Application of a self-controlled case series study to a database study in children

Drug Safety

Volumn 37, Issue 4, 2014, Pages 259-268

  Ueyama, Hanae ^a   Hinotsu, Shiro ^a   Tanaka, Shiro ^a   Urushihara, Hisashi ^a   Nakamura, Masaki ^b   Nakamura, Yuji ^b   Kawakami, Koji ^a  

^a KYOTO UNIVERSITY   (Japan)

^b Medical Data Vision Co   (Japan)

Author keywords

[No Author keywords available]

Indexed keywords

PALIVIZUMAB; MONOCLONAL ANTIBODY;

ARTICLE; BRONCHITIS; CASE STUDY; COHORT ANALYSIS; COMPARATIVE STUDY; CONFIDENCE INTERVAL; DATA BASE; DIARRHEA; DRUG SAFETY; ECZEMA; HOSPITAL PATIENT; HUMAN; INCIDENCE; JAPAN; OUTPATIENT; PHARMACOEPIDEMIOLOGY; POSTMARKETING SURVEILLANCE; PRIORITY JOURNAL; SELF CONTROL; CASE CONTROL STUDY; DRUG SURVEILLANCE PROGRAM; DRUG-RELATED SIDE EFFECTS AND ADVERSE REACTIONS; FACTUAL DATABASE; FEMALE; INFANT; MALE; NEWBORN; PRESCHOOL CHILD; PROCEDURES; SAFETY; STATISTICS AND NUMERICAL DATA;

ADVERSE DRUG REACTION REPORTING SYSTEMS; ANTIBODIES, MONOCLONAL, HUMANIZED; CASE-CONTROL STUDIES; CHILD, PRESCHOOL; COHORT STUDIES; DATABASES, FACTUAL; DRUG-RELATED SIDE EFFECTS AND ADVERSE REACTIONS; FEMALE; HUMANS; INCIDENCE; INFANT; INFANT, NEWBORN; JAPAN; MALE; PHARMACOEPIDEMIOLOGY; SAFETY;

EID: 84898796751     PISSN: 01145916     EISSN: 11791942     Source Type: Journal    
DOI: 10.1007/s40264-014-0148-9     Document Type: Article

References (18)

1. Coloma PM, Schuemie MJ, Trifiro G, et al. Combining electronic healthcare databases in Europe to allow for large-scale drug safety monitoring: the EU-ADR project. Pharmacoepidemiol Drug Saf. 2011;20(1):1-11.
2. Linder JA, Haas JS, Iyer A, et al. Secondary use of electronic health record data: spontaneous triggered adverse drug event reporting. Pharmacoepidemiol Drug Saf. 2010;19(12):1211-5.
3. Bello A, Hemmelgarn B, Manns B, Tonelli M, for Alberta Kidney Disease Network. Use of administrative databases for health-care planning in CKD. Nephrol Dial Transplant. 2012; doi: 10.1093/ndt/gfs163.
4. Smoyer Tomic KE, Amato AA, Fernandes AW. Incidence and prevalence of idiopathic inflammatory myopathies among commercially insured, medicare supplemental insured, and medicaid enrolled populations: an administrative claims analysis. BMC Musculoskelet Disord. 2012;13(1):103.
5. Smith EG, Zhao S, Rosen AK. Using the patient safety indicators to detect potential safety events among US veterans with psychotic disorders: clinical and research implications. Int J Qual Health Care. 2012;24(4):321-9.
6. Schoonen WM, Thomas SL, Somers EC, et al. Do selected drugs increase the risk of lupus? A matched case-control study. Br J Clin Pharmacol. 2010;70(4):588-96.
7. Gibson JE, Hubbard RB, Smith CJ, Tata LJ, Britton JR, Fogarty AW. Use of self-controlled analytical techniques to assess the association between use of prescription medications and the risk of motor vehicle crashes. Am J Epidemiol. 2009;169(6):761-8.
8. Dore DD, Seeger JD, Arnold Chan K. Use of a claims-based active drug safety surveillance system to assess the risk of acute pancreatitis with exenatide or sitagliptin compared to metformin or glyburide. Curr Med Res Opin. 2009;25(4):1019-27.
9. Ministry of Health, Labour and Welfare (MHLW). National database guideline in Japan (in Japanese). Available: http://www.mhlw.go.jp/stf/shingi/ 2r98520000016v8d-att/2r98520000016vcn.pdf. Accessed Aug 29 2013.
10. Kimura S, Sato T, Ikeda S, Noda M, Nakayama T. Development of a database of health insurance claims: standardization of disease classifications and anonymous record linkage. J Epidemiol. 2010;20(5):413-9.
11. Akazawa M, Imai H, Igarashi A, Tsutani K. Potentially inappropriate medication use in elderly Japanese patients. Am J Geriatr Pharmacother. 2010;8(2):146-60.
12. Hashikata H, Harada KH, Kagimura T, Nakamura M, Koizumi A. Usefulness of a large automated health records database in pharmacoepidemiology. Environ Health Prev Med. 2011;16(5):313-9.
13. Douglas IJ, Smeeth L. Exposure to antipsychotics and risk of stroke: self controlled case series study. BMJ. 2008;337:a1227.
14. Pratt NL, Roughead EE, Ramsay E, Salter A, Ryan P. Risk of hospitalization for stroke associated with antipsychotic use in the elderly: a self-controlled case series. Drugs Aging. 2010;27(11):885-93.
15. Whitaker HJ, Farrington CP, Spiessens B, Musonda P. Tutorial in biostatistics: the self-controlled case series method. Stat Med. 2006;25(10):1768-97.
16. The IMpact-RSV study group. Palivizumab, a humanized respiratory syncytial virus monoclonal antibody, reduces hospitalization from respiratory syncytial virus infection in high-risk infants. Pediatrics. 1998;102(3 Pt 1):531-7.
17. Feltes TF, Cabalka AK, Meissner HC, et al. Palivizumab prophylaxis reduces hospitalization due to respiratory syncytial virus in young children with hemodynamically significant congenital heart disease. J Pediatr. 2003;143(4):532-40.
18. 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(S1):50-61.