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Study Protocol Use of Benzodiazepines and Risk of Hip/Femur Fracture

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Study Protocol Use of Benzodiazepines and Risk of Hip/Femur Fracture 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 approved 29 Feb 2012 PROTECT_WP2_Final Protocol_Benzo_HIP fracture_Nov14 2011Amend1_approved29Feb2012 Page 1 of 177 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 Miguel Gil 2 Database 2 (Bifap) lead Consuelo Huerta 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 (GPRD) lead Arlene Gallagher/ Dan Dedman /Jenny Campbell 13 Database 3 (GPRD) 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 Mark de Groot7 and Raymond Schlienger14 WG1 coleads Olaf Klungel7 and Robert Reynolds5 WP2 coleads 1 Universidad de Alcalá, Madrid, Spain 2 Agencia Espanola 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, New York, USA (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 (GPRD) 14 Novartis Pharma, Switzerland (Novartis) PROTECT_WP2_Final Protocol_Benzo_HIP fracture_Nov14 2011Amend1_approved29Feb2012 Page 2 of 177 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. 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 4.2.1. GPRD /THIN/Mondriaan/BIFAP Databases .................................................................................. 9 4.2.2. Bavarian Claims Database .......................................................................................................... 10 5. Study Designs ................................................................................................................................. 10 5.1 Descriptive study ............................................................................................................................ 11 5.1.1 Study Population ............................................................................................................................ 11 5.1.2 Exposure description ...................................................................................................................... 12 5.1.3 Outcome description ...................................................................................................................... 15 5.2 Analytical studies ............................................................................................................................ 16 5.2.1 Study population ............................................................................................................................ 16 5.2.2 Outcome Definition ........................................................................................................................ 17 5.2.3 Exposure definition ........................................................................................................................ 18 5.2.4 Potential confounders .................................................................................................................... 20 5.2.5 Analysis ........................................................................................................................................... 20 5.3 Cohort study ................................................................................................................................... 21 5.3.1 Follow‐up ........................................................................................................................................ 21 5.3.2 Analysis ........................................................................................................................................... 21 5.4 Nested case‐control study .............................................................................................................. 22 5.4.1 Case definition ................................................................................................................................ 22 5.4.2 Selection of controls ....................................................................................................................... 22 5.4.3 Exposure definition ........................................................................................................................ 22 5.4.4 Analysis ........................................................................................................................................... 22 5.5 Case‐crossover analysis .................................................................................................................. 23 5.5.1 Study population ............................................................................................................................ 23 5.5.2 Analysis ........................................................................................................................................... 23 5.6 Self‐controlled case series analysis ................................................................................................ 23 5.6.1 Study population ............................................................................................................................ 23 5.6.2 Analysis ........................................................................................................................................... 24 6. Instrumental variable analysis........................................................................................................ 24 7. Limitations ...................................................................................................................................... 25 8. References ...................................................................................................................................... 27 9 Annexes .......................................................................................................................................... 30 9.1 Annex I Codes for exposure and outcome ..................................................................................... 30 9.2 Annex II Codes for benzodiazepines indication ............................................................................. 36 9.3 Annex III Codes for potential confounders .................................................................................... 56 9.3.1 Codes for group b) Well established risk factors for fracture ........................................................ 56 9.3.2 Codes for group c) Risk factors immediately related to the outcome ........................................... 85 9.3.3 Codes for group d) Other risk factors that have been associated with fracture in the past. ........ 88 PROTECT_WP2_Final Protocol_Benzo_HIP fracture_Nov14 2011Amend1_approved29Feb2012 Page 3 of 177 10. APPENDIX (Amendments) ............................................................................................................ 173
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