Acute Pulmonary Embolism: Impact of Selection Bias in Prospective Diagnostic Studies

I.J.C. Hartmann; M.H. Prins; H.R. Büller; J.D. Banga; the ANTELOPE study group; on behalf of

doi:10.1055/s-0037-1615640

Thrombosis and Haemostasis, Inhaltsverzeichnis

Thromb Haemost 2001; 85(04): 604-608
DOI: 10.1055/s-0037-1615640

Review Articles

Schattauer GmbH

Acute Pulmonary Embolism: Impact of Selection Bias in Prospective Diagnostic Studies

I.J.C. Hartmann

¹Department of Radiology, University Medical Center, Utrecht

,

M.H. Prins

²Department of Clinical Epidemiology and Biostatistics, Amsterdam Medical Center, University of Amsterdam

,

H.R. Büller

³Department of Vascular Medicine, Academic Medical Center, University of Amsterdam

,

J.D. Banga

⁴Department of Internal Medicine, University Medical Center, Utrecht, the Netherlands

,

the ANTELOPE study group

› Institutsangaben

Abstract

Summary

We evaluated selection bias in a prospective study of 1162 consecutive patients with suspected pulmonary embolism. Of these, 983 were eligible, and 627 could actually be included. During two months extensive data were collected on all non-included patients. Finally, our patient characteristics were compared with those of the PIOPED study (1990) and the study of Hull et al. (1994). Compared with included patients, the non-included patients had more often non-diagnostic V/Q scans (50% vs. 36%, p <0.01) and were more often already hospitalized (31% vs. 22%, P = 0.04). The subgroup of patients not included due to refusal or inability to give informed consent (IC) was older (mean age 61 vs. 53 years, P <0.01), more often suffered from malignancies (26% vs. 11%, P <0.01) and frequently had non-diagnostic V/Q scans (57%) as compared to included patients. In our study, 54% of all patients screened was eventually included versus 27% in the PIOPED study. In the PIOPED study patients who had contra-indications for pulmonary angiography were excluded, while in the study of Hull et al. those with inadequate cardiorespiratory reserve were excluded. In studies on new diagnostic technologies, patient selection bias does occur. The potential for such a selection bias should be taken into account when diagnostic strategies are devised to improve their generalizability and acceptability.

Keywords

Pulmonary embolism - diagnosis - selection bias - perfusion scintigraphy - spiral CT

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Referenzen

References
1 Silverstein MD, Heit JA, Mohr DN, Petterson TM, O’Fallon WM, Melton LJ. Trends in the incidence of deep vein thrombosis and pulmonary embolism: a 25-year population-based study. Arch Intern Med 1998; 158: 585-93.
2 Anderson Jr FA, Wheeler HB, Goldberg RJ, Hosmer DW, Patwardhan NA, Jovanovic B, Forcier A, Dalen JE. A population-based perspective of the hospital incidence and case-fatality rates of deep vein thrombosis and pulmonary embolism. The Worcester DVT Study. Arch Intern Med 1991; 151: 933-8.
3 Dalen JE, Alpert JS. Natural history of pulmonary embolism. Prog Cardiovasc Dis 1975; 17: 257-70.
4 Dismuke SE, Wagner EH. Pulmonary embolism as a cause of death. The changing mortality in hospitalized patients. JAMA 1986; 255: 2039-42.
5 Palareti G, Leali N, Coccheri S, Poggi M, Manotti C, D’Angelo A, Pengo V, Erba N, Moia M, Ciavarella N, Devoto G, Berrettini M, Musolesi S. Bleeding complications of oral anticoagulant treatment: an inception-c ohort, prospective collaborative study (ISCOAT). Italian Study on Complications of Oral Anticoagulant Therapy. Lancet 1996; 348: 423-8.
6 van der Meer FJ, Rosendaal FR, Vandenbroucke JP, Briet E. Assessment of a bleeding risk index in two cohorts of patients treated with oral anticoagulants. Thromb Haemost 1996; 76: 12-6.
7 Miniati M, Prediletto R, Formichi B, Formichi B, Marini C, Di Ricco G, Tonelli L, Allescia G, Pistolesi M. Accuracy of clinical assessment in the diagnosis of pulmonary embolism. Am J Respir Crit Care Med 1999; 159: 864-71.
8 Hampson NB, Culver BH. Clinical aspects of pulmonary embolism. Semin Ultrasound CT. MR 1997; 18: 314-22.
9 Cheely R, McCartney WH, Perry JR, Delany DJ, Bustad L, Wynia VH, Griggs TR. The role of noninvasive tests versus pulmonary angiography in the diagnosis of pulmonary embolism. Am J Med 1981; 70: 17-22.
10 van Beek EJ, Kuijer PM, Buller HR, Brandjes DP, Bossuyt PM, ten Cate JW. The clinical course of patients with suspected pulmonary embolism. Arch Intern Med 1997; 157: 2593-8.
11 The PIOPED. investigators.. Value of the ventilation/perfusion scan in acute pulmonary embolism. Results of the prospective investigation of pulmonary embolism diagnosis (PIOPED). JAMA 1990; 263: 2753-9.
12 Hull RD, Hirsh J, Carter CJ, Jay RM, Dodd PE, Ockelford PA, Coates G, Gill GJ, Turpie AG, Doyle DJ, Büller HR, Raskob GE. Pulmonary angiography, ventilation lung scanning, and venography for clinically suspected pulmonary embolism with abnormal perfusion lung scan. Ann Intern Med 1983; 98: 891-9.
13 Bell WR, Simon TL. Current status of pulmonary thromboembolic disease: pathophysiology, diagnosis, prevention, and treatment. Am Heart J 1982; 103: 239-62.
14 Stein PD, Athanasoulis C, Alavi A, Greenspan RH, Hales CA, Saltzman HA, Vreim CE, Terrin ML, Weg JG. Complications and validity of pulmonary angiography in acute pulmonary embolism. Circulation 1992; 85: 462-8.
15 Hull RD, Raskob GE, Carter CJ, Coates G, Gill GJ, Sackett DL, Hirsh J, Thompson M. Pulmonary embolism in outpatients with pleuritic chest pain. Arch Intern Med 1988; 148: 838-44.
16 Khorasani R, Gudas TF, Nikpoor N, Polak JF. Treatment of patients with suspected pulmonary embolism and intermediate-probability lung scans: is diagnostic imaging underused?. AJR Am J. Roentgenol 1997; 169: 1355-7.
17 Kuijer PM, Turkstra F, van Beek EJ, ten Cate JW, Buller HR. A survey of the diagnostic and therapeutic management of patients with suspected pulmonary embolism in the Netherlands. Neth J. Med 1997; 50: 261-6.
18 Cooper TJ, Hayward MWJ, Hartog M. Survey on the use of pulmonary scintigraphy and angiography for suspected pulmonary thromboembolism in the UK. Clin Radiol 1991; 43: 243-5.
19 Henschke CI, Mateescu I, Yankelevitz DF. Changing practice patterns in the workup of pulmonary embolism. Chest 1995; 107: 940-5.
20 Sanson BJ, Lijmer JG, Mac GM, Turkstra F, Prins MH, Buller HR. Comparison of a clinical probability estimate and two clinical models in patients with suspected pulmonary embolism. ANTELOPE-Study Group. Thromb Haemost 2000; 83: 199-203.
21 Hull RD, Raskob GE, Ginsberg JS, Panju AA, Brill Edwards P, Coates G, Pineo GF. A noninvasive strategy for the treatment of patients with suspected pulmonary embolism. Arch Intern Med 1994; 154: 289-97.
22 Hull RD, Hirsh J, Carter CJ, Raskob GE, Gill GJ, Jay RM, Leclerc JR, David M, Coates G. Diagnostic value of ventilation-perfusion lung scanning in patients with suspected pulmonary embolism. Chest 1985; 88: 819-28.