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Effects of Pharmacological Exposure on Ovarian Cancer (EPOC)

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Effects of Pharmacological Exposure on Ovarian Cancer (EPOC) Sharp et al. Ovarian Pharmacoepidemiology ENCePP Protocol Effects of pharmacological exposure on Ovarian Cancer (EPOC) PROTCOL & ANALYSIS PLAN Project funded by Health Research Board Date: 01/08/2014 Version: V1.0 V1.0 PUBLIC ©NCRI 2014 Page 1 of 28 Sharp et al. Ovarian Pharmacoepidemiology ENCePP Protocol 1. Project Synopsis Project Title: Translating basic science into improved patient outcomes in ovarian cancer: an Ireland-UK collaboration investigating common pharmacological exposures and tumour characteristics, recurrence, survival and mortality. Research theme: Pharmacoepidemiology NCRI Staff Members: Mr Chris Brown, Dr Linda Sharp Funding source: Health Research Board Project duration: 2013 - 2015 Project Overview: By combining data from large pharmacoepidemiology databases in Ireland and the UK, will conduct a population-based study investigating associations between use of statins, beta-blockers and NSAIDs and ovarian cancer progression and outcome. This study will provide valuable population-based evidence on the effects of these common drugs on ovarian cancer and contribute to improved health outcomes for women affected by this cancer. Investigators: Dr Kathleen Bennett, Pharmacology & Therapeutics, Trinity College, St James’s Hospital Dublin Dr Thomas Ian Barron, Department of Pharmacology & Therapeutics, Trinity College Dublin Prof Liam Murray, Centre for Public Health, Queen’s University Belfast Dr John Coulter, Gynaecological Oncology, South Infirmary Victoria University Hospital, Cork Collaborators: Prof Carmel Hughes, School of Pharmacy, Queen’s University Belfast Dr Chris Cardwell, Centre for Public Health, Queen’s University Belfast Prof Rose Anne Kenny, Department of Medical Gerontology , Trinity College Dublin Prof John O’Leary, Histopathology , Trinity College Dublin Dr Sharon O’Toole, Obstetrics and Gynaecology/Histopathology, Trinity College Dublin Figure 1 - Project Overview Statins Beta-Blockers NSAIDs Drugs type/dose/duration Pre-diagnosis Pre/post-diagnosis exposure OVARIAN exposure CANCER Stage/Grade Treatment Recurrence Survival V1.0 PUBLIC ©NCRI 2014 Page 2 of 28 Sharp et al. Ovarian Pharmacoepidemiology ENCePP Protocol 2. Contents 1. Project Synopsis .............................................................................................................................. 2 2. Contents .......................................................................................................................................... 3 3. Abbreviations .................................................................................................................................. 5 4. Project description .......................................................................................................................... 6 5. Drugs of interest ............................................................................................................................. 7 6. Research questions ......................................................................................................................... 9 6.1. Data Sources ............................................................................................................................... 9 6.1.1. Dataset 1 - Ireland ................................................................................................................... 9 6.1.2. Dataset 2- Northern Ireland .................................................................................................. 10 6.1.3. Dataset 3- United Kingdom ................................................................................................... 11 6.2. Data Harmonisation .................................................................................................................. 11 6.3. Study population ....................................................................................................................... 11 6.4. Study design .............................................................................................................................. 11 6.5. Analysis Phase 1 ........................................................................................................................ 12 6.6. Analysis Phase 2 ........................................................................................................................ 13 6.7. Analysis Phase 3 ........................................................................................................................ 14 7. Outcome definitions ..................................................................................................................... 14 8. Drug definitions............................................................................................................................. 15 9. Covariates ..................................................................................................................................... 16 10. Sample size considerations ....................................................................................................... 17 11. Blinding ..................................................................................................................................... 17 12. Confounding .............................................................................................................................. 18 13. Missing data .............................................................................................................................. 18 14. Predictive modelling ................................................................................................................. 18 15. Interim analysis ......................................................................................................................... 18 16. Multiplicity ................................................................................................................................ 18 17. Software .................................................................................................................................... 19 18. Project Timeline ........................................................................................................................ 19 19. Reporting................................................................................................................................... 19 20. References ................................................................................................................................ 20 Appendix 1. Analysis tables ............................................................................................................... 24 Appendix 2. Drugs of Interest ........................................................................................................... 27 V1.0 PUBLIC ©NCRI 2014 Page 3 of 28 Sharp et al. Ovarian Pharmacoepidemiology ENCePP Protocol Listing of tables Table 1 - Baseline Characteristics ......................................................................................................... 24 Table 2 - Treatment at diagnosis .......................................................................................................... 25 Table 3 - Prescription history ................................................................................................................ 25 Table 4 - Survival estimates .................................................................................................................. 26 Table 5 - Effect of treatment on Tumour stage .................................................................................... 26 V1.0 PUBLIC ©NCRI 2014 Page 4 of 28 Sharp et al. Ovarian Pharmacoepidemiology ENCePP Protocol 3. Abbreviations Summary of abbreviations used in alphabetical order ATC WHO Anatomical Therapeutic Chemical (classification) CA-125 Cancer antigen 125 CI Confidence interval COIS Clinical Oncology Information System EPD Enhanced Prescribing Database EPOC Effects of pharmacological exposure on Ovarian Cancer GMS General Medical Services Scheme Prescription Refill Database GP General practitioner CPRD Clinical Practice Research Database HIPE Hospital Inpatient Enquiry scheme HR Hazard ratios HSE Health Service Executive ICD International Classification of Diseases IRE Ireland NCDR National Cancer Data Repository NCIN National Cancer Intelligence Network NCRI National Cancer Registry of Ireland NHS National Health Service NI Northern Ireland NI GRO Northern Ireland General Register Office NICR Northern Ireland Cancer Registry NSAIDs Non-steroidal anti-inflammatory drugs OR Odds ratios OS Overall Survival PCRS Primary Care Reimbursement Services PFS Progression free survival STROBE Strengthening the Reporting of Observational studies in Epidemiology TRO Tumour Registration Officer TVO Tumour Verification Officer UK United Kingdom V1.0 PUBLIC ©NCRI 2014 Page 5 of 28 Sharp et al. Ovarian Pharmacoepidemiology ENCePP Protocol 4. Project description Almost 250,000 ovarian cancers are diagnosed worldwide each year. Incidence rates are high in northern Europe, including in the Ireland and UK. These countries also have low survival and, consequently, among the highest ovarian cancer mortality rates in the world. The relatively young average age at diagnosis, advanced stage, and poor survival, means that ovarian cancer constitutes a major burden in terms of years of life lost. Research into factors that influence disease spread at diagnosis, and treatment response and survival would be of considerable
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