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Research Methods for Obtaining Primary Evidence

Published online by Cambridge University Press:  10 March 2009

Roman Jaeschke  and
David L. Sackett
Roman Jaeschke
Affiliation:
McMaster University
David L. Sackett
Affiliation:
Chedoke–McMaster Hospitals
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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.

Type
Special Section: Alternative Methods for Assessing Technology, Part 1
Information
International Journal of Technology Assessment in Health Care , Volume 5 , Issue 4 , October 1989 , pp. 503 - 519
Copyright
Copyright © Cambridge University Press 1989

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References

REFERENCES

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.CrossRefGoogle Scholar
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.Google Scholar
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.CrossRefGoogle Scholar
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), 23–30.Google ScholarPubMed
Boston Collaborative Drug Surveillance Program. Reserpine and breast cancer. Lancet, 1974, ii, 669–71.Google Scholar
Brett, G. Z.The value of lung cancer detection by six-monthly chest radiographs. Thorax, 1968, 23, 414–20.CrossRefGoogle ScholarPubMed
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.CrossRefGoogle Scholar
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.CrossRefGoogle ScholarPubMed
Christie, D.Before-and-after comparison: A cautionary role. British Medical Journal, 1979, 2, 1629–30.CrossRefGoogle ScholarPubMed
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.CrossRefGoogle Scholar
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.CrossRefGoogle Scholar
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.Google Scholar
Detsky, A. S. & Sackett, D. L.When was a “negative” trial big enough? Archives of Internal Medicine, 1985, 145, 709–12.CrossRefGoogle Scholar
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.Google Scholar
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.Google Scholar
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.CrossRefGoogle Scholar
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.CrossRefGoogle Scholar
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.CrossRefGoogle Scholar
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.CrossRefGoogle Scholar
Gowdey, C. W.A guide to the pharmacology of placebos. Canadian Medical Journal, 1983, 128, 921–25.Google Scholar
Greenland, S., Thomas, D. C. & Morgenstern, H.The rare-disease assumption revisited. American Journal of Epidemiology, 1986, 124, 869–76.CrossRefGoogle ScholarPubMed
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.Google Scholar
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.CrossRefGoogle ScholarPubMed
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, 79–105.Google Scholar
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, 57–77.Google Scholar
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, 295–304.CrossRefGoogle ScholarPubMed
Guyatt, G., Tugwell, P., Feeny, D. et al. , A framework for clinical evaluation of diagnostic technologies. Canadian Medical Association Journal, 1986, 134, 587–94.Google ScholarPubMed
Guyatt, G., Sackett, D. & Adachi, J.A clinician's guide for conducting randomized trials in individual patients. Canadian Medical Association Journal, 1988, 139, 497–503.Google ScholarPubMed
Guyatt, G., Walter, S. & Norman, G.Measuring change over time: Assessing the usefulness of evaluative instruments. Journal of Chronic Diseases, 1987, 40, 171–78.CrossRefGoogle ScholarPubMed
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.CrossRefGoogle Scholar
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.CrossRefGoogle ScholarPubMed
Heinonen, O. P., Shapiro, S., Tuominen, L. & Thrunen, M. I.Reserpine use in relation to breast cancer. Lancet, 1974, ii, 675–77.CrossRefGoogle Scholar
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.CrossRefGoogle Scholar
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.CrossRefGoogle ScholarPubMed
Ibrahim, M. A.The case-control study: Consensus and controversy. Journal of Chronic Diseases, 1979, 32, 1–139.CrossRefGoogle Scholar
Kirschner, B. & Guyatt, G.A methodological framework for assessing health indices. Journal of Chronic Diseases, 1985, 38, 27–36.CrossRefGoogle Scholar
LaHaba, A. F., Curet, J. O., Pelegrina, I. & Bangdivala, I.Thrombophlebitis among oral and nonoral contraceptive users. Obstetrics and Gynecology, 1971, 38, 259–63.Google Scholar
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.CrossRefGoogle ScholarPubMed
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.CrossRefGoogle ScholarPubMed
Miettinen, O. S.Theoretical epidemiology. New York: Wiley, 1985.Google Scholar
National Institutes of Health Consensus Development Conference. CEA as a cancer marker. NIH Consensus Development Conference Summary, 1981, 3, 7.Google Scholar
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.Google Scholar
Rauwolfia derivatives and cancer. Lancet, 1974, ii, 701–02.Google Scholar
Royal College of General Practitioners. Oral contraceptives and health An interim report. Turnbridge Wells, England: Pitman, 1974.Google Scholar
Sackett, D. L.Bias in analytic research. Journal of Chronic Diseases, 1970, 32, 51–63.CrossRefGoogle Scholar
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, 81–89.Google Scholar
Sackett, D. L. & Gent, M.Controversy in counting and attributing events in clinical trials. New England Journal of Medicine, 1979, 301, 1410–12.CrossRefGoogle ScholarPubMed
Shapiro, S. & Sloan, D.Comment. Journal of Chronic Diseases, 1979, 32, 105–07.CrossRefGoogle Scholar
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.CrossRefGoogle ScholarPubMed
Vessey, M. P.Discussion following Drs. Labarthe and Shapiro. The case-control study: Consensus and controversy. Journal of Chronic Diseases, 1979, 32, 109.Google Scholar
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.CrossRefGoogle ScholarPubMed
Zelen, M.The randomization and stratification of patients to clinical trials. Journal of Chronic Diseases, 1974, 278, 365–75.CrossRefGoogle Scholar