Abstract
Most human diseases have avoidable causes. This is true not only of infectious diseases, but also a large proportion of cardio-vascular diseases and cancer (Doll and Peto 1981). A major goal of epidemiology is therefore to find the causes of disease in a population and then intervene to remove them.
Access this chapter
Tax calculation will be finalised at checkout
Purchases are for personal use only
Preview
Unable to display preview. Download preview PDF.
References
Alpha-Tocopherol Beta Carotene Cancer Prevention Study Group (1994) The effect of vitamin E and beta carotene on the incidence of lung cancer and other cancers in male smokers. N Engl J Med 330:1029–1035
Altman DG, Schulz KF, Moher D, Egger M, Davidoff F, Elbourne D, Gotzsche PC, Lang T (2001) The revised CONSORT statement for reporting randomized trials: explanation and elaboration. Ann Intern Med 134:663–694
Anderson GL, Prentice RL (1999) Individually randomized intervention trials for disease prevention and control. Stat Methods Med Res 8:287–309
Antiplatelet Trialists’ Collaboration (1994) Collaborative overview of randomised trials of antiplatelet therapy-I: Prevention of death, myocardial infarction, and stroke by prolonged antiplatelet therapy in various categories of patients. BMJ 308:81–106
Armitage P, Berry G (1987) Statistical methods in medical research. Blackwell, Oxford
ATBC (Alpha-Tocopherol Beta Carotene) Cancer Prevention Study Group (1994) The alpha-tocopherol, beta-carotene lung cancer prevention study: design, methods, participant characteristics, and compliance. Ann Epidemiol 4:1–10
Atienza AA, King AC (2002) Community-based health intervention trials: an overview of methodological issues. Epidemiol Rev 24:72–79
Begg C, Cho M, Eastwood S, Horton R, Moher D, Olkin I, Pitkin R, Rennie D, Schulz KF, Simel D, Stroup DF (1996) Improving the quality of reporting of randomized controlled trials. The CONSORT statement. JAMA 276:637–639
Bonithon-Kopp C, Kronborg O, Giacosa A, Rath U, Faivre J (2000) Calcium and fibre supplementation in prevention of colorectal adenoma recurrence: a ran domised intervention trial. European Cancer Prevention Organisation Study Group. Lancet 356:1300–1306
Buring J E (2002) Special issues related to randomized trials of primary prevention. Epidemiol Rev 24:67–71
CAST (Chinese Acute Stroke Trial) Collaborative Group (1997) CAST: randomised placebo-controlled trial of early aspirin use in 20,000 patients with acute ischaemic stroke. Lancet 349:1641–1649
Collins R, Gray R, Godwin J, Peto R (1987) Avoidance of large biases and large random errors in the assessment of moderate treatment effects: the need for systematic overviews. Stat Med 6:245–254
COMMIT Research Group (1991) Community Intervention Trial for Smoking Cessation (COMMIT): summary of design and intervention. J Natl Cancer Inst 83:1620–1628
Cuzick J, Sasieni P, Davies P, Adams J, Normand C, Frater A, van Ballegooijen M, van den Akker-van Marle E (2000) A systematic review of the role of human papilloma virus (HPV) testing within a cervical screening programme: summary and conclusions. Br J Cancer 83:561–565
De Gruttola VG, Clax P, DeMets DL, Downing GJ, Ellenberg SS, Friedman L, Gail MH, Prentice R, Wittes J, Zeger SL (2001) Considerations in the evaluation of surrogate endpoints in clinical trials. summary of a National Institutes of Health workshop. Control Clin Trials 22:485–502
Divine GW, Brown JT, Frazier LM (1992) The unit of analysis error in studies about physicians’ patient care behavior. J Gen Intern Med 7:623–629
Doll R (1998) Controlled trials: the 1948 watershed. BMJ 317:1217–1220
Doll R (2002) Proof of causality: deduction from epidemiological observation. Perspect Biol Med 45:499–515
Doll R, Peto R (1981) The causes of cancer: quantitative estimates of avoidable risks of cancer in the United States today. J Natl Cancer Inst 66:1191–1308
Donner A (1998) Some aspects of the design and analysis of cluster randomized trials. Appl Statist 47:95–113
Early Breast Cancer Trialists’ Collaborative Group (1998)Tamoxifen for early breast cancer: an overview of the randomised trials. Lancet 351:1451–1467
Freedman LS, Graubard BI, Schatzkin A (1992) Statistical validation of intermediate endpoints for chronic diseases. Stat Med 11:167–178
Gambia Hepatitis Study Group (1987) The Gambia Hepatitis Intervention Study. Cancer Res 47:5782–5787
Green SB (2002) Design of randomized trials. Epidemiol Rev 24:4–11
Heart Protection Study Collaborative Group (2002a) MRC/BHF Heart Protection Study of antioxidant vitamin supplementation in 20,536 high-risk individuals: a randomised placebo-controlled trial. Lancet 360:23–33
Heart Protection Study Collaborative Group (2002b) MRC/BHF Heart Protection Study of cholesterol lowering with simvastatin in 20,536 high-risk individuals: a randomised placebo-controlled trial. Lancet 360:7–22
Hennekens CH, Buring JE (1998) Validity versus generalizability in clinical trial design and conduct. J Card Fail 4:239–241
Hennekens CH, Buring JE, Manson JE, Stampfer M, Rosner B, Cook NR, Belanger C, LaMotte F, Gaziano JM, Ridker PM, Willett W, Peto R (1996) Lack of effect of long-term supplementation with beta carotene on the incidence of malignant neoplasms and cardiovascular disease. N Engl J Med 334:1145–1149
Hill AB (1962) Statistical methods in clinical and preventive medicine. Livinstone, Edinburgh
Horowitz HS (1996) The effectiveness of community water fluoridation in the United States. J Public Health Dent 56:253–258
IARC (1998) Carotenoids. IARC handbooks of cancer prevention 2. International Agency for Research on Cancer, Lyon
IARC (2003) Tobacco smoke and involuntary smoking. IARC monographs on the evaluation of carcinogenic risks to humans 83, IARC Press, Lyon
IBIS Investigators (2002) First results from the International Breast Cancer Intervention Study (IBIS-I): a randomised prevention trial. Lancet 360:817–824
ISIS-1 (First International Study of Infarct Survival) Collaborative Group (1986) Randomised trial of intravenous atenolol among 16 027 cases of suspected acute myocardial infarction: ISIS-1. Lancet 2:57–66
ISIS-2 (Second International Study of Infarct Survival) Collaborative Group (1988) Randomised trial of intravenous streptokinase, oral aspirin, both, or neither among 17,187 cases of suspected acute myocardial infarction: ISIS-2. Lancet 2:349–360
ISIS-3 (Third International Study of Infarct Survival) Collaborative Group (1992) ISIS-3: a randomised comparison of streptokinase vs tissue plasminogen activator vs anistreplase and of aspirin plus heparin vs aspirin alone among 41,299 cases of suspected acute myocardial infarction. Lancet 339:753–770
ISIS-4 (Fourth International Study of Infarct Survival) Collaborative Group (1995) ISIS-4: a randomised factorial trial assessing early oral captopril, oral mononitrate, and intravenous magnesium sulphate in 58,050 patients with suspected acute myocardial infarction. Lancet 345:669–685
Jacobs ET, Giuliano AR, Roe DJ, Guillen-Rodriguez JM, Hess LM, Alberts DS, Martinez ME (2002) Intake of supplemental and total fiber and risk of colorectal adenoma recurrence in the wheat branfiber trial. Cancer Epidemiol Biomarkers Prev 11:906–914
Kerry SM, Bland JM (1998) The intracluster correlation coefficient in cluster randomisation. BMJ 316:1455
Klar N, Donner A (1997) The merits of matching in community intervention trials: a cautionary tale. Stat Med 16:1753–1764
Knatterud GL (2002) Management and conduct of randomized controlled trials. Epidemiol Rev 24:12–25
Koepsell TD, Wagner EH, Cheadle AC, Patrick DL, Martin DC, Diehr PH, Perrin EB, Kristal AR, Allan-Andrilla CH, Dey LJ (1992) Selected methodological issues in evaluating community-based health promotion and disease prevention programs. Annu Rev Public Health 13:31–57
Koutsky LA, Ault KA, Wheeler CM, Brown DR, Barr E, Alvarez FB, Chiacchierini LM, Jansen KU (2002) A controlled trial of a human papillomavirus type 16 vaccine. N Engl J Med 347:1645–1651
Lavori P, Kelsey J (eds) (2002) Clinical trials. Epidemiol Rev 24:1–90
Medical Research Council Whooping-Cough Immunization Committee (1951) The prevention of whooping cough by vaccination. Br Med J 1951, i: 1463–1471
Moher D, Schulz KF, Altman DG (2001) The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomised trials. Lancet 357:1191–1194
Omenn GS, Goodman G, Thornquist M, Barnhart S, Balmes J, Cherniack M, Cullen M, Glass A, Keogh J, Liu D, Meyskens F, Jr., Perloff M, Valanis B, Williams J, Jr. (1996a) Chemoprevention of lung cancer: the beta-Carotene and Retinol Efficacy Trial (CARET) in high-risk smokers and asbestos-exposed workers. IARC Sci Publ 67–85
Omenn GS, Goodman GE, Thornquist MD, Balmes J, Cullen MR, Glass A, Keogh JP, Meyskens FL, Valanis B, Williams J H, Barnhart S, Hammar S (1996b) Effects of a combination of beta carotene andvitamin A on lung cancer and cardiovascular disease. N Engl J Med 334:1150–1155
Peto R, Baigent C (1998) Trials: the next 50 years. Large scale randomised evidence of moderate benefits. BMJ 317:1170–1171
Peto R, Collins R, Gray R (1995) Large-scale randomized evidence: large, simple trials and overviews of trials. J Clin Epidemiol 48:23–40
Peto R, Doll R, Buckley JD, Sporn MB (1981) Can dietary beta-carotene materially reduce human cancer rates? Nature 290:201–208
Peto R, Pike MC, Armitage P, Breslow NE, Cox DR, Howard SV, Mantel N, McPherson K, Peto J, Smith PG (1976) Design and analysis of randomized clinical trials requiring prolonged observation of each patient. I. Introduction and design. Br J Cancer 34:585–612
Peto R, Pike MC, Armitage P, Breslow NE, Cox DR, Howard SV, Mantel N, McPherson K, Peto J, Smith PG (1977) Design and analysis of randomized clinical trials requiring prolonged observation of each patient. II. analysis and examples. Br J Cancer 35:1–39
Plummer M, Franceschi S (2002) Strategies for HPV prevention. Virus Res 89: 285–293
Prentice RL (1989) Surrogate endpoints in clinical trials: definition and operational criteria. Stat Med 8:431–440
Puska P, Koskela K, Pakarinen H, Puumalainen P, Soininen V, Tuomilehto J (1976) The North Karelia Project: a programme for community control of cardiovascular diseases. Scand J Soc Med 4:57–60
Schatzkin A, Freedman LS, Dorgan J, McShane LM, Schiffman MH, Dawsey SM (1996) Surrogate end points in cancer research: a critique. Cancer Epidemiol Biomarkers Prev 5:947–953
Schatzkin A, Freedman LS, Schiffman MH, Dawsey SM (1990) Validation of intermediate end points in cancer research. J Natl Cancer Inst 82:1746–1752
Schatzkin A, Gail M (2002) The promise and peril of surrogate end points in cancer research. Nat Rev Cancer 2:19–27
Simon R (2001) Clinical trials in cancer. In: DeVita VT, Hellman S, Rosenberg SA (eds) Cancer: principles and practice of oncology. Lippincott Williams & Wilkins, Philadelphia, PA, p 521
Steering Committee of the Physicians’ Health Study Research Group (1989) Final report on the aspirin component of the ongoing Physicians’ Health Study. N Engl J Med 321:129–135
Stewart BW, McGregor D, Kleihues P (eds) (1996) Principles of chemoprevention, IARC Scientific Publications 139. International Agency for Research on Cancer, Lyon
Temple R, Ellenberg SS (2000) Placebo-controlled trials and active-control trials in the evaluation of new treatments. Ann Int Med 133:455–463
World Cancer Research Fund — American Institute for Cancer Research (CRFAICR) (1997) Food, nutrition and the prevention of cancer: a global perspective. American Institute for Cancer Research, Washington DC
Yusuf S, Collins R, Peto R (1984) Why do we need some large, simple randomized trials? Stat Med 3:409–422
Author information
Authors and Affiliations
Editor information
Editors and Affiliations
Rights and permissions
Copyright information
© 2005 Springer-Verlag Berlin Heidelberg
About this chapter
Cite this chapter
Franceschi, S., Plummer, M. (2005). Intervention Trials. In: Ahrens, W., Pigeot, I. (eds) Handbook of Epidemiology. Springer, Berlin, Heidelberg. https://doi.org/10.1007/978-3-540-26577-1_9
Download citation
DOI: https://doi.org/10.1007/978-3-540-26577-1_9
Publisher Name: Springer, Berlin, Heidelberg
Print ISBN: 978-3-540-00566-7
Online ISBN: 978-3-540-26577-1
eBook Packages: Mathematics and StatisticsMathematics and Statistics (R0)