Lubsen J, Pocock SJ. Factorial trials in cardiology: pros and cons. Eur Heart J.1994;15:585-588.
Moher D, Jones A, Lepage L.for the CONSORT Group. Use of the CONSORT statement and quality of reports of randomized trials:
a comparative before-and-after evaluation. JAMA.2001;285:1992-1995.
Devereaux PJ, Manns BJ, Ghali WA, Quan H, Guyatt GH. The reporting of methodological factors in randomized controlled trials
and the association with a journal policy to promote adherence to the Consolidated
Standards of Reporting Trials (CONSORT) checklist. Control Clin Trials.2002;23:380-388.
Begg C, Cho M, Eastwood S.
et al. Improving the quality of reporting of randomized controlled trials:
the CONSORT statement. JAMA.1996;276:637-639.
Moher D, Schulz KF, Altman DG.for the CONSORT Group. The CONSORT statement: revised recommendations for improving the quality
of reports of parallel-group randomised trials. Lancet.2001;357:1191-1194.
Cairns JA, Gent M, Singer J.
et al. Aspirin, sulfinpyrazone, or both in unstable angina. N Engl J Med.1985;313:1369-1375.
ISIS-2 (Second International Study of Infarct Survival) Collaborative
Group. Randomised trial of intravenous streptokinase, oral aspirin, both,
or neither among 17,187 cases of suspected acute myocardial infarction: ISIS-2. Lancet.1988;2:349-361.
Gruppo Italiano per lo Studio della Sopravvivenza nell'Infarto Miocardico. GISSI-2: a factorial randomised trial of alteplase versus streptokinase
and heparin versus no heparin among 12,490 patients with acute myocardial
The International Study Group. In-hospital mortality and clinical course of 20,891 patients with suspected
acute myocardial infarction randomised between alteplase and streptokinase
with or without heparin. Lancet.1990;336:71-75.
Califf RM, Topol EJ, Stack RS.
et al. for the TAMI Study Group. Evaluation of combination thrombolytic therapy and timing of cardiac
catheterization in acute myocardial infarction. Circulation.1991;83:1543-1556.
Third International Study of Infarct Survival Collaborative Group. 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.1992;339:753-770.
Gruppo Italiano per lo Studio della Sopravvivenza nell'Infarto
Miocardico. GISSI-3: effects of lisinopril and transdermal glyceryl trinitrate
singly and together on 6-week mortality and ventricular function after acute
myocardial infarction. Lancet.1994;343:1115-1122.
ISIS-4 (Fourth International Study of Infarct Survival) Collaborative
Group. 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.1995;345:669-685.
Cairns JA, Gill J, Morton B.
et al. for the EMPAR Collaborators. Fish oils and low-molecular-weight heparin for the reduction of restenosis
after percutaneous transluminal coronary angioplasty: the EMPAR Study. Circulation.1996;94:1553-1560.
Rapola JM, Virtamo J, Ripatti S.
et al. Randomised trial of alpha-tocopherol and beta-carotene supplements
on incidence of major coronary events in men with previous myocardial infarction. Lancet.1997;349:1715-1720.
The PARAGON Investigators. International, randomized, controlled trial of lamifiban (a platelet
glycoprotein IIb/IIIa inhibitor), heparin, or both in unstable angina. Circulation.1998;97:2386-2395.
Rapola JM, Virtamo J, Ripatti S.
et al. Effects of alpha tocopherol and beta carotene supplements on symptoms,
progression, and prognosis of angina pectoris. Heart.1998;79:454-458.
The Medical Research Council's General Practice Research Framework. Thrombosis prevention trial: randomised trial of low-intensity oral
anticoagulation with warfarin and low-dose aspirin in the primary prevention
of ischaemic heart disease in men at increased risk. Lancet.1998;351:233-241.
Fragmin and fast Revascularization during InStability in Coronary artery
disease (FRISC II) Investigators. Invasive compared with non-invasive treatment in unstable coronary-artery
disease: FRISC II prospective randomised multicentre study. Lancet.1999;354:708-715.
GISSI-Prevenzione Investigators. Dietary supplementation with n-3 polyunsaturated fatty acids and vitamin
E after myocardial infarction: results of the GISSI-Prevenzione Trial. Lancet.1999;354:447-455.
Teo KK, Burton JB, Buller CE.
et al. Long-term effects of cholesterol lowering and angiotensin-converting
enzyme inhibition on coronary atherosclerosis: the Simvastatin/enalapril Coronary
Atherosclerosis Trial (SCAT). Circulation.2000;102:1748-1754.
Stone GW, Grines CL, Cox DA.
et al. for the CADILLAC Investigators. Comparison of angioplasty with stenting, with or without abciximab,
in acute myocardial infarction. N Engl J Med.2002;346:957-966.
Heart Protection Study Collaborative Group. MRC/BHF Heart Protection Study of cholesterol lowering with simvastatin
in 20,536 high-risk individuals: a randomised placebo-controlled trial. Lancet.2002;360:7-22.
Heart Protection Study Collaborative Group. MRC/BHF Heart Protection Study of antioxidant vitamin supplementation
in 20,536 high-risk individuals: a randomised placebo-controlled trial. Lancet.2002;360:23-33.
ISIS (International Studies of Infarct Survival) Pilot Study Investigators. Randomized factorial trial of high-dose intravenous streptokinase,
of oral aspirin, and of intravenous heparin in acute myocardial infarction. Eur Heart J.1987;8:634-642.
Burr ML, Gilbert JF, Holliday RM.
et al. Effects of changes in fat, fish, and fibre intakes on death and myocardial
reinfarction: diet and reinfarction trial (DART). Lancet.1989;2:757-761.
Steering Committee of the Physicians' Health Study Research Group. Final report on the aspirin component of the ongoing Physicians' Health
Study. N Engl J Med.1989;321:129-135.
Hennekens CH, Buring JE, Manson JE.
et al. Lack of effect of long-term supplementation with beta carotene on the
incidence of malignant neoplasms and cardiovascular disease. N Engl J Med.1996;334:1145-1149.
TIMI IIIB Investigators. Effects of tissue plasminogen activator and a comparison of early invasive
and conservative strategies in unstable angina and non-Q-wave myocardial infarction:
results of the TIMI IIIB Trial. Circulation.1994;89:1545-1556.
Bovill EG, Tracy RP, Knatterud GL.
et al. Hemorrhagic events during therapy with recombinant tissue plasminogen
activator, heparin, and aspirin for unstable angina (Thrombolysis in Myocardial
Ischemia, phase IIIB trial). Am J Cardiol.1997;79:391-396.
O'Connor CM, Meese RB, McNulty S.
et al. for the DUCCS-II Investigators. A randomized factorial trial of reperfusion strategies and aspirin
dosing in acute myocardial infarction. Am J Cardiol.1996;77:791-797.
The GUSTO-IIb Angioplasty Substudy Investigators. A clinical trial comparing primary coronary angioplasty with tissue
plasminogen activator for acute myocardial infarction. N Engl J Med.1997;336:1621-1628.
Post Coronary Artery Bypass Graft Trial Investigators. The effect of aggressive lowering of low-density lipoprotein cholesterol
levels and low-dose anticoagulation on obstructive changes in saphenous-vein
coronary-artery bypass grafts. N Engl J Med.1997;336:153-162.
Lincoff AM, Tcheng JE, Califf RM.
et al. for the PROLOG Investigators. Standard versus low-dose weight-adjusted heparin in patients treated
with the platelet glycoprotein IIb/IIIa receptor antibody fragment Abciximab
(c7E3 Fab) during percutaneous coronary revascularization. Am J Cardiol.1997;79:286-291.
Baigent C, Collins R, Appleby P, Parish S, Sleight P, Peto R.for the ISIS-2 (Second International Study of Infarct Survival) Collaborative
Group. ISIS-2: 10 year survival among patients with suspected acute myocardial
infarction in randomised comparison of intravenous streptokinase, oral aspirin,
both, or neither. BMJ.1998;316:1337-1343.
Yusuf S, Sleight P, Pogue J, Bosch J, Davies R, Dagenais G.for the Heart Outcomes Prevention Evaluation Study Investigators. Effects of an angiotensin converting enzyme inhibitor, ramipril, on
cardiovascular events in high-risk patients. N Engl J Med.2000;342:145-153.
Yusuf S, Dagenais G, Pogue J, Bosch J, Sleight P.for the Heart Outcomes Prevention Evaluation Study Investigators. Vitamin E supplementation and cardiovascular events in high-risk patients. N Engl J Med.2000;342:154-160.
Collaborative Group of the Primary Prevention Project (PPP). Low-dose aspirin and vitamin E in people at cardiovascular risk: a
randomised trial in general practice. Lancet.2001;357:89-95.
Correa P, Fontham ETH, Bravo JC.
et al. Chemoprevention of gastric dysplasia: randomized trial of antioxidant
supplements and anti-helicobacter pylori therapy. J Natl Cancer Inst.2000;92:1881-1888.
Galinkin JL, Fazi LM, Cuy RM.
et al. Use of intranasal fentanyl in children undergoing myringotomy and tube
placement during halothane and sevoflurane anesthesia. Anesthesiology.2000;93:1378-1383.
Heinala P, Alho H, Kiianmaa K, Lonnqvist J, Kuoppasalmi K, Sinclair JD. Targeted use of naltrexone without prior detoxification in the treatment
of alcohol dependence: a factorial double-blind, placebo-controlled trial. J Clin Psychopharmacol.2001;21:287-292.
Grant A, Gordon B, Mackrodat C, Fern E, Truesdale A, Ayers S. The Ipswich childbirth study: one year follow up of alternative methods
used in perineal repair. BJOG.2001;108:34-40.
Neoptolemos JP, Dunn JA, Stocken DD.
et al. Adjuvant chemoradiotherapy and chemotherapy in resectable pancreatic
cancer: a randomised controlled trial. Lancet.2001;358:1576-1585.
Kenyon SL, Taylor DJ, Tarnow-Mordi W.for the ORACLE Collaborative Group. Broad-spectrum antibiotics for preterm, prelabour rupture of fetal
membranes: the ORACLE I randomised trial. Lancet.2001;357:979-988.
Kenyon SL, Taylor DJ, Tarnow-Mordi W.for the ORACLE Collaborative Group. Broad-spectrum antibiotics for spontaneous preterm labour: the ORACLE
II randomised trial. Lancet.2001;357:989-994.
Halliday HL, Patterson CC, Halahakoon CW.for the European Multicenter Steroid Study Group. A multicenter, randomized open study of early corticosteroid treatment
(OSECT) in preterm infants with respiratory illness: comparison of early and
late treatment and of dexamethasone and inhaled budesonide. Pediatrics.2001;107:232-240.
Tjan-Heijnen VC, Postmus PE, Ardizzoni A.
et al. Reduction of chemotherapy-induced febrile leucopenia by prophylactic
use of ciprofloxacin and roxithromycin in small-cell lung cancer patients:
an EORTC double-blind placebo-controlled phase III study. Ann Oncol.2001;12:1359-1368.
Wit FW, Wood R, Horban A.
et al. Prednisolone does not prevent hypersensitivity reactions in antiretroviral
drug regimens containing abacavir with or without nevirapine. AIDS.2001;15:2423-2429.
Cohen HJ, Feussner JR, Weinberger M.
et al. A controlled trial of inpatient and outpatient geriatric evaluation
and management. N Engl J Med.2002;346:905-912.
Fawzi WW, Msamanga G, Hunter D.
et al. Randomised trial of vitamin supplements in relation to vertical transmission
of HIV-1 in Tanzania. J Acquir Immune Defic Syndr.2000;23:246-254.
Karlstrom PO, Bergh T, Lundkvist O. Addition of gonadotropin-releasing hormone agonist and/or two inseminations
with husband's sperm do not improve the pregnancy rate in superovulated cycles. Acta Obstet Gynecol Scand.2000;79:37-42.
Doft BH, Wisniewski SR, Kelsey SF, Fitzgerald SG. Diabetes and postoperative endophthalmitis in the endophthalmitis vitrectomy
study. Arch Ophthalmol.2001;119:650-656.
Sazawal S, Black RE, Menon VP.
et al. Zinc supplementation in infants born small for gestational age reduces
mortality: a prospective, randomized, controlled trial. Pediatrics.2001;108:1280-1286.
Piantadosi S. Clinical Trials: A Methodologic Perspective. New York, NY: John Wiley; 2000:392.
Altman DG, Bland JM. Interaction revisited: the difference between two estimates. BMJ.2003;326:219.
Altman DG, Schulz KF, Moher D.
et al. for the CONSORT Group. The revised CONSORT statement for reporting randomized trials: explanation
and elaboration. Ann Intern Med.2001;134:663–694.
Brittain E, Wittes J. Factorial designs in clinical trials: effects of non-compliance and
subadditivity. Stat Med.1989;8:161-171.
Schulz KF, Chalmers I, Hayes RJ, Altman DG. Empirical evidence of bias: dimensions of methodological quality associated
with estimates of treatment effects in controlled trials. JAMA.1995;273:408-412.
Moher D, Pham B, Jones A.
et al. Does the quality of reports of randomised trials affect estimates of
intervention efficacy reported in meta-analyses? Lancet.1998;352:609-613.
Jüni P, Altman DG, Egger M. Assessing the quality of controlled clinical trials. BMJ.2001;323:42-46.
Liberati A, Himel HN, Chalmers TC. A quality assessment of randomized control trials of primary treatment
of breast cancer. J Clin Oncol.1986;4:942-951.