MEDICINE AND PUBLIC ISSUES
Unanswered Questions about the Periodic Health Examination WALTER 0. SPITZER, M.D., M.P.H., and BRUCE P. BROWN, M.D., Hamilton, Ontario, Canada
The periodic health examination in its application as a screening procedure in asymptomatic, ostensibly healthy persons is explored with a focus on the following issues: (a) the impact on health, (b) the content of a beneficial health examination, and (c) the effect of the examination on the physician-patient relation. The application discussed is distinct from use of the examination as a tool for diagnosis, prognosis, or therapeutic planning for patients with a specific illness. The discussion also shows a relatively recent change in the goal for the clinical assessment. There has been a shift in emphasis from establishing a diagnosis as the main outcome event of the periodic "checkup" to the identification of an intervention of value to the patient. Evidence from various studies that throw some light on related questions is considered. Special ethical issues surrounding the unsolicited medical assessment are identified. Finally, some ground rules for decisions about the periodic health examination are proposed.
"We are paying too little attention, and respect, to the built-in durability and sheer power of the human organism. Its surest tendency is toward stability and balance. It is a distortion, with something profoundly disloyal about it, to picture the human being as a teetering, fallible contraption, always needing watching and patching, always on the verge of flapping to pieces; this is the doctrine that people hear most often, and most eloquently, on all our information media. We ought to be developing a much better system for general education about human health, with more curricular time for acknowledgement, and even some celebration, of the absolute marvel of good health that is the real lot of most of us most of the time." (1)
about what we do in patient care have been prompted by the stresses of rising expectations for excellence and availability of health care and the concurrent rise in costs of health services. Most activities in health care require careful scrutiny at regular intervals. Among them, preventive measures in general and the periodic health examination in particular deserve priority today. Justification for such activities continues to be based primarily on paradigms that are being rendered increasingly irrelevant by the evolution of
MANY QUESTIONS
• From the Department of Clinical Epidemiology and Biostatistics and the Department of Family Medicine, School of Medicine, McMaster University, Hamilton, Ontario, Canada. Annals of Internal Medicine 83:257-263, 1975
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medical science and changing patterns of health and disease in the population. For instance, the feasibility and the undeniable value of prevention and early diagnosis in many once highly prevalent infectious diseases was followed by an axiomatic acceptance of prevention for all illness. Such acceptance is reinforced by what is generally taken as self-evident common sense and by simplistic analogies between the care of the human body and preventive maintenance of manmade machines. Further reinforcement stems from a tendency of the health professions to oversell prevention, to overestimate their ability to deal effectively with detected disease, and to overvalue the benefit of their care to patients. Less than a medical generation ago, establishing a diagnosis was the main outcome event of the "history and physical" .(which may or may not have included minimal ancillary investigation). The emphasis has shifted so that today the outcome event of greater interest is to identify an intervention of value to the patient. This change in goal of the clinical assessment of a patient provides a common thread for the seven questions raised in this article. We define the periodic health examination as a group of tasks that are part of a systematic complete "workup" of a patient as undertaken by physicians who accept standards of performance taught in North American or British medical schools and who adhere reasonably well to normative techniques of interview and examination. Arbitrarily, one criterion is that a history and physical assessment must be included in what we designate as a health examination. Additional investigation may also be incorporated with varying degrees of comprehensiveness. We restrict discussion of the periodic health examination to its application as a screening procedure in asymptomatic, ostensibly healthy persons. This application is distinct from use of the examination as a tool for diagnosis or prognostic elucidation, for assessment of the course of an illness under surveillance, or for therapeutic planning. Here are the questions to be answered: 1. What Can Be Helped?
What conditions, risk factors, or diseases can reasonably be found in a preclinical state whose natural outcome can be altered or palliated in a way that benefits the patient or society? The answer depends on the criteria chosen for evalua257
tion of screening procedures (see Question 6) and the rigor with which they are applied. Several reviews have been published (2-5) that have attempted to identify those conditions where preclinical detection could be of some benefit. Most of the reviews assess the appropriateness of targets and the merits of procedures for use in mass screening programmes. From those sources and from reports of original investigation, a list of conditions, risk factors, and disorders for which we feel there is reasonable evidence, although frequently incomplete or equivocal, to support selective screening that can be incorporated in periodic health examinations has been summarized in Table 1. The entities in this list are not proposed as appropriate targets for total population screening. They are suggested only as conditions worthy of search in persons under care by doctors with whom they have a firm ongoing tacit or explicit "contract" for health services. The shortness of the list is discouraging. Moreover, wellreasoned challenges to the value of most detection efforts for most of the entities can be found (37, 38). Insufficient attention is given to the ever-present possibility that early identification of disease may represent a disservice to the patient and to society. As pointed out by Feinleib and Zelen (39) early diagnosis in the asymptomatic patient may accomplish nothing more than advancing the starting point for the measurement of survival. Knowledge of disease, not life, is then prolonged. The potential harm of stigmatization and psychological distress as reported in the recently described "nondiseases" such as "cardiac nondisease" (40, 41) must always be weighed against the potential gain of earlier intervention. 2. Does Help Really Occur?
Is a periodic lifetime health examination program, with aggressive initiative by the health providers and with high compliance by the patients, associated with improved health status for the population?
This is the key question. The answers are being sought in four randomized controlled trials (42, 43). Only the project of Collen and his colleagues of the Kaiser-Permanente group has published results to date. The care in the design of that study and the accomplishments in implementation, particularly the long-term follow-up, are impressive. Large-scale health-care controlled trials such as the Kaiser-Permanente study are easy to conceptualize but exceedingly difficult to execute with satisfactory rigor. The main results from Northern California indicate that for middle-aged persons, representative of enrolees of a prepaid group health plan (aged 35 to 54 at entry to the trial), there was lower mortality after 7 years in the screened cohort (35.6 per 1000 versus 39.2 in the control cohort). Differences in total deaths were not statistically significant. As summarized by Knox (42), a group of "potentially postponable" causes of death was singled out for special comparison. The group of disorders was defined on the basis of medical opinion before the results of the survey were known and included carcinoma of large bowel, rectum, breast, cervix, uterus, kidney, and prostate and deaths from hypertension, hypertensive cardiovascular disease, and intracranial hemorrhage. There were 19 deaths in the screened group and 41 in the control group. Moreover, not all these conditions seemed to be the subject of procedures designed to detect them, and what proportion of them were actually detected in the multiphasic checkup was not reported. The comparisons on prevalence of disability of major chronic disorders and of utilization of physician and hospital services gave equivocal results. Even when the differences were statistically significant, their clinical or practical significance was marginal. Assuming that longer follow-ups at Kaiser may confirm the findings reported to date in their population and may even provide more encouraging evidence, two important concerns remain: (a) Will findings from studies focusing on total populations (such as those under a governmental universal health insurance plan) support the meagre favourable evidence now available? (b) Will differences in the Kaiser-Permanente study be sustained in the absence of the persistent recall procedures required to attain the reported high participation rates? Such procedures could be prohibitively costly in situations where the support resources of very large groups are not available and where the target population is not as accessible as in a situation where enrollment is largely through employment.
Table 1. Targets for Appropriate Pre-Clinical Detection of Disease Stage in Life The fetus and first year of life Preschool age Childhood and adolescence Adulthood
The aged
258
Targets for Selective Screening Rhesus incompatibility with mother Phenylketonuria Congenital dislocation of hip Some congenital heart defects Hearing abnormalities Amblyopia Smoking Congenital heart defects Smoking Breast cancer Cancer of the cervix Cancer of the colon and rectum Hypertension Bacteriuria in pregnancy Hypertension Conditions and states amenable to rehabilitative intervention where the goal is not cure or extension of life but improvement of quality of life
References 6-9 10, 11 3, 12 3 3, 12 3, 12 13-18 3 13-17, 19-21 22-24 24, 25 26 27-31 32, 33 27-31
34-36
3 . Asymptomatic Solicitors Versus Repetitive Recipients
Are asymptomatic persons who solicit a periodic health examination different in health status from persons on whom the checkup is professionally imposed? What is the clinical and particularly the prognostic significance of the request for a health examination if it is the only apparent stimulus impelling a person to seek care? We have often been taught by senior, experienced, clinical colleagues that the act of seeking a medical assessment
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is a significant symptom in and of itself. A patient may thus communicate information about a health need that may not be otherwise expressed (44). Feinstein (45) suggested the term iatrotropic stimulus for a patient-determined reason to consult with a doctor. Is the health examination done in response to such an iatrotropic stimulus more productive or more beneficial to a patient than an iatrogenic checkup? The answer to the question is vital to those deliberating strategies of primary care. We have found only one reference that provides any data about the issue. In Wolfe and Badgley's book, The Family Doctor (46), in which 3203 health checkups done by family physicians were analyzed, the overall yield of "significant findings" was 2 7 % . However, for checkups done in patients with a symptomatic presentation, the yield was 3 8 % ; for asymptomatic patients it was 1 1 % . 4. Is It Worth the Cost?
Should a health services system make provision for periodic health examinations of all citizens of a state throughout their lifetime? Let us assume that the average lifetime frequency of examination, adopted on grounds of scientific evidence, is once every 2 years. We then discuss the question from our experience with Canadian governmental universal health insurance and from the standpoint of society. Based on the Ontario Medical Association fee schedule* a conservative estimate of cost for each periodic health examination, including a modest battery of ancillary procedures, is $30.00. The amount does not include additional investigation of false-positives nor loss of work time, travel cost of patients, and so forth. In the Province of Ontario, which is adequately doctored and where 4 9 % of the physicians are in family practice, biennial examinations that could be done by family practitioners would then cost 120 million dollars. The total represents approximately 5% of the total health budget, 2 5 % of payments by the government plan to all doctors, and nearly 40% of payments made to family physicians. For a government already staggering with a health budget that consumes more of the public purse than any other category of provincial expenditure (even more than expenditures for education), adding even a fraction of the 120 million calculated to that budget is not feasible especially when the measures have not been shown to be associated with an improved health status of the population or savings in services such as hospitalization. Whether the price of the periodic health examination is paid privately and entrepreneurially or publicly through national health insurance, can society afford the cost? Should it pay the cost given how little we know about the benefits? 5. What are the Components?
Which are the minimally
required components
of an
* The schedule, as of 1 May 1975, allows the following fees for services: complete general assessment by family physician, $16.00; complete blood count, erythrocyte sedimentation rate, and differential leukocyte count, $12.48; urinalysis, $2.87; electrocardiogram including interpretation, $6.50; and chest X-ray, two views, $9.00.
effective programme of periodic health
examinations?
(a) What should be done? The periodic health examination, as defined in the introduction, can be done with widely varying degrees of comprehensiveness. A patient may feel quite reassured after a cursorily taken history and a rapidly completed physical supplemented by a urinalysis, a complete blood count, and a chest X-ray. Another patient, having experienced the type of thorough checkup done at the University of Pittsburgh Executive Health Evaluation Clinic (47), for example, could understandably feel, if told that all is well, that he possesses a virtual guarantee of health for at least a year. Not only is the "history and physical" a component of the health checkup but it is itself composed of many subcomponents. If done thoroughly, the aggregate of those elements becomes the most time-consuming constituent of the procedure. Should an examination of the rectum be done with every examination? Given Collens' preliminary findings about reductions achieved in mortality associated with carcinoma of the large bowel and rectum, should a search of polyps with barium enema always be included? Should the ears be examined in the adult? Should blood pressures be taken in adolescents? How productive is the examination of the abdomen? What is a minimum acceptable package in the neurological part of the examination? Which questions need to be included in the history or a self-administered questionnaire? The case for evaluating each paraclinical test separately in a multiphasic programme has been made convincingly by various authors (48, 49). The constituents of the "history and physical" clinical part of the health examination should receive the same scrutiny. Up to the present time, the packages offered seem to be assembled on the basis of altruistic educated guesses and normative professional consensus (50) at best, and expediency motivated by profitability at the other extreme. We still do not really know what to include in the periodic checkup. (b) Who should do it? Evidence is accumulating that the physician can sometimes be safely replaced by nurse practitioners and other categories of physician extenders (34, 51-58). Many of the multiphasic programmes have appropriately reduced physician involvement. Are we ready to confront the possibility that the physician should be excluded entirely from the periodic health examination? On the other hand, are we ignoring the possible value of the physician-wellpatient contact? A patient requesting the "complete physical" may not be asking for more than needed reassurance. When complying with the request, the physician knowingly or unwittingly often performs a therapeutic act rather than an investigative procedure. Empirical support for the existence of such an interaction was recently published by Glazunov and colleagues (59). It may be argued that reassurance can be given without doing a "physical." But to the patient, the examination may be a necessary validating adjunct of the reassurance statement. Spitzer and Brown • Periodic Health Exemlnation
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6. What Harm Might Be Done?
(c) Which subgroups of the population? We suspect that the segments of the population least likely to afford comprehensive checkups or to have access to them are those in which the yield might be highest and conceivably worthwhile. Choice of age groups for priority would appear to be a less difficult problem. Quite reasonably, our clinical instincts and common sense suggest that infancy and the preretirement decade deserve a concentration of effort. And yet, Anderson (60), having evaluated over 6668 consecutive routine physical examinations of infants under 12 months done by 83 private pediatricians in Connecticut, found only 130 (1.9%) clinically significant abnormalities, many of which would have been readily detectable by a physician extender. Moreover, in less than half of the discovered problems could it be argued that early intervention might have been beneficial to the patient. Lack of sensitivity and disappointing end results dampen enthusiasm about health examinations in the preretirement group. In Schor's and associates' (47) classical study, of 192 executives aged 40 to 59 who had received a very comprehensive regular checkup and who died, the condition leading to death was not recognized at the last examination and was not known prior to the last hospitalization in 59% of the cases. (d) How often should a checkup or its components done?
"When the patient seeks medical advice, the doctor's ethical position is relatively simple: he attempts to do his best with the knowledge and resources available to him. He cannot be fairly criticized when the state of medical knowledge does not enable him to treat effectively or even to diagnose accurately. . . . The position is quite different in screening, when a doctor or a public authority takes the initiative in investigating the possibility of illness or disability in people who have not reported signs or symptoms. There is then a presumptive undertaking, not merely that abnormality will be identified if it is present, but that those affected will derive benefit from subsequent treatment or care. This commitment is at least implicit, and except for research or the protection of public health, no one should be expected to submit to the inconvenience of investigation or the anxieties of case finding without the prospect of medical benefit."
be
This question is probably the one about which we know the least. The difficulties of the practitioner in trying to decide what to do are illustrated well in the sphere of health maintenance in infancy. Since 1967, the American Academy of Pediatrics has recommended monthly wellbaby visits in the first 6 months and bimonthly ones in the second 6 months (50). This represents 10 visits in the first year of life if one includes one initial newborn nursery visit. More recently, revised standards specify a maximum of 6 health maintenance visits for children who receive competent parenting, who have no manifested health problems, and who are developing satisfactorily (58). Hoekelman (58) and his colleagues at Rochester, New York, did an excellently designed and well-executed randomized controlled health-care trial (61) in which they compared nurse practitioners with pediatricians as providers of health supervision in infancy. More importantly to the topic of this article, they also compared the currently advocated 6-visit schedule with an abbreviated 3-visit schedule. On the basis of the endpoint chosen for the study, well-baby care delivered by nurse practitioners was as adequate as that delivered by pediatricians and the use of the abbreviated schedule by either professional did not reduce the adequacy of care. On the basis of their own findings, the Kaiser-Permanente group advocates annual examinations for adults more than 45 years of age and triennial checkups for younger adults (62). However, we have not found the data that support the recommendation in their reports nor does the design of studies published seem to make it possible to obtain such data. 260
What ethical issues must be considered when implementing a programme of periodic health examinations? To the extent that the periodic health examination is "medical investigation that does not arise from a patient's request for advice for specific complaints" (63), it is screening; and, if initiated by the physician or society, at least two special ethical issues arise. McKeown (64), in a chapter of the book Controversy in Internal Medicine argues that a medical procedure must be examined much more carefully under such circumstances than when the same procedure is employed but triggered by the presence of a symptom. We cite McKeown's exact description of the differences between the circumstances contrasted.
McKeown also suggests that if a screening measure such as the periodic health examination is shown to be beneficial to individuals or to a population, such evidence invites widespread, if not universal, application of the measure and entails the allocation of extensive resources. The potential magnitude of such a phenomenon was illustrated in the calculation of Ontario costs for biennial periodic health examinations. If the recommendations of the American Academy of Pediatrics about periodic well-baby visits were accepted, pediatricians would have little time for anything else (58, 65). Introduction of a screening measure is usually accomplished at the expense of other possible uses of health manpower and equipment. The diversion may be justified, but the burden of evidence rests on those proposing the new measure. The World Health Organization (WHO) criteria for validation of screening procedures should also apply to the periodic health examination as defined in this paper (66). It is gratifying to note that ethical as well as scientific considerations were taken into account when the criteria were developed. Selected points from the WHO document are summarized here.
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• Screening must lead to an improvement in end results among those in whom early diagnosis is achieved. • The therapy for the condition must favourably alter its natural history, not simply by advancing the point in time at which diagnosis occurs, but by improving survival, function, or both.
• Available health services must ensure diagnostic confirmation and provide long-term care. • Compliance among asymptomatic patients in whom an early diagnosis has been achieved must be at a level to be effective in altering the natural history of the disease. • The long-term beneficial effects must outweigh the long-term detrimental effects. • The effectiveness of potential components of multiphasic screening should be shown individually prior to their combination. • If the benefits of screening accrue to the community at large, the community benefit must withstand scientific scrutiny. • The cost-benefit and cost-effectiveness characteristics of mass screening and long-term therapy must be known. • The burden of disability for the condition in question must warrant action. • The cost, sensitivity; specificity, and acceptability of the screening test must be known. The criteria are invoked widely as the basis for current evaluations of screening procedures. However, the practice of a growing segment of the North American health industry is appreciably different. We are witnessing the proliferation of unvalidated procedures that medical investigators have explicitly proscribed such as the use of spirometry for mass screening (67). Many other procedures and most tests included in multiphasic checkup programmes have not been validated and do not meet the WHO criteria. The multiphasic screening component of the periodic health examination is already a multimillion-dollar enterprise with at least 150 automated health testing centres in the United States in 1974, many of which are reported to be operated by private physician groups (61). What are the forces that have led to the proliferation of such programmes in the absence of good evidence about their benefit to the population? With the exception of the KaiserPermanente group and the Health Insurance Plan, evidence from controlled studies is not even being sought in the early stages of implementation. Why is there such a marked difference between what is actually marketed by the U.S. health industry and what is recommended in the scientific literature, especially by academic groups outside of the United States (4, 42, 65, 68)? 7. What Decision Should Be Made?
Is the absence of definitive evidence about the value of the periodic health examination sufficient justification to abandon the practice? We now turn to the other side of the coin. It is important to advocate abandonment or redepolyment of clinical or preventive manoeuvres on the basis of evidence that clearly shows harmful effects of a particular procedure or wasteful investment of resources. To advocate discontinuance on the basis of lack of evidence should be done much more cautiously. First, one runs the risk of committing the analogue of the statisticians' type II error: declaring that there is "no effect" when indeed there is an effect. Those of us who have been dubious about the cervical Papanicolaou smear for the past few years because of the paucity of evidence about its effectiveness may well regret
not having withheld our verdicts for some time; recent reports (24, 25) on disease-specific mortality rates justify hope that the screening measure may be beneficial. Before too long, it may well be thought fortunate that the epidemiologic skeptics were not prematurely heeded on that issue. A similar sequence could develop in the matter of the periodic health examination. Secondly, we have no data to show that harm is done in patients subjected to periodic health examinations. The studies done have been designed to assess efficacy or conformity with normative standards. No work has been done in which side effects such as the sequelae of stigmatization, loss of jobs or of promotion, anxiety, unfavourable alteration of quality of life, and costs of follow-up of false-positives have been the endpoints under assessment. The sample sizes required to enable detection of such target events may be an insurmountable obstacle for a long time. Conclusion
It is a disservice to society and to science to engage in evangelical advocacy of any of the possible policy alternatives about the periodic health examination. The seven questions bring into focus the only certainty about the whole subject: we have a compelling mandate to inquire into these matters with the highest attainable rigor of clinical and health-care research. The controlled studies cited in this article represent a bold beginning but they also show how lengthy and arduous a road remains to be covered. The most difficult task for some of us who care for patients is more immediate. Having reviewed the evidence, having contemplated what needs to be done in the future, we must now shift our perspective from that of the comfortable epidemiologic armchair to the realities of the clinic or the office where the important decisions are made. In our practice, on the basis of the evidence found, the interpretation of it, or on the basis of well-reasoned opinion when evidence has not been available, we will proceed as follows for the foreseeable future: • We or our nurse practitioners will do a complete general assessment, including a history and physical, on all new patients joining the practice and on newborns in order to establish a baseline of knowledge about their health status. Newborns will be screened for phenylketonuria and examined carefully to detect congenital dislocation of the hip and congenital heart defects that may warrant intervention. Our nurse practitioners will do health supervision of children in their first year of life not less than three and not more than six times. • We will assess vision and hearing in children in their second and fourth years of life. • We will take initiative to repeat general assessments in asymptomatic patients only as often as needed to maintain sufficient knowledge about the patients which in turn will permit judicious and efficient clinical problem-solving when symptoms do arise. The average lifetime frequency anticipated will probably be in the range of 3 to 5 years. • Smoking status will be assessed at each examination in all patients of adolescent age or older. • In the course of otherwise scheduled complete checkups, females 30 years and older will receive a Papanicolaou smear and will be taught how to Spitzer and Brown • Periodic Health Examination
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do breast self-examination. • All patients 30 and older will have their blood pressures checked at each visit or every 3 months, whichever is less frequent. • Prenatal supervision of healthy women will include at least one complete history and physical, routine and microscopic urinalyses, and a test of potential or actual isoimmunizations due to rhesus incompatibility. • We will be alert to increases in incidence and prevalence of health problems in our community and in our practice and institute prescriptive screening for target diseases that might arise and for which intervention may be beneficial.
tacks in m e n after giving u p cigarette smoking. Lancet 2:13451348, 1974 18. FABIA J : Cigarettes pendant la grossesse, poids de naissance et mortalite perinatale. Can Med Assoc J 109:1104-1107, 1973 19.
The programme of periodic health examinations outlined is our current opinion about what should be offered in practice. But, beyond opinion, we need evidence, and while we await the results of inquiry under way or to be initiated in the future, good clinical judgment, the best of common sense, flexibility, and patient-oriented motivation should help us avoid major pitfalls in practice and in policy.
23.
24.
27.
1. THOMAS L : Notes of a biology-watcher: your very good health. N Engl J Med 287:761, 1972 2. SUSSER M : Prevention and health maintenance revisited (editorial). Bull NY Acad Med 5 1 : (issue no. 1 ) , 1975 3. BAILEY E N , K I E H L PS, A K R A M D S , et al: Screening in pediatric
practice. Ped Clin North Am 21:123-165, 1974 4. COCHRANE A L , HOLLAND W W : Validation of screening procedures. Br Med Bull 27:3-8, 1971 5. Screening for Disease. Series reprinted from Lancet 2: (issue n o . 7884-7895), 1974 6. ZIPURSKY A : T h e universal prevention of R h immunization. Clin Obstet Gynecol 14:869-884, 1971 FINN
R,
et
al:
Prevention
of
Rh-haemolytic disease: final results of the "high-risk" clinical trial. Br Med J 2:607-609, 1971 8. W O O D R O W
JC,
CLARKE
CA,
MCCONNELL
RB,
et
al:
Preven-
tion of Rh-haemolytic disease: results of the Liverpool "lowrisk" clinical trial. Br Med J, 2:610-612, 1971 9. EKLUND J, NEVANLINNA R: Rh prevention: a report and analysis of a national programme. J Med Genet 10:1-7, 1973 10. RAINE D N : Screening for disease: inherited metabolic disease. Lancet 2:966-998, 1974 11. H O L T Z M A N N
12. 13. 14.
15.
NA, M E E K AG, MELLITS E D : Neonatal
screening
for phenylketonuria. JAMA 229:667-670, 1974 H O L T K S : Screening for disease: infancy a n d childhood. Lancet 2:1057-1060, 1974 D O L L R, H I L L A B : Lung cancer and other causes of death in relation to smoking. Br Med J 2:1071-81, 1956 H A M M O N D E C , H O R N D : Smoking and death rates—report on forty-four months of follow-up on 187,783 men. I. Total mortality. II. Death rates by causes. JAMA 166:1159-72, 12941308, 1958 D U N N J E J R , LINDEN G, BRESLOW L : Lung cancer mortality experience of men in certain occupations in California. Am J Public Health 50:1475-87, 1960
16.
BEST
EWR,
JOSIE
GH,
WALKER
CB:
A
Canadian
study
mortality in relation to smoking habits, a preliminary Can J Public Health 52:99-106, 1961 17.
262
G O R D O N T, K A N N E L W B , M C G E E
D:
Death
and
28.
The
interrelationship
of
at-
S,
GOLDBERG
JD,
BOYES
DA,
KNOWELDEN
HUTCHISON
GB:
Lead
time
in
and implications for periodicity of 100:357-366, 1974 J,
PHILLIPS
AJ:
The
evaluation
of
DALES
LG,
FRIEDMAN
GD,
RAMCHARAN
S. et
al:
Multiphasic
VETERANS
ADMINISTRATION
COOPERATIVE
STUDY
GROUP
ON
V E T E R A N S A D M I N I S T R A T I O N COOPERATIVE STUDY G R O U P O N A N T I -
T H E FRAMINGHAM
STUDY:
KANNEL WB, GORDEN T
(editors):
Coronary heart disease, atherothrombotic brain infarction, intermittent claudiation—a multivariate analysis of some factors related to their incidence: F r a m i n g h a m study, 16-year folInvestigation of Cardiovascular low-up in An Epidemiological Disease. Washington, D.C., Government Printing Office, 1971 30.
VETERANS
ADMINISTRATION
COOPERATIVE
STUDY
GROUP
ON
ANTIHYPERTENSIVE A G E N T S : Effects of treatment on morbidity in hypertension. I I I . Influence of age, diastolic pressure, and prior cardiovascular disease: further analysis of side effects. Circulation 45:991-1004, 1972 31. TAGUCHI J, FREIS E D : Partial reduction of blood pressure and prevention of complications in hypertension. N Engl J Med 291:329-331, 1974 32.
SAVAGE W E , N A J J
SN, K A S S E H :
D e m o g r a p h i c and
prognostic
characteristics of bacteriuria in pregnancy. Medicine (Baltimore) 46:385-407, 1967 33. B R U M F I T W : Bacteriuria in relation to renal disease in adults, with special reference to women of child-bearing age. Milbank Mem Fund 41:22-32, 1969 34.
K A T Z S, V I G N O S PJ, M O S K O W I T Z W, et a l : C o m p r e h e n s i v e
out-
patient care in rheumatoid arthritis. A controlled study. JAMA 206:1249-1254, 1968 35. ISAACS B : Geriatric patients: d o their families care? Br Med J 4:282-286, 1971 36.
37. 38. 39. 40. 41.
42. 43.
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SHAPIRO
HYPERTENSIVE A G E N T S : Effects of treatment on morbidity in hypertension. II. Results in patients with diastolic pressure, a n d prior cardiovascular disease: further analysis of side effects. Circulation 45:991-1004, 1972
of
report.
coronary
C:
ANTIHYPERTENSIVE A G E N T S : Effects of treatment on morbidity in hypertension: results in patients with diastolic blood pressure averaging 115 through 129 m m Hg. JAMA 202:1028-1034, 1967
29.
WTA,
BUCK
check-up evaluation study. I I I . Outpatient clinic utilization, hospitalization and mortality experience after seven years. Prev Med 2:221-235, 1973
References
DONOHOE
JA,
cancer control measures: summary of the conclusion of U I C C Symposium held in Sheffield in September 1972. Br J Cancer 28:105-107, 1973 25. K I N L E N LJ, D O L L R : Trends in mortality from cancer of the uterus in Canada and in England and Wales. Br J Prev Soc Med 27:146-149, 1973
• Requests for reprints should be addressed to Walter O. Spitzer, M.D., Department of Clinical Epidemiology and Biostatistics, McMaster University, 1200 Main Street West, Hamilton, O N L8S 4J9, Canada.
CA,
M B , TONASCIA
breast cancer detection screening. Am J Epidemiol
26.
A C K N O W L E D G M E N T S : T h e authors thank Mrs. Raffaella Cowell, statistical assistant, for her help in identifying reference material and for her constructive criticism of the manuscript. Grant support: National Health grant 215-6204, Health and Welfare, Canada. Presented in abbreviated form at the Symposium on the Periodic Health Examination sponsored by the American Federation for Clinical Research, Atlantic City, New Jersey, 3 M a y 1975. Received 21 May 1975; accepted 27 May 1975.
7. CLARKE
MEYER
maternal smoking and increased perinatal mortality with other risk factors. Further analysis of the Ontario perinatal mortality study, 1960-1961. Am J Epidemiol 100:443-452, 1975 20. ROGOT E : Smoking and mortality among U.S. veterans. J Chronic Dis 27:189-203, 1974 21. MUSTARD J F , M U R P H Y E A : Effect of smoking on blood coagulation and platelet survival in man. B Med J 1:846-849, 1963 22. SHAPIRO S, STRAX P, V E N E T L, et al: Changes in 5-year breast cancer mortality in a breast cancer screening program in Proceedings of the Seventh National Cancer Conference. Philadelphia, J. B. Lippincott Company, 1973, pp. 663-678
K A T Z S, FORD A B , H E I P L E K G , et al: Studies of illness in the
aged: recovery after fracture of the hip. J Gerontol 19:285293, 1964 LAWSON D H , M I L L E R A W F : Screening for bacteria: a critical re-appraisal. Arch Intern Med 132:904-908, 1973 SACKETT D L : Screening for disease: cardiovascular disease. Lancet 2:1189-1191, 1974 FEINLEIB M , Z E L E N M : Some pitfalls in the evaluation of screening programs. Arch Environ Health 19:412-415, 1969 BERGMAN AB, STAMM SJ: T h e morbidity of cardiac non-disease in school children. N Engl J Med 276:1008-1013, 1967 CAYLER G G , L Y N N D B , STEIN E M : Effect of cardiac 'nondisease' on intellectual and perceptual motor development. Br Heart 7 35:543-547, 1973 K N O X E G : Screening for disease: multiphasic screening. Lancet 2:1434-1436, 1974 SHAPIRO S: Automated multiphasic health testing. Efficacy of
the concept. Hospitals 45:45-48, 1971 44. M C W H I N N E Y I R : Beyond diagnosis. N Engl J Med 287:384-387, 1972 45. F E I N S T E I N A R : Clinical Judgement. Baltimore, T h e Williams & Wilkins Company, 1967, pp. 144, 317 46. W O L F E S, BADGLEY R F : The Family Doctor. Toronto, M a c Millan of Canada, 1973, pp. 33-44 47.
SCHOR SS, CLARK T W , PARKHURST LW, et al: A n evaluation of
the periodic health examination. Ann Intern Med 61:999-1005, 1964 48. HOLLAND W W , WHITEHEAD T P : Value of new laboratory tests in diagnosis and treatment. Lancet 2:391-394, 1974 49.
BRADWELL AR, CARMALT M H B , W H I T E H E A D T P : Explaining the
unexpected abnormal results of biochemical profile investigation. Lancet 2:1071-1074, 1974 50. COUNCIL O N PEDIATRIC PRACTICE: Standard of Child Health Care. Evanston, Illinois. American Academy of Pediatrics, 1967', pp. 20-29 51. L E W I S C E , RESNIK B A : Nurse clinics and progressive ambulatory patient care. N Engl J Med 277:1236-1241, 1967 52. CHARNEY E, K I T Z M A N H : T h e child-health nurse (pediatric nurse practitioner) in private practice: a controlled study. N Engl J Med 285:1353-1358, 1971 53.
SCHLESINGER E R , L O W E R Y W D , GLASER D B , et a l : A controlled
test of the use of registered nurses for prenatal care. Serv Res 88:400-404, 1973 54.
55.
SPITZER
WO,
KERGIN
DJ,
YOSHIDA
MA,
et
al:
practi-
SIBLEY J C , SPITZER
WO,
RUDNICK
KV,
et
al:
Quality-of-care
appraisal in primary care: a quantitative method. Ann Med 83:46-52, 1975 58. H O E K E L M A N R A : What constitutes adequate well-baby Pediatrics 55:313-326, 1975 59.
Intern care?
GLAZUNOV IS, D O W D J E , JAKSIC Z, et a l : Repetitive health ex-
aminations as an intervention measure. Bull WHO 49:423-432, 1973 60. ANDERSON F P : Evaluation of t h e routine physical examination of infants in the first year of life. Pediatrics 45:950-960, 1970 61.
SPITZER
WO,
FEINSTEIN
AR,
SACKETT D L :
What
is a
health
care trial? JAMA. In press 62. C O L L E N M F : Multiphasic testing as a triage to medical care in Controversy in Internal Medicine, 2nd ed., edited by INGELFINGER FJ, EBERT RV, FINLAND M , et al. Philadephia, W. B. Saunders Co., 1974, pp. 85-91 63.
NUFFIELD
PROVINCIAL H O S P I T A L S T R U S T :
Screening
in
Medical
Care, London, Oxford University Press, 1968, p . 5 64. M C K E O W N T : Unvalidated procedures have n o place in screening programs. See Reference 62, pp. 92-98 65. BERGMAN AB, DASSEL SW, WEDGEWOOD R J : Time motion study of practicing pediatricians. Pediatrics 38:254-263, 1966 66. WORLD HEALTH ORGANIZATION: Mass Health Examinations. Public Health Paper 45. Geneva, World Health Organization, 1971
tioners in primary care. I I I . T h e Southern Ontario randomized trial. Can Med Assoc J 108: 1006-1016, 1973
67.
SPITZER
workshop on screening programs for early diagnosis of airway obstruction. Am Rev Resp Dis 109:567-571, 1974 68. Multiphasic Health Screening. Canberra, Australia, Multiphasic Health Screening Services Committee of the National Health and Medical Research Council of Australia, 1972
WO,
SACKETT D L ,
SIBLEY J C , et
al:
randomized trial of the nurse practitioner. 290:251-256, 1974 56.
Nurse
Health
patients. Ann Intern Med 80:137-142, 1974 57.
SACKETT
DL,
SPITZER
WO,
GENT
M,
et
al:
The
Burlington
N Engl The
J Med
Burlington
randomized trial of the nurse practitioner: health outcomes of
MACKLEM NATIONAL
P T , S T A F F O F T H E D I V I S I O N O F L U N G DISEASES, H E A R T AND L U N G I N S T I T U T E : C o n f e r e n c e report:
Spitzer and Brown • Periodic Health Examination
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Unanswered Questions about the Periodic Health Examination WALTER 0. SPITZER, M.D., M.P.H., and BRUCE P. BROWN, M.D., Hamilton, Ontario, Canada
The periodic health examination in its application as a screening procedure in asymptomatic, ostensibly healthy persons is explored with a focus on the following issues: (a) the impact on health, (b) the content of a beneficial health examination, and (c) the effect of the examination on the physician-patient relation. The application discussed is distinct from use of the examination as a tool for diagnosis, prognosis, or therapeutic planning for patients with a specific illness. The discussion also shows a relatively recent change in the goal for the clinical assessment. There has been a shift in emphasis from establishing a diagnosis as the main outcome event of the periodic "checkup" to the identification of an intervention of value to the patient. Evidence from various studies that throw some light on related questions is considered. Special ethical issues surrounding the unsolicited medical assessment are identified. Finally, some ground rules for decisions about the periodic health examination are proposed.
"We are paying too little attention, and respect, to the built-in durability and sheer power of the human organism. Its surest tendency is toward stability and balance. It is a distortion, with something profoundly disloyal about it, to picture the human being as a teetering, fallible contraption, always needing watching and patching, always on the verge of flapping to pieces; this is the doctrine that people hear most often, and most eloquently, on all our information media. We ought to be developing a much better system for general education about human health, with more curricular time for acknowledgement, and even some celebration, of the absolute marvel of good health that is the real lot of most of us most of the time." (1)
about what we do in patient care have been prompted by the stresses of rising expectations for excellence and availability of health care and the concurrent rise in costs of health services. Most activities in health care require careful scrutiny at regular intervals. Among them, preventive measures in general and the periodic health examination in particular deserve priority today. Justification for such activities continues to be based primarily on paradigms that are being rendered increasingly irrelevant by the evolution of
MANY QUESTIONS
• From the Department of Clinical Epidemiology and Biostatistics and the Department of Family Medicine, School of Medicine, McMaster University, Hamilton, Ontario, Canada. Annals of Internal Medicine 83:257-263, 1975
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medical science and changing patterns of health and disease in the population. For instance, the feasibility and the undeniable value of prevention and early diagnosis in many once highly prevalent infectious diseases was followed by an axiomatic acceptance of prevention for all illness. Such acceptance is reinforced by what is generally taken as self-evident common sense and by simplistic analogies between the care of the human body and preventive maintenance of manmade machines. Further reinforcement stems from a tendency of the health professions to oversell prevention, to overestimate their ability to deal effectively with detected disease, and to overvalue the benefit of their care to patients. Less than a medical generation ago, establishing a diagnosis was the main outcome event of the "history and physical" .(which may or may not have included minimal ancillary investigation). The emphasis has shifted so that today the outcome event of greater interest is to identify an intervention of value to the patient. This change in goal of the clinical assessment of a patient provides a common thread for the seven questions raised in this article. We define the periodic health examination as a group of tasks that are part of a systematic complete "workup" of a patient as undertaken by physicians who accept standards of performance taught in North American or British medical schools and who adhere reasonably well to normative techniques of interview and examination. Arbitrarily, one criterion is that a history and physical assessment must be included in what we designate as a health examination. Additional investigation may also be incorporated with varying degrees of comprehensiveness. We restrict discussion of the periodic health examination to its application as a screening procedure in asymptomatic, ostensibly healthy persons. This application is distinct from use of the examination as a tool for diagnosis or prognostic elucidation, for assessment of the course of an illness under surveillance, or for therapeutic planning. Here are the questions to be answered: 1. What Can Be Helped?
What conditions, risk factors, or diseases can reasonably be found in a preclinical state whose natural outcome can be altered or palliated in a way that benefits the patient or society? The answer depends on the criteria chosen for evalua257
tion of screening procedures (see Question 6) and the rigor with which they are applied. Several reviews have been published (2-5) that have attempted to identify those conditions where preclinical detection could be of some benefit. Most of the reviews assess the appropriateness of targets and the merits of procedures for use in mass screening programmes. From those sources and from reports of original investigation, a list of conditions, risk factors, and disorders for which we feel there is reasonable evidence, although frequently incomplete or equivocal, to support selective screening that can be incorporated in periodic health examinations has been summarized in Table 1. The entities in this list are not proposed as appropriate targets for total population screening. They are suggested only as conditions worthy of search in persons under care by doctors with whom they have a firm ongoing tacit or explicit "contract" for health services. The shortness of the list is discouraging. Moreover, wellreasoned challenges to the value of most detection efforts for most of the entities can be found (37, 38). Insufficient attention is given to the ever-present possibility that early identification of disease may represent a disservice to the patient and to society. As pointed out by Feinleib and Zelen (39) early diagnosis in the asymptomatic patient may accomplish nothing more than advancing the starting point for the measurement of survival. Knowledge of disease, not life, is then prolonged. The potential harm of stigmatization and psychological distress as reported in the recently described "nondiseases" such as "cardiac nondisease" (40, 41) must always be weighed against the potential gain of earlier intervention. 2. Does Help Really Occur?
Is a periodic lifetime health examination program, with aggressive initiative by the health providers and with high compliance by the patients, associated with improved health status for the population?
This is the key question. The answers are being sought in four randomized controlled trials (42, 43). Only the project of Collen and his colleagues of the Kaiser-Permanente group has published results to date. The care in the design of that study and the accomplishments in implementation, particularly the long-term follow-up, are impressive. Large-scale health-care controlled trials such as the Kaiser-Permanente study are easy to conceptualize but exceedingly difficult to execute with satisfactory rigor. The main results from Northern California indicate that for middle-aged persons, representative of enrolees of a prepaid group health plan (aged 35 to 54 at entry to the trial), there was lower mortality after 7 years in the screened cohort (35.6 per 1000 versus 39.2 in the control cohort). Differences in total deaths were not statistically significant. As summarized by Knox (42), a group of "potentially postponable" causes of death was singled out for special comparison. The group of disorders was defined on the basis of medical opinion before the results of the survey were known and included carcinoma of large bowel, rectum, breast, cervix, uterus, kidney, and prostate and deaths from hypertension, hypertensive cardiovascular disease, and intracranial hemorrhage. There were 19 deaths in the screened group and 41 in the control group. Moreover, not all these conditions seemed to be the subject of procedures designed to detect them, and what proportion of them were actually detected in the multiphasic checkup was not reported. The comparisons on prevalence of disability of major chronic disorders and of utilization of physician and hospital services gave equivocal results. Even when the differences were statistically significant, their clinical or practical significance was marginal. Assuming that longer follow-ups at Kaiser may confirm the findings reported to date in their population and may even provide more encouraging evidence, two important concerns remain: (a) Will findings from studies focusing on total populations (such as those under a governmental universal health insurance plan) support the meagre favourable evidence now available? (b) Will differences in the Kaiser-Permanente study be sustained in the absence of the persistent recall procedures required to attain the reported high participation rates? Such procedures could be prohibitively costly in situations where the support resources of very large groups are not available and where the target population is not as accessible as in a situation where enrollment is largely through employment.
Table 1. Targets for Appropriate Pre-Clinical Detection of Disease Stage in Life The fetus and first year of life Preschool age Childhood and adolescence Adulthood
The aged
258
Targets for Selective Screening Rhesus incompatibility with mother Phenylketonuria Congenital dislocation of hip Some congenital heart defects Hearing abnormalities Amblyopia Smoking Congenital heart defects Smoking Breast cancer Cancer of the cervix Cancer of the colon and rectum Hypertension Bacteriuria in pregnancy Hypertension Conditions and states amenable to rehabilitative intervention where the goal is not cure or extension of life but improvement of quality of life
References 6-9 10, 11 3, 12 3 3, 12 3, 12 13-18 3 13-17, 19-21 22-24 24, 25 26 27-31 32, 33 27-31
34-36
3 . Asymptomatic Solicitors Versus Repetitive Recipients
Are asymptomatic persons who solicit a periodic health examination different in health status from persons on whom the checkup is professionally imposed? What is the clinical and particularly the prognostic significance of the request for a health examination if it is the only apparent stimulus impelling a person to seek care? We have often been taught by senior, experienced, clinical colleagues that the act of seeking a medical assessment
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is a significant symptom in and of itself. A patient may thus communicate information about a health need that may not be otherwise expressed (44). Feinstein (45) suggested the term iatrotropic stimulus for a patient-determined reason to consult with a doctor. Is the health examination done in response to such an iatrotropic stimulus more productive or more beneficial to a patient than an iatrogenic checkup? The answer to the question is vital to those deliberating strategies of primary care. We have found only one reference that provides any data about the issue. In Wolfe and Badgley's book, The Family Doctor (46), in which 3203 health checkups done by family physicians were analyzed, the overall yield of "significant findings" was 2 7 % . However, for checkups done in patients with a symptomatic presentation, the yield was 3 8 % ; for asymptomatic patients it was 1 1 % . 4. Is It Worth the Cost?
Should a health services system make provision for periodic health examinations of all citizens of a state throughout their lifetime? Let us assume that the average lifetime frequency of examination, adopted on grounds of scientific evidence, is once every 2 years. We then discuss the question from our experience with Canadian governmental universal health insurance and from the standpoint of society. Based on the Ontario Medical Association fee schedule* a conservative estimate of cost for each periodic health examination, including a modest battery of ancillary procedures, is $30.00. The amount does not include additional investigation of false-positives nor loss of work time, travel cost of patients, and so forth. In the Province of Ontario, which is adequately doctored and where 4 9 % of the physicians are in family practice, biennial examinations that could be done by family practitioners would then cost 120 million dollars. The total represents approximately 5% of the total health budget, 2 5 % of payments by the government plan to all doctors, and nearly 40% of payments made to family physicians. For a government already staggering with a health budget that consumes more of the public purse than any other category of provincial expenditure (even more than expenditures for education), adding even a fraction of the 120 million calculated to that budget is not feasible especially when the measures have not been shown to be associated with an improved health status of the population or savings in services such as hospitalization. Whether the price of the periodic health examination is paid privately and entrepreneurially or publicly through national health insurance, can society afford the cost? Should it pay the cost given how little we know about the benefits? 5. What are the Components?
Which are the minimally
required components
of an
* The schedule, as of 1 May 1975, allows the following fees for services: complete general assessment by family physician, $16.00; complete blood count, erythrocyte sedimentation rate, and differential leukocyte count, $12.48; urinalysis, $2.87; electrocardiogram including interpretation, $6.50; and chest X-ray, two views, $9.00.
effective programme of periodic health
examinations?
(a) What should be done? The periodic health examination, as defined in the introduction, can be done with widely varying degrees of comprehensiveness. A patient may feel quite reassured after a cursorily taken history and a rapidly completed physical supplemented by a urinalysis, a complete blood count, and a chest X-ray. Another patient, having experienced the type of thorough checkup done at the University of Pittsburgh Executive Health Evaluation Clinic (47), for example, could understandably feel, if told that all is well, that he possesses a virtual guarantee of health for at least a year. Not only is the "history and physical" a component of the health checkup but it is itself composed of many subcomponents. If done thoroughly, the aggregate of those elements becomes the most time-consuming constituent of the procedure. Should an examination of the rectum be done with every examination? Given Collens' preliminary findings about reductions achieved in mortality associated with carcinoma of the large bowel and rectum, should a search of polyps with barium enema always be included? Should the ears be examined in the adult? Should blood pressures be taken in adolescents? How productive is the examination of the abdomen? What is a minimum acceptable package in the neurological part of the examination? Which questions need to be included in the history or a self-administered questionnaire? The case for evaluating each paraclinical test separately in a multiphasic programme has been made convincingly by various authors (48, 49). The constituents of the "history and physical" clinical part of the health examination should receive the same scrutiny. Up to the present time, the packages offered seem to be assembled on the basis of altruistic educated guesses and normative professional consensus (50) at best, and expediency motivated by profitability at the other extreme. We still do not really know what to include in the periodic checkup. (b) Who should do it? Evidence is accumulating that the physician can sometimes be safely replaced by nurse practitioners and other categories of physician extenders (34, 51-58). Many of the multiphasic programmes have appropriately reduced physician involvement. Are we ready to confront the possibility that the physician should be excluded entirely from the periodic health examination? On the other hand, are we ignoring the possible value of the physician-wellpatient contact? A patient requesting the "complete physical" may not be asking for more than needed reassurance. When complying with the request, the physician knowingly or unwittingly often performs a therapeutic act rather than an investigative procedure. Empirical support for the existence of such an interaction was recently published by Glazunov and colleagues (59). It may be argued that reassurance can be given without doing a "physical." But to the patient, the examination may be a necessary validating adjunct of the reassurance statement. Spitzer and Brown • Periodic Health Exemlnation
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6. What Harm Might Be Done?
(c) Which subgroups of the population? We suspect that the segments of the population least likely to afford comprehensive checkups or to have access to them are those in which the yield might be highest and conceivably worthwhile. Choice of age groups for priority would appear to be a less difficult problem. Quite reasonably, our clinical instincts and common sense suggest that infancy and the preretirement decade deserve a concentration of effort. And yet, Anderson (60), having evaluated over 6668 consecutive routine physical examinations of infants under 12 months done by 83 private pediatricians in Connecticut, found only 130 (1.9%) clinically significant abnormalities, many of which would have been readily detectable by a physician extender. Moreover, in less than half of the discovered problems could it be argued that early intervention might have been beneficial to the patient. Lack of sensitivity and disappointing end results dampen enthusiasm about health examinations in the preretirement group. In Schor's and associates' (47) classical study, of 192 executives aged 40 to 59 who had received a very comprehensive regular checkup and who died, the condition leading to death was not recognized at the last examination and was not known prior to the last hospitalization in 59% of the cases. (d) How often should a checkup or its components done?
"When the patient seeks medical advice, the doctor's ethical position is relatively simple: he attempts to do his best with the knowledge and resources available to him. He cannot be fairly criticized when the state of medical knowledge does not enable him to treat effectively or even to diagnose accurately. . . . The position is quite different in screening, when a doctor or a public authority takes the initiative in investigating the possibility of illness or disability in people who have not reported signs or symptoms. There is then a presumptive undertaking, not merely that abnormality will be identified if it is present, but that those affected will derive benefit from subsequent treatment or care. This commitment is at least implicit, and except for research or the protection of public health, no one should be expected to submit to the inconvenience of investigation or the anxieties of case finding without the prospect of medical benefit."
be
This question is probably the one about which we know the least. The difficulties of the practitioner in trying to decide what to do are illustrated well in the sphere of health maintenance in infancy. Since 1967, the American Academy of Pediatrics has recommended monthly wellbaby visits in the first 6 months and bimonthly ones in the second 6 months (50). This represents 10 visits in the first year of life if one includes one initial newborn nursery visit. More recently, revised standards specify a maximum of 6 health maintenance visits for children who receive competent parenting, who have no manifested health problems, and who are developing satisfactorily (58). Hoekelman (58) and his colleagues at Rochester, New York, did an excellently designed and well-executed randomized controlled health-care trial (61) in which they compared nurse practitioners with pediatricians as providers of health supervision in infancy. More importantly to the topic of this article, they also compared the currently advocated 6-visit schedule with an abbreviated 3-visit schedule. On the basis of the endpoint chosen for the study, well-baby care delivered by nurse practitioners was as adequate as that delivered by pediatricians and the use of the abbreviated schedule by either professional did not reduce the adequacy of care. On the basis of their own findings, the Kaiser-Permanente group advocates annual examinations for adults more than 45 years of age and triennial checkups for younger adults (62). However, we have not found the data that support the recommendation in their reports nor does the design of studies published seem to make it possible to obtain such data. 260
What ethical issues must be considered when implementing a programme of periodic health examinations? To the extent that the periodic health examination is "medical investigation that does not arise from a patient's request for advice for specific complaints" (63), it is screening; and, if initiated by the physician or society, at least two special ethical issues arise. McKeown (64), in a chapter of the book Controversy in Internal Medicine argues that a medical procedure must be examined much more carefully under such circumstances than when the same procedure is employed but triggered by the presence of a symptom. We cite McKeown's exact description of the differences between the circumstances contrasted.
McKeown also suggests that if a screening measure such as the periodic health examination is shown to be beneficial to individuals or to a population, such evidence invites widespread, if not universal, application of the measure and entails the allocation of extensive resources. The potential magnitude of such a phenomenon was illustrated in the calculation of Ontario costs for biennial periodic health examinations. If the recommendations of the American Academy of Pediatrics about periodic well-baby visits were accepted, pediatricians would have little time for anything else (58, 65). Introduction of a screening measure is usually accomplished at the expense of other possible uses of health manpower and equipment. The diversion may be justified, but the burden of evidence rests on those proposing the new measure. The World Health Organization (WHO) criteria for validation of screening procedures should also apply to the periodic health examination as defined in this paper (66). It is gratifying to note that ethical as well as scientific considerations were taken into account when the criteria were developed. Selected points from the WHO document are summarized here.
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• Screening must lead to an improvement in end results among those in whom early diagnosis is achieved. • The therapy for the condition must favourably alter its natural history, not simply by advancing the point in time at which diagnosis occurs, but by improving survival, function, or both.
• Available health services must ensure diagnostic confirmation and provide long-term care. • Compliance among asymptomatic patients in whom an early diagnosis has been achieved must be at a level to be effective in altering the natural history of the disease. • The long-term beneficial effects must outweigh the long-term detrimental effects. • The effectiveness of potential components of multiphasic screening should be shown individually prior to their combination. • If the benefits of screening accrue to the community at large, the community benefit must withstand scientific scrutiny. • The cost-benefit and cost-effectiveness characteristics of mass screening and long-term therapy must be known. • The burden of disability for the condition in question must warrant action. • The cost, sensitivity; specificity, and acceptability of the screening test must be known. The criteria are invoked widely as the basis for current evaluations of screening procedures. However, the practice of a growing segment of the North American health industry is appreciably different. We are witnessing the proliferation of unvalidated procedures that medical investigators have explicitly proscribed such as the use of spirometry for mass screening (67). Many other procedures and most tests included in multiphasic checkup programmes have not been validated and do not meet the WHO criteria. The multiphasic screening component of the periodic health examination is already a multimillion-dollar enterprise with at least 150 automated health testing centres in the United States in 1974, many of which are reported to be operated by private physician groups (61). What are the forces that have led to the proliferation of such programmes in the absence of good evidence about their benefit to the population? With the exception of the KaiserPermanente group and the Health Insurance Plan, evidence from controlled studies is not even being sought in the early stages of implementation. Why is there such a marked difference between what is actually marketed by the U.S. health industry and what is recommended in the scientific literature, especially by academic groups outside of the United States (4, 42, 65, 68)? 7. What Decision Should Be Made?
Is the absence of definitive evidence about the value of the periodic health examination sufficient justification to abandon the practice? We now turn to the other side of the coin. It is important to advocate abandonment or redepolyment of clinical or preventive manoeuvres on the basis of evidence that clearly shows harmful effects of a particular procedure or wasteful investment of resources. To advocate discontinuance on the basis of lack of evidence should be done much more cautiously. First, one runs the risk of committing the analogue of the statisticians' type II error: declaring that there is "no effect" when indeed there is an effect. Those of us who have been dubious about the cervical Papanicolaou smear for the past few years because of the paucity of evidence about its effectiveness may well regret
not having withheld our verdicts for some time; recent reports (24, 25) on disease-specific mortality rates justify hope that the screening measure may be beneficial. Before too long, it may well be thought fortunate that the epidemiologic skeptics were not prematurely heeded on that issue. A similar sequence could develop in the matter of the periodic health examination. Secondly, we have no data to show that harm is done in patients subjected to periodic health examinations. The studies done have been designed to assess efficacy or conformity with normative standards. No work has been done in which side effects such as the sequelae of stigmatization, loss of jobs or of promotion, anxiety, unfavourable alteration of quality of life, and costs of follow-up of false-positives have been the endpoints under assessment. The sample sizes required to enable detection of such target events may be an insurmountable obstacle for a long time. Conclusion
It is a disservice to society and to science to engage in evangelical advocacy of any of the possible policy alternatives about the periodic health examination. The seven questions bring into focus the only certainty about the whole subject: we have a compelling mandate to inquire into these matters with the highest attainable rigor of clinical and health-care research. The controlled studies cited in this article represent a bold beginning but they also show how lengthy and arduous a road remains to be covered. The most difficult task for some of us who care for patients is more immediate. Having reviewed the evidence, having contemplated what needs to be done in the future, we must now shift our perspective from that of the comfortable epidemiologic armchair to the realities of the clinic or the office where the important decisions are made. In our practice, on the basis of the evidence found, the interpretation of it, or on the basis of well-reasoned opinion when evidence has not been available, we will proceed as follows for the foreseeable future: • We or our nurse practitioners will do a complete general assessment, including a history and physical, on all new patients joining the practice and on newborns in order to establish a baseline of knowledge about their health status. Newborns will be screened for phenylketonuria and examined carefully to detect congenital dislocation of the hip and congenital heart defects that may warrant intervention. Our nurse practitioners will do health supervision of children in their first year of life not less than three and not more than six times. • We will assess vision and hearing in children in their second and fourth years of life. • We will take initiative to repeat general assessments in asymptomatic patients only as often as needed to maintain sufficient knowledge about the patients which in turn will permit judicious and efficient clinical problem-solving when symptoms do arise. The average lifetime frequency anticipated will probably be in the range of 3 to 5 years. • Smoking status will be assessed at each examination in all patients of adolescent age or older. • In the course of otherwise scheduled complete checkups, females 30 years and older will receive a Papanicolaou smear and will be taught how to Spitzer and Brown • Periodic Health Examination
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do breast self-examination. • All patients 30 and older will have their blood pressures checked at each visit or every 3 months, whichever is less frequent. • Prenatal supervision of healthy women will include at least one complete history and physical, routine and microscopic urinalyses, and a test of potential or actual isoimmunizations due to rhesus incompatibility. • We will be alert to increases in incidence and prevalence of health problems in our community and in our practice and institute prescriptive screening for target diseases that might arise and for which intervention may be beneficial.
tacks in m e n after giving u p cigarette smoking. Lancet 2:13451348, 1974 18. FABIA J : Cigarettes pendant la grossesse, poids de naissance et mortalite perinatale. Can Med Assoc J 109:1104-1107, 1973 19.
The programme of periodic health examinations outlined is our current opinion about what should be offered in practice. But, beyond opinion, we need evidence, and while we await the results of inquiry under way or to be initiated in the future, good clinical judgment, the best of common sense, flexibility, and patient-oriented motivation should help us avoid major pitfalls in practice and in policy.
23.
24.
27.
1. THOMAS L : Notes of a biology-watcher: your very good health. N Engl J Med 287:761, 1972 2. SUSSER M : Prevention and health maintenance revisited (editorial). Bull NY Acad Med 5 1 : (issue no. 1 ) , 1975 3. BAILEY E N , K I E H L PS, A K R A M D S , et al: Screening in pediatric
practice. Ped Clin North Am 21:123-165, 1974 4. COCHRANE A L , HOLLAND W W : Validation of screening procedures. Br Med Bull 27:3-8, 1971 5. Screening for Disease. Series reprinted from Lancet 2: (issue n o . 7884-7895), 1974 6. ZIPURSKY A : T h e universal prevention of R h immunization. Clin Obstet Gynecol 14:869-884, 1971 FINN
R,
et
al:
Prevention
of
Rh-haemolytic disease: final results of the "high-risk" clinical trial. Br Med J 2:607-609, 1971 8. W O O D R O W
JC,
CLARKE
CA,
MCCONNELL
RB,
et
al:
Preven-
tion of Rh-haemolytic disease: results of the Liverpool "lowrisk" clinical trial. Br Med J, 2:610-612, 1971 9. EKLUND J, NEVANLINNA R: Rh prevention: a report and analysis of a national programme. J Med Genet 10:1-7, 1973 10. RAINE D N : Screening for disease: inherited metabolic disease. Lancet 2:966-998, 1974 11. H O L T Z M A N N
12. 13. 14.
15.
NA, M E E K AG, MELLITS E D : Neonatal
screening
for phenylketonuria. JAMA 229:667-670, 1974 H O L T K S : Screening for disease: infancy a n d childhood. Lancet 2:1057-1060, 1974 D O L L R, H I L L A B : Lung cancer and other causes of death in relation to smoking. Br Med J 2:1071-81, 1956 H A M M O N D E C , H O R N D : Smoking and death rates—report on forty-four months of follow-up on 187,783 men. I. Total mortality. II. Death rates by causes. JAMA 166:1159-72, 12941308, 1958 D U N N J E J R , LINDEN G, BRESLOW L : Lung cancer mortality experience of men in certain occupations in California. Am J Public Health 50:1475-87, 1960
16.
BEST
EWR,
JOSIE
GH,
WALKER
CB:
A
Canadian
study
mortality in relation to smoking habits, a preliminary Can J Public Health 52:99-106, 1961 17.
262
G O R D O N T, K A N N E L W B , M C G E E
D:
Death
and
28.
The
interrelationship
of
at-
S,
GOLDBERG
JD,
BOYES
DA,
KNOWELDEN
HUTCHISON
GB:
Lead
time
in
and implications for periodicity of 100:357-366, 1974 J,
PHILLIPS
AJ:
The
evaluation
of
DALES
LG,
FRIEDMAN
GD,
RAMCHARAN
S. et
al:
Multiphasic
VETERANS
ADMINISTRATION
COOPERATIVE
STUDY
GROUP
ON
V E T E R A N S A D M I N I S T R A T I O N COOPERATIVE STUDY G R O U P O N A N T I -
T H E FRAMINGHAM
STUDY:
KANNEL WB, GORDEN T
(editors):
Coronary heart disease, atherothrombotic brain infarction, intermittent claudiation—a multivariate analysis of some factors related to their incidence: F r a m i n g h a m study, 16-year folInvestigation of Cardiovascular low-up in An Epidemiological Disease. Washington, D.C., Government Printing Office, 1971 30.
VETERANS
ADMINISTRATION
COOPERATIVE
STUDY
GROUP
ON
ANTIHYPERTENSIVE A G E N T S : Effects of treatment on morbidity in hypertension. I I I . Influence of age, diastolic pressure, and prior cardiovascular disease: further analysis of side effects. Circulation 45:991-1004, 1972 31. TAGUCHI J, FREIS E D : Partial reduction of blood pressure and prevention of complications in hypertension. N Engl J Med 291:329-331, 1974 32.
SAVAGE W E , N A J J
SN, K A S S E H :
D e m o g r a p h i c and
prognostic
characteristics of bacteriuria in pregnancy. Medicine (Baltimore) 46:385-407, 1967 33. B R U M F I T W : Bacteriuria in relation to renal disease in adults, with special reference to women of child-bearing age. Milbank Mem Fund 41:22-32, 1969 34.
K A T Z S, V I G N O S PJ, M O S K O W I T Z W, et a l : C o m p r e h e n s i v e
out-
patient care in rheumatoid arthritis. A controlled study. JAMA 206:1249-1254, 1968 35. ISAACS B : Geriatric patients: d o their families care? Br Med J 4:282-286, 1971 36.
37. 38. 39. 40. 41.
42. 43.
August 1975 • Annals of Internal Medicine • Volume 83 • Number 2
Downloaded from https://annals.org by Tulane University user on 01/11/2019
SHAPIRO
HYPERTENSIVE A G E N T S : Effects of treatment on morbidity in hypertension. II. Results in patients with diastolic pressure, a n d prior cardiovascular disease: further analysis of side effects. Circulation 45:991-1004, 1972
of
report.
coronary
C:
ANTIHYPERTENSIVE A G E N T S : Effects of treatment on morbidity in hypertension: results in patients with diastolic blood pressure averaging 115 through 129 m m Hg. JAMA 202:1028-1034, 1967
29.
WTA,
BUCK
check-up evaluation study. I I I . Outpatient clinic utilization, hospitalization and mortality experience after seven years. Prev Med 2:221-235, 1973
References
DONOHOE
JA,
cancer control measures: summary of the conclusion of U I C C Symposium held in Sheffield in September 1972. Br J Cancer 28:105-107, 1973 25. K I N L E N LJ, D O L L R : Trends in mortality from cancer of the uterus in Canada and in England and Wales. Br J Prev Soc Med 27:146-149, 1973
• Requests for reprints should be addressed to Walter O. Spitzer, M.D., Department of Clinical Epidemiology and Biostatistics, McMaster University, 1200 Main Street West, Hamilton, O N L8S 4J9, Canada.
CA,
M B , TONASCIA
breast cancer detection screening. Am J Epidemiol
26.
A C K N O W L E D G M E N T S : T h e authors thank Mrs. Raffaella Cowell, statistical assistant, for her help in identifying reference material and for her constructive criticism of the manuscript. Grant support: National Health grant 215-6204, Health and Welfare, Canada. Presented in abbreviated form at the Symposium on the Periodic Health Examination sponsored by the American Federation for Clinical Research, Atlantic City, New Jersey, 3 M a y 1975. Received 21 May 1975; accepted 27 May 1975.
7. CLARKE
MEYER
maternal smoking and increased perinatal mortality with other risk factors. Further analysis of the Ontario perinatal mortality study, 1960-1961. Am J Epidemiol 100:443-452, 1975 20. ROGOT E : Smoking and mortality among U.S. veterans. J Chronic Dis 27:189-203, 1974 21. MUSTARD J F , M U R P H Y E A : Effect of smoking on blood coagulation and platelet survival in man. B Med J 1:846-849, 1963 22. SHAPIRO S, STRAX P, V E N E T L, et al: Changes in 5-year breast cancer mortality in a breast cancer screening program in Proceedings of the Seventh National Cancer Conference. Philadelphia, J. B. Lippincott Company, 1973, pp. 663-678
K A T Z S, FORD A B , H E I P L E K G , et al: Studies of illness in the
aged: recovery after fracture of the hip. J Gerontol 19:285293, 1964 LAWSON D H , M I L L E R A W F : Screening for bacteria: a critical re-appraisal. Arch Intern Med 132:904-908, 1973 SACKETT D L : Screening for disease: cardiovascular disease. Lancet 2:1189-1191, 1974 FEINLEIB M , Z E L E N M : Some pitfalls in the evaluation of screening programs. Arch Environ Health 19:412-415, 1969 BERGMAN AB, STAMM SJ: T h e morbidity of cardiac non-disease in school children. N Engl J Med 276:1008-1013, 1967 CAYLER G G , L Y N N D B , STEIN E M : Effect of cardiac 'nondisease' on intellectual and perceptual motor development. Br Heart 7 35:543-547, 1973 K N O X E G : Screening for disease: multiphasic screening. Lancet 2:1434-1436, 1974 SHAPIRO S: Automated multiphasic health testing. Efficacy of
the concept. Hospitals 45:45-48, 1971 44. M C W H I N N E Y I R : Beyond diagnosis. N Engl J Med 287:384-387, 1972 45. F E I N S T E I N A R : Clinical Judgement. Baltimore, T h e Williams & Wilkins Company, 1967, pp. 144, 317 46. W O L F E S, BADGLEY R F : The Family Doctor. Toronto, M a c Millan of Canada, 1973, pp. 33-44 47.
SCHOR SS, CLARK T W , PARKHURST LW, et al: A n evaluation of
the periodic health examination. Ann Intern Med 61:999-1005, 1964 48. HOLLAND W W , WHITEHEAD T P : Value of new laboratory tests in diagnosis and treatment. Lancet 2:391-394, 1974 49.
BRADWELL AR, CARMALT M H B , W H I T E H E A D T P : Explaining the
unexpected abnormal results of biochemical profile investigation. Lancet 2:1071-1074, 1974 50. COUNCIL O N PEDIATRIC PRACTICE: Standard of Child Health Care. Evanston, Illinois. American Academy of Pediatrics, 1967', pp. 20-29 51. L E W I S C E , RESNIK B A : Nurse clinics and progressive ambulatory patient care. N Engl J Med 277:1236-1241, 1967 52. CHARNEY E, K I T Z M A N H : T h e child-health nurse (pediatric nurse practitioner) in private practice: a controlled study. N Engl J Med 285:1353-1358, 1971 53.
SCHLESINGER E R , L O W E R Y W D , GLASER D B , et a l : A controlled
test of the use of registered nurses for prenatal care. Serv Res 88:400-404, 1973 54.
55.
SPITZER
WO,
KERGIN
DJ,
YOSHIDA
MA,
et
al:
practi-
SIBLEY J C , SPITZER
WO,
RUDNICK
KV,
et
al:
Quality-of-care
appraisal in primary care: a quantitative method. Ann Med 83:46-52, 1975 58. H O E K E L M A N R A : What constitutes adequate well-baby Pediatrics 55:313-326, 1975 59.
Intern care?
GLAZUNOV IS, D O W D J E , JAKSIC Z, et a l : Repetitive health ex-
aminations as an intervention measure. Bull WHO 49:423-432, 1973 60. ANDERSON F P : Evaluation of t h e routine physical examination of infants in the first year of life. Pediatrics 45:950-960, 1970 61.
SPITZER
WO,
FEINSTEIN
AR,
SACKETT D L :
What
is a
health
care trial? JAMA. In press 62. C O L L E N M F : Multiphasic testing as a triage to medical care in Controversy in Internal Medicine, 2nd ed., edited by INGELFINGER FJ, EBERT RV, FINLAND M , et al. Philadephia, W. B. Saunders Co., 1974, pp. 85-91 63.
NUFFIELD
PROVINCIAL H O S P I T A L S T R U S T :
Screening
in
Medical
Care, London, Oxford University Press, 1968, p . 5 64. M C K E O W N T : Unvalidated procedures have n o place in screening programs. See Reference 62, pp. 92-98 65. BERGMAN AB, DASSEL SW, WEDGEWOOD R J : Time motion study of practicing pediatricians. Pediatrics 38:254-263, 1966 66. WORLD HEALTH ORGANIZATION: Mass Health Examinations. Public Health Paper 45. Geneva, World Health Organization, 1971
tioners in primary care. I I I . T h e Southern Ontario randomized trial. Can Med Assoc J 108: 1006-1016, 1973
67.
SPITZER
workshop on screening programs for early diagnosis of airway obstruction. Am Rev Resp Dis 109:567-571, 1974 68. Multiphasic Health Screening. Canberra, Australia, Multiphasic Health Screening Services Committee of the National Health and Medical Research Council of Australia, 1972
WO,
SACKETT D L ,
SIBLEY J C , et
al:
randomized trial of the nurse practitioner. 290:251-256, 1974 56.
Nurse
Health
patients. Ann Intern Med 80:137-142, 1974 57.
SACKETT
DL,
SPITZER
WO,
GENT
M,
et
al:
The
Burlington
N Engl The
J Med
Burlington
randomized trial of the nurse practitioner: health outcomes of
MACKLEM NATIONAL
P T , S T A F F O F T H E D I V I S I O N O F L U N G DISEASES, H E A R T AND L U N G I N S T I T U T E : C o n f e r e n c e report:
Spitzer and Brown • Periodic Health Examination
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