Methodological challenges in the coding and adjudication of sudden deaths in a large simple trial with observational follow-up: The ziprasidone observational study of cardiac outcomes (ZODIAC)

Pharmacoepidemiology and Drug Safety

Volumn 20, Issue 11, 2011, Pages 1192-1198

  Geier, Jamie L ^a   Karayal, Onur N ^a   Lewis, Michael ^b   Camm, John A ^c   Keane, Martin ^d   Kremer, Charlotte Me ^a   Kolluri, Sheela ^a   Reynolds, Robert ^a   Eng, Sybil ^a   Strom, Brian L ^d  

^a PFIZER INC   (United States)

^b EPES Epidemiology GmbH   (Germany)

^c ST GEORGE S HOSPITAL   (United Kingdom)

^d UNIVERSITY OF PENNSYLVANIA   (United States)

Author keywords

ICD 10; Large simple trial; Readjudication; Sudden death

Indexed keywords

OLANZAPINE; ZIPRASIDONE;

ALGORITHM; ARTICLE; FOLLOW UP; HEART ARRHYTHMIA; HUMAN; INTERNATIONAL CLASSIFICATION OF DISEASES; OBSERVATIONAL STUDY; PRIORITY JOURNAL; RISK FACTOR; SUDDEN DEATH;

ANTIPSYCHOTIC AGENTS; BENZODIAZEPINES; CAUSE OF DEATH; CLINICAL CODING; DEATH, SUDDEN; DEATH, SUDDEN, CARDIAC; ENDPOINT DETERMINATION; FOLLOW-UP STUDIES; HEART; HUMANS; INCIDENCE; INTERNATIONAL CLASSIFICATION OF DISEASES; PIPERAZINES; PRODUCT SURVEILLANCE, POSTMARKETING; QUESTIONNAIRES; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RESEARCH DESIGN; RISK; SCHIZOPHRENIA; SENSITIVITY AND SPECIFICITY; THIAZOLES; TIME FACTORS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 80555126759     PISSN: 10538569     EISSN: 10991557     Source Type: Journal    
DOI: 10.1002/pds.2185     Document Type: Article

References (23)

1. Scorza FA, Cysneiros RM, Terra VC, et al. Omega-3 consumption and sudden cardiac death in schizophrenia. Prostaglandins Leukot Essent Fatty Acids 2009; 81: 241-245.
2. Strom BL, Faich GA, Reynolds RF, et al. The Ziprasidone Observational Study of Cardiac Outcomes (ZODIAC): design and baseline subject characteristics. J Clin Psychiatry 2008; 69: 114-121.
3. Strom BL, Eng SM, Faich G, et al. Comparative Mortality Associated with Ziprasidone and Olanzapine in Real-World Use among 18, 154 Patients with Schizophrenia: The Ziprasidone Observational Study of Cardiac Outcomes (ZODIAC). Am J Psych 2011; 168: 193-201.
4. Anderson RN, Rosenberg HM. Disease classification: measuring the effect of the Tenth Revision of the International Classification of Diseases on cause-of-death data in the United States. Statist Med 2003; 22: 1551-1570.
5. De Coster CP, Li B, Quan H. Comparison and Validity of Procedures Coded With ICD-9-CM and ICD-10-CA/CCI. Medical Care 2008; 46 (6): 627-634.
6. Li B, Evans D, Faris P, et al. Risk adjustment performance of Charlson and Elixhauser comorbidities in ICD-9 and ICD-10 administrative databases. BMC Health Serv Res 2008; 8: 12.
7. Maier W, Philipp M, Zaudig M. Comparison of the ICD-10-classification with the ICD-9- and the DSM-III-classification of mental disorders. Pharmacopsychiatry 1990; 23(Supl 4): 183-187.
8. Iribarren C, Crow R, Hannan PJ et al. Validation of Death Certificate Diagnosis of Out-of-Hospital Sudden Cardiac Death. Am J Cardiol 1998; 82:50-53.
9. Fox CS, Evans JC, Larson MG et al. A Comparison of Death Certificate Out-of-Hospital Coronary Heart Disease with Physician-Adjudicated Sudden Cardiac Death. Am J Cardiol 2005; 95:856-859.
10. Hennessy S, Leonard CE, Palumbo CM et al. Diagnostic codes for sudden cardiac death and ventricular arrhythmia functioned poorly to identify outpatient events in EPIC's General Practice Research Database. Pharmacoepidemiology and Drug Safety 2008; 17: 1131-1136.
11. Hennessy S, Leonard CE, Freeman CP et al. Validation of diagnostic codes for outpatient-originating sudden cardiac death and ventricular arrhythmia in Medicaid and Medicare claims data. Pharmacoepidemiology and Drug Safety 2010; 19: 555-562.
12. Chung CP, Murray KT, Stein CM et al. A computer case definition for sudden cardiac death. Pharmacoepidemiology and Drug Safety 2010; 19:563-572.
13. Ray WA, Meredity S, Thapa PB et al. Antipsychotics and the risk of sudden death. Arch Gen Psychiatry 2001; 58(12): 1161-1167.
14. Hennessy S, Bilker WB, Knauss JS et al. Cardiac arrest and ventricular arrhythmia in patients taking antipsychotic drugs: cohort study using administrative data. BMJ 2002; 325: 1070-1072.
15. Reilly JG, Ayis SA, Ferrier IN et al. Thioridazine and sudden unexplained death in psychiatric in-patients. Br J Psychiatry 2002;180:515-522.
16. Straus SM, Bleumink GS, Dieleman JP et al. Antipsychotics and the risk of sudden cardiac death. Arch Intern Med 2004 Jun 28;164(12):1293-7.
17. Ray WA, Chng CP, Murray KT et al. Atypical Antipsychotic Drugs and the Risk of Sudden Cardiac Death. NEJM 2009; 360: 225-35.
18. Lovett Doust. Sinus tachycardia and abnormal cardiac rate variation in schizophrenia. Neuropsychobiology 1980;6(6):305-12.
19. Brown S. Excess mortality of schizophrenia. A meta-analysis. Br J Psychiatry 1997; 171:502-508.
20. Hennekens CH, Hennekens AR, Hollar D et al. Schizophrenia and increased risks of cardiovascular disease. Am Heart J 2005 Dec;150(6):1115-21.
21. Mines D. Commentary on the validation studies of sudden cardiac death and ventricular arrhythmia by Hennessy et al. and Chung et al. Pharmacoepidemiology and Drug Safety 2010; 19: 573-575.
22. Leonard CE, Feeman CP, Deo R et al. Response to commentary entitled 'Commentary on the validation studies of sudden cardiac death and ventricular arrhythmia by Hennessy et al. and Chung et al. Pharmacoepidemiology and Drug Safety 2010; 19: 576.
23. Ray WA, Murray KT, Stein CM. Reply to 'commentary..." Pharmacoepidemiology and Drug Safety 2010; 19: 577-578.