Epidemiologic research with administrative databases: Red herrings, false alarms and pseudo-epidemics

Human Reproduction

Volumn 30, Issue 8, 2015, Pages 1749-1752

  Grimes, David A ^a  

^a UNIVERSITY OF NORTH CAROLINA SCHOOL OF MEDICINE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CLINICAL RESEARCH; DATA BASE; EPIDEMIC; EPIDEMIOLOGICAL DATA; EPIDEMIOLOGICAL MONITORING; FUZZY SYSTEM; HUMAN; NOTE; PRACTICE GUIDELINE; REGISTER; ADVERSE EFFECTS; FEMALE; INFERTILITY; INFERTILITY THERAPY; NEOPLASMS; PREGNANCY; RISK;

CLUPEIDAE;

FEMALE; HUMANS; INFERTILITY; NEOPLASMS; PREGNANCY; REPRODUCTIVE TECHNIQUES, ASSISTED; RISK;

EID: 84939611112     PISSN: 02681161     EISSN: 14602350     Source Type: Journal    
DOI: 10.1093/humrep/dev151     Document Type: Note

References (47)

1. Altman DG. The scandal of poor medical research. BMJ 1994;308:283-284.
2. nd edn. Washington, DC: American College of Obstetricians and Gynecologists, 2004.
3. Boffetta P, McLaughlin JK, La Vecchia C, Tarone RE, Lipworth L, Blot WJ. False-positive results in cancer epidemiology: a plea for epistemological modesty. J Natl Cancer Inst 2008;100:988-995.
4. Chalmers I. Raising the standards of clinical trials and research. Bull World Health Organ 2007;85:658-659.
5. Chambers GM, Adamson GD, Eijkemans MJ. Acceptable cost for the patient and society. Fertil Steril 2013;100:319-327.
6. Cousineau TM, Domar AD. Psychological impact of infertility. Best Pract Res Clin Obstet Gynaecol 2007;21:293-308.
7. Dinger J, Shapiro S. Combined oral contraceptives, venous thromboembolism, and the problem of interpreting large but incomplete datasets. J Fam Plann Reprod Health Care 2012;38:2-6.
8. Dinger JC, Heinemann LA, Kuhl-Habich D. The safety of a drospirenone-containing oral contraceptive: final results from the European Active Surveillance Study on oral contraceptives based on 142,475 women-years of observation. Contraception 2007;75:344-354.
9. Dinger J, Bardenheuer K, Heinemann K. Cardiovascular and general safety of a 24-day regimen of drospirenone-containing combined oral contraceptives: final results from the International Active Surveillance Study of Women Taking Oral Contraceptives. Contraception 2014;89:253-263.
10. Fjerstad M, Westhoff C, Lifford KL. Immediate complications after medical compared with surgical termination of pregnancy. Obstet Gynecol 2010;115:660; author reply 660-661.
11. Fraser IS. Added health benefits of the levonorgestrel contraceptive intrauterine system and other hormonal contraceptive delivery systems. Contraception 2013;87:273-279.
12. Grimes DA. Epidemiologic research using administrative databases: garbage in, garbage out. Obstet Gynecol 2010;116:1018-1019.
13. Grimes DA, Raymond EG. Medical abortion for adolescents. BMJ 2011;342:d2185.
14. Grimes DA, Schulz KF. Cohort studies: marching towards outcomes. Lancet 2002;359:341-345.
15. Grimes DA, Schulz KF. False alarms and pseudo-epidemics: the limitations of observational epidemiology. Obstet Gynecol 2012;120:920-927.
16. Hill AB. The environment and disease: association or causation. Proc R Soc Med 1965;58:295-300.
17. Ioannidis JP. Why most published research findings are false. PLoS Med 2005;2:e124.
18. Ioannidis JP. Why most discovered true associations are inflated. Epidemiology 2008;19:640-648.
19. Ioannidis JP, Tatsioni A, Karassa FB. Who is afraid of reviewers' comments? Or, why anything can be published and anything can be cited. Eur J Clin Invest 2010;40:285-287.
20. Jones EF, Beniger JR, Westoff CF. Pill and IUD discontinuation in the United States, 1970-1975: the influence of the media. Fam Plann Perspect 1980;12:293-300.
21. Lam JU, Rebolj M, Dugue PA, Bonde J, von Euler-Chelpin M, Lynge E. Condom use in prevention of Human Papillomavirus infections and cervical neoplasia: systematic review of longitudinal studies. J Med Screen 2014;21:38-50.
22. Levine MA, El-Nahas AI, Asa B. Relative risk and odds ratio data are still portrayed with inappropriate scales in the medical literature. J Clin Epidemiol 2010;63:1045-1047.
23. Lidegaard O, Lokkegaard E, Jensen A, Skovlund CW, Keiding N. Thrombotic stroke and myocardial infarction with hormonal contraception. N Engl J Med 2012a;366:2257-2266.
24. Lidegaard O, Nielsen LH, Skovlund CW, Lokkegaard E. Venous thrombosis in users of non-oral hormonal contraception: follow-up study, Denmark 2001-10. BMJ 2012b;344:e2990.
25. Ness RB, Grisso JA, Klapper J, Schlesselman JJ, Silberzweig S, Vergona R, Morgan M, Wheeler JE. Risk of ovarian cancer in relation to estrogen and progestin dose and use characteristics of oral contraceptives. SHARE Study Group. Steroid Hormones and Reproductions. Am J Epidemiol 2000;152:233-241.
26. Nevadunsky NS, Van Arsdale A, Strickler HD, Moadel A, Kaur G, Levitt J, Girda E, Goldfinger M, Goldberg GL, Einstein MH. Obesity and age at diagnosis of endometrial cancer. Obstet Gynecol 2014;124:300-306.
27. Niinimaki M, Pouta A, Bloigu A, Gissler M, Hemminki E, Suhonen S, Heikinheimo O. Immediate complications after medical compared with surgical termination of pregnancy. Obstet Gynecol 2009;114:795-804.
28. Niinimaki M, Suhonen S, Mentula M, Hemminki E, Heikinheimo O, Gissler M. Comparison of rates of adverse events in adolescent and adult women undergoing medical abortion: population register based study. BMJ 2011;342:d2111.
29. Reigstad MM, Larsen IK, Myklebus TÅ, Robsahm TE, Oldereid NB, Omland AK, Vangen S, Brinton LA, Storeng R. Cancer risk among parous women following assisted reproductive technology. Hum Reprod 2015a;30:1952-1963.
30. Reigstad MM, Larsen IK, Myklebust TÅ, Robsahm TE, Oldereid NB, Omland AK, Vangen S, Brinton LA, Storeng R. Risk of breast cancer following fertility treatment - a registry based cohort study of parous women in Norway. Int J Cancer 2015b;136:1140-1148.
31. Russell C. Living can be hazardous to your health: how the news media cover cancer risks. J Natl Cancer Inst Monogr 1999:167-170.
32. Schulz KF, Grimes DA. The Lancet Handbook of Essential Concepts in Clinical Research. London: Elsevier, 2006
33. Severinsen MT, Kristensen SR, Overvad K, Dethlefsen C, Tjonneland A, Johnsen SP. Venous thromboembolism discharge diagnoses in the Danish National Patient Registry should be used with caution. J Clin Epidemiol 2010;63:223-228.
34. Shapiro S. Bias in the evaluation of low-magnitude associations: an empirical perspective. Am J Epidemiol 2000;151:939-945.
35. Shapiro S. Causation, bias and confounding: a hitchhiker's guide to the epidemiological galaxy Part 2. Principles of causality in epidemiological research: confounding, effect modification and strength of association. J Fam Plann Reprod Health Care 2008;34:185-190.
36. Silver N. The Signal and the Noise. New York: The Penguin Press, 2012.
37. Simera I, Moher D, Hirst A, Hoey J, Schulz KF, Altman DG. Transparent and accurate reporting increases reliability, utility, and impact of your research: reporting guidelines and the EQUATOR Network. BMC Med 2010;8:24.
38. Skjeldestad FE. Increased number of induced abortions in Norway after media coverage of adverse vascular events from the use of third-generation oral contraceptives. Contraception 1997;55:11-14.
39. Smith GD. Reflections on the limitations to epidemiology. J Clin Epidemiol 2001;54:325-331.
40. Smith R. The highly profitable but unethical business of publishing medical research. J R Soc Med 2006;99:452-456.
41. Taubes G. Epidemiology faces its limits. Science 1995;269:164-169.
42. U.S. Food and Drug Administration. Best practices for conducting and reporting pharmacoepidemiologic safety studies using electronic healthcare data sets, http://wwwfdagov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/defaulthtm (accessed May 10, 2015).
43. von Elm E, Egger M. The scandal of poor epidemiological research. BMJ 2004;329:868-869.
44. von Elm E, Altman DG, Egger M, Pocock SJ, Gotzsche PC, Vandenbroucke JP. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies. Lancet 2007;370:1453-1457.
45. Wakeham K, Kavanagh K. The burden of HPV-associated anogenital cancers. Curr Oncol Rep 2014;16:402.
46. Winkelstein WJ. Smoking and cervical cancer - current status: a review. Am J Epidemiol 1990;131:945-957; discussion 958-960.
47. Young SS, Karr A. Deming, data and observational studies. A process out of control and needing fixing. Significance 2011:120.