Study Results for All Patients
The patient's history and complete physical examination provided the basis for evaluating all studies. Important conclusions often were based on clinical findings alone. For example, obesity, hypertension, carotid bruits, valvular heart disease, thyroid nodules/goiter, hernias, neuropsychiatric disorders, prostate status, and dermatologic and inherited connective tissue conditions were important discoveries; detecting many of these permitted corroborative laboratory studies during the visit. Details of the clinical assessment were subsequently related to the laboratory results, thereby supporting and adding credibility to treatment and preventive strategies discussed in the closing review.
Renal function tests, serum proteins, and calcium levels were consistently within their normal ranges. Urinalysis also was normal in this study group.
Glucose levels were ≥130 mg/dL in 40 individuals (8.0%, Figure 2). Glycosylated hemoglobin levels were measured after elevations were found, and appropriate follow-up was arranged. Further evaluation for these individuals included a conference with our nutritionist and ophthalmologist; medication often was begun with arrangements made for later follow-up. Cholesterol levels often were elevated: 57.4% of patients had levels >200 mg/L (Figure 3). Treatment recommendations were based on additional findings in nutrition and exercise assessments as well as cardiac studies; the use of statins frequently was recommended. Thyroid function was assessed using thyroid-stimulating hormone levels (Figure 4): levels in 47 (9.4%) patients were >4.5 μIU/mL, and in 10 (2.0%) patients were gt;10 μIU/mL. Eleven individuals (2.2%) had reduced levels (<0.5 μIU/mL). Patients with abnormal levels were further evaluated by measuring circulating thyroid hormone levels and antithyroid antibodies. Treatment and/or later follow-up was then recommended.
PSA levels were usually tightly clustered at low levels (Figure 5). No man younger than 42 years old had a level above 3.0 ng/mL. One 49-year-old man had symptomatic prostatitis and a PSA of 7.4 ng/mL (that fell to 3.8 ng/mL following treatment). Otherwise, the youngest individual with a level >4.0 ng/mL was aged 52 years. Altogether, 19 (5.2%) patients had a PSA level >4.0 ng/mL. Free (unbound) PSA fraction was determined in those with elevated total levels and/or individuals with an abnormal prostate examination; they also were referred to Urology. Seven of the 19 men with high PSA levels (36.8%) were found to have adenocarcinoma on biopsy. Thirteen men had had a previous prostatectomy and had PSA levels <0.1. PSA measurement was not recommended for men aged over 75 years old.
Hemoglobin levels showed anemia in 10 women (7.4%) and 25 men (6.8%). They were above the normal range in 5 women (3.7%) and 46 men (12.6%). (Figure 6) Serum iron levels were measured in individuals with anemia, and further evaluation was arranged (usually to include endoscopy).
Elevated uric acid levels were frequent in men-96 patients (26.3%)-but less frequent in women-8 patients (5.9%); low levels were rare (Figure 7). Although such levels have been associated with an increased risk of hypertension13,21 that relationship was not seen in this population, possibly because those with hypertension often had been recognized and treated earlier. Only 5 had a history of clinical gout, and a new diagnosis was established for 2 more. Particular attention was given to the use of diuretics in individuals with high levels, and treatment was recommended or adjusted where appropriate.
Four hundred fifty-three individuals had ophthalmology evaluations. Cataracts were found in 33 (7.3%). Intraocular pressure was elevated in 12 (2.6%)-visual field studies were done for follow-up. Macular degeneration was present in 3. One had persistent strabismus and another had a choroidal nevus. Follow-up was arranged through the Ophthalmology service.
Audiology studies were performed in 467 individuals and were abnormal in 165 (35.3%). Hearing loss was more frequent in men (41.2% of men tested vs. 18.3% of women tested). Most showed symmetric high-tone sensory-neural loss of varying severity, but the loss was asymmetric in 24 (14.5%), leading to recommendations for further study. Amplification was discussed frequently but only a few patients chose this on their first visit.
Pulmonary function studies were performed in 456 patients: 79 (17.3%) had changes consistent with mild to moderate ventilatory obstruction, and 11 (2.4%) had restrictive changes. These findings were discussed with particular emphasis on smoking, environmental exposures, and exercise where interventions could be helpful. Most chest X-rays were unremarkable but 3 showed scoliosis, and several revealed mild fibrosis that did not correlate with altered pulmonary function. One had changes consistent with earlier granulomatous disease but no active pulmonary disease was found. One X-ray showed a very large diaphragmatic eventration and hiatus hernia for which surgery was recommended. Another revealed a radiographic density in the stomach later shown to be a large asymptomatic leiomyoma.
Baseline electrocardiograms were obtained on all patients. Eleven abnormal patterns were found; 5 had not been identified previously and are included in Table 4. Treadmill stress tests were performed on 304 individuals. Twelve (3.9%) had unequivocally positive tests; 3 were hospitalized directly for further studies and the others were evaluated electively in Cardiology. Twenty-two (7.2%) asymptomatic individuals were suspected to have false-positive results because of finding ST-segment changes at the peak of exercise. Most of these latter patterns were seen in younger men with vigorous fitness programs and involved treadmill exercise of at least 9 minutes. The changes resolved quickly at the end of the study. Cardiology referral and/or nuclear stress testing was recommended to clarify the picture, and all 22 had a clear report with at least 1 year of follow-up.
Blood pressure was measured several times during the visit, first upon arrival in the morning and then later during the physical examination (and still later if it remained high). It also was measured during the treadmill stress test. As shown in Figure 8, 235 individuals had systolic pressure levels consistently >120 mm Hg. Treatment was initiated frequently, but some individuals preferred longitudinal follow-up after counseling regarding exercise, with weight control and diet advice.
Weight, presented as body mass index (BMI), is shown in Figure 9. The levels were lower in women, with 57.7% having a BMI <25 (compared with only 27.7% of men). For women, 12.3% had a BMI ≥30 while 25.9% of men fell into the same range. These data were central to discussions and recommendations both with the nutritionist and in the closing clinical data review.
Flexible sigmoidoscopy was performed on 143 individuals; 97 (67.8%) showed normal findings. Benign polyps were found in 31 (21.7%). Tubular adenomas were found in 14 (9.9%), and follow-up colonoscopies were recommended. One study showed colitis.
The majority of women were up-to-date on mammography and gynecologic evaluations. Thus, only 57 needed mammography as part of their visit. All were normal except for 3 in whom benign cysts were found and 1 for whom biopsy showed intraductal neoplasia. Fifty-five women had gynecologic consultation; only 1 atypical Pap test pattern was found (1.8%). Bone density evaluation by dual-energy X-ray absorptiometry (DEXA) scanning in 25 women identified 6 individuals with osteopenia (24%) and 5 with densities consistent with osteoporosis (20%). Both the nutritionist's review and the closing clinical summary emphasized calcium repletion and exercise strategies for those at risk.
New Findings Based on Visit
A different perspective on these data is gained by reviewing findings and diagnoses that were new based on the visit. These conditions were not already under treatment, and the patients were unaware of them. While the figures present the data obtained for all 500 individuals, Table 4 summarizes the wide variety of new observations and diagnoses based on findings from this visit alone (it includes biopsy reports received several days later). This distinction is important because many were already being treated for hypertension, hypercholesterolemia, and/or diabetes (for these individuals, our data sometimes led to recommendations for management changes). Our findings were summarized in follow-up correspondence with the patient as well as with their local physicians. Frequently, as noted above, treatment was begun or arrangements were made for follow-up in our clinics or at home.
As presented in Figure 9, elevated weight was 1 of the most frequent findings and obviously was not a new situation. Based on BMI calculations, 51.4% of men were overweight and 25.9% were obese. Figures for women showed 30% were overweight and 12.3% obese. Specific recommendations for both diet and lifestyle emphasized preventative strategies and proposed that subsequent visits could assess progress. Although their numerical assessment is not within the scope of this study, returnees often had made progress in their goals.
One-third (165) of these 500 individuals received a new diagnosis or had 1 or more important clinical findings identified on the basis of this visit alone. Several diagnoses were made often, and usually were obvious to the individual. Although excess weight was frequent (see Figure 9), many individuals were unaware of their BMI status. Many individuals already were being treated for diabetes, hypertension, and hypercholesterolemia, but some remained inadequately controlled. Our findings (summarized in the figures and Table 4) provided an opportunity to present recommendations for changes in medications, diet, exercise, and lifestyle.
Individual findings were interpreted in their clinical context. Viewing test results without clinical confirmation or follow-up has shown that 95% of individuals may be described as "normal" on the basis of a single test while only 77% will have no abnormalities on 5 independent tests. Only about 36% will have all values within the normal ranges for 20 independent studies.22,62,63 Confirmatory testing was done for findings outside the normal ranges, often on the day of the visit (for example, glycosylated hemoglobin for hyperglycemia, circulating thyroid hormone and antibody levels for abnormal thyroid-stimulating hormone findings, free PSA for elevated total levels, and echocardiographic and thallium studies for equivocal stress tests). The follow-up studies reduced the likelihood of misinterpreting the initial data.
Multiplex screening has been evaluated in the past, and the idea of evaluating asymptomatic individuals is hardly new. Early advocates include Dobell18 in 1861 and Barès5 in 1902. The AMA issued a manual for conducting periodic examinations in 1925,2 and Fisk and Crawford24 related their experience in 1927. In 1925 Edie noted "The proposal that healthy people be examined at regular intervals… is notable for the logic of its theory and the slowness of its adoption."19 Others noted that limited therapeutic options in earlier years damped enthusiasm.15,54,66
Later reports found "significant disease" in one-quarter to one-third of those examined for the first time.14,15 Not surprisingly, the findings were influenced by the population studied and the extent of the testing. A 1964 study37 from Chicago evaluated data from 200 patients-in 66 the physical examination alone revealed a new diagnosis and the medical history revealed 26. A 1977 study26 from Montreal reported a significant number of new medical problems in a group of patients for whom multiphasic screening was used; 21 of 25 important new problems were identified by laboratory testing or the physical examination. A 16-year follow-up27 of over 5000 men and women aged 35-54 years at entry showed a 30% reduction in deaths from "potentially postponable causes" among those with multiphasic health checkups (a mean of 6.8 visits per person over the interval). However, in 1981 a study60 of 7229 individuals in London failed to identify significant differences in morbidity or mortality between control and screening groups over a 9-year interval. A 1992 evaluation of cancer prevention in New Hampshire and Vermont concluded that a periodic medical examination was the "strongest determinant of receiving preventive services,"59 but the data did not include information about other conditions. By contrast, a Swedish study64 failed to identify significant value of "general health screening" on mortality from 1970-1990. Unfortunately, it is difficult to compare these results because they used different testing protocols. In 1981, the Medical Practice Committee of the American College of Physicians presented a guide for basic recommendations stratified by age.40
United States preventive screening studies have reported success for breast32 and colorectal cancer49, type 2 diabetes30, and hypertension.57 Burton et al12 concluded that a worksite physical examination program for bank employees reduced short-term disability days and was a significant return on investment (although the data included only 3 years' follow-up).
Barriers to comprehensive evaluations have been remarkably consistent among reports. Prominent difficulties relate to time/record-keeping, coordination and costs. Better documentation can improve delivery of preventive services.55
Cost is an important and potentially limiting consideration. Faulkner and Schauffler20 identified the level of insurance coverage for preventive care as an important determinant of the receipt of services in adults aged 18-64 years. However, a review of 1914 patients in 10 primary-care practices in North Carolina concluded that "adding reimbursement for preventive services to Medicare…will not by itself lead to effective implementation of preventive services‥"44 Importantly, German et al28 reported that 63% of community-dwelling individuals aged ≥65 years had free preventive visits when they were offered; participants had a significantly lower death rate than controls (8.3% vs 11.1%). Short-term costs and claims for participants in a periodic screening examination were higher for 710 men in a single United States corporation than for nonparticipants, but long-term data were not presented.6 Evaluating charges when a benefit for preventive services was offered to older Medicare beneficiaries (2105 with intervention, 2090 control) showed no negative cost impact and a "modest" health benefit,10 but reevaluating this population 2 years after the program ended showed no differences.11 Adding a "preventive care benefit package" for 2 years in a health maintenance organization (HMO) did not yield lower cost per quality-adjusted life year48 (although survivors noted fewer depressive symptoms, less decline in self-rated health status, and higher satisfaction with health). Oboler et al46 noted that interest in having tests "decreased substantially when the charges were known."
In 2007, Boulware et al9 reviewed periodic health evaluations based on studies from 1973 to 2004. Lack of consistency in earlier reports-in terms of definitions, content, studies offered, follow-up, etc.-complicated their interpretations. Their definition of the periodic health examination included the clinical history, risk assessment, and "tailored" physical examination. They did not evaluate delivery of services (for instance, counseling and immunization were considered to be "outcomes"). Reports in their review showed "various levels of intensity" in the studies as well as heterogeneity in the testing provided. Such variation in the basic data made broad conclusions difficult to support. One finding was that "patient worry" likely was lessened by the experience. They opined that large-scale trials likely will be expensive and difficult to perform, and that changing technology and emphasis will complicate comparisons.
It is noteworthy that in 2005, Prochazka et al52 concluded that most primary care providers believe that an annual physical examination detects subclinical illness and that it was desired by most patients. Oboler and LaForce45 emphasized that the complete physical examination might support the physician-patient relationship even though some studies could be offered less frequently (according to recommended protocols). O'Malley47 noted that both patients and physicians value the nurturing of a long-term relationship. Laine36 commented that "fear of becoming ill and facing complex medical decisions without benefit of a familiar physician may also motivate the public's desire for annual examination."
Although most acute office visits provide little time for preventive services, Stone et al61 reported that practice reorganizations could increase their use. Both Yarnall et al67 and Mehrotra et al41 reported that time constraints often limit physicians' abilities to provide preventive services. The latter group emphasized that many preventive services can be provided by nonphysicians. Despite the fact that preventive gynecologic and general health examinations were common reasons to see a physician, the authors found that most preventive services were delivered at other visits. Fenton et al23 noted that completing screening for colorectal, prostate, and breast cancer was more likely to be associated with periodic health examinations in a managed care setting. Sirovich et al58 emphasized that prostate cancer screening presents a good opportunity to advocate colorectal cancer screening.
In contrast to the concerns of Boulware et al,9 the data reported here have internal consistency, although not generalizability. The study interval was chosen partially because no new approaches were introduced during this period. Later additions to the program have included routine measurement of iron and ferritin levels (as a screen for hemochromatosis) and options (not necessarily recommendations) for metabolic treadmill testing and various imaging techniques.
Important limitations are intrinsic to this study and to interpreting these results. Although a single clinician performed the initial evaluation of 500 individuals over a 15-month period in the same clinic with the same tests, the study is based on a convenience sample and there is no control group. Selection bias was likely imposed by considering only individuals seen at a single institution in a program that did not accept insurance. The long-term outcomes of findings and recommendations are not analyzed here, partially because not all individuals returned at regular intervals (particularly those from other countries).
The population covered by this study also has demographic limitations. For example, it was 73% male. Only 2.9% of Americans were African-American. Twenty-five percent of patients came from a wide variety of other countries (49.7% of these were from the Middle East). The new diagnoses encountered may not be representative of other countries, regions, or socioeconomic groups. Considerable expansion of the scale of the program would be required to address this issue.
During the study interval, flexible sigmoidoscopy was used because it required minimal sedation and could be included in a single day's visit. However, subsequent reports33,38,50 have indicated the superiority of colonoscopy, which has been recommended in later years. This change improved the evaluation but necessitated a 2-day visit. "Virtual" radiologic approaches17,25,34 and fecal DNA mutation analysis1,16,25 may change this offering in the future, but both approaches remain under development.
The broad range of findings revealed by the current study makes it difficult to exclude specific tests, procedures, or portions of the physical examination as uninformative. Although plain chest X-rays infrequently showed intrinsic lung disease (smoking was uncommon in this population), they revealed a gastric mass (later found to be a large leiomyoma) and a very large diaphragmatic eventration and hiatus hernia that required surgical repair. Neither of these had been suspected from the history and/or physical examination alone. Urinalysis rarely showed findings unsuspected from clinical data (as has been noted before). Merenstein et al43 included the chest X-ray, electrocardiogram and urinalysis in their "not recommended" category. Although many routine blood analytes were not frequently abnormal, it would have been difficult (and more expensive) to eliminate them from multichannel testing. Boland et al7 cited the review of systems and the physical examination as particularly valuable for case finding in 100 randomly selected records from the Mayo Clinic. Their study showed relatively low therapeutic yield for the complete blood count, urinalysis, thyroid studies, chest X-ray, electrocardiogram, and chemistry testing. The same authors,8 in another review of laboratory tests, noted the value of the lipid profile. van Walraven et al65 noted that testing varied widely in Ontario, driven largely by "physician factors."
I consider it important, however, that basic data, even if normal, be obtained and documented as part of an initial visit. Although they were infrequently abnormal, chest X-rays and electrocardiograms occasionally revealed changes. These baseline studies are valuable for long-term care, but protocols for subsequent visits have not repeated them unless clinically indicated. Not surprisingly, interpreting abnormal findings in later years was aided by comparison with earlier data.
The current report shows that a comprehensive, single-day outpatient evaluation can reveal unanticipated and important diagnoses based on clinical and laboratory findings in presumably healthy adults. One-third of the individuals seen left with a new finding, similar to the frequency reported by Boland et al.7 Including counseling (for example, nutritional review), immunizations (including travel prophylaxis), and a medical summary clarified recommendations and simplified follow-up. Limiting the visit to a single day whenever possible is an important goal, assuring that all studies will be completed without requiring (and, hence, depending upon) return visits. Having a very full single day appealed to these individuals, most of whom did not live nearby.
Most of the new findings reported here led to recommendations for definitive care. This is a significant contrast to earlier comments (and criticisms) that it is of little value to make a diagnosis for which there is no treatment option or that doing so merely identified early changes whose treatment might not affect the natural history of the condition.15,54,66 This also reflects the range of current therapeutics.
An important example of new data that provided valuable information to patients is related to weight. As shown in Figure 9, 77.3% of men and 42.3% of women were overweight. As recently reported in both Great Britain35 and the United States,4 individuals often are not aware of how they fit into BMI guidelines on the basis of primary care visits. Presenting the BMI figure supported by both nutritional and laboratory data was an important part of the summary discussion. Interestingly, return visits showed that many of these well-motivated individuals had made considerable progress through a combination of diet and exercise.
Providing this experience required considerable organization, involving both prior scheduling and coordination throughout the day of the visit. Once the basic protocols were established, however, planning individual visits became simpler. The program remains intrinsically labor intensive.
It is important to emphasize that having sufficient physician time available for both the initial evaluation and the summary conference has been a central feature of this program. It has permitted extensive clinical data gathering from both the history and the physical examination. In addition, detailed presentation and explanation of the results strengthened the basis for the recommendations.
The cost for the visit was related to the studies performed; the average cost was about $2000. As discussed above, this imposes a limit on the generalizability of the results. Obviously, deciding whether a specific test has value depending on the anticipated frequency of abnormalities in the population imposes an important economic constraint on data gathering. As shown here, significant findings, often leading to new diagnoses and/or management interventions, may appear at low frequency. In such cases, appropriate care for the individual inverts global cost-benefit analysis. Assuming that a test or a part of the physical examination or review of systems not performed will be normal or that it will add nothing to current or future care plans is hazardous. With the wide range of current therapeutics, optimal comprehensive care for individuals must consider all available data. Financial constraints and competing health care needs may limit data gathering in large populations, but these findings show that important, treatable conditions may be detected later or not at all without basic information.
An additional consideration arises from appreciating the increasing complexity in the natural history of many important conditions. For example, detecting prostate cancer is now recognized to offer the affected man several treatment options,3,56 and it is not clear whether early detection consistently affects morbidity and mortality. More detailed molecular analysis of biopsy or biomarker material may prove useful for determining risks and expectations for these men; this is an area of considerable importance that requires further study.
Although it is difficult to assess the economic value of this program, surveys of patient satisfaction (62% return rate for English-speaking patients) consistently supported the experience. Recommendations for improvement were largely related to the convenience of the facilities and scheduling details; these have been addressed whenever possible. Patients appreciated having a complete clinical database, and this appears to strengthen not only their satisfaction, but also their likelihood of following recommendations. Han,29 in his review of such visits, noted that strengthening physician-patient relationships is a legitimate goal that is considerably aided by providing a complete examination, a notion already advanced by Prickman et al.51 Long-term relationships aid compliance with recommendations and treatment protocols.
A program of this type could provide an ideal venue for the extensive counseling likely to be needed as genetic and biomarker testing becomes available. Interpreting complex multimarker data sets will require considering a broad array of biologic, clinical, and personal data. While recent studies of type 2 diabetes39,42 showed that multimarker DNA variant analysis did not substantially increase risk prediction over that based on commonly recognized risk factors, future, more extensive marker sets are likely to be helpful. This type of approach is changing rapidly. The combined results should help stratify risks and strengthen recommendations for prevention and care.
I conclude that this program has provided a comprehensive, initial health evaluation and can be a useful model for comparison with other approaches to providing case-finding and preventive services. It involves an efficient use of patient and staff time. The program has permitted prompt access to the resources of many colleagues and tests. This report emphasizes medical conditions of sufficient prevalence that they should be considered in comprehensive medical evaluations. As screening becomes more efficient (and, possibly, less costly), these problems should receive attention. This is particularly timely now that preventive and therapeutic approaches can be applied more broadly to lessen long-term disease burden and improve quality of life.
The author gratefully recognizes support from Nell and George Berry, Nathan Cohen, Francis Day, Shirley and Bill Griffin, Ruth and George Harms, and Steve Lazinsky during this study.
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