Comparison of evidence on harms of medical interventions in randomized and nonrandomized studies

CMAJ. Canadian Medical Association Journal

Volumn 174, Issue 5, 2006, Pages 635-641

  Papanikolaou, Panagiotis N ^a   Christidi, Georgia D ^a   Ioannidis, John P A ^a  

^a UNIVERSITY OF IOANNINA   (Greece)

Author keywords

[No Author keywords available]

Indexed keywords

ACETYLSALICYLIC ACID; ANTICOAGULANT AGENT; ANTITHROMBOCYTIC AGENT; FOLIC ACID; ISONIAZID; NAPROXEN; PERTUSSIS VACCINE; ROFECOXIB;

ACUTE HEART INFARCTION; ARTICLE; BLEEDING; BLOOD VESSEL INJURY; BRAIN DISEASE; BRAIN HEMORRHAGE; COMPARATIVE STUDY; CONTROLLED STUDY; CONVULSION; EXPERIMENTAL DESIGN; FEASIBILITY STUDY; HUMAN; HYPOTONIC HYPORESPONSIVE EPISODE; IATROGENIC DISEASE; MULTIPLE PREGNANCY; RANDOMIZATION; RISK ASSESSMENT; SPONTANEOUS ABORTION; TOXIC HEPATITIS; WOUND INFECTION;

EID: 33644752689     PISSN: 08203946     EISSN: 14882329     Source Type: Journal    
DOI: 10.1503/cmaj.050873     Document Type: Article

References (47)

1. Ioannidis JP, Lau J. Completeness of safety reporting in randomized trials: an evaluation of 7 medical areas. JAMA 2001;285:437-43.
2. Ioannidis JP, Evans SJ, Gotzsche PC, et al; CONSORT Group. Better reporting of harms in randomized trials: an extension of the CONSORT statement. Ann Intern Med 2004;141:781-8.
3. Topol EJ. Failing the public health - rofecoxib, Merck, and the FDA. N Engl J Med 2004;351:1707-9.
4. Lasser KE, Allen PD, Woolhandler SJ, et al. Timing of new black box warnings and withdrawals for prescription medications. JAMA 2002;287:2215-20.
5. Jick H. The discovery of drug-induced illness. N Engl J Med 1977;296:481-5.
6. Vandenbroucke JP. Benefits and harms of drug treatments. BMJ 2004;329:2-3.
7. Stephens MD, Talbot JC, Routledge PA, editors. The detection of new adverse reactions. 4th ed. London (UK): Macmillan Reference; 1998.
8. Edwards IR, Aronson JK. Adverse drug reactions: definitions, diagnosis, and management. Lancet 2000;356:1255-9.
9. Ioannidis JP, Lau J. Improving safety reporting from randomised trials. Drug Saf 2002;25:77-84.
10. Papanikolaou PN, Ioannidis JP. Availability of large-scale evidence on specific harms from systematic reviews of randomized trials. Am J Med 2004;17:582-9.
11. Ioannidis JP, Haidich AB, Pappa M, et al. Comparison of evidence of treatment effects in randomized and nonrandomized studies. JAMA 2001;286:821-30.
12. Furukawa TA, Streiner DL, Hori S. Discrepancies among megatrials. J Clin Epidemiol 2000;53:1193-9.
13. Lau J, Ioannidis JP, Schmid CH. Quantitative synthesis in systematic reviews. Ann Intern Med 1997;127:820-6.
14. Cappelleri JC, Ioannidis JP, Schmid CH, et al. Large trials vs meta-analysis of smaller trials: How do their results compare? JAMA 1996;276:1332-8.
15. Geier DA, Geier MR. An evaluation of serious neurological disorders following immunization: a comparison of whole-cell pertussis and acellular pertussis vaccines. Brain Dev 2004;26:296-300.
16. Rosenthal S, Chen R, Hadler S. The safety of acellular pertussis vaccine vs whole-cell pertussis vaccine: a postmarketing assessment. Arch Pediatr Adolesc Med 1996;150:457-60.
17. Le Saux N, Barrowman NJ, Moore DL, et al. Canadian Paediatric Society/Health Canada Immunization Monitoring Program-Active (LMPACT). Decrease in hospital admissions for febrile seizures and reports of hypotonic- hyporesponsive episodes presenting to hospital emergency departments since switching to acellular pertussis vaccine in Canada: a report from IMPACT. Pediatrics 2003;112:e348.
18. Kaplan RC, Heckbert SR, Koepsell TD, et al. Risk factors for hospitalized gastrointestinal bleeding among older persons. Cardiovascular Health Study Investigators. J Am Geriatr Soc 2001;49:126-33.
19. Johnsen SP, Sørensen HT, Mellemkjoer L, et al. Hospitalisation for upper gastrointestinal bleeding associated with use of oral anticoagulants. Thromb Haemost 2001;86:563-8.
20. Jick H, Porter J. Drug-induced gastrointestinal bleeding. Lancet 1978;2:87-9.
21. Quilliam BJ, Lapane KL, Eaton CB, et al. Effect of antiplatelet and anticoagulant agents on risk of hospitalization for bleeding among a population of elderly nursing home stroke survivors. Stroke 2001;32:2299-304.
22. Shorr RJ, Ray WA, Daugherty JR, et al. Concurrent use of nonsteroidal anti-inflammatory drugs and oral anticoagulants places elderly persons at high risk for hemorrhagic peptic ulcer disease. Arch Intern Med 1993;153:1665-70.
23. Själander A, Engström G, Berntorp E, et al. Risk of haemorrhagic stroke in patients with oral anticoagulation compared with the general population. J Intern Med 2003;254:434-8.
24. Fogelholm R, Eskola K, Kiminkinen T, et al. Anticoagulant treatment as a risk factor for primary intracerebral haemorrhage. J Neurol Neurosurg Psychiatry 1992;55:1121-4.
25. Iso H, Hennekens CH, Stampfer MJ, et al. Prospective study of aspirin use and risk of stroke in women. Stroke 1999;30:1764-71.
26. Kronmal RA, Hart RG, Manolio TA, et al. Aspirin use and incident stroke in the Cardiovascular Health Study. CHS Collaborative Research Group. Stroke 1998;29: 887-94.
27. Nolan CM, Goldberg SV, Buskin SE. Hepatotoxicity associated with isoniazid preventive therapy. A 7-year survey from a public health tuberculosis clinic. JAMA 1999;281:1014-8.
28. Salpeter SR. Fatal isoniazid-induced hepatitis. Its risk during chemoprophylaxis. West J Med 1993;159:560-4.
29. Hair A, Duffy K, McLean J, et al. Groin hernia repair in Scotland. Br J Surg 2000;87: 1722-6.
30. Koch A, Zippel R, Marusch F, et al. Prospective multicenter study of antibiotic prophylaxis in operative treatment of appendicitis. Dig Surg 2000;17:370-8.
31. Guller U, Jain N, Peterson ED, et al. Laparoscopic appendectomy in the elderly. Surgery 2004;135:479-88.
32. Gindler J, Li Z, Berry RJ, et al. Folic acid supplements during pregnancy and risk of miscarriage; Jiaxing City Collaborative Project on Neural Tube Defect Prevention. Lancet 2001;358:796-800.
33. Windham GC, Shaw GM, Todoroff K, et al. Miscarriage and use of multi-vitamins or folic acid. Am J Med Genet 2000;90:261-2.
34. Li Z, Gindler J, Wang H, et al. Folic acid supplements during early pregnancy and likelihood of multiple births: a population-based cohort study. Lancet 2003;361:380-4.
35. Werler MM, Cragan JD, Wasserman CR, et al. Multivitamin supplementation and multiple births. Am J Med Genet 1997;71:93-6.
36. Ericson A, Kallen B, Aberg A. Use of multivitamins and folic acid in early pregnancy and multiple births in Sweden. Twin Res 2001;4:63-6.
37. Horwitz PA, Berlin JA, Sauer WH, et al.; Registry Committee of the Society for Cardiac Angiography Interventions. Bleeding risk of platelet glycoprotein IIb/IIIa receptor antagonists in broad-based practice (results from the Society for Cardiac Angiography and Interventions Registry). Am J Cardiol 2003;91:803-6.
38. Ray WA, Stein M, Daugherty JR, et al. COX-2 selective non-steroidal anti-inflammatory drugs and risk of serious coronary heart disease. Lancet 2002;360:1071-3.
39. Mamdani M, Rochon P, Juurlink DN, et al. Effect of selective cyclooxygenase 2 inhibitors and naproxen on short-term risk of acute myocardial infarction in the elderly. Arch Intern Med 2003;163:481-6.
40. Ioannidis JPA. Why most published research findings are false. PLoS J Med 2005;2:e124.
41. Ioannidis JPA. Contradicted and initially stronger effects in highly cited clinical research. JAMA 2005;294:218-28.
42. Benson K, Hartz AJ. A comparison of observational studies and randomized, controlled trials. N Engl J Med 2000;342:1878-86.
43. Concato J, Shah N, Horwitz RI. Randomized, controlled trials, observational studies, and the hierarchy of research designs. N Engl J Med 2000;342:1887-92.
44. Ioannidis JP, Haidich AB, Lau J. Any casualties in the clash of randomized and observational evidence? BMJ 2001;322:879-80.
45. LeLorier J, Gregoire G, Benhaddad A, et al. Discrepancies between meta-analyses and subsequent large randomized, controlled trials. N Engl J Med 1997;337:536-42.
46. Ioannidis JP, Cappelleri JC, Lau J. Issues in comparisons between meta-analyses and large trials. JAMA 1998;279:1089-93.
47. Cook RJ, Sackett DL. The number needed to treat: a clinically useful measure of treatment effect. BMJ 1995;310:452-4.