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Impact of Seven-Valent Pneumococcal Conjugate Vaccination

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Impact of Seven-Valent Pneumococcal Conjugate Vaccination UCL SCHOOL OF PHARMACY Department of Practice and Policy BMA House, Tavistock Square WC1H 9JP Impact of Seven-Valent Pneumococcal Conjugate Vaccination (PCV7) on Childhood Pneumococcal Diseases in the UK Aisha El-Turki Thesis presented for the degree of Doctor of Philosophy Centre for Paediatric Pharmacy Research Department of Practice and Policy University College London School of Pharmacy PLAGIARISM STATEMENT This thesis describes research conducted in the School of Pharmacy, University Collage of London between March 2009 and February 2013 under the supervision of Professor Ian Wong, Professor David Taylor and Dr Paul Long. I certify that the research described is original and that any parts of the work that have been conducted by collaboration are clearly indicated. I also certify that I have written all the text herein and have clearly indicated by suitable citation any part of this dissertation that has already appeared in publication. September 13th 2013 _____________________________________ _____________ Signature Date 2 ABSTRACT Streptococcus pneumoniae is the leading cause of infectious childhood conditions such as Otitis Media (OM) and Pneumonia. Amoxicillin is the recommended first-line treatment for these indications. But because of growing resistance to penicillin based and other antibiotics prevention via effective immunisation is a more desirable approach. PCV7 was introduced in the UK in 2006. Studies conducted in the USA and Europe have shown that the use of this vaccine successfully reduces the incidence of OM and pneumonia. Yet its impact on community antibiotic use in the UK has not to date been adequately described. This thesis presents the findings of two retrospective cohort studies that analysed the diagnosed incidence of OM and pneumonia and the associated antibiotic prescribing, using the IMS DA and THIN GP databases. The extensive data manipulation conducted shows that the overall number of (all cause) pneumonia episodes in children recorded by GPs declined by 14% between 2006 and 2010. Associated antibiotic prescribing fell by 10%. In addition, the research presented here identified a fall of more than a third in primary care recorded OM diagnoses and antibiotic prescribing for the treatment of OM in children between 2006 and 2010. These data represent new evidence that the introduction of the original conjugated PCV7 contributed to a decline in antibiotic prescribing by GPs. However, additional prescribing behaviour change drivers were involved and consumption by patients may have fallen faster than the available data sets suggest. The PCV7 has now been replaced by the PCV13. Against this background a range of additional policy questions are discussed. They include issues relating to bacterial serotype replacement trends and virulence shifts, and the implications of effective infant and child protection for the health of older adults at high risk of contracting pneumococcal infections. 3 TABLE OF CONTENTS PLAGIARISM STATEMENT .................................................................................... 2 ABSTRACT ............................................................................................................. 3 TABLE OF CONTENTS ........................................................................................... 4 TABLE OF FIGURES .............................................................................................. 8 TABLE OF TABLES ................................................................................................11 TABLE OF BOXES .................................................................................................12 ACKNOWLEDGEMENTS .......................................................................................13 LIST OF ABBREVIATIONS ....................................................................................14 OVERVIEW OF THESIS CHAPTERS ....................................................................17 CHAPTER ONE: INTRODUCTION .........................................................................20 1. BACKGROUND ..................................................................................................20 1.1 Pneumococcal diseases ...................................................................................20 1.1.1 Invasive pneumococcal diseases ...........................................................23 1.1.2 Non-invasive pneumococcal diseases ....................................................25 1.2 Otitis media .......................................................................................................25 1.2.1 Classification of Otitis Media ..................................................................27 1.2.2 Burden of disease ..................................................................................29 1.2.3 Risk factors ............................................................................................29 1.2.4 Pathology and Complications .................................................................36 1.2.5 Diagnosis ...............................................................................................37 1.2.6 Clinical management ..............................................................................38 1.3 Pneumonia .......................................................................................................44 1.3.1 Classification of pneumonias ..................................................................47 1.3.2 Burden of disease ..................................................................................50 4 1.3.3 Risk factors ............................................................................................51 1.3.4 Pathology and Complications .................................................................57 1.3.5 Symptoms and Diagnosis .......................................................................58 1.3.6 Clinical management ..............................................................................60 1.4 Seven-valent pneumococcal conjugate vaccination (Prevnar 7®, PCV7) ..........65 1.4.1 Antibiotic resistance and the introduction of the PCV7 ...........................65 1.4.2 What is PCV7? .......................................................................................68 1.4.3 PCV7 efficacy and safety .......................................................................72 1.4.4 Adverse effects ......................................................................................74 1.4.5 Who should receive the PCV7 vaccine? .................................................74 1.5 Summary ..........................................................................................................76 CHAPTER TWO: STUDY DESIGN, RESEARCH TOOLS AND METHODOLOGY .78 2.1 Study design .....................................................................................................78 2.2 Research tools ..................................................................................................79 2.2.1 IMS Disease Analyser (IMS DA) database .............................................81 2.2.2 The Health Improvement Network (THIN) database ...............................86 2.3 Justification of the datasets used in this study ...................................................92 2.4 Definitions and Statistical Methods ...................................................................93 2.4.1 Age classification ...................................................................................93 2.4.2 Incidence ................................................................................................94 2.4.3 Confidence intervals ...............................................................................97 2.5 Methodology .....................................................................................................98 2.5.1 Study strand ONE – Systematic Review and Meta-analysis ...................99 2.5.2 Study strand TWO – Validation Study .................................................. 106 5 2.5.3 Study strand THREE – OM Cohort Study ............................................. 110 2.5.4 Study strand FOUR – Pneumonia Cohort Study ................................... 115 CHAPTER THREE: SYSTEMATIC REVIEW & META-ANALYSIS ....................... 119 3.1 Results............................................................................................................ 119 3.2 Discussion ...................................................................................................... 131 3.3 Hypothesis, Aims and Objectives .................................................................... 135 3.3.1 Hypothesis ........................................................................................... 135 3.3.2 Aims ..................................................................................................... 135 3.3.3 Objectives ............................................................................................ 135 CHAPTER FOUR: VALIDATION STUDY.............................................................. 137 4.1 Results............................................................................................................ 137 4.2 Discussion ...................................................................................................... 140 4.3 CONCLUSION ................................................................................................ 141 CHAPTER FIVE: THE IMPACT OF PCV7 ON THE INCIDENCE OF OM AND ANTIBIOTIC PRESCRIBING
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