both the findings and his interpretation of them in terms of diagnoses, and he may even include t r e a t m e n t suggestions. He does not gain this ability to extend his findings into clinical advice and guidance merely from his experience and skill in examining gross specimens and microscopic tissue sections. He has benefited from long experience in relating what he sees in the gross specimen and on the slide with the clinical findings, the entire clinical picture. There is continual feed-back of clinical information to the histopathologic observations, and refinement of the pathologist's ability to predict clinical events such as diagnosis, prognosis, and response to treatment, from the gross and microscopic observations. A similar situation exists for the diagnostic radiologist. Attempts have been made in clinical chemistry and other areas of laboratory medicine to provide similar interpretative and predictive support. Some of these have been quite successful; others have been too rudim e n t a r y to be considered a success. More efforts need to be made by laboratorians along these lines, especially in key, complex areas such as therapeutic drug monitoring, metabolic disease, genetic disease and intensive care. These can succeed only if they are u n d e r t a k e n in close communication and collaboration with patient care physicians. Computer strategies - such as multivariate analysis and cluster analysis - can assist us in this task; expert systems will be helpful, but none of these can take the place of a close and significant interaction with patient care physicians and the clinical setting. All of the measures t h a t I have discussed can assist in solving problems of laboratory utilization and will help bring about more responsible use of the clinical laboratory in medicine. There are two elements, however, interwoven in all eight of these measures; these, in my belief, will have by far the greatest effect. Neither of 268

these can provide quick or easy solutions but in the long r u n they will have the profoundest effect on standards of care. These two are: (a) Education; (b) Close communication and interaction between laboratory and clinical medicine. 7. EDUCATION

We have noted t h a t educational programs for house staff and physicians have been disappointing. Schroeder (7) observed t h a t efforts at behavioral modification t h r o u g h education will probably fail until we have a generation of physicians who understand and can use Bayesian logic and who have the requisite facility with computer use. The teaching of laboratory medicine to medical students, at least in the United States, has not been very effective. It has largely occurred early in the curriculum and focussed too extensively on techniques rather t h a n basic principles. Formal courses of instruction on the u s e of the laboratory are an exception r a t h e r than the rule in the United States. Much of the teaching of laboratory use is done by clinicians while the students are on clerkship and is episodic, anecdotal and tends to cultivate high use. At the University of Minnesota, in 1968, we organized a course for medical students in the fourth year, largely an elective year. This was an elective course organized and t a u g h t by Drs. Ward, Burke and Horwitz, and was oriented towards the discriminant use of the laboratory in medicine. It has been a very successful teaching program (42): while it started with one student, it quickly swelled to be fully enrolled with 50 students, three times a year. It focussed on test selection strategies, the logic of test use and interpretation of laboratory data using a case-by-case problem-solving format. This course has been the model for other courses at a n u m b e r of institutions. It has survived the departure from our institution of Drs. Ward and Burke, and continues to flourish in our curriculum. I believe we need to intensify and expand our efforts in the education of medical students in logical problemsolving, and logical and economical test use. We should try to ally ourselves with general internists in this effort. Many of these individuals are interested in decision analysis and are attempting to teach medical students to use these methods in ~real time" clinical problem solving. I feel certain t h a t efforts to modify the lavish style of laboratory use of house staff and physicians, especially at teaching hospitals, will succeed only when a more intensive and successful effort is made to educate medical students in decision making and logic of test use. 8. COMMUNICATION

A gap has appeared and is growing between the clinical laboratory and clinical medicine. The high technology we have introduced into medicine and its capabilities to generate data have in some strange way helped to make us more remote r a t h e r t h a n closer to the clinical arena. Computers can help us bridge the gap but they canCLINICAL BIOCHEMISTRY, VOLUME 19, OCTOBER 1986

RESPONSIBLE LABORATORYUSE not do it alone. It will take individual persons in direct and intimate communication with clinicians and our presence in the clinical arena in case study. Donald Van Slyke, one of the leading progenitors of Laboratory Medicine, in his Presidential Address to the International Federation of Clinical Chemistry in 1957, noted that Clinical Chemistry encompassed ~not only development of methods but the study of all the phenomena of the body's normal chemical processes and the alterations they undergo in disease." As Director of the Clinical Chemistry Laboratory at the Hospital of the Rockefeller Institute, he regularly made rounds, and as a visiting clinical biochemist noted in 1932, often instructed the clinicians as to what studies to conduct (43). Van Slyke himself recalled t h a t at the Rockefeller - to quote him - "the clinicians took us into their group and almost by force imposed their enthusiasms and their problems on us" (43).

Conclusions In conclusion, interactions between physicians and the elaborate and costly technologies now available for diagnosis and m a n a g e m e n t of patients are a major concern to those who would restrain costs and yet assure high quality medical care. Abandonment of these technologies or t u r n i n g aside from development of new ones is a drastic and inappropriate response to this problem. Modification of physician behavior, though a difficult and time-consuming approach, is undoubtedly the most appropriate and effective long-range strategy for developing more responsible and logical use of the clinical laboratory. We in Laboratory Medicine can play a crucial role in this process by helping to improve the education of medical students in the use of the laboratory and by carrying this educational process into the residency and beyond. For this to be effective, we must, by our own efforts, help to close the gap in communication between clinics and laboratory. If we can influence the practice of medicine by bringing about more effective, more prudent, and more logical use of the laboratory, we will not only contribute to increased cost effectiveness in medicine but will achieve a great deal towards the goal of improved standards of care.

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