Information de reference pour ce titreAccession Number: | 01445491-200708000-00008.
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Author: | Wurst, K. E. 1,2,*; Ephross, S. A. 1; Loehr, J. 2; Clark, D. W. 1; Guess, H. A. 2,++
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Institution: | (1)Worldwide Epidemiology, GlaxoSmithKline, Research Triangle Park, NC, USA (2)University of North Carolina, Chapel Hill, NC, USA (*)Correspondence to: Worldwide Epidemiology, 17.2136D, GlaxoSmithKline, Box 13398, Research Triangle Park, NC 27709, USA.
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Title: | |
Source: | Pharmacoepidemiology & Drug Safety. 16(8):867-877, August 2007.
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Abstract: | Objective: The purpose of this research was (1) to validate that ventricular septal defect (VSD), tetralogy of Fallot (TOF), and coarctation of the aorta (COA) can be studied in the UK General practice research database (GPRD) and (2) to understand which of the available GPRD components (computerized medical records, questionnaires, and maternal/infant free text) provide maximal information about these heart defects.
Methods: Using a practitioner questionnaire, the positive predictive value (PPV) of the computerized medical record for VSD, TOF, and COA were determined. Both infant and maternal free text was examined. Concordance between the infant free text information and questionnaires was calculated. The proportion of infant information captured in the maternal free text was determined.
Results: A 93% response rate was achieved. Based on questionnaire responses, an overall PPV of 93.5% was achieved (VSD = 95%, TOF = 90%, COA = 100%). Approximately half of the records contained infant free text information including information on the type and size of VSD, echocardiogram findings, and surgery. Concordance between the infant's free text and questionnaire information occurred in most of the cases (92-100%). The proportion of infant information in the maternal free text was low (4-19%).
Conclusion: The GPRD computerized medical records are sufficient to assess VSD, TOF, and COA. This study confirms that maternal free text provides a low yield of limited information pertaining to the infants' defect, while the infant free text may provide an additional information usually obtainable from practitioner questionnaires. The information provided by an infant free text may limit the need for practitioner questionnaire validation. Copyright (C) 2007 John Wiley & Sons, Ltd.
Copyright (C) 2007 John Wiley & Sons, Inc.
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Author Keywords: | GPRD; congenital heart defects; validation; free text; practitioner questionnaire.
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References: | 1. Moss and Adams' Heart Disease in Infants, Children, and Adolescents: Including the Fetus and Young Adult. Lippincott Williams & Wilkins: Philadelphia, 2001.
2. Anonymous. Congenital Heart Defects. American Heart Association. 2005; Available from http://www.americanheart.org/pre...- ouverture dans une nouvelle fenêtre.
3. Briggs G, Freeman R, Yaffe S. Drugs in Pregnancy and Lactation. Lippincott Williams & Wilkins: New York, 2002.
4. McEvoy G. AHFS Drug Information. American Society of Health-System Pharmacists: Bethesda, 2004.
5. Mitchell AA. Systematic identification of drugs that cause birth defects-a new opportunity. N Engl J Med 2003; 349: 2556-2559.
6. White AD, Andrews EB. The pregnancy registry program at Glaxo Wellcome Company. J.Allergy Clin Immunol 1999; 103: S362-S363.
7. Honein MA, Paulozzi LJ, Cragan JD, Correa A. Evaluation of selected characteristics of pregnancy drug registries. Teratology 1999; 60: 356-364.
8. Reiff-Eldridge R, Heffner CR, Ephross SA, Tennis PS, White AD, Andrews EB. Monitoring pregnancy outcomes after prenatal drug exposure through prospective pregnancy registries: a pharmaceutical company commitment. Am J Obstet Gynecol 2000; 182: 159-163.
9. Czeizel AE, Petik D, Vargha P. Validation studies of drug exposures in pregnant women. Pharmacoepidemiol Drug Saf 2003; 12: 409-416.
10. Gelfand J, Margolis DH. The UK general practice research database. In Pharmacoepidemiology, Strom B (ed.). John Wiley and Sons: New York, 2005; 337-346.
11. Busby A, Ritvanen A, Dolk H, et al. Survey of informed consent for registration of congenital anomalies in Europe. Br Med J 2005; 331: 140-141.
12. Jick SS. Pregnancy outcomes after maternal exposure to fluconazole. Pharmacotherapy 1999; 19: 221-222.
13. Ruigomez A, Garcia Rodriguez LA, Cattaruzzi C, et al. Use of cimetidine, omeprazole, and ranitidine in pregnant women and pregnancy outcomes. Am J Epidemiol 1999; 150: 476-481.
14. Garcia-Rodriguez L, Perez-Gutthan S, Jick S. The UK general practice research database. In Pharmacoepidemiology, Strom B (ed.). John Wiley and Sons: New York, 2000; 375-382.
15. Anonymous. GPRD-Excellence in Public Health Research-Why GPRD? History. GPRD. 2007; Available from http://www.gprd.com/whygprd/hist...- ouverture dans une nouvelle fenêtre.
16. Anonymous. The General Practice Research Database: Information for Researchers. 1-21. 1996; London, England, Office of Population and Censuses and Surveys.
17. Foy M. GPRD Newsletter. GPRD: London, 2002.
18. Rubino A. The Mother-Baby Link in FF-GPRD. 2003; London, GPRD. On-line GPRD User's Group Workshop.
19. Wood L, Martinez C. The general practice research database: role in pharmacovigilance. Drug Saf 2004; 27: 871-881.
20. Hardy JR, Holford TR, Hall GC, Bracken MB. Strategies for identifying pregnancies in the automated medical records of the General Practice Research Database. Pharmacoepidemiol Drug Saf 2004; 13: 749-759.
21. Boneva RS, Botto LD, Moore CA, Yang Q, Correa A, Erickson JD. Mortality associated with congenital heart defects in the United States: trends and racial disparities, 1979-1997. Circulation 2001; 103: 2376-2381.
22. Llewellyn A, Stowe ZN, Strader JR, Jr. The use of lithium and management of women with bipolar disorder during pregnancy and lactation. J Clin Psychiatry 1998; 59 (Suppl. 6): 57-64.
23. Arpino C, Brescianini S, Robert E, et al. Teratogenic effects of antiepileptic drugs: use of an International Database on Malformations and Drug Exposure (MADRE). Epilepsia 2000; 41: 1436-1443.
24. Canger R, Battino D, Canevini MP, et al. Malformations in offspring of women with epilepsy: a prospective study. Epilepsia 1999; 40: 1231-1236.
25. Koren G, Pastuszak A, Ito S. Drugs in pregnancy. N Engl J Med 1998; 338: 1128-1137.
26. Fleiss J. Statistical Methods for Rates and Proportions. John Wiley and Sons: New York, 1981.
27. Hanley JA, McNeil BJ. A method of comparing the areas under receiver operating characteristic curves derived from the same cases. Radiology 1983; 148: 839-843.
28. Wurst KE, Ephross SA, Loehr J, Clark DW, Guess HA. Evaluation of the general practice research database congenital heart defects prevalence: comparison to United Kingdom national systems. Birth Defects Res A Clin Mol Teratol 2007; 79: 309-316.
29. Soriano JB, Maier WC, Visick G, Pride NB. Validation of general practitioner-diagnosed COPD in the UK General Practice Research Database. Eur J Epidemiol 2001; 17: 1075-1080.
30. Nazareth I, King M, Haines A, Rangel L, Myers S. Accuracy of diagnosis of psychosis on general practice computer system. Br Med J 1993; 307: 32-34.
31. VanStaa T, Abenheim L. The quality of information recorded on a UK database of primary care records: a study of hospitalizations due to hypoglycemia and other conditions. Pharmacoepidemiol Drug Saf 1994; 3: 15-21.
32. Lawrenson R, Todd JC, Leydon GM, Williams TJ, Farmer RD. Validation of the diagnosis of venous thromboembolism in general practice database studies. Br J Clin Pharmacol 2000; 49: 591-596.
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Language: | English.
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Document Type: | Original Reports.
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Journal Subset: | Pharmacology.
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ISSN: | 1053-8569
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DOI Number: | https://dx.doi.org/10.1002/pds.1...- ouverture dans une nouvelle fenêtre
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