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Research Methods for Obtaining Primary Evidence

  • Roman Jaeschke (a1) and David L. Sackett (a2)

Extract

The use of new therapeutic and diagnostic technologies has become commonplace in modern medical practice. To avoid both clinical disappointment and the waste of money, health, and lives, the introduction of these technologies will have to be based on evidence that these technologies will do more good than harm. The evidence supporting their use should be derived using research methods designed to deal with placebo effects, confounders, and biases. Some of these methods, and the rationale for their use, are discussed in this article. Although the value of evidence derived from randomized controlled trials is stressed, the importance of reviewing critically the methodological details of such trials and interpreting their results with caution is emphasized. The benefits and risks of relying on case-control and cohort studies are reviewed.

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Armstrong, B., Stevens, N. & Doll, R.Retrospective study of the association between use of rauwolfia derivatives and breast cancer in English women. Lancet, 1974, ii, 672–75.
Barsamian, E. M. The rise and fall of internal mammary ligation in the treatment of angina pectoris and the lessons learned. In Bunker, J.P., Barnes, B. A. & Mosteller, F. (eds.), Costs, risks, and benefits of surgery. New York: Oxford University Press, 1977, 212–20.
Battezzati, M., Tagliaferro, S. & Cattano, A. D.Clinical evaluation of bilateral internal mammary ligation as a treatment of coronary heart disease. American Journal of Cardiology, 1959, 4, 180–83.
Bonow, R. O. & Epstein, S. E.Indications for coronary artery bypass surgery in patients with chronic angina pectoris: Implications of the multicenter randomized trials. Circulation, 1985, 72 (Suppl. V), 2330.
Boston Collaborative Drug Surveillance Program. Reserpine and breast cancer. Lancet, 1974, ii, 669–71.
Brett, G. Z.The value of lung cancer detection by six-monthly chest radiographs. Thorax, 1968, 23, 414–20.
Caprotil-Digoxin Multicenter Study Group. Comparative effects of therapy with caprotil and digoxin in patients with mild to moderate heart failure. Journal of the American Medical Association, 1988, 259, 539–44.
Chassin, M. R. & McCue, S. M.A randomized trial of medical quality assurance. Improving physicians' use of pelvimetry. Journal of the American Medical Association, 1986, 256, 1012–16.
Christie, D.Before-and-after comparison: A cautionary role. British Medical Journal, 1979, 2, 1629–30.
Cobb, L. A., Thomas, G. I., Dillard, D. H. et al. , An evaluation of internal mammary artery ligation by a double-blind technique. New England Journal of Medicine, 1959, 260, 1115–18.
Coronary Drug Project Research Group. Influence of adherence to treatment and response of cholesterol on mortality in the Coronary Drug Project. New England Journal of Medicine, 1980, 303, 1038–41.
Department of Clinical Epidemiology and Biostatistics, McMaster Unviersity Health Science Centre. How to use medical journals: II. To learn about a diagnostic test. Canadian Medical Association Journal, 1981, 124, 703–10.
Detsky, A. S. & Sackett, D. L.When was a “negative” trial big enough? Archives of Internal Medicine, 1985, 145, 709–12.
Diamond, E. G., Kittle, C. F. & Crockett, J. E.Comparison of internal mammary artery ligation and sham operation for angina pectoris. American Journal of Cardiology, 1960, 5, 484–86.
Dixon, A. K., Fry, I. K., Kingham, J. G. et al. , Computed tomography in patients with an abdominal mass: Effective and efficient. A controlled trial. Lancet, 1980, i, 1199–201.
Dronfield, M. W., Langman, M. J. S., Atkinson, M. et al. , Outcome of endoscopy and barium radiography for acute upper gastrointerstinal bleeding: Controlled trial in 1037 patients. British Medical Journal/Clinical Research, 1982, 284, 545–48.
EC/IC Bypass Study Group. Failure of extracranial-intracranial arterial bypass to reduce the risk of ischemic stroke: Results of an international randomized trial. New England Journal of Medicine, 1985, 313, 1191–200.
Fish, R. G., Crymes, T. P. & Lovell, M. G.Internal-mammary-artery ligation for angina pectoris: Its failure to provide relief. New England Journal of Medicine, 1958, 259, 418–20.
Freiman, J., Chalmers, T. C., Smith, H. et al. , The importance of beta, the type II error and sample size in the design and interpretation of the randomized controlled trial. New England Journal of Medicine, 1978, 299, 690–94.
Gowdey, C. W.A guide to the pharmacology of placebos. Canadian Medical Journal, 1983, 128, 921–25.
Greenland, S., Thomas, D. C. & Morgenstern, H.The rare-disease assumption revisited. American Journal of Epidemiology, 1986, 124, 869–76.
Guyatt, G. H. & Drummond, M. F.Guidelines for the clinical and economic assessment of health technologies: The case of magnetic resonance. International Journal of Technology Assessment in Health Care, 1987, 3, 551–66.
Guyatt, G. H. & Drummond, M. F.The ethics and feasibility of randomized trials of diagnostic technology: A reply. International Journal of Technology Assessment in Health Care, 1985, 1, 901–03.
Guyatt, G., Drummond, M. E., Feeny, D. et al. , Guidelines for health technology assessment: Diagnostic technologies. In Feeny, D., Guyatt, O. & Tugwell, P. (eds.), Health care technology. Montreal: The Institute for Research on Public Health, 1986, 79105.
Guyatt, G., Drummond, M. F., Feeny, D. et al. , Guidelines for health technology assessment: Therapeutic technologies. In Feeny, D., Guyatt, G. & Tugwell, P. (eds.), Health care technology. Montreal: The Institute for Research on Public Health, 1986, 5777.
Guyatt, G., Tugwell, P., Feeny, D. et al. , The role of before-after studies of therapeutic impact in the evaluation of diagnostic technologies. Journal of Chronic Diseases, 1986, 39, 295304.
Guyatt, G., Tugwell, P., Feeny, D. et al. , A framework for clinical evaluation of diagnostic technologies. Canadian Medical Association Journal, 1986, 134, 587–94.
Guyatt, G., Sackett, D. & Adachi, J.A clinician's guide for conducting randomized trials in individual patients. Canadian Medical Association Journal, 1988, 139, 497503.
Guyatt, G., Walter, S. & Norman, G.Measuring change over time: Assessing the usefulness of evaluative instruments. Journal of Chronic Diseases, 1987, 40, 171–78.
Hayden, G. F., Kranmer, M. S. & Horowitz, R. I.The case-control study: A practical guide for the clinician. Journal of the American Medical Association, 1981, 247, 326–31.
Haynes, R. B., Mukherjee, J., Sackett, D. L. et al. , (for the EC/IC Bypass Study Group). Functional status changes following medical or surgical treatment for cerebral ischemia. Results of the Extracranial-Intracranial Bypass Study. Journal of the American Medical Association, 1987, 257, 2043-46.
Heinonen, O. P., Shapiro, S., Tuominen, L. & Thrunen, M. I.Reserpine use in relation to breast cancer. Lancet, 1974, ii, 675–77.
Horowitz, R. I. & Feinstein, A. R.Alternative analytic methodsfor the case-control studies of estrogen and endometrial cancer. New England Journal of Medicine, 1978, 299 1089–94.
Hull, R., Hirsch, J., Sackett, D. L. et al. , Combined use of leg scanning and impedance plethysmography in suspected venous thrombosis. An alternative to venography. New England Journal of Medicine, 1977, 296, 1497–500.
Ibrahim, M. A.The case-control study: Consensus and controversy. Journal of Chronic Diseases, 1979, 32, 1139.
Kirschner, B. & Guyatt, G.A methodological framework for assessing health indices. Journal of Chronic Diseases, 1985, 38, 2736.
LaHaba, A. F., Curet, J. O., Pelegrina, I. & Bangdivala, I.Thrombophlebitis among oral and nonoral contraceptive users. Obstetrics and Gynecology, 1971, 38, 259–63.
Laupacis, A., Sackett, D. L. & Roberts, R.An assessment of clinically useful measures of the consequences of treatment. New England Journal of Medicine, 1988, 318, 1728–33.
McDonald, I. G., Guyatt, G. H., Gutman, J. M. et al. , The contribution of a non-invasive test to clinical care. Journal of Clinical Epidemiology, 1988, 41, 151–61.
Miettinen, O. S.Theoretical epidemiology. New York: Wiley, 1985.
National Institutes of Health Consensus Development Conference. CEA as a cancer marker. NIH Consensus Development Conference Summary, 1981, 3, 7.
Oliver, M. F., Heady, J. A., Morris, J. N. & Cooper, J.WHO cooperative trial on primary prevention of ischemic heart disease using clofibrate to lower serum cholesterol: Mortality follow-up. Report of the Committee of Principal Investigators. Lancet, 1980, ii, 379–85.
Rauwolfia derivatives and cancer. Lancet, 1974, ii, 701–02.
Royal College of General Practitioners. Oral contraceptives and health An interim report. Turnbridge Wells, England: Pitman, 1974.
Sackett, D. L.Bias in analytic research. Journal of Chronic Diseases, 1970, 32, 5163.
Sackett, D. L. Pitfalls and biases in evaluating new therapeutic technologies. In McNiel, B. J. & Cravalho, E. G. (eds.), Critical issues in medical technology. New York: Auburn House, 1982, 8189.
Sackett, D. L. & Gent, M.Controversy in counting and attributing events in clinical trials. New England Journal of Medicine, 1979, 301, 1410–12.
Shapiro, S. & Sloan, D.Comment. Journal of Chronic Diseases, 1979, 32, 105–07.
Spitzer, W. O., Sackett, D. L., Sibley, J. C. et al. , The Burlington trial of the nurse practitioner. New England Journal of Medicine, 1974, 290, 251–56.
Vessey, M. P.Discussion following Drs. Labarthe and Shapiro. The case-control study: Consensus and controversy. Journal of Chronic Diseases, 1979, 32, 109.
White, C. E., Albanese, M. A., Brown, D. D. & Caplan, R. M.The effectiveness of continuing medical education in changing behavior of physicians caring for patients with acute myocardial infarction. Annals of Internal Medicine, 1985, 102, 686–92.
Zelen, M.The randomization and stratification of patients to clinical trials. Journal of Chronic Diseases, 1974, 278, 365–75.

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