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APPENDIX A CASE STUDY OF Â£ MULTIPHASIC HEALTH TESTING Morris F. Coll en INTRODUCTION Multiphasic health testing (MHT) is an example of an equipment- embodied technological system. It has a long history of irreg- ular development and sporadic diffusion as it has attempted to satisfy a variety of objectives in preventive medicine and in health care delivery. The most advanced MHT systems have complex problems of interfacing people (both patients and health profes- sionals) to equipment and equipment to computers. Most patient users find it very acceptable, but many physicians are reluctant to adopt it. Some national governments have a policy of actively supporting MHT and others discourage it. Industry has not found it profitable to market, but many companies make MHT available to their employees. MHT is difficult to evaluate since the total MHT system has benefits greater than the sum of its parts. With the increasing public interest in health care, preventive medi- cine, and "health maintenance organizations" (HMO's), it is likely that the role of MHT in this country will require careful reexam- ination by policymakers. DEFINITIONS AND PURPOSES Definitions Personal preventive services in primary care are based to some extent upon periodic reevaluation of the health status of people. Such health examinations (health evaluations, health appraisals, or health checkups) are usually initiated by the patient, but l24
l25 they may result from the recommendation of a physician, a health care program, or a public health agency. The traditional method for a patient to obtain a health checkup is to see a primary care physician, who takes a medical history from the patient, provides a physical examination, and then arranges for diagnostic tests and procedures that in the physician's judgment are necessary to complete the health evalu- ation. The physician then makes a determination as to whether the patient is well or sick and recommends appropriate followup care. MHT is a systemized approach to providing the laboratory testing portion of a health checkup and it employs automated laboratory procedures and specially trained allied health per- sonnel to collect data on patients' medical histories, clinical laboratory, X-ray, and other physiological test measurements in a programmed sequence. A multiphasic health checkup (MHC) is a health examination provided by using MHT followed by a physical examination and a physician's decision if the patient is well or sick, with recommendations for appropriate followup care. MHT developed from the experience of public health mass screening, which was modified in order to furnish personal preventive medi- cal services to meet the needs of individual patients and their physicians. Automated multiphasic health testing (AMHT) addi- tionally employs automated equipment and computerized decision rules to sort out those who have diseases. Multiphasic health testing services (MHTS) is the expanded use of MHT programs (either manual or automated) within health care delivery systems to provide adjunctive services such as entry triage, health coun- seling, health education, and preventive health maintenance. MHT involves more equipment-embodied technology than the traditional health checkup, and, as used herein, multiphasic health testing includes both MHT and AMHT programs. Functions and Purposes of MHT Since MHT should always function as an integral part of some medical community, program, or system (e.g., a medical founda- tion, a health care delivery system, a public health program, an industry, a military program, etc.), its functions and purposes should support the goals and objectives of the overall program. Functional Objectives of MHT For personal preventive services in primary care medicine, the usual purposes of MHT are:
l26 l. Provide reassurance, since many patients who come to see their physicians for a health checkup are worried about their health. 2. Define the health status of examinees and determine in- dividual fitness (health appraisal). Monitor the status of the continuing health of individuals by periodic examinations (health surveillance). 3. Detect unknown abnormalities (disease detection or case finding). Monitor previously detected abnormalities by the periodic examination of patients with known diabetes, hyperten- sion, etc. (patient surveillance and disease monitoring). 4. Serve as a referral laboratory for physicians for their patients who need early sickness or diagnostic surveys (diag- nostic adjunct). 5. Serve as an entry mode to the health care system (triage). 6. Provide hospital admission examinations. 7. Improve accessibility of health care by making health checkups more readily available. 8. Provide health education and health maintenance to im- prove health habits and behavior. 9. Provide efficient, satisfying, and good-quality testing service to patients. l0. Provide efficient, satisfying, and good-quality service to physicians. Save physician time by providing a high-utility report, comprehensive in content and readable in format. ll. Provide a comprehensive, good-quality, patient health profile to furnish baseline measurements for continuing or future care. l2. Be a cost-effective program. l3. Help to contain the cost of the process of providing medical care by decreasing use of hospital beds and cost of ancil- lary (clinical laboratory and X-ray) services. l4. Improve the outcome of patients by decreasing morbidity, disability, and mortality. Specific Functional Objectives for Each Test Phase Each MHT program must define specific objectives for each test selected for its examinees, depending upon their racial, ethnic, and socioeconomic characteristics. Objectives should include: l. A desired sensitivity and specificity for each test. The determination of the accuracy required for each test and the set- ting of boundary limits for "normal" and "abnormal" will define the percentage of true-positives and true-negatives, and false- positives and false-negatives. This determines the prevalence of true-positives for each phase in the population to be tested.
l27 2. An expected cost-effectiveness for each phase. The usual objective of a test phase is to detect a significant number of true-positives for the target conditions at a reasonable cost. Principles of Operation of MHT General Principles Many writers have advocated principles to guide MHT programs, and these generally include that MHT should be an integrated com- ponent of a health care program and closely related to its phy- sicians' services. Such integration is most effective in a formal organized system of care, but it can also function in an informal cooperative relationship, in which case the linkages must be truly operational. Provision for diagnoses, followup, and treatment is essential, for without it MHT will fall into disrepute. Thus it is necessary that there be (l) a defined or target population of adequate size that agrees to use MHT for checkups and (2) a group of primary care physicians who will sup- port MHT by referring to it patients for examination and accept- ing patients referred from MHT for followup care. Test Selection for Health Problems It is important to identify a set of health conditions, test, and preventive procedures for each MHT program, customized to fit the needs of its target population. A different MHT group of tests is appropriate for children than for adults. It is ad- visable to have a somewhat different battery of tests for young, middle-aged, and older adults. The World Health Organization advocates stringent criteria111 before a screening program is undertaken. From the Kaiser-Permanente experience, it is recommended that MHT for personal health services should select (l) conditions and (2) tests that fulfill the following criteria: l. Criteria for Selecting Conditions for Testing a. They are important health problems for the individual and/or the community. These include riot only conditions that are potentially disabling or life threatening (e.g., hypertension, breast cancer, etc.), but also conditions that impair the quality of life (e.g., impaired hearing, anxiety, etc.). b. Each condition should (i) be prevalent in the population tested with a sufficient frequency and (ii) have a test available to detect the condition with sufficient sensitivity and speci- ficity so that the cost per positive test is acceptable to both
l28 provider and user of services. In other words, the predicted yield rate in the target population must be appreciable; if the condition is rare it will probably be too expensive to detect. c. Appropriate health care services should be available for the condition, whether this be further diagnostic, curative, or rehabilitative services; health and psychosocial counseling; or palliative careâas may be indicated for each patient's prob- lem. It is ideal (but not always achievable in reality) if the test can detect the disease early enough and if effective ther- apy is available such that the entire process of detection, diagnosis, and treatment can be demonstrated to be cost-effective. 2. Criteria for Specific Test Selection a. Cost per test must be acceptable to users as a rea- sonable charge. b. Cost per positive test. This criterion is the result of the cost per test and the prevalence in the target population and is basic to test selection. (For reassurance of health and absence of disease, the cost per true-negative test becomes im- portant. ) c. Cost per true-positive test. This criterion intro- duces the essential specification of sensitivity and specificity of a test, which impact followup costs. (See pp. l33-l58 and Table 4.) d. Cost-effectiveness. This criterion attempts to mea- sure the cost to effectively detect the condition early. Ideally, a test should be able to detect a condition before irreparable changes disable the patient. Cost-effectiveness is sometimes de- fined as including therapy, i.e., the ability to alter the course of the condition or disease. e. Acceptable to patient. The test must be harmless, cause no unreasonable discomfort, and take a reasonable length of time. HISTORY OF DEVELOPMENT AND DIFFUSION OF MHT Over the past 45 years, multiphasic health testing (MHT) evolved as a systemized approach to provide health examinations more ef- ficiently to large groups. The concept of health checkups is not new, as for decades the practice of periodic health examinations has been recommended generally. In order to decrease the cost of providing such examinations, some of the principles and meth- ods of systems engineering have been applied in multiphasic health testing. There was a gradual evolution through the various his- torical steps of screening, mass screening, multiphasic screening, automated multiphasic screening, and multiphasic health testing to the most advanced automated multiphasic health testing services.
l29 Screening as a public health measure in the United States began prior to l900, with the screening of immigrants by the Marine Hospital Service in order to identify those with signifi- cant disease who might become a burden on the country. This was extended to screening communities for communicable diseases. As communicable diseases gradually diminished in importance, the Public Health Service expanded its attention to screening for chronic noncommunicable diseases. In order to decrease the costs of examinations of large num- bers of people, screening techniques were developed that con- sisted of simple, quick, and often only approximate tests that could, with reasonable accuracy, sort out persons likely to have the disease that was to be detected. In l948, Breslow16 first introduced the term "multiphasic screening" as an extension of the mass screening technique. Since tuberculosis, syphilis, diabetes, and heart disease had been proven to be detectable in the general population on a mass scale, and since it was not un- common for a group of people to be surveyed for tuberculosis and then surveyed again some months later for syphilis or diabetes, the multiphasic survey was conceived with a view of combining tests for several of these diseases in one "package." As early as l948 an editorial in the Journal of the American Medical Association suggested that "in contrast to periodic health examinations, these screening procedures are capable of a very wide application; they are relatively inexpensive per per- son tested, and they require relatively little time on the part of physicians. . . ,"66 In l950, Ryder and Getting140 reported the historic action of the Council of the Massachusetts Medical Society, which voted in May l949 to establish five pilot multiphasic clinics (called "Health Protection Clinics") offering, on a voluntary basis, health examinations under the auspices of the district medical societies in cooperation with the community hospitals and other interested groups. In l95l, the first multiphasic screening project within a comprehensive prepaid health plan was initiated in Kaiser- Permanente's Oakland medical center and a year later in its San Francisco medical center.35 These were supervised and conducted by the same physicians who furnished the physical examinations, treatment, and followup care as an integral part of the group practice, prepaid medical care plan. In l95l, the President's Commission on the Health Needs of the Nation recommended periodic health examinations as a means of chronic disease control and suggested that multiphasic screen- ing be used to detect early disease. In l955, the American Medical Association began to offer health examinations to its physicians at its annual meetings, and in l96l,
l30 through its Section on Pathology and Physiology, initiated typ- ical multiphasic health testing examinations at its annual meet- ings. In l960, the American Public Health Association strongly endorsed multiphasic screening, and in l96l the U.S. Public Health Service established the Chronic Diseases Division, which began to provide grants and contracts to establish and evaluate multiphasic screening programs. In the late l950's, multiphasic screening began to receive severe criticism for its poor quality of testing. The advent of electronics and automation into medicine improved the quality of testing and augmented screening capabilities so that not only more tests, but also more accurate and quantitative measurements, could be used. In l963-64, with the partial support of a grant from the U.S. Public Health Service, the multiphasic screening programs then operating in the Kaiser-Permanente Oakland and San Francisco medical centers were replaced by the first automated multiphasic health testing (AMHT) programs. 8/39 The two programs have oper- ated continuously since that date and have provided more than one-half million examinations. In l966, a special committee of the U.S. Senate held extensive hearings on multiphasic screening, which resulted in a publica- tion of abstracts53 but no legislative action. Comprehensive bibliographies were published in l963 (Siegel, Mandel and Lillick110) and in l97l (Gelman84) . The first books on multi- phasic screening were published in l968.llt9,188 The first compre- hensive monograph on multiphasic health testing and adjunctive services (MHTS) appeared in l977.40 A great impetus to multiphasic health testing resulted from a series of joint meetings of physicians and engineers arranged by Devey of the Engineering Foundation5,13 in the late l960's and early l970's, followed by conferences sponsored by the Soci- ety for Advanced Medical Systems (SAMS),59 the International Health Evaluation Association (IHEA),130 and the annual Technicon symposia.14 By l968, organized medicine recognized the increasing impor- tance of MHT by establishing the Intersociety Committee on Multi- phasic Health Screening, which included l0 major national medical groups, as well as the American Medical Association. Although it was not unusual for some MKT programs to incorpo- rate physical examinations performed by physicians on site, in l969 in the Kaiser-Permanente Oakland's MHT, a team of specially trained nurse practitioners (under physician supervision) began to provide complete physical examinations. Garfield advocated MHT as an entry mode to medical care81"83 using multiphasic test- ing and physical examinations provided by nurse practitioners to triage patients into health care, preventive care, or sick care.
l3l In l970, Sanazaro, then the Director of the HEW's National Center for Health Services Research and Development, sponsored a series of workshops that resulted in the publication of Pro- visional Guidelines for Automated Multiphasic Health Testing and Services,132 a major milestone in providing definitions and guidelines for operation and test selection. In l972, the American Medical Association published its com- prehensive Statement on Multiphasic Health Testing,160 in which it reviewed the status of MHT programs at that time and advocated that multiphasic testing "should be integrated into the health care system in a manner that will assist the physician in the man- agement of his patients." It prescribed principles and ethical concepts, and provided guidelines for establishing and operating MHT units. The AMHT Program Directory, International 1972-7314Â° detailed specifications of about 200 operational MHT programs. CURRENT STATUS OF MHT The Kaiser-Permanente multiphasic health testing (MHT) program, which has been operational in the Oakland medical center since l964, has served as a demonstration model and provided the basis for many of the MHT programs that followed. It also served as the research and developmental center for evaluating many test phases of MHT. Recently multiphasic health testing centers have been reported to be opening at a rate of two a week in some urban areas of the United States, some operated by nonphysicians; and at least in the State of Florida, legislation has been introduced to regulate MHT centers as to their supervision, quality, costs, and adver- tising.108 MHT programs are now widespread throughout the developed countries of the world. As of l976 there were about 300 in the United States, about 40 in Japan, about 30 in Europe, and a few in Australia, Asia, Canada, and Latin America. Based upon the experience of the Kaiser-Permanente program, it is predictable that, as health maintenance organizations (HMO's) increase throughout the United States, about one-fourth of adults served by those HMO's will have a health checkup each year by a sys- temized multiphasic-type approach. IMPACT OF PUBLIC POLICY ON DEVELOPMENT AND DIFFUSION On pp. l28-l3l, the historical impact of governmental agencies and of public policies on the development and diffusion of MHT was presented chronologically. It is evident that official govern- ment policy can have a great influence on the diffusion of MHT.
l32 Japan has at least 40 MHT units, and its government supports the concept. England's ministry of health does not support MHT, and there are only two units in that country. Community policies and public attitudes also have enhanced or inhibited the diffusion of MHT, especially from the viewpoint of the consumer (patient). The increasing trend to organized ar- rangements for payments for health care will probably encourage personal preventive health maintenance services and stimulate MHT development customized for the community it serves. Consumer cooperative groups and unions are increasingly nego- tiating for periodic health examinations as a health welfare benefit. It can be expected that the general public increasingly will want health checkups as it becomes more aware of the fact that company executives, political leaders, union groups, and health plan members are receiving such health services. An aspect of the community's traditional protection of its members that can be fulfilled by MHT is the detection of asymp- tomatic communicable diseases such as tuberculosis, gonorrhea, and syphilis. The experience with sickle-cell screening programs has alerted minority groups that, in addition to the potential benefits, there can be problems associated with identifying ge- netic or environmental high-risk groups. It has been suggested that one should balance any possible medical benefits against potential societal harm (such as by having health status stig- matize an ethnic group98). Elinson67 believes that whether or not a person will use MHT services or engage in any preventive health behavior is likely to depend on a wide variety of personal, social, and psycholog- ical factors, and on factors characterizing the organization of health services. On the one hand, for example, preventive be- havior depends on the person's orientation to health care, the perceived value of the service offered, and concern about health. On the other hand, the utilization of preventive opportunities depends on the physical proximity and convenience of the services offered, the response one expects from health personnel, and the monetary and psychological costs of using the service. Concern is often expressed that systems technology provides assembly line medicine and that computers tend to dehumanize and depersonalize the medical care process. Hall,90 Past-President of the American Medical Association, coined the acronym "AMHTLC" to emphasize that "Automated Multiphasic Health Testing" (AMHT) must include "Tender Loving Care" (TLC), and advised that all MHT personnel show concern, patience, understanding, and kindness to each patient, as health care personnel should do in all medical care services. MHT patients have no difficulty in separating the laboratory services (whether clinical laboratory, X-ray, or MHT) from their primary care physician, so the extensive technology of
l33 the laboratory does not detract from the patient-physician rela- tionship; on the contrary, the more modern the laboratory tech- nology, the more confidence the patient has in the physician's technical support. The common practice of AMHT to apply in- dividualized normal values to each patient (by age, sex, etc.) greatly enhances quality and individualization of test results. EVALUATION OF MHT MHT, to be properly evaluated, must be studied to determine to what extent it achieves its defined objectives within its over- all health care delivery environment (see pp. l25-l27). Evaluation of Resources Used An essential aspect of the evaluation of MHT involves identify- ing and measuring all resources used in the program. The number of full-time equivalents of personnel and the use of space, equipment, and supplies are also important to identify and mea- sure by a cost analysis. For the health care delivery system within which MHT is located, the costs of resources used should include the costs of followup care from MHT referrals. Cost analyses of the Oakland Kaiser-Permanente MHT have been reported41,42 and will be used as the basis of this case study. Included are the physician costs for interpretations of electro- cardiograms and X rays. The total direct costs are made up of about 70 percent for salaries and wages (including fringe bene- fits) , 21 percent for supplies, and 9 percent for equipment de- preciation. Indirect expenses are allocated to each test phase and applied to salaries and wages to cover actual expense of services from other departments, such as accounting, payroll, personnel, and purchasing. Indirect costs also include plant operation, comprised of "equivalent costs of ownership" (depre- ciation, finance charges, interest, and interest expense) and "maintenance" (janitorial services, maintenance supplies, tele- phone, and utilities). For this MHT, the total cost per MHT examinations has been maintained around $20 primarily by gradu- ally increasing the volume of patients processed to offset in- creasing payroll costs. Unit costs of MHT are critically related to the patient load. The Oakland Kaiser-Permanente MHT examined in l973 about 3,000 patients per month. If only l,000 patients were examined monthly, the cost per patient would prob- ably increase to $40-$50.40
l34 Effectiveness of MHT The measurement of the degree of attainment of program objectives is usually defined as the effectiveness of a program. The pri- mary objective of MHT is to economically provide a good-quality health checkup, i.e., to determine the health status of the ex- aminee, detect unknown disease, monitor the status of known disease, and reassure the well. Accordingly, evaluation of MHT effectiveness should as a minimum determine the yield and re- ferral rates, the effectiveness of detecting targeted asympto- matic disease, and the patient's satisfaction with the process. Some measure of physicians' acceptance of and satisfaction with the program should also be included in effectiveness evaluation, if MHT is to function as a successful participant in the health care community. WHO advocates that evaluations of effectiveness of screening programs should consider the effect of MHT on patient outcome.111 However, patient outcome is probably more dependent upon effec- tiveness of therapy than upon effectiveness of disease detection. The ability to favorably alter the course of the condition should be a criterion for MHT test selection and is an important factor in MHT cost-benefit analysis, but it is essential that evaluation distinguish between the medical care process of (l) disease de- tection and diagnosis and (2) treatment and rehabilitation. For example, from the viewpoints of the patient, family, employer, and society there are clear social benefits for planning purposes from effective early detection of an incurable disease, even though the treatment may not be effective in altering the natural course of the disease. Determination of Health Status of Examinees There has accumulated an extensive literature on health status indices. A useful and simple method for the triage of MHT ex- aminees for referral to appropriate care services is that devel- oped by Garfield83 and Richart,135 and it will be used in this case study. Such classification of patients is done after the MHT data and physical findings become available. These results are compared with the patient's complaints to determine health status. A patient (Pt.) is classified as "well" if he has no significant medical complaint or problem (see Table l) and if the doctor (Dr.) or other examiners record that he has no clinically significant finding or abnormality. He is classified as "worried- well" if he has a significant medical complaint or problem but there are no clinically significant findings. A patient is "asymptomatic-sick" if he has no complaints but he is found to have a clinically significant finding (e.g., elevated blood
l35 TABLE l Average Health Status (HS) Mix for New Patients Receiving Health Evaluations3 Health Status (Dr./Pt.) Number HS Group,% Well (Well/Well) 3,573 56.8 Worried-Well (Well/Sick) 729 ll.6 Asymptomati c- Sick (Sick/Well) 247 03.9 Sick (Sick/Sick) l,736 27. 7 6,285 l00.0 3Modified from Garfield et al.8' pressure). A patient is "sick" if he has a significant complaint and is found to have a significant abnormality. For example, a group of adults who had not seen a physician in the last year and who asked for a multiphasic checkup were clas- sified as shown in Table l. Those classified as "well" comprised 56.8 percent, as "worried-well" ll.6 percent, as "asymptomatic- sick" 3.9 percent, and as "sick" 27.7 percent. Thus it is evident that in this group, "health" care was indicated for 68 percent ("well" and "worried-well") and "sick" care was needed for only 32 percent ("sick" and "asymptomatic-sick"). Thus MHT can be used to evaluate health status and to separate out those who need "health" care from those who need "medical" or "sick" care. Each patient can then be referred to followup care in accordance with his individual needs. Yield Rates of MHT The yield rate of positive findings from a given test depends upon the prevalence of the abnormality in the population being tested and upon the sensitivity and specificity of the test. Yield sometimes is applied to previously undetected abnormalities, but herein it refers to all positive tests. The yield rate for a test is defined to be the number of positives as a percentage of the total number of patients tested. Table 2 shows how the yield rates, or percent positive (%+), are greatly influenced by the ages of the examinees. The yield rate essentially determines the referral rate of patients to physicians for followup care. One can predict the yield by knowing the prevalence of the con- ditions that produce a positive test and the sensitivity and the specificity of the test. The yield will be the sum of the true- positives and the false-positives. For a sample of N persons, one
l36 TABLE 2 Cost per Positive Test by Under 40 40-59 Age-Group 60 and Over Test %+ $/+ %+ ?/+ %+ $/+ Blood pressure 0. 4 88 4. 3 8 ll. 5 3 EKG l0. 2 9 l7. 7 5 3l. 5 3 Chest X ray 2. l 69 7. 4 20 l9. 2 8 3Modified from Collen et al.k2 can predict the yield (y) of positive cases from MHT if the popu- lation being tested has a disease with a prevalence (p) and the test has a sensitivity (a) and a specificity (b), then: y = Np(a) + N(i - p) (l - b). For example, the predicted yield for breast cancer from four annual examinations of a group of l0,000 women age 50 and over, in which the prevalence is 0.0l, for which testing by mammography detects 90 percent of cancers and 99.l percent of noncancers," would then be: y = (l0,000 x 0.0l x 0.90) + (l0,000 x 0.99 x 0.009l) = l80 "positives." This yield would result in a referral of 90 true-positives and 90 in whom the surgical biopsies would not confirm the presence of cancer (false-positives). If a population group of younger women (e.g., age 35-50) were selected wherein the prevalence of this disease was only 0.005, the sensitivity was 80 percent, and the specificity was 99 percent, then: y = (l0,000 x 0.005 x 0.80) + (l0,000 x 0.995 x 0.0l) = l40 "positives," or 40 true-positives and l00 false-positives would be referred. This demonstrates the relatively higher costs of testing for lower prevalence diseases due to the larger proportion of the case yield who are false-positives.
l37 Diagnoses Reported Following MHT The final diagnoses reported by the physicians following the MHT and physical examinations comprise the conventional measure for evaluating the effectiveness of MHT in disease detection of a population group, since these diagnoses are an indication of (a) whether the physicians decided that the positive test was a true or false one, and (b) whether they thought the positive test was clinically important (i.e., warranted therapy). In one group of "new" examinees, less than one-third had clinically important abnormalities (asymptomatic-sick or sick in Table l). Table 3 shows that for another group of more than 30,000 examinations (for which the criteria were not identical and some persons had more than one examination) some clinically important abnormality was reported in almost two-thirds of the examinations. The most com- mon diagnosis was obesity and the second most common was hyper- tension. For many cases, the condition was already known (not "new" to the physician), and the MHT was being used to monitor the status of the disease. Effects of False-Positives and False-Negatives The validity of a screening test is the measure of the fre- quency with which the result of that test is confirmed by an acceptable diagnostic procedureâi.e., the ability of the test to separate out accurately those who have the condition sought from those who do not. Applying a screening test to a population will TABLE 3 Ten Most Frequent Diagnoses Found in 30,000 Consecutive Checkups and Percent Newly Detected Rank Diagnosis Per l00 % New Some Important Abnormality 65.0 l Obesity l7.3 25 2 Hypertension, primary 7.6 28 3 Anxiety state 7.3 3l 4 Osteoarthritis 3.8 20 5 Diabetes mellitus 3.3 39 6 Fibrocystic disease, breast (women) 3.2 29 7 Varicose veins 3.l 34 8 Psychophysiological Reaction, Gastrointestinal 3.0 40 9 Benign prostatic hypertrophy (men) 3.0 58 l0 Anemia (women only) 2.0 78
l38 produce four categories of results, provided that the whole population is also examined definitively to establish the actual prevalence of the disease. These four categories are shown in Table 4 and they have been discussed extensively in the litera- ture. llt/71 , 87, 159/ 172 For quantitative and semiquantitative tests it is possible to vary the sensitivity and specificity by changing the screening ' level at which the test is considered to be positive. However, changing the screening level to increase the sensitivity will de- crease the specificity, and a change to increase specificity will correspondingly decrease sensitivity. MHT tests are selected with a sufficient sensitivity to detect an acceptable proportion of patients who have the disease (true- positives) , but if the test is too sensitive it will produce some test results that may identify a person as having the disease (or abnormality) when in fact this is not true (false-positives). Sim- ilarly, the test selected usually will have sufficient specificity to identify an acceptable proportion of patients who do not have the disease, but if it is too specific it will miss too many who do have the disease (false-negatives). A frequent criticism of MHT from physicians has been that it produces an excessive number of false-positive test results, thereby increasing costs by gen- erating secondary tests, using more doctors' and patients' time, and increasing patient anxiety. More serious is the increasing concern to providers of care from medical liability from false- negative tests. Accordingly, it is important to consider in de- tail the effects of false-positive and false-negative tests when evaluating an MHT. a TABLE 4 Categories of Screening Test Results Total Screening Test Patients Health Status Test Results Sick Well Results Positive (+) True +'s False +'s Total + Negative (-) False -'s True -'s Total - Total cateogry Total sick Total well Total tested Sensitivity = '* Specificity True -' Total sick " " - Total well Modified from Thorner and Remein.172
l39 Costs of False-Positives Attempts to evaluate and quantitate the costs of false-positives involve comparisons of the expected value of treatment with the expected value of nontreatment in a group of patients with known disease prevalence, the value (costs) of treating the sick, the value (costs) of reassuring the nonsick, the costs of working up the nonsick, and the costs of not treat- ing the sick who, if not tested, would have gone undetected. These types of cost-benefit studies are difficult to carry out. A cost- effectiveness study bearing on this issue follows on pp. l43-l45. The costs of false-positives must be shared by those who bene- fit by having the disease detected early and by those who are re- assured by the fact that they do not have the disease. The value of detecting the disease early is, of course, influenced by the ability of the treatment to alter the natural history of the dis- ease and prevent or postpone overt disability. For example, there is now convincing evidence that the higher the blood pressure, the shorter the life. In order to treat hyper- tension earlier and decrease the subsequent incidence of stroke, there is increasing support for early detection of asymptomatic hypertensionâespecially since hypertension is a relatively high- prevalence disease. Although for lower-prevalence diseases the problem of false- positives is relatively more costly, again, the potential dis- abling capabilities of the disease are a basic consideration. For example, the prevalence of breast cancer is low, but the value of periodic mammography for asymptomatic women over age 50 is becom- ing more convincing. (See Appendix B. ) Costs of False-Negatives A false-negative is a more serious error if the condition missed is potentially a disabling one, e.g., failing to detect early pulmonary tuberculosis by the screening chest X ray has always been a great concern to the radiologist, whether the screening program was only for a single disease, tuber- culosis, or whether in a multiphasic program it was for several conditions including tuberculosis. Failing to detect by mammography an early nonpalpable cancer of the breast may cost the patient a possible cure if she does not come in until she palpates a lump in the breast or axilla. As MHT testing increases its sensitivity to attempt to minimize false-negatives, its testing costs and followup costs will increase. Since it is unlikely that any program has sufficient resources to achieve l00 percent sensitivity, the actual expenditures will be limited by the program's goals and budget, and the community's rate of malpractice suits. The increasing impact of medical lia- bility (malpractice) settlements upon the practice of medicine has generated the concept of "defensive medicine." This results in
l40 a physician ordering additional tests, procedures, and consulta- tions that he deems necessary to support or defend, if challenged, the diagnosis and treatment that he has provided his patient. The increasing accountability of a physician for false-negative diag- nosis significantly influences the average physician's mode of practice. On pp. l43-l45 is presented a cost comparison of patients evalu- ated by MHT as compared to the traditional physician's health examination, and Table 5 shows the significantly lower costs for the MHT group for the initial workup and l2 months followup care. These data do not indicate any increased costs which might be due to excess false-positives in the MHT group, and may even raise the question whether the higher costs in the traditional group might be due to excess numbers of false-negatives. Value of Finding a Negative Test It is difficult to objec- tively evaluate the worth of finding a negative test. We know how to express the value to the patient of telling l in l2 adults that they have hypertension, or l in 500 women over age 50 that they have a breast cancer, in terms of the likelihood of future dis- ability and mortality. On the other hand, how do we express the value of a negative test, that of telling the other ll adults that they do not have hypertension or the 499 women that they do not have breast cancer? Surely the reassurance and the avoidance of the costs associated with a positive test to the patient, to the family, to the community, and to the health care system have some value, perhaps even more value than the finding of a posi- tive test. Garfield81 has stated that the emphasis on disease by the evaluation of MHT on its yield of sickness rather than its yield of health is a product of preoccupation with sickness that has historically prevailed throughout medicine. Efficiency of MHT In health care systems, the evaluation of program efficiency is usually defined as the ratio between an output (net attainment of program objectives) and an input (program resources expended, usually expressed as average dollar costs). Often this ratio has been inverted and expressed, for example, as dollar cost per positive case for multiphasic testing. In evaluating the efficiency of MHT to achieve its objective of providing a disease detection and monitoring program, it is necessary to measure costs to identify clinically important con- ditions for the various MHT phases. In such a study, it is es- sential to establish accurate cost centers to provide reliable unit costs and to define precisely which clinically important
l4l test results or findings are considered to be "positive." Such a study provides useful information as to which tests will be most efficient in the examinations of a specified population. Using a cost analysis for the Kaiser-Perroanente program, the MHT costs for a representative test (chest X ray) will be con- sidered as an example. Table 2 shows the cost per positive test for young, middle-aged, and older persons. The unit cost for a chest X ray, including the radiologist's interpretation, was $l.45. Clinically important abnormalities that were reported included: suspicious density or lung lesion, lung fibrosis, hyperlucent lung, mediastinal abnormality, hilar enlargement, other cardio- vascular abnormality, or bone lesion. Not included were the fol- lowing conditions: lung calcifications, fibro-nodular or fibro-calcific lesion, pleural thickening or adhesions, blunted costrophrenic angle, rib anomaly, scoliosis, previous chest sur- gery, mastectomy, calcific or tortuous aorta. The definition of "abnormal" is critical in establishing yield rates and unit costs. Table 2 shows for chest X rays the tenfold increase in fre- quency of clinically important abnormalities (as defined above) reported in adults over age 60, as compared to those under age 40. The unit cost per positive chest X ray for a clinically important abnormality in the 60 years or older age-group was $8. The low prevalence and high unit cost per positive test for chest X rays for young adults has caused many MHT programs to omit chest X rays for this group. It must be emphasized that these unit costs were related to an MHT patient load of about 2,000 per month at that time. If only l,000 persons were examined monthly, the cost per patient would probably double. If 3,000 persons could be tested per month, the unit cost would probably decrease by about one-third. These data clearly demonstrate how the prevalence of an abnormal test is de- pendent upon age composition of specific population examined. Finally, it is important to emphasize that in order to evaluate the true efficiency of any test for case detection, it requires an extension of the analysis to determine the cost per proven "true" positive case, which requires expensive followup confirmatory and validating procedures. (See Appendix B.49) Cost-Effectiveness of MHT Introduction A very useful method of evaluating MHT is by comparing its costs to some alternative process for achieving the same speci- fied objectives. Comparing MHT with another program (or even no program) as to costs to achieve the same objectives does not
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l43 require putting dollar values on the changes in health status or other patient outcomes that may be affected. Cost-Effectiveness of Alternative Health Examination Modes If it is necessary to respond to the public's demand for peri- odic health examinations, or if an organizational decision is made to provide health examinations to a group of people, the question then arises as to which is the most cost-effective examination method. The following study compared, for patients "new" to the doctor, the costs of health examinations provided by MHT (with and without nurse practitioner physical examinations) to the traditional health examinations provided by physicians. 1>8 ' 50,8; The Kaiser-Permanente Oakland medical center's MHT has been described elsewhere.40 One group of patients received a system- ized battery of tests and a self-administered history, followed by a l5-minute scheduled visit for a physical examination by a physician in the medical department (the MHT-MD group). Patients who completed the MHT could alternatively receive an immediate physical examination by trained nurse practitioners, supervised by a physician (the MHT-RN group).163 Also available was a "tra- ditional" medical checkup (the TMC group) provided by the same medical department physicians who, during a 30-minute scheduled visit, took a history and did a physical examination. The physi- cians who provided care in the traditional medical department were the same internists who did followup MHT physician physical examinations and also who supervised the nurse practitioners. After the physician saw the patient, in any of the above modes, he (and/or the nurse practitioner) would refer the patient to appropriate specialty clinics for "examination followup" clinical laboratory tests, X rays, EKG's, and other special diagnostic procedures necessary to arrive at a final diagnosis. This study was conducted in l972-74, comparing 6,285 similarly selected patients receiving (a) traditional medical checkups (TMC), (b) multiphasic health checkups with physician physical examina- tions (MHT-MD), or (c) multiphasic checkups with nurse practi- tioner physical examinations (MHT-RN). Their health status was determined by chart review and they were classified as "well," "asymptomatic-sick," "worried-well," or "sick" (see pp. l25-l26). All data were then adjusted so that the groups were comparable by age, sex, and health status. Since the same physicians pro- vided the examinations and arranged followup care for all three groups, the quality of care was assumed to be similar. Table 5 shows the use and cost of services for the initial examination visit by the three modes. The costs shown are costs to the Health Plan for the services provided to its members and do not represent fees or charges that would have been paid by
l44 nonmember patients (e.g., MHT cost to Health Plan for a member was $l7.46, but the charge to a nonmember patient would have been $30-$40). The multiphasic panel of tests replaced the individ- ually selected tests that were ordered by the physicians in the traditional mode. The great decrease in physician time for the initial physical examination was obviously the main saving in both MHT-MD and MHT-RN. Table 5 also shows the followup visits and tests ordered by the physicians to complete the health examination. Many patients did not have their health examination fully completed at the ini- tial visit since the evaluation of possible variations from normal required further diagnostic tests (clinical laboratory, radiology, ECG, etc.) and/or physician specialist consultation visits (in- ternal medicine, ophthalmology, gynecology, dermatology, etc.) to confirm the validity of the finding or for further diagnostic evaluation. The costs for ancillary services (clinical labora- tory, radiology, ECG, and other diagnostic procedures) used for the followup evaluation workups are also shown. The impact of the more comprehensive initial testing of MHT is shown here by comparing the sum of clinical laboratory plus radiology plus special diagnostic procedures for followup evaluations ($7.06 for TMC, $5.l5 for MKT-MD, and $5.05 for MHT-RN). These data show that any false-positive tests generated from the initial MHT examination did not produce excessive followup tests and did not increase followup costs of ancillary services. The total physician time (initial and followup) represented by scheduled minutes used for each of the three health examina- tion modes was very different. The traditional (TMC) examina- tion method, based upon the required use of physicians for both the initial examination and the followup visits, used a total of 43.6 minutes of MD time, on the average. The MHT-MD mode re- duced the physician time used in the initial examination by one- half and decreased somewhat the physician time used for followup evaluation, so that the average total was only 25.5 minutes, or 42 percent less MD time than was associated with the traditional health examination. The MHT-RN approach further decreased the use of the initial physician time to only that for supervising the nurse practitioners who performed the routine physical exam- inations. As a result, the total MD time used for the MHT-RN mode of health examination was only l3.8 minutes, or 68 percent less than TMC and 46 percent less than MHT-MD. Table 5 compares the total costs for providing health examin- ations by the three methods tested. The total cost for a health examination is the sum of the resources used on the initial ex- amination visit and on the evaluation followup visits. The average total cost for a health examination by the traditional
l45 (TMC) physician mode was $6l.42. As an alternative, by first providing a multiphasic health testing battery of tests, fol- lowed by either a physician (MHT-MD) or nurse practitioner (MHT-RN) physical examination, the total costs for a health ex- amination were decreased to $44.80 and $43.l0, respectively (for a decrease in total costs of 27 percent and 30 percent, respec- tively) . Since the total costs for ancillary tests (MHT), clin- ical laboratory, X-ray, and ECG) were similar for all three modes (about $22), the_cost differences are entirely due to saving of physician time. Of additional importance was the finding that the initial in- creased comprehensiveness of the MKT examination, when serving as the entry mode to a health care system, had a significant eco- nomic impact on the subsequent followup care for at least l year. Table 6 compares the total resource costs utilized per l,000 pa- tients for l2 months beginning with the health evaluation. These costs include all physicians plus all supporting personnel, over- head, and facilities' costs, etc. Patients who received the multiphasic health checkup (MHT-MD group) saved $25,2l3 per l,000 patients per year as compared to those who received ini- tially a traditional medical checkup (TMC). Contrary to state- ments that multiphasic testing increases cost of care, the total cost of care for the MHT-MD group over l2 months was only 80.8 percent of the TMC group (for the MHT-RN group only 75.2 percent of TMC). This decrease of l9 percent in total care costs per year was primarily due to saving in physicians' time, and this saving generally applied to patients in all health status cate- gories . TABLE 6 Summary of l2-Month Total Resource Costs ($/Yr/l,000 Examinees, Adjusted for Age, Sex, and Health Status) TMC MHT-MD3 MHT-RN* MD costs 93,673 68,7l4 54,683 (% of traditional) (l00) (73) (58) Total costs l3l,l79 l05,966 98,629 (% of traditional) (l00) (8l) (75) aModified from Collen.51 ^Modified from Garfield, B. R., et al.83
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l47 Cost-Effectiveness of MHT Test Phases An important evaluation of MHT is to assess each of its test phases as to its costs and its effectiveness in detecting the targeted condition, as compared to (a) no testing at all (i.e., the traditional custom of waiting for patients to come in with a complaint), or (b) some alternative testing method. Since this is a very time-consuming and expensive process, it is usually not done for every phase. "A Case Study of Mammography, as an example of a specific test-evaluation process, comprises Appendix B.1>9 Cost-Benefits of MHT Although it would be desirable to conduct cost-benefit studies of health checkups and of the MHT mode of providing such check- ups, no such cost-benefit studies have yet been completed due to the inability to measure and include all benefits. Klarman102 classifies benefits under three headings: (a) direct benefits, which are potential savings in the use of health resources; (b) indirect benefits, which represent gains in future savings; and (c) intangible benefits, which relate to value and quality of human life. Emlet69 has suggested a comprehensive model for cost-benefit analysis of MHT, but such a study has not yet been completed. A limited cost-benefit study of MHT has been conducted at Kaiser-Permanente Oakland and San Francisco. It measured the effect of MHT on disability, mortality, and the earnings of non- disabled survivors.56"58 In this project, a "study" group of approximately l,229 men who were Kaiser Health Plan members, initially ages 45-54, were urged to undertake annual MHT examina- tions. A "control" group of similar composition and size were not so urged but were followed up in a similar fashion for each subject's health experience. The group described herein con- stitutes the one age-sex subgroup in which a favorable effect on disability was found, and is referred to again in the follow- ing section. Expenses associated with health-related events were compiled for the study and control groups. Medical care utilization was measured in the study and control group subjects in the Health Plan. Disability rates were measured in subjects who remained in the Kaiser Plan and responded to mailed questionnaires. Self- rated disability has limitations but does provide some measure of health status. Table 7 depicts the net difference in earnings in the study and control groups. Rows A contain the proportions of survivors
l48 with no disability and partial disability adjusted to relate to the initial population, so as to account for additional losses in earnings due to mortality. "No disability" was defined in the survey questionnaire as a present state of health enabling one to do one's usual work with no limitation. "Partial dis- ability" was defined as a present state of health that caused one to limit or cut down on the amount or kind of work one was doing. The combined proportions of living men with no disability and partial disability (Rows A) were multiplied by annual .income estimates to give the average annual earnings per man in the ini- tial populations (Rows B). The study-control group differences, shown in Row C, represent the differences in average annual earn- ings due to differences in disability prevalence and mortality, per man in the initial populations. The study-control group differences in net earnings, after deducting the HHT expenses and additional outpatient clinic ex- penses, are shown in Row D. It can be seen that the total eco- nomic impact favored the study group every year. The total difference for the 7-year period is more than $800 per man. It can therefore be concluded that urging 45-54-year-old men to have an MHT examination every year has important cost-benefits. It should also be pointed out that the amount of the savings as- sociated with greater MHT exposure applied to men in the middle income range, who formed the majority of the subjects in this study. For men with higher incomes the difference would be greater; for men with lower incomes, it would be less. The study did not demonstrate, however, that multiphasic health checkups provided similar cost-benefits for other groups, such as 35-44-year-old males or 35-54-year-old females. Effect on Mortality of Urging Multiphasic Checkups The most important objective of periodic health checkups is to decrease morbidity and mortality. The only randomized clinical trial, a long-term controlled study of the effect of urging adults to have annual multiphasic health checkups, has been con- ducted over the past l0 years by the Kaiser-Permanente Medical Care Program and has been reported in several articles, ^,55-57'133 and recently reviewed by Friedman.78 From a pool of 46,000 eli- gible Kaiser Foundation Health Plan members, ages 35-54, two groups were randomly selected. The "study" group of 5,l56 members has been urged to have a multiphasic health checkup (MHC) every year. The "control" group of 5,557 members has been left alone. Both groups have been followed up in idential fashion to assess- mortal- ity.
l49 The major findings to date are summarized in Tables 8 and 9. Although the control group subjects are entitled to the checkups and voluntarily take them (about 20 percent of the group comes in each year), the "dosage" of checkups has been higher in the study group (about 65 percent each year) due to urging. By July l975, the average number of checkups per person was 5.2 in the study group and 2.0 in the control group. About 68 percent of both groups are still Health Plan subscribers. The death rate through l973 has been significantly lower in the study group for conditions hypothesized in advance to be detectable by checkups and amenable to therapy that would prevent or postpone mortality. The death rate for these potentially postponable conditions (largely the accessible cancers and hypertensive disease) has been 6.8/l,000/9 years in the study group, based on 35 deaths, and l0.7/l,000/9 years in the control group, based on 59 deaths (p < 0.05) . The two conditions chiefly responsible for the study- control difference in mortality were hypertension and colorectal cancer. Although the overall mortality rates from all causes are sim- ilar for the study and the control groups (Table 8), an interest- ing observation has been made that in the entire population of l0,7l3 persons there is a gradient risk of mortality from all causes according to the number of checkups the subjects have re- ceived, whether in the study or control group. The mortality rates and age-standardized mortality ratios for all causes of death in all subjects are shown in Table 9. The mortality rates were calculated on a person-year basis in such a way that having more checkups was not confounded with survival. It has been determined that serious illness at the start of the study was not responsible for this mortality gradient. Obviously, in departing from comparison of the study and control groups, and comparing different degrees of cooperation of use of checkups, the bias of self-selection can become important. The characteristics of the low and high utilizers of checkups have not yet been compared to determine the extent to which the mortality gradient can be ex- plained by the effects of self-selection. The differences in mortality attributable to checkups are thus overstated in Table 9, whereas in the study versus control group comparison they are understated due to the effect of crossovers between the two groups. A true measure of the effect of checkups on mortality probably is somewhere between the figures shown in Tables 8 and 9. Acceptance of HHT to Patients Studies of social determinants of the use of preventive medical services,93 which would include MHT, suggest that people are less
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l5l TABLE 9 Mortality Rates and Standard Mortality Ratios, All Subjects, l965-73 Person-Years Crude of Mortality No. of Observations Number Rate Standardized MHC's to in This of (Deaths/l,000 Mortality Dec. l973 Category Deaths Per son- Years) Ratio 0 38,384.33 3l0 8.08 l.38 l l9,039.42 ll2 5.88 l.02 2 ll,l88.58 5l 4.56 0.74 3 7,873.67 36 4.57 0.7l 4-6 l3,282.50 59 4.44 0.62 7+ 3,959.00 l3 3.28 0.40 likely to use preventive services when they are poor, have little education, are isolated from community groups and social net- works, have limited health knowledge, have unfavorable attitudes towards preventive care, and have little confidence in the health care system. They are also less likely to use such services when their pattern of medical care is fragmented and episodic as com- pared with a more regular and continuous association with a medi- cal provider. Table l0 shows that in one group of patients their acceptance of MHT was related to their social class; upper classes expected more and so the majority rated MHT to be about as ex- pected, whereas lower classes apparently expected less so the majority rated MHT to be much better than expected. Patients' acceptance of and satisfaction with MHT is dependent upon prior orientation of examinees as to the multiphasic process, how it TABLE l0 Patients Acceptance of MHT Compared to Expectations (843 Patients) Social Class (Hollingshead) All Upper Middle Lower Much better than expected 28 l9 30 59 A little better than expected 17 l5 20 l8 About as expected 54 65 49 22 Disappointed l l l l (p < 0.00l)
u 0) c i 0) n en c 0) ^4 vo o o m r* A 0 â¢ â¢ â¢ â¢ â¢ z O ^ O rn o o ^ 73 in 0) 0) â¢ iH tJ UH O U1 S â¢rH ft id 3 >i in y H U1 CN O 0) -rl â¢ 1 Qi > Q O O O O rH O jj 3 â¢O â¢P O a) rH 0) â¢H id fi UH 0) 0 01 X â¢H oi >i 4J 0) â¢r) rH Id rH 01 id 4J â¢H 01 CN n r- in c id -H â¢ i â¢ â¢ M rj PTJ Q rH CN CN rH O O 0) 4J â¢H rH 3 "* ( 3 0) 0) O 0) 4J jj â¢H in r o CN r*- no Gv H 0) 0) â¢ i â¢ â¢ â¢ â¢ p R Z in VD rH o m CN 5 0) n â¢H 73 4-) â¢o 3 0) C 0) â¢H 0) â¢H ^1 UH 'O ^i UH 0) in C E rH 0i â¢rH O â¢P ft r4 -lH rH ^ r^ Tf rH r* - â¢H 4J 3 id U1 Id Id en i â PO Gv i â m W id 01 1i h t/1 rH CN rH rH rH rH 01 in A C 4J â¢H o O C â¢a UH U) â¢H -H 0 rrj t 4J id 0 4-* 0) r.^ 0 rH â¢H id id ft C UH UH e â¢a oi U1 â¢U vi o 0) O r>1 *H Â»S> O rf *f iJ, r^ 0) â¢H U â¢rl tH rH 4J UH 0) 0) id oo o (N in in o 0 id .c I/I ft E> t/l I*- vo oo r*- r*- co D â¢H i-l rH 4J rH â¢P id nJ *-* ^* - ^^ *-* - --* ^^ 0 c o) Ul n in CN i" o o u o 3; vD r*- QO 0o ^ ^* â¢H H H rH rH rH rH 4J UH o â¢d J5 W o id o X 4J || || || 4J -U || || || M fc â¢i -H q UH 0) fcW 2,22 &'H 2^Z 0 â¢ â¢ *"0 rH C c io q (0 "-H. 0) rH O> o 4J -H 4J Q. â¢rl 01 â¢r) era QzqE OZ OIM sSojo S3 UH U J3 â¢P n â¢H QI i i 'H O II 3 5 B S 1 4Jg UE-iEn +J CJEHEn fti O EnSS fti â¢% EHÂ§Â£ Â§ m l52
l53 works and what it is expected to accomplish. Once patients have an understanding of the MHT process, their acceptance of the multiphasic examination is excellent.156 The individual patient's relationships with MHT are, in one respect, similar to those of a patient in any clinical laboratory or X-ray department, when the MHT serves as a referral or auxiliary service for the physician. The 25-year experience of Northern California Kaiser-Permanente supports the view that MHT is very acceptable to patients. Many surveys have been conducted, and the results of one recent patient satisfaction survey is shown in Table ll. The great majority (87- 96 percent) of examinees were as satisfied with a checkup that was provided using the multiphasic approach either with physician (MHT-MD) or nurse-practitioner (MHT-RN) physical examinations as compared to the traditional medical checkup (TMC). This was true whether or not the patients were symptomatic (i.e., with health complaints) . Patient compliance with medical advice is another measure of the effectiveness of the care process. An evaluation of patient arrivals following referral for recommended followup medical care showed similar arrival/referral ratios for the multiphasic and traditional modes of health checkups. Patient time used for an MHT checkup, on the average, is con- siderably less than for a traditional checkup. Accordingly, time lost from work or usual activity is usually less from a multi- phasic health checkup. Acceptance of MHT by Physicians Health checkups are generally accepted by primary care practi- tioners as a routine part of their work. In the traditional mode of practice, the patient comes to the physician because he wants reassurance that he is well, or because he has some medical com- plaint, or because he has been advised by the physician or some- one else to have a checkup. In the MHT approach, the reasons for the checkup are usually the same. The process, however, is un- traditional in that the physician does not usually see the patient until after the individual has had the multiphasic battery of tests and the physician is presented with a computer-generated multiphasic report, which often is unsolicited. Most physicians, on initial exposure to a multiphasic followup patient and its computer report will resent this variation from their customary and traditional routine. The acceptance of physicians of MHT is also influenced by ethical and medicolegal considerations. McKeown113 emphasized the unconventional impact of screening on the usual practice of the physician in which the screened patient arrives following
l54 MHT examination. In those instances where a public health au- thority or an organization has initiated the screening procedures and not the patient, McKeown raises ethical questions as to the physician's responsibility in such cases. This question applies primarily to mass screening programs and not to personal health checkups, whether the latter use the traditional or multiphasic modes. The American Medical Association in its guidelines has attempted to formulate ethical principles for MHT.160 Bates7 surveyed 4l7 physicians to ascertain their acceptance and fol- lowup of multiphasic screening tests and demonstrated the lack of responsiveness of practitioners in confirming an abnormal test or initiating management of detected abnormalities. He sug- gested that MHT was of value to the physician in providing new diagnoses, and in providing data for the physician which, even for normal tests, may make other tests unnecessary and furnish baseline information against which to compare future test re- sults. Bates suggested that, since physician behavior consti- tutes the "major block" in patient followup, three choices appear open: improve followup through physician education, make alternate arrangements for followup, or delete the test from MHT because followup is not carried out. Williamson, in a study of physician responses to hospital admission screening test re- sults, found that only 35 to 78 percent of physicians, depending upon educational efforts, showed any response to unexpected ab- normalities, as determined by a retrospective chart review. Mechanic points out that medical decisions are influenced by the physician's willingness to assume risks involved in the decision-making process. Physicians usually adopt a conserva- tive decision rule, which makes it a more serious "error" to dis- miss a sick patient than to retain a well person; accordingly, a large part of the differential diagnostic process is involved in "ruling out" possible diseases that also might account for the pa- tient's symptoms. However, it is a basic concept of MHT to com- prehensively screen for a large number of symptoms and laboratory tests. The result is that many physicians express concern that the larger number of tests increases the number of false-positives and thereby increases the evaluation followup costs of a health checkup. On the other hand, the possibility that the fewer tests provided to a patient by the traditional approach increases the number of false-negatives and thereby increases the followup to- tal costs of medical care must also be considered. Both problems are very difficult to evaluate and have been referred to in prior sections. Personal economics undoubtedly have some role in the accept- ability of MHT by physicians. Medical checkups are often an im- portant source of income for internists, general practitioners, and other primary care physicians. On the other hand, many
l55 physicians find that giving routine physical examinations is boring and uninteresting. They are glad to turn over health assessment activities to MHT and nurse practitioners or other paraprofessionals so that they can devote most of their time to the care of the sick. Recommended Tests and Periodicity for MHT Lists have been published of recommended specific tests for screening or health testing, but each MHT program should select tests in accordance with its objectives, the population it serves, and the criteria for selection of tests and conditions as described in prior sections. Studies are needed to determine the optimal interval between health checkups, since there is little data available directed to this question. Frame and Carlson77 provided a critical review of tests suit- able for periodic health checkups. Gelman reviewed tests fur- nished by 40 MHT units, and Bates7 reviewed physicians' use of screening tests in ambulatory practice. Breslow et al. devel- oped lists of recommended conditions and tests for personal pre- ventive health services for adults; and these are used as the basis for Table l2. Breslow's task force advised that these tests should be given three times during the l7-35 age period: one between l7 and 20, another in the mid-twenties, and a third in the mid-thirties. Subsequently, Breslow and Somers advocated a "lifetime health-monitoring program."20 The Mayo Clinic is quoted as recommending two examinations at regular intervals for persons between the ages of l8 to 30, three between 3l and 40, four between 4l and 50, five between 5l and 60, and annually for persons over 60.26 Table l2 lists a summary of recommended tests for adults age 35 or more. Kaiser-Permanente's studies indicate that periodic multiphasic health checkups do favorably decrease mortality after age 35, so it would appear advisable to recommend health examina- tions every l-2 years after age 35, and less often for younger persons. Summary of MHT Evaluation Since MHT is still an evolving component of health care delivery, its objectives are still developing and its applications are be- coming more diversified. Accordingly, its evaluation must be a continuing and iterative process. However, as of l977, the ex- tent to which MHT has achieved its objectives can be summarized as follows:
l56 TABLE l2 Recommended Tests for Adults Ages 35 or More0 FIC ASPH ATPM APHA TF B&S CKP History X X X X X Height and weight X XXX X X Blood pressure X XXX X X EKG X x x x(l) X X Vision X X X X Tonometry X X X X Hearing x(l) x(l) x(l) X X Spirometry X X Mammography (females) X X X x(2) x(2) Chest X ray X X Podiatric examination x(l) Dental examination x(l) Laboratory examinations Serum cholesterol X XXX X X Serum triglycerides X X X X Serum glucose X X X x x(3) Serum uric acid X X Serum SCOT X X Serum BUN X Serum creatinine X X Serum calcium X Serum triiodothyronine (Tj) X Serum tryoxine (Tt,) X Hemoglobin/hematocrit x X X Blood count (exclude differential) X X Urinalysis X X (exclude microscopic sediment) X VDRL X X X X Tuberculin X X X Pap smear (females) X XXX X X Stool guaiac X XXX X Physical examination, general X XXX X X Breast examination (females) X X X X Rectal examination X X X X Sigmoidoscopy X X KEY: Recommended age 60+; (2) recommended age 50+; (3) after challenge dose. FIC = Fogarty International Center Report for HEW, l974; ASPH = Assoc. of Schools of Public Health, Breslow Report, l973; ATPM = Assoc. of Teachers of Preventive Med., Breslow Report, l973; APHA = American Public Health Assoc. Proposal for National Health Ins., l974; TF = Breslow's Task Force, l975; B&S = Breslow and Somers20; CKP = Collen, Kaiser-Permanente, l977. Modified from Breslow et a!.19 and Collen et al.40
l57 l. From the viewpoint of the patient, MHT: a. Decreases the length of time necessary to complete a health checkup, is less costly, and is very acceptable. b. Effectively detects some diseases before symptoms ap- pear, evaluates health status, and refers for appropriate fol- lowup care. c. Improves long-term outcome by decreasing mortality from potentially postponable conditions; and for men aged 45-54 (in one study) decreases losses due to disability, which in- creases net earnings. 2. From the viewpoint of the physician, MHT: a. Serves as a referral center for his patients for good- quality testing at a low cost, effectively detects some previously unknown disease, and monitors status of some known disease. b. Saves physician time by transferring many routine repetitive tasks to allied health personnel and automated instru- ments . c. Can improve quality and personalization of health checkup by providing (l) normal values individualized for each patient by age, sex, etc., and (2) greater accuracy by automated equipment and better quality control measures. d. Can improve the data base available to physicians, thereby decreasing the amount of time spent in routine data gath- ering for diagnosis and allowing more time with the patient for therapy. Can store data in computerized files for subsequent clinical, epidemiological, and health services research. 3. From the viewpoint of the medical facility administrator, MHT: a. Provides a "health center" component to a medical facility for health care and personal preventive health mainte- nance services. b. Can be customized for the medical needs of the popu- lation that uses his facility, including its outpatient clinics, hospital, and surrounding community physicians. c. Provides a good-quality, effective health examination process at a lower cost per examination for ambulatory outpa- tients or hospital admissions. 4. From the viewpoint of the health care systems planner, MHT: a. Is effective and efficient for early disease detection, health surveillance, and disease monitoring. b. Provides the most efficient method of providing health examinations to a large population. c. Increases accessibility to and decreases costs of pri- mary care services by an alternative entry mode (especially if
l58 physical examinations, determinations of patient health status, and triage to needed services are performed by nurse practition- ers) . In summary, although it is not yet possible to quantify all the benefits of multiphasic health checkups to patients, there is now accumulating evidence of improved outcome to some middle- aged groups; of effective reassurance to the well and worried- well who constitute the majority who seek health checkups; of effective early disease detection and monitoring; of improved quality of testing; and of overall improved cost-effectiveness of health care delivery for all health status groups when multi- phasic health checkups serve to provide the entry mode to primary care. POLICY IMPLICATIONS In the United States, the increasing interest in preventive medi- cine, the inclusion of health checkups by some Blue Shield plans, the passage of the Health Maintenance Act of l973, and the con- cept that "health care is a right"81 will all tend to increase the public demand for periodic health examinations. Already this demand is encouraging the opening of MHT programs as stand-alone, commercial for-profit laboratories, and these will require govern- mental regulating just as do clinical laboratories. A review of 25 years of MHT experience suggests the following guidelines45 for a successful MHT program: l. MHT must have good standards of quality, including: a. Accurate testing procedures, so as to achieve accept- able reproducibility and validity of test measurements. This requires a continuing program of quality control monitoring of personnel and equipment. b. High utility, that is, provide good test sensitivity and specificity for detection of important diseases for which effective therapy is available. c. Comprehensiveness of testing, so as to screen for many common conditions (e.g., a chemistry test panel alone will not satisfy patients who expect a relatively complete battery of tests). 2. MHT must provide good service, which means: a. Integrating the MHT program into the community of pa- tients and physicians. All patients should be referred to their physicians, and MHT laboratory reports should be provided only to the patient's physician for interpretation and prescription.
l59 b. Acceptability to the community physicians, so as to obtain their support and conserve their time. MHT reports should be provided in sufficient time, and be of such format and content so as to significantly decrease the physician time requirements for a health checkup. c. Acceptability to patients, through prompt and pleasant service to examinees at each test station and efficient schedul- ing, organization, and followup procedures. Reliable service is essential, since patients will be dissatisfied if equipment or personnel failures too often result in "test not done," or "un- satisfactory test," which requires return of the patient to the laboratory for repeat testing. d. Maintaining continuing patient records. The occa- sional checkup is of lesser value than periodic health examina- tions. Providing the physician with test results of prior examinations for comparison permits trend analysis for border- line abnormalities and aids in better diagnoses. 3. MHT must achieve a good economy, which means: a. Processing a sufficiently large number of patients each day so that the unit cost per patient for the MHT labora- tory will be less than by traditional methods. b. Selecting tests with an acceptable cost per positive case. This requires "tailoring" the MHT test phases to the specific needs of the community of patients and physicians served (e.g., providing chest X rays to adult groups but not to children, modifying medical questionnaires for different socio- economic and ethnic groups, etc.). History shows that whenever one of these basic requirements of quality, service, or economy has not been met, the MHT program failed. Where all three requirements are fulfilled, the program should be successful for the MHT unit, the patients, the physi- cians, and the community. ACKNOWLEDGMENTS Much of the material in this case study is abstracted from M. F. Collen, ed., Multiphasic Health Testing Services, John Wiley & Sons, Inc., New York City, l977, with the permission of the publisher. Most of the studies referred to were supported in part by grants from HEW (CH 05-8, DC 00l42, HSM ll0-70-407, HS 00288, ROl-HS-0l486) and the Kaiser Foundation Research Institute. The Kaiser-Permanente experience cited in this case study is the result of 25 years of support by the physicians of the Per- manente Medical Group.
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