Verfügbarkeit: Methodological approaches in pharmacoepidemiology

Methodological approaches in pharmacoepidemiology: application to spontaneous reporting

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Bibliographische Detailangaben
Weitere Verfasser:	Bégaud, Bernard (HerausgeberIn)
Format:	Buch
Sprache:	English
Veröffentlicht:	Amsterdam <<[u.a.]>> Elsevier 1993
Online-Zugang:	Inhaltsverzeichnis
Beschreibung:	Weitere Ausgabe: Auch in: Post-marketing surveillance ; 7,1/2
Beschreibung:	175 S. graph. Darst.
ISBN:	0444815775

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Datensatz im Suchindex

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adam_text	IMAGE 1 METHODOLOGICAL APPROACHES IN PHARMACOEPIDEMIOLOGY APPLICATION TO SPONTANEOUS REPORTING PUBLISHED ALSO AS POST MARKETING SURVEILLANCE, VOL. 7,1+2 ELSEVIER AMSTERDAM - LONDON - NEW YORK - TOKYO IMAGE 2 CONTENTS ACKNOWLEDGEMENTS 5 LIST OF CONTRIBUTORS 7 INDEX OF TABLES 13 PREFACE 15 RENE JEAN ROYER INTRODUCTION 17 JACQUES DANGOUMAU 1. MEASUREMENT OF FREQUENCY IN PHARMACOVIGILANCE 21 ANNIE FOURRIER, JEAN-CHARLES PERE DEFINITIONS 21 INCIDENCE RATE 22 PREVALENCE RATE 22 ESTIMATION OF AN INCIDENCE RATE FROM SPONTANEOUS REPORTS 23 PRACTICAL CONCLUSIONS 24 REFERENCES 24 2. ESTIMATION OF THE NUMERATOR IN SPONTANEOUS REPORTING 27 FRANCOISE HARAMBURU, ANNIE FOURRIER, JEAN-CHARLES PERE, BERNARD BEGAUD CASE DEFINITION AND IDENTIFICATION 27 CASE DEFINITION 27 CASE IDENTIFICATION 28 SELECTION OF THE STUDY PERIOD 28 CONSIDERATION OF MULTIPLE EVENTS 29 CASE VALIDATION 29 INFORMATION REQUIRED 29 IMPUTABILITY 30 CLASSICAL ALGORITHMS 30 APPROACHES BASED ON BAYES THEOREM 33 REPORTING CHARACTERISTICS 35 UNDERREPORTING 35 THE REPORTER 36 RECORDING METHOD 36 IMAGE 3 10 GEOGRAPHICAL DISTRIBUTION OF CASES 36 PRACTICAL CONCLUSIONS 36 REFERENCES 37 3. ESTIMATION OF UNDERREPORTING 39 FRANGOISE HARAMBURU FACTORS INFLUENCING REPORTING 39 THE PATIENT 39 THE REPORTER 39 THE ADVERSE EFFECT 40 METHODS OF COLLECTION 40 HUMAN AND GEOGRAPHICAL FACTORS 41 THE MEDIA 42 THE DRUG 43 PRACTICAL ESTIMATION OF UNDERREPORTING 44 PRACTICAL CONCLUSIONS 48 REFERENCES 49 4. ESTIMATION OF THE DENOMINATOR IN SPONTANEOUS REPORTING 51 BERNARD BEGAUD, JEAN-CHARLES PERE, GHADA MIREMONT VERIFICATION OF THE CONSISTENCY BETWEEN THE NUMERATOR AND THE DENOMINATOR 51 REALITY OF EXPOSURE 51 STOCK BUILDING 52 NONCOMPLIANCE WITH TREATMENT 52 EXPOSURE CONDITIONS 53 DOSE 53 INDICATION 54 LENGTH OF TREATMENT 54 PATHOPHYSIOLOGICAL CONSISTENCY 57 SELECTING THE REFERENCE PERIOD 57 SELECTING THE UNIT OF MEASUREMENT 59 PACKAGES 59 NUMBER OF UNITS 59 TREATMENT-DAYS 60 TREATMENT-MONTHS OR TREATMENT-YEARS 61 DEFINED DAILY DOSE (DDD) 61 TREATED PATIENTS OR TREATMENTS 62 USE OF DATABASES 63 ESTIMATION OF THE AVERAGE DURATION OF TREATMENT (ADT) 63 ESTIMATION BASED ON HIGH AND LOW HYPOTHESES 64 PRACTICAL CONCLUSIONS 65 REFERENCES 66 APPENDIX 67 IMAGE 4 11 FICTITIOUS EXAMPLE OF THE CALCULATION OF THE DENOMINATOR OF AN INCIDENCE RATE IN SPONTANEOUS REPORTING 67 5. CONFIDENCE INTERVALS IN PHARMACOVIGILANCE 71 PASCALE TUBERT-BITTER, BERNARD BEGAUD CONFIDENCE INTERVAL: DEFINITIONS 71 THE PROBABILITY DISTRIBUTIONS USED IN PHARMACOVIGILANCE 72 LEVEL OF CONFIDENCE IN PHARMACOVIGILANCE 73 PRACTICAL CALCULATIONS 74 SAMPLE SIZE LESS THAN 100 74 SAMPLE SIZE GREATER THAN OR EQUAL TO 100 75 VERY FREQUENT EFFECTS (0. KLN 0.9) 75 RARE EFFECTS (K/N 0.1) 76 IF JFC = 0 77 SPONTANEOUS REPORTING 78 RELEVANCE OF CONFIDENCE INTERVALS FOR PHARMACOVIGILANCE 79 REFERENCES 80 6. IF NOTHING GOES WRONG, IS EVERYTHING ALL RIGHT ? 89 BERNARD BEGAUD, PASCALE TUBERT-BITTER ZERO NUMERATORS 90 PRACTICAL CALCULATIONS AND LIMITATIONS 90 REQUIREMENTS CONCERNING SAMPLE SIZE 91 NON-ZERO NUMERATORS 92 SPONTANEOUS REPORTING 92 REFERENCES 94 7. EXPECTED NUMBER OF ADVERSE REACTIONS IN A SAMPLE 99 BERNARD BEGAUD, GHADA MIREMONT, PASCALE TUBERT-BITTER SAMPLE SIZE LESS THAN 100 100 SAMPLE SIZE GREATER THAN OR EQUAL TO 100 100 COMPUTATIONS FOR M 20: THE POISSON DISTRIBUTION 101 COMPUTATIONS FOR M 20: APPROXIMATION BY THE NORMAL DISTRIBUTION 102 APPLICATIONS IN SPONTANEOUS REPORTING 102 ESTIMATION OF THE EXPECTED NUMBER OF CASES IN A SAMPLE 103 PRACTICAL CONCLUSIONS 104 REFERENCES 104 8. COMPARING SAFETY OF DRUGS 119 PASCALE TUBERT-BITTER, BERNARD BEGAUD CLINICAL TRIALS AND COHORT STUDIES 120 IMAGE 5 12 EXPECTED NUMBERS GREATER THAN 5 121 AT LEAST ONE EXPECTED NUMBER SMALLER THAN 5 122 MATCHED-PAIR DESIGN 123 SPONTANEOUS REPORTING 124 LOSS OF STATISTICAL POWER DUE TO UNDERREPORTING 125 UNEQUAL UNDERREPORTING OF TWO DRUGS 126 REFERENCES 128 9. RISK AND ITS ASSESSMENT 139 LUCIEN ABENHAIM, YOLA MORIDE QUESTIONS POSED BY THE VARIOUS HEALTH PROFESSIONALS INVOLVED 139 TYPES OF RISK 140 RISK 141 EXCESS RISK 141 RELATIVE RISK 142 ATTRIBUTABLE FRACTION OF THE RISK AMONG EXPOSED CASES 143 ETIOLOGIC FRACTION OF THE RISK IN THE POPULATION 144 REFERENCE RISK 146 DEFINITION , 146 EVENTS KNOWN TO BE EXCLUSIVELY DRUG RELATED 147 ACCURACY OF CASE DEFINITION 148 PRACTICAL CONCLUSIONS 148 REFERENCES 149 10. MODELLING IN PHARMACOVIGILANCE 151 PASCALE TUBERT-BITTER PRELIMINARY HYPOTHESES 152 THE PRINCIPLE OF MODELLING 152 MODELS 154 PRACTICAL CONCLUSIONS 156 REFERENCES 156 GLOSSARY 157 BERNARD BEGAUD POSTFACE 171 BERNARD BEGAUD SUBJECT INDEX 173
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spelling	Analyse d'incidence en pharmacovigilance Methodological approaches in pharmacoepidemiology application to spontaneous reporting [ed. by ARME-P. Ed. board Bernard Bégaud ...] Amsterdam <<[u.a.]>> Elsevier 1993 175 S. graph. Darst. txt rdacontent n rdamedia nc rdacarrier Weitere Ausgabe: Auch in: Post-marketing surveillance ; 7,1/2 Bégaud, Bernard edt Association pour la recherche méthodologique en pharmacovigilance Sonstige (DE-588)5116618-5 oth GBV Datenaustausch application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=021728233&sequence=000001&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA Inhaltsverzeichnis
spellingShingle	Methodological approaches in pharmacoepidemiology application to spontaneous reporting
title	Methodological approaches in pharmacoepidemiology application to spontaneous reporting
title_alt	Analyse d'incidence en pharmacovigilance
title_auth	Methodological approaches in pharmacoepidemiology application to spontaneous reporting
title_exact_search	Methodological approaches in pharmacoepidemiology application to spontaneous reporting
title_full	Methodological approaches in pharmacoepidemiology application to spontaneous reporting [ed. by ARME-P. Ed. board Bernard Bégaud ...]
title_fullStr	Methodological approaches in pharmacoepidemiology application to spontaneous reporting [ed. by ARME-P. Ed. board Bernard Bégaud ...]
title_full_unstemmed	Methodological approaches in pharmacoepidemiology application to spontaneous reporting [ed. by ARME-P. Ed. board Bernard Bégaud ...]
title_short	Methodological approaches in pharmacoepidemiology
title_sort	methodological approaches in pharmacoepidemiology application to spontaneous reporting
title_sub	application to spontaneous reporting
url	http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=021728233&sequence=000001&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA
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