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• W2078113853 abstract "Selection bias in patient referral is a major cause of contradictory findings in the medical literature and results from the disproportionate referral of more severely affected patients to academic medical centers. Although the problem pertains to most fields of medicine, this communication will illustrate the impact of selection bias on the understanding of the natural history of surgical conditions. Patients with a specific disease may have a variety of initial manifestations; therefore, the clinical spectrum may include some who have abnormal test results but are asymptomatic, others who are symptomatic to a greater or lesser degree, a few patients who have complications of the disease, and fewer still who actually die of the disease. Selection bias in the referral process originates from disproportionate selection of patients from the various parts of the clinical spectrum. Thus, in comparison with the patients admitted to a community hospital, those referred to an academic medical center are usually oversampled from the more complicated patients at the “severe” end of the clinical spectrum.1White KL Williams TF Greenberg BG The ecology of medical care.N Engl J Med. 1961; 265: 885-892Crossref PubMed Scopus (484) Google Scholar, 2Ellenberg JH Nelson KB Sample selection and the natural history of disease: studies of febrile seizures.JAMA. 1980; 243: 1337-1340Crossref PubMed Scopus (100) Google Scholar Moreover, compared with all patients who have a specific disease, referral patients are younger on the average, are more likely to be men, and may have an altered distribution of clinical features. As a consequence, the natural history of a disease among referral patients may differ substantially from that of the same disease among patients who receive care in their home community. When reports from academic institutions are improperly generalized to the community, this selection bias may lead to misrepresentation of the clinical picture of a disease, confusion of referral factors with etiologic ones, overestimation of the value of certain laboratory tests, and overstatement of the frequency of poor prognostic outcomes. Furthermore, it may result in recommendations for therapy that are inappropriate at the community level, as shown in the following examples. The general concept of a disease influences the approaches to its management. Much of the literature on pelvic fractures, for example, has originated from large trauma centers and indicates that these injuries generally occur among young adults (usually men) as a result of severe trauma, such as motor vehicle accidents, falls from heights, and excavation cave-ins.3Huittinen V-M Slätis P Fractures of the pelvis: trauma mechanism, types of injury and principles of treatment.Acta Chir Scand. 1972; 138: 563-569PubMed Google Scholar The primary clinical problem in these patients is said to be the identification and management of associated vascular and urinary tract injuries.4Zannis VJ Wood M Laparotomy for pelvic fracture.Am J Surg. 1980; 140: 841-845Abstract Full Text PDF PubMed Scopus (9) Google Scholar To what extent is such an approach indicated among patients with pelvic fracture in the community? A study of the unselected pelvic fractures (excluding coccygeal fractures) that occurred among the residents of Rochester, Minnesota,5Melton III, LJ Sampson JM Morrey BF Ilstrup DM Epidemiologic features of pelvic fractures.Clin Orthop. 1981; 155: 43-47PubMed Google Scholar revealed that more than half were due to only moderate trauma, usually a fall from standing height or less; that 64% of the patients were older than 35 years of age; and that more than two thirds of the patients were women. The pattern of occurrence of pelvic fractures by age and sex revealed the classic picture of osteoporotic fractures (Fig. 1): the incidence was greater among women than among men, and the rate of occurrence increased exponentially with advancing age. The multiple, severe pelvic fractures (Key and Conwell6Conwell HE Reynolds FC Key and Conwell's Management of Fractures, Dislocations, and Sprains. Seventh edition. CV Mosby Company, St. Louis1961: 719Google Scholar type III) of most concern in trauma practices accounted for only 20% of the pelvic fractures that were due to severe trauma in the community and for only 10% of all pelvic fractures. Of the Rochester patients, 43% had fractures of isolated bones (type I), and another 37% had single breaks in the pelvic ring (type II); most of the latter patients were elderly and had a unilateral fracture of both pubic rami. A further 9% of the overall patient group had isolated acetabular fractures (type IV). These data clearly show that patients with isolated or single pelvic fractures are vastly underrepresented in published clinical series. This misrepresentation leads to a biased view of pelvic fractures as a condition usually associated with severe trauma. Analysis of the complete clinical spectrum of pelvic fractures in the community, however, reveals that this condition, in general, is more accurately related to osteoporosis. Such fractures are typically associated with only moderate trauma, and serious associated injuries are uncommon. The management of patients is also affected by what are believed to be the etiologic agents or risk factors for a disease. The reported association between endometrial cancer and diabetes mellitus provides an illustration of this influence: does one disease cause the other, or are both caused by some third factor that they have in common, such as obesity? If such a relationship exists, women with diabetes should be subjected to intensive surveillance for endometrial cancer; and, conversely, diabetes should be ruled out in women who undergo an operation for endometrial cancer. These efforts may be inappropriate, however, if no actual association exists. This question was addressed in a study7Malkasian GD Annegers JF Endometrial carcinoma: comparison of Olmsted County and Mayo Clinic referral patients.Mayo Clin Proc. 1980; 55: 614-618PubMed Google Scholar that compared residents of Olmsted County, Minnesota (where the Mayo Clinic is located), in whom endometrial cancer was first diagnosed during the 20-year period 1953 through 1972 (N = 95) with women from elsewhere who were referred to the Mayo Clinic during this same time interval for the initial treatment of endometrial cancer (N = 1,108). As shown in Table 1, the patients from Olmsted County were unselected, constituting 100% of the cases of endometrial cancer that were diagnosed in the population during the study period. The women referred from progressively greater distances, however, represented a progressively smaller proportion of the cases that should have arisen in those distant populations during the time of the study. More than 40% of the series consisted of women from the “other United States,” for example, yet these patients were estimated to constitute less than 1% of all cases of endometrial cancer from that region. Consequently, one must doubt that the women who were referred were “representative” of the ones who were not. In terms of associated disease, they seemed not to be representative because 105 patients had previously diagnosed diabetes, whereas only 53 cases of diabetes were expected. Diabetes was not more frequent among the unselected patients with endometrial cancer from Olmsted County, but 75% more cases were observed than were expected among women from southeastern Minnesota, exclusive of Rochester. Outside this area, from 2 to 3 times as many cases of diabetes were observed as were expected among the cohort with endometrial cancer.Table 1Distribution of Mayo Clinic Patients With Endometrial Cancer During the Period 1953 Through 1972, Shown by Geographic Area of Residence and Prevalence of Prior Diabetes MellitusPatients with endometrial cancerPatients with endometrial cancer and prior diabetes mellitusGeographic area of origin*Geographic areas are mutually exclusive.No. in study% of expected cases in residence area†Expected number is based on the age- and sex-specific person-years at risk in each geographic area and the age- and sex-specific incidence rates for endometrial cancer.8ObservedExpected‡Expected number is based on the age distribution of patients with endometrial cancer and the age- and sex-specific prevalence rates for diabetes mellitus.9RatioOlmsted County9510034.30.7Southeastern Minnesota874074.01.8100-mile radius11315145.32.6Minnesota, Iowa, Wisconsin34732815.71.8Other United States5280.24922.82.1Outside United States33?41.33.1 Total1,20310553.42.0* Geographic areas are mutually exclusive.† Expected number is based on the age- and sex-specific person-years at risk in each geographic area and the age- and sex-specific incidence rates for endometrial cancer.8McDonald TW Annegers JF O'Fallon WM Dockerty MB Malkasian Jr, GD Kurland LT Exogenous estrogen and endometrial carcinoma: case-control and incidence study.Am J Obstet Gynecol. 1977; 127: 572-580Abstract Full Text PDF PubMed Scopus (239) Google Scholar‡ Expected number is based on the age distribution of patients with endometrial cancer and the age- and sex-specific prevalence rates for diabetes mellitus.9Palumbo PJ Elveback LR Chu C-P Connolly DC Kurland LT Diabetes mellitus: incidence, prevalence, survivorship, and causes of death in Rochester, Minnesota, 1945–1970.Diabetes. 1976; 25: 566-573Crossref PubMed Google Scholar Open table in a new tab This trend of increasing diabetes prevalence with greater referral distance strongly suggests, and not surprisingly so, that diabetes is a risk factor for selection for referral—a woman with both endometrial cancer and diabetes is somewhat more likely to be referred than a woman with endometrial cancer alone. These data do not support the hypothesis that endometrial cancer and diabetes are etiologically related. In fact, a population-based case-control study found no association between endometrial cancer and prior diabetes,8McDonald TW Annegers JF O'Fallon WM Dockerty MB Malkasian Jr, GD Kurland LT Exogenous estrogen and endometrial carcinoma: case-control and incidence study.Am J Obstet Gynecol. 1977; 127: 572-580Abstract Full Text PDF PubMed Scopus (239) Google Scholar and a recent population-based cohort study found no significant excess of endometrial cancer among patients with diabetes mellitus.10Ragozzino M Melton III, LJ Chu C-P Palumbo PJ Subsequent cancer risk in the incidence cohort of Rochester, Minnesota, residents with diabetes mellitus.J Chronic Dis. 1982; 35: 13-19Abstract Full Text PDF PubMed Scopus (217) Google Scholar The selection process for referral of patients usually enhances the probability that a patient being assessed for a specific disease will have it, and this outcome may influence the estimation of the usefulness of a laboratory test. For example, the predictive value of an abnormal test result increases with the prevalence of a disease and will thus be deemed higher in referral practices than in the community. Much of the debate of the past 20 years concerning the desirability of excluding surgically correctable causes of hypertension relates to this phenomenon. If the prevalence of hypertensive renal disease, for example, is high, as it might be in the patient population at a referral hypertension clinic, then the predictive value of an abnormal (“positive”) result of a test like urinary N–acetyl-β-D-glucosamine will be substantial (Table 2). On the basis of such information, a recommendation might be made that the test be considered for large-scale screening efforts among hypertensive patients in general.11Mansell MA Jones NF Ziroyannis PN Marson WS N-Acetyl-β-D-glucosaminidase: a new approach to the screening of hypertensive patients for renal disease.Lancet. 1978; 2: 803-805Abstract PubMed Scopus (36) Google Scholar With the much lower prevalence of secondary hypertension in the general population,12Berglund G Andersson O Wilhelmsen L Prevalence of primary and secondary hypertension: studies in a random population sample.Br Med J. 1976; 2: 554-556Crossref PubMed Scopus (193) Google Scholar however, most abnormal test results will be false-positive findings, and the predictive value of a “positive” test will be low (Table 2).Table 2Relationship Between a “Positive” Test for Urinary N-Acetyl-β-D-glucosamine (NAG) and Renal Disease in a Tertiary Hypertension Clinic and in a Primary Care Practice*Sensitivity = true positives (“hits” among disease present) = 316/390 = 34/42 = 81%.Renal disease (no. of patients)In hypertension clinicIn primary care practiceNAGPresentAbsentTotalPresentAbsentTotalIncreased (“positive”)31617148734268302Normal744395138690698 Total3906101,000429581,000Specificity = true negatives (“misses” among disease absent) = 439/610 = 690/958 = 72%.Predictive value = disease present among “hits” = 316/487 = 65% in hypertension clinic.34/302 = 11% in primary care practice.* Sensitivity = true positives (“hits” among disease present) = 316/390 = 34/42 = 81%. Open table in a new tab Specificity = true negatives (“misses” among disease absent) = 439/610 = 690/958 = 72%. Predictive value = disease present among “hits” = 316/487 = 65% in hypertension clinic. 34/302 = 11% in primary care practice. This sequence of events has been repeated many times: a test seems promising in a specialty practice, recommendations are then made for its widespread use, and the test subsequently proves to be of limited value outside of large medical centers with many referral patients. The main factor behind these divergent results is the selected nature of the referral patients. The selection process for referral also concentrates those patients who suffer adverse outcomes of disease, but groups of such patients rarely provide an accurate reflection of the risk of these complications. Gastric carcinoma, for example, can occur in the portion of the stomach that remains after a subtotal gastrectomy. Although gastric carcinoma has been reported to develop in many patients after gastrectomy,13Morgenstern L Yamakawa T Seltzer D Carcinoma of the gastric stump.Am J Surg. 1973; 125: 29-37Abstract Full Text PDF PubMed Scopus (119) Google Scholar does it necessarily follow from these case reports that the likelihood of occurrence of gastric stump carcinoma is sufficiently great to justify routine endoscopic screening of all patients who have undergone subtotal gastrectomy? In the population-based cohort of residents of Olmsted County, Minnesota, who had surgical treatment of benign peptic ulcer disease in the period 1935 through 1959 (N = 338), a subsequent carcinoma in the gastric remnant developed in only 2 patients during 5,600 person-years of follow-up, whereas 2.6 cases were expected (relative risk = 0.8).14Schafer LW Larson DE Melton III, LJ Higgins JA Ilstrup DM The risk of gastric carcinoma after surgical treatment for benign ulcer disease: a population-based study in Olmsted County, Minnesota.N Engl J Med. 1983; 309: 1210-1213Crossref PubMed Scopus (111) Google Scholar Despite persistent reports to the contrary from Europe, patients who have undergone subtotal gastrectomy do not seem to be at a substantially increased risk for development of a carcinoma in the gastric remnant. This finding of no increased risk has been confirmed in other recent studies.15Sandler RS Johnson MD Holland KL Risk of stomach cancer after gastric surgery for benign conditions: a case-control study.Dig Dis Sci. 1984; 29: 703-708Crossref PubMed Scopus (25) Google Scholar, 16Tokudome S Kono S Ikeda M Kuratsune M Sano C Inokuchi K Kodama Y Ichimiya H Nakayama F Kaibara N Koga S Yamada H Ikejiri T Oka N Tsurumaru H A prospective study on primary gastric stump cancer following partial gastrectomy for benign gastroduodenal diseases.Cancer Res. 1984; 44: 2208-2212PubMed Google Scholar Moreover, most gastric carcinomas are not associated with prior gastrectomy, and most patients with a subtotal gastrectomy do not subsequently have gastric cancer. The cases of gastric carcinoma that are observed generally appear decades after the original operation, in patients who are then usually quite elderly. The savings, in years of life, would not seem to justify the substantial cost of a program of routine endoscopic surveillance of asymptomatic patients with a prior subtotal gastrectomy.17Logan RFA Langman MJS Screening for gastric cancer after gastric surgery.Lancet. 1983; 2: 667-670Abstract PubMed Scopus (39) Google Scholar The results of vascular operations seem to be better in major medical centers where large numbers of procedures are done than in less busy services.18Luft HS Bunker JP Enthoven AC Should operations be regionalized? The empirical relation between surgical volume and mortality.N Engl J Med. 1979; 301: 1364-1369Crossref PubMed Scopus (1411) Google Scholar In these two different settings, however, the patients attended may not be entirely comparable. Could differences in the characteristics of the patients selected for referral to an academic medical center, in comparison with those not referred, influence the assessment of the effectiveness of therapy? As shown in Figure 2, residents of Rochester, Minnesota, who were initially diagnosed as having an abdominal aortic aneurysm during the period 1971 through 1980 (N = 174) had much worse survival than did patients who were referred to the Mayo Clinic for surgical treatment of an abdominal aneurysm from areas of the United States outside of Rochester (N = 579). After 5 years, only 47% of the Rochester patients were still alive as compared with 70% of the referral patients. In comparison with the referral patients, however, the Rochester patients were more likely to be women (39% versus 15%), were older (median age 74 years versus 67 years), were more likely to have had a ruptured aneurysm (13% versus 7%), and were less likely to have undergone operation (41% versus 100%). When the comparison was confined to those patients in whom the aneurysm was diagnosed during life, who did not have a ruptured aneurysm at the time of diagnosis, and who underwent operation, the survival of Rochester patients was as good as that of the referral patients (Fig. 2). After 5 years, 78% of such Rochester patients were still alive in comparison with 74% of the comparable referral patients; however, only a third of the Rochester patients were in this more favorable category in contrast with more than 90% of the referral patients. This study revealed differences between referral patients and local patients that had a substantial impact on overall outcome. Normally, poorer outcomes might have been attributed to less expert care for the local patients, but in the present investigation, both groups received care at the same institution.19Bickerstaff LK Hollier LH Van Peenen HJ Melton III, LJ Pairolero PC Cherry KJ Abdominal aortic aneurysms: the changing natural history.J Vasc Surg. 1984; 1: 6-12PubMed Scopus (202) Google Scholar, 20Bickerstaff LK Hollier LH Van Peenen HJ Melton LJ Pairolero PC Cherry KJ Abdominal aortic aneurysm repair combined with a second surgical procedure: morbidity and mortality.Surgery. 1984; 95: 487-491PubMed Google Scholar For comparable local and referral patients, the outcomes were the same. Similar results have been reported elsewhere: the operative mortality rates in a community hospital21Coghlan WP Cuddy VD Pupi PA Abdominal aortic aneurysm in the community hospital.Penn Med. 1975; 78: 63-67Google Scholar and in a teaching hospital22Pasch AR Ricotta JJ May AG Green RM DeWeese JE Abdominal aortic aneurysm: the case for elective resection.Circulation 70 Suppl. 1984; 1: 1-4Google Scholar were almost identical for both elective operations for aneurysms and emergency surgical procedures for ruptured abdominal aortic aneurysms. The proportion of patients who initially had a ruptured aneurysm, however, was twice as great in the community hospital, and therefore the overall case fatality rate was higher. The selection of patients for referral and the resultant distortion of the age and sex distribution and the clinical spectrum of disease can even affect judgments about the optimal organization of medical care. In particular, the underrepresentation of elderly patients can mask the existence of unserved populations of patients. This distortion was illustrated in a recent study of total hip arthroplasty.23Melton III, LJ Stauffer RN Chao EYS Ilstrup DM Rates of total hip arthroplasty: a population-based study.N Engl J Med. 1982; 307: 1242-1245Crossref PubMed Scopus (49) Google Scholar During the period 1969 through 1982, 304 total hip arthroplasties were performed on residents of Rochester, Minnesota, whereas 12,423 such procedures were performed at the Mayo Clinic on patients who resided elsewhere. As shown in Figure 3, the Rochester patients were older (57% of Rochester patients were 70 years old or older in comparison with 29% of referral patients, and 21% of Rochester patients were at least 80 years old in comparison with 5% of referral patients) and more likely to be women (75% of Rochester patients in comparison with 51% of referral patients). These differences were related to the fact that more than a third of the total hip arthroplasties in Rochester patients were done for fractures, typically osteoporosis-related fractures of the proximal femur, in contrast with only 16% among the other patients who underwent this operation at the Mayo Clinic. (The higher proportion of Rochester patients with hip fractures was not due to substantially different initial fracture management; only an estimated 12% of all Rochester patients with hip fracture during this period underwent a total hip arthroplasty, including insertion of a Bateman prosthesis, and some of these procedures were revisions of conventional hip pinning that had failed.) Total hip arthroplasty seems to be the initial procedure of choice in a small proportion of patients with hip fracture. The underrepresentation of these patients in the referral series indicates that nationally there may be a relatively large pool of patients who experience a hip fracture but cannot feasibly be transported long distances to a major medical center where total hip arthroplasty can be performed. With the current organization of medical care, serving this subgroup of elderly patients will be difficult in many communities, but the problem was not apparent from inspection of only the data on referral patients at a major medical center. Patients are selected for referral to academic medical centers on the basis of age, severity of disease, presence of complications, and other factors. This selection process alters the clinical spectrum of diseases or surgical conditions as seen at major medical centers and, therefore, also influences the perceived natural history of these conditions. The resulting distortion between the natural history of a disease at large medical centers and that in the community is called selection bias. This selection bias can cause disagreement between practitioners in the community and those at teaching centers regarding the definition of and risk factors for various diseases, the utility of laboratory tests, the prognosis to be expected in a given group of patients, and the effectiveness of specific therapeutic or prophylactic procedures." @default.
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• W2078113853 title "Selection Bias in the Referral of Patients and the Natural History of Surgical Conditions" @default.
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