Self-controlled case series and misclassification bias induced by case selection from administrative hospital databases: Application to febrile convulsions in pediatric vaccine pharmacoepidemiology

American Journal of Epidemiology

Volumn 178, Issue 12, 2013, Pages 1731-1739

  Quantin, Catherine ^a,b   Benzenine, Eric ^a   Velten, Michel ^c,d   Huet, Frédéric ^a   Paddy Farrington, C ^e   Tubert Bitter, Pascale ^f,g  

^a DIJON UNIVERSITY HOSPITAL   (France)

^b UNIVERSITÉ DE BOURGOGNE   (France)

^c UNIVERSITÉ DE STRASBOURG   (France)

^d Paul Strauss Comprehensive Cancer Center   (France)

^e OPEN UNIVERSITY   (United Kingdom)

^f CENTRE FOR RESEARCH IN EPIDEMIOLOGY AND POPULATION HEALTH   (France)

^g UNIVERSITÉ PARIS SACLAY   (France)

Author keywords

Administrative data; Bias; Febrile convulsions; Pharmacoepidemiology; Positive predictive value; Power; Vaccines

Indexed keywords

VACCINE;

ALGORITHM; CHILD HEALTH; EPIDEMIOLOGY; HOSPITAL SECTOR; SAMPLING BIAS; VACCINE;

ARTICLE; CASE STUDY; CHILD; CHILD HOSPITALIZATION; CHILDHOOD DISEASE; CLASSIFICATION ALGORITHM; DRUG SAFETY; FEBRILE CONVULSION; FRANCE; HUMAN; INFANT; MAJOR CLINICAL STUDY; PEDIATRIC HOSPITAL; PHARMACOEPIDEMIOLOGY; PREDICTIVE VALUE; PRESCHOOL CHILD; SENSITIVITY ANALYSIS; VALIDATION STUDY;

ADMINISTRATIVE DATA; BIAS; FEBRILE CONVULSIONS; PHARMACOEPIDEMIOLOGY; POSITIVE PREDICTIVE VALUE; POWER; VACCINES;

ALGORITHMS; BIAS (EPIDEMIOLOGY); CAUSALITY; CHILD, PRESCHOOL; DATABASES, FACTUAL; FEMALE; FRANCE; HOSPITAL ADMINISTRATION; HUMANS; INFANT; MALE; PHARMACOVIGILANCE; RESEARCH DESIGN; SEIZURES, FEBRILE; VACCINES;

FRANCE;

EID: 84890604248     PISSN: 00029262     EISSN: 14766256     Source Type: Journal    
DOI: 10.1093/aje/kwt207     Document Type: Article

References (72)

1. Farrington P, Pugh S, Colville A, et al. A new method for active surveillance of adverse events from diphtheria/tetanus/pertussis and measles/mumps/rubella vaccines. Lancet. 1995;345(8949):567-569.
2. Chan KA, Andrade SE, Boles M, et al. Inhibitors of hydroxymethylglutaryl- coenzyme A reductase and risk of fracture among older women. Lancet. 2000;355(92222): 2185-2188.
3. Ray WA, Daugherty JR, Griffin MR. Lipid-lowering agents and the risk of hip fracture in a Medicaid population. Inj Prev. 2002;8(4):276-279.
4. Cameron JC, Walsh D, Finlayson AR, et al. Oral polio vaccine and intussusception: a data linkage study using records for vaccination and hospitalization. Am J Epidemiol. 2006; 163(6):528-533.
5. Verhamme K, Sturkenboom M. Study designs in paediatric pharmacoepidemiology. Eur J Clin Pharmacol. 2011; 67(1 suppl):67S-74S.
6. Habel LA, Cooper WO, Sox CM, et al. ADHD medications and risk of serious cardiovascular events in young and middleaged adults. JAMA. 2011;306(24):2673- 2683.
7. Blin P, Lassalle R, Dureau-Pournin C, et al. Insulin glargine and risk of cancer: a cohort study in the French National Healthcare Insurance Database. Diabetologia. 2012;55(3): 644-653.
8. Fagot JP, Blotiere PO, Ricordeau P, et al. Does insulin glargine increase the risk of cancer compared with other basal insulins? A French nationwide cohort study based on national administrative databases. Diabetes Care. 2013;36(2):294-301.
9. Neumann A, Weill A, Ricordeau P, et al. Pioglitazone and risk of bladder cancer among diabetic patients in France: a population-based cohort study. Diabetologia. 2012;55(7): 1953-1962.
10. Takahashi Y, Nishida Y, Asai S. Utilization of health care databases for pharmacoepidemiology. Eur J Clin Pharmacol. 2012;68(2):123-129.
11. Moro ML, Nobilio L, Voci C, et al. A population based cohort study to assess the safety of pandemic influenza vaccine, Focetria in Emilia-Romagna region, Italy-part two. Vaccine. 2013;31(10):1438-1446.
12. Shapiro S. Automated record linkage: a response to the commentary and letters to the editor. Clin Pharmacol Ther. 1989;46(4):395-398.
13. Faich GA, Stadel BV. The future of automated record linkage for postmarketing surveillance: a response to Shapiro. Clin Pharmacol Ther. 1989;46(4):387-389.
14. Strom BL, Carson JL. Automated data bases used for pharmacoepidemiology research. Clin Pharmacol Ther. 1989;46(4):390-394.
15. Shapiro S. The role of automated record linkage in the postmarketing surveillance of drug safety: a critique. Clin Pharmacol Ther. 1989;46(4):371-386.
16. Mullooly JP. Misclassification model for person-time analysis of automated medical care databases. Am J Epidemiol. 1996;144(8):782-792.
17. Couris CM, Colin C, Rabilloud M, et al. Method of correction to assess the number of hospitalized incident breast cancer cases based on claims databases. J Clin Epidemiol. 2002; 55(4):386-391.
18. Arbogast PG, Ray WA. Use of disease risk scores in pharmacoepidemiologic studies. Stat Methods Med Res. 2009;18(1):67-80.
19. Noize P, Bazin F, Dufouil C, et al. Comparison of health insurance claims and patient interviews in assessing drug use: data from the Three-City (3C) Study. Pharmacoepidemiol Drug Saf. 2009;18(4):310-319.
20. Hartzema AG, Racoosin JA, MaCurdy TE, et al. Utilizing Medicare claims data for real-time drug safety evaluations: Is it feasible?. Pharmacoepidemiol Drug Saf. 2011;20(7):684-688.
21. Ray WA. Improving automated database studies. Epidemiology. 2011;22(3):302-304.
22. Dart AB, Martens PJ, Sellers EA, et al. Validation of a pediatric diabetes case definition using administrative health data in Manitoba, Canada. Diabetes Care. 2011;34(4):898-903.
23. Kawai VK, Murray KT, Stein CM, et al. Validation of a computer case definition for sudden cardiac death in opioid users. BMC Res Notes. 2012;5:473.
24. Bernard MA, Benichou J, Blin P, et al. Use of health insurance claim patterns to identify patients using nonsteroidal antiinflammatory drugs for rheumatoid arthritis. Pharmacoepidemiol Drug Saf. 2012;21(6):573-583.
25. Farrington CP. Relative incidence estimation from case series for vaccine safety evaluation. Biometrics. 1995;51(1):228-235.
26. Whitaker HJ, Farrington CP, Spiessens B, et al. Tutorial in biostatistics: the self-controlled case series method. Stat Med. 2006;25(10):1768-1797.
27. Farrington P, Pugh S, Colville A, et al. A new method for active surveillance of adverse events from diphteria/tetanus/pertussis and measles/mumps/rubella vaccines. Lancet. 1995;345(8949):567-569.
28. Murphy TV, Gargiullo PM, Massoudi MS, et al. Intussusception among infants given an oral rotavirus vaccine. N Engl J Med. 2001;344(8):564-572.
29. Miller E, Waight P, Farrington CP, et al. Idiopathic thrombocytopenic purpura and MMR vaccine. Arch Dis Child. 2001;84(3):227-229.
30. Mutsch M, Zhou W, Rhodes P, et al. Use of the inactivated intranasal influenza vaccine and the risk of Bell's palsy in Switzerland. N Engl J Med. 2004;350(9):896-903.
31. Miller E, Andrews N, Stowe J, et al. Risks of convulsion and aseptic meningitis following measles-mumps-rubella vaccination in the United Kingdom. Am J Epidemiol. 2007;165(6):704-709.
32. France EK, Glanz J, Xu S, et al. Risk of immune thrombocytopenic purpura after measles-mumps-rubella immunization in children. Pediatrics. 2008;121(3):e687-e692.
33. Naleway AL, Belongia EA, Donahue JG, et al. Risk of immune hemolytic anemia in children following immunization. Vaccine. 2009;27(52):7394-7397.
34. Gwini SM, Coupland CA, Siriwardena AN. The effect of influenza vaccination on risk of acute myocardial infarction: selfcontrolled case-series study. Vaccine. 2011;29(6):1145-1149.
35. Patel MM, Lopez-Collada VR, Bulhoes MM, et al. Intussusception risk and health benefits of rotavirus vaccination in Mexico and Brazil. N Engl J Med. 2011; 364(24):2283-2292.
36. Sun Y, Christensen J, Hviid A, et al. Risk of febrile seizures and epilepsy after vaccination with diphtheria, tetanus, acellular pertussis, inactivated poliovirus, and Haemophilus influenzae type B. JAMA. 2012;307(8):823-831.
37. Arnheim-Dahlstrom L, Hallgren J, Weibull CE, et al. Risk of presentation to hospital with epileptic seizures after vaccination with monovalent AS03 adjuvanted pandemic A/H1N1 2009 influenza vaccine (Pandemrix): self controlled case series study. BMJ. 2012;345:e7594.
38. Weldeselassie YG, Whitaker HJ, Farrington CP. Use of the self-controlled case-series method in vaccine safety studies: review and recommendations for best practice. Epidemiol Infect. 2011;139(12):1805-1817.
39. Hubbard R, Farrington P, Smith C, et al. Exposure to tricyclic and selective serotonin reuptake inhibitor antidepressants and the risk of hip fracture. Am J Epidemiol. 2003;158(1):77-84.
40. Hubbard R, Lewis S, West J, et al. Bupropion and the risk of sudden death: a self-controlled case-series analysis using the Health Improvement Network. Thorax. 2005;60(10):848-850.
41. Grosso A, Douglas I, Hingorani A, et al. Oral bisphosphonates and risk of atrial fibrillation and flutter in women: a selfcontrolled case-series safety analysis. PLoS One. 2009;4(3): e4720.
42. Douglas IJ, Evans SJ, Pocock S, et al. The risk of fractures associated with thiazolidinediones: a self-controlled caseseries study. PLoS Med. 2009;6(9):e1000154.
43. Gibson JE, Hubbard RB, Smith CJ, et al. Use of selfcontrolled analytical techniques to assess the association between use of prescription medications and the risk of motor vehicle crashes. Am J Epidemiol. 2009;169(6):761-768.
44. Donaldson GC, Hurst JR, Smith CJ, et al. Increased risk of myocardial infarction and stroke following exacerbation of COPD. Chest. 2010;137(5):1091-1097.
45. Minassian C, D'Aiuto F, Hingorani AD, et al. Invasive dental treatment and risk for vascular events: a self-controlled case series. Ann Intern Med. 2010;153(8):499-506.
46. Pariente A, Fourrier-Reglat A, Ducruet T, et al. Antipsychotic use and myocardial infarction in older patients with treated dementia. Arch Intern Med. 2012;172(8):648-653.
47. Butt DA, Mamdani M, Austin PC, et al. The risk of hip fracture after initiating antihypertension drugs in the elderly. Arch Intern Med. 2012;172(22):1739-1744.
48. Maclure M, Fireman B, Nelson JC, et al. When should case-only designs be used for safety monitoring of medical products? Pharmacoepidemiol Drug Saf. 2012;21(1 suppl):50S-61S.
49. Nordmann S, Biard L, Ravaud P, et al. Case-only designs in pharmacoepidemiology: a systematic review. PLoS One. 2012;7(11):e49444.
50. Kopec JA, Esdaile JM. Bias in case-control studies. A review. J Epidemiol Community Health. 1990;44(3):179-186.
51. Brenner H, Savitz DA. The effects of sensitivity and specificity of case selection on validity, sample size, precision, and power in hospital-based case-control studies. Am J Epidemiol. 1990;132(1):181-192.
52. Chavance M, Dellatolas G, Lellouch J. Correlated nondifferential misclassifications of disease and exposure: application to a cross-sectional study of the relation between handedness and immune disorders. Int J Epidemiol. 1992; 21(3):537-546.
53. Kristensen P. Bias from nondifferential but dependent misclassification of exposure and outcome. Epidemiology. 1992;3(3):210-215.
54. Magder LS, Hughes JP. Logistic regression when the outcome is measured with uncertainty. Am J Epidemiol. 1997;146(2):195-203.
55. Farrington CP, Nash J, Miller E. Case series analysis of adverse reactions to vaccines: a comparative evaluation. Am J Epidemiol. 1996;143(11):1165-1173.
56. Fetter RB, Shin Y, Freeman JL, et al. Case mix definition by diagnosis-related groups. Med Care. 1980;18(2 suppl):iii, 1S-53S.
57. French Law No. 94-748 of August 2, 1991. J.O. No. 179. Paris, p. 10255.
58. French Order of July 22, 1996. J.O. No. 173 of July 26, 1996, p. 11308.
59. French Law No. 2003-1199 of December 19, 2003. J.O. No. 293.
60. French Circular No. 119, 1989. Health Mo. Ministerial J.O. No. 90/2, pp. 29-71.
61. Couris CM, Polazzi S, Olive F, et al. Breast cancer incidence using administrative data: correction with sensitivity and specificity. J Clinical Epidemiol. 2009;62(6):660-666.
62. Quantin C, Benzenine E, Fassa M, et al. Evaluation of the interest of using discharge abstract databases to estimate breast cancer incidence in two French departments. Stat J IAOS. 2012;28:73-85.
63. Remontet L, Mitton N, Couris CM, et al. Is it possible to estimate the incidence of breast cancer from medico-administrative databases? Eur J Epidemiol. 2008;23(10):681-688.
64. Uhry Z, Colonna M, Remontet L, et al. Estimating infranational and national thyroid cancer incidence in France from cancer registries data and national hospital discharge database. Eur J Epidemiol. 2007;22(9):607-614.
65. Quantin C, Benzenine E, Ferdynus C, et al. Advantages and limitations of using national administrative data on obstetric blood transfusions to estimate the frequency of obstetric hemorrhages. J Public Health (Oxf). 2013;35(1):147-156.
66. Quantin C, Benzenine E, Hagi M, et al. Estimation of national colorectal-cancer incidence using claims databases. J Cancer Epidemiol. 2012;2012:298369.
67. Tuppin P, De Roquefeuil L, Weill A, et al. French national health insurance information system and the permanent beneficiaries sample. Rev Epidemiol Sante Publique. 2010; 58(4):286-290.
68. Goldberg M, Jougla E, Fassa M, et al. The French health information system. Stat J IAOS. 2012;28(1-2):31-41.
69. Martin-Latry K, Begaud B. Pharmacoepidemiological research using French reimbursement databases: Yes we can! Pharmacoepidemiol Drug Saf. 2010;19(3):256-265.
70. Barlow WE, Davis RL, Glasser JW, et al. The risk of seizures after receipt of whole-cell pertussis or measles, mumps, and rubella vaccine. N Engl J Med. 2001;345(9):656-661.
71. Huang WT, Gargiullo PM, Broder KR, et al. Lack of association between acellular pertussis vaccine and seizures in early childhood. Pediatrics. 2010;126(2): 263-269.
72. Zhou X, Obuchowski NA, McClish DK. Statistical Methods in Diagnostic Medicine. 2nd ed. Hoboken, NJ: Wiley; 2011.