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Study Protocol Use of Benzodiazepines and Risk of Hip/Femur Fracture a Methodological Comparison Across Data Sources and Epidemiological Design

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Study Protocol Use of Benzodiazepines and Risk of Hip/Femur Fracture a Methodological Comparison Across Data Sources and Epidemiological Design WP2 Framework for pharmacoepidemiological studies WG1 Databases Study Protocol Use of benzodiazepines and risk of hip/femur fracture A methodological comparison across data sources and epidemiological design Version: Final Nov 14, 2011 with Amendment 1 – Jan 2012, approved 29 Feb 2012 Version: Final Nov 14 2011 with Amendment 2 - Jan 2013, approved 31 December 2013 Version: Final Nov 14 2011 with Amendment 3 – Jun 2013, approved 31 December 2013 Version: Final Nov 14 2011 with Amendment 4 – Oct 2013, approved 31 December 2013 PROTECT_WP2 Final Protocol_BenzoHIPfracture_14Nov2011_Amend 4_Dec 2013 Page 1 of 193 WG1 Drug AE group Name Role Francisco de Abajo 1, 2 Protocol Lead Luis Alberto García Rodríguez 3 Protocol Backup Ulrik Hesse 4 Protocol Reviewer Andrew Bate 5 Protocol Reviewer Saga Johanson 6 Protocol Reviewer Frank de Vries 7 Protocol Reviewer Marietta Rottenkolber 8 Database 1 (Bavaria) lead Joerg Hasford 8 Database 1 (Bavaria) backup Consuelo Huerta 2 Database 2 (Bifap) lead Miguel Gil 2 Database 2 (Bifap) backup Ulrik Hesse4 Database 3 (DKMA) lead Frank de Vries7 Database 3 (DKMA) backup Montserrat Miret 11 and Jeane Pimienta 12 Database 3 (CPRD) lead Arlene Gallagher/ Dan Dedman /Jenny Campbell 13 Database 3 (CPRD) backup Olaf Klungel 7 Database 4 (Mondriaan) lead Liset van Dijk 7, 9 Database 4 (Mondriaan) backup Yolanda Alvarez 10 Database 5 (THIN) lead Ana Ruigomez 3 Database 5 (THIN) backup 1 Universidad de Alcalá, Madrid, Spain 2 Agencia Española de Medicamentos y Productos Sanitarios, Madrid, Spain (AEMPS) 3 Fundación Centro Español de Investigación Farmacoepidemiológica, Madrid, Spain (CEIFE) 4 Lægemiddelstyrelsen (Danish Medicines Agency), Copenhagen, Denmark (DKMA) 5 Pfizer Ltd, Walton Oaks, Dorking Road, Tadworth, UK (Pfizer) 6 AstraZeneca AB, Molndal, Sweden (AZ) 7 Universiteit Utrecht, Utrecht, The Netherlands (UU) 8 Ludwig-Maximilians-Universität-München, Munich, Germany (LMU- Muenchen) 9 Netherlands Institute for Healthcare Research, Utrecht, The Netherlands (NIVEL) 10 European Medicines Agency, London, United Kingdom (EMA) 11 Merck KGaA, Geneva, Switzerland (ME) 12 GlaxoSmithKline Research and Development LTD, UK (GSK) 13 General Practice Research Database, London, United Kingdom (CPRD) PROTECT_WP2 Final Protocol_BenzoHIPfracture_14Nov2011_Amend 4_Dec 2013 Page 2 of 193 Contents 1 Context of the studies ......................................................................................................... 6 2 Background .......................................................................................................................... 6 3 Objectives ............................................................................................................................ 7 4 Methods .............................................................................................................................. 7 4.1 Data Source ...................................................................................................................................... 7 4.1.1 Bavarian Claims Database (Germany) .............................................................................................. 7 4.1.2 BIFAP (Spain) .................................................................................................................................... 7 4.1.3 National Databases (Denmark) ........................................................................................................ 7 4.1.4 Clinical Practice Research Datalink (formerly General Practice Research Database) (UK) .............. 8 4.1.5 Mondriaan (The Netherlands) .......................................................................................................... 9 4.1.6 The Health Improvement Network (UK) .......................................................................................... 9 4.2 Period of valid data collection .......................................................................................................... 9 5 Study Designs .................................................................................................................... 10 5.1 Descriptive study ............................................................................................................................ 10 5.1.1 Study Population ............................................................................................................................ 10 5.1.2 Exposure description ...................................................................................................................... 11 5.1.2.1 Prevalence of benzodiazepine use by sex and age ........................................................................................ 11 5.1.2.2 Prevalence of benzodiazepine use stratified by indication............................................................................ 13 5.1.2.3 Prevalence of benzodiazepine use stratified by number of prescriptions ...................................................... 14 5.1.3 Outcome description ...................................................................................................................... 15 5.1.3.1 Prevalence of the (lifetime) hip/femur fractures by sex and age over the first year ...................................... 15 5.1.3.2 (Cumulative) Incidence of hip/femur fractures by sex and age per year ...................................................... 16 5.2 Analytical studies ............................................................................................................................ 16 5.2.1 Study population for the cohort and the nested case-control design ........................................... 16 5.2.2 Study population for the case only designs: case-crossover and self-controlled case series ........ 18 5.2.2 Outcome Definition ........................................................................................................................ 18 5.2.3 Exposure definition ........................................................................................................................ 19 5.2.4 Potential confounders .................................................................................................................... 22 5.2.5 Analysis ........................................................................................................................................... 22 5.3 Cohort study ................................................................................................................................... 23 5.3.1 Follow-up ........................................................................................................................................ 23 5.3.2 Analysis ........................................................................................................................................... 23 5.4 Nested case-control study .............................................................................................................. 24 5.4.1 Case definition ................................................................................................................................ 24 5.4.2 Selection of controls ....................................................................................................................... 24 5.4.3 Exposure definition ........................................................................................................................ 25 5.4.4 Analysis ........................................................................................................................................... 26 5.5 Case-crossover analysis .................................................................................................................. 27 5.5.1 Study population ............................................................................................................................ 27 5.5.2 Cases and control dates ................................................................................................................. 27 5.5.3 Exposure definition ........................................................................................................................ 27 5.5.4 Analysis ........................................................................................................................................... 28 5.6 Self-controlled case series analysis ................................................................................................ 29 5.6.1 Study population ............................................................................................................................ 29 5.6.2 Exposure definition ........................................................................................................................ 30 5.6.3 Statistical analysis ........................................................................................................................... 32 6 Instrumental variable analysis .......................................................................................... 33 7 Limitations ......................................................................................................................... 33 8 References ......................................................................................................................... 35 9 Annexes ............................................................................................................................. 38 PROTECT_WP2 Final Protocol_BenzoHIPfracture_14Nov2011_Amend
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