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Papers on the self-controlled case series method

The original article

Farrington CP. Relative incidence estimation from case series for vaccine safety evaluation. Biometrics. 1995; 51: 228-235.

Suggested introductions to SCCS

Petersen I, Douglas I and Whitaker H. Self-controlled case series methods – an alternative to standard epidemiological study designs. British Medical Journal. 2016; 354: i4515. DOI:10.1136/bmj.i4515

Whitaker HJ, Farrington CP, Spiessens B and Musonda P. Tutorial in biostatistics: The self-controlled case series method. Statistics in Medicine. 2006; 25(10): 1768-1797. DOI:10.1002/sim.2302 [Accepted version, April 05]

More introductions to SCCS and case only designs

Hallas J and Pottegard A. Use of self-controlled designs in pharmacoepidemiology. Journal of internal medicine. 2014; 275: 581-589. DOI:10.1111/joim.12186

Maclure M, Fireman B, Nelson JC, Hua W, Shoaibi A, Paredes A, Madigan D. When should case-only designs be used for safety monitoring of medical products? Pharmacoepidemiology and Drug Safety. 2012; 21,Suppl 1: 50-61. DOI:10.1002/pds.2330.

Grosso A, Douglas I, MacAllister R, et al. Use of the self-controlled case series method in drug safety assessment. Expert opinion on drug safety. 2011; 10(3): 337-340. DOI:10.1517%2F14740338.2011.562187

Whitaker HJ, Hocine M and Farrington CP. The methodology of self-controlled case series studies. Statistical Methods in Medical Research. 2009; 18(1): 7-26. DOI:10.1177/0962280208092342

Reviews of published studies using the SCCS method

Ghebremichael-Weldeselassie Y, Farrington CP and Whitaker HJ. Use of the self-controlled case series method beyond vaccine safety: a systematic review and discussion. Forthcoming…

Gault N, Castañeda-Sanabria J, De Rycke Y, Guillo S, Foulon S, Tubach F. Self-controlled designs in pharmacoepidemiology involving electronic healthcare databases: A systematic review. BMC Medical Research Methodology. 2017; 17(1). DOI:10.1186/s12874-016-0278-0

Nordmann S, Biard L, Ravaud P, Esposito-Farèse M, Tubach F. Case-Only Designs in Pharmacoepidemiology: A Systematic Review. PLoS ONE. 2012; 7(11). DOI:10.1371/journal.pone.0049444

Weldeselassie YG, Whitaker HJ and Farrington CP. Use of the self-controlled case series method in vaccine safety studies: review and recommendations for best practice. Epidemiology and Infection, 2011, 139(12): 1805-1817. [Accepted version, July 11]

SCCS in a wider context with other methods

Uddin MJ, Groenwold RHH, ali MS, de Boer A, Roes KCB, Chowdhury MAB and Klungel OH. Methods to control for unmeasured confounding in pharmacoepidemiology: an overview. International Journal of Clinical Pharmacy. 2016; 38(3), 714–723. DOI:10.1007/s11096-016-0299-0 

Li R, Stewart B, Weintraub E. Evaluating efficiency and statistical power of self-controlled case series and self-controlled risk interval designs in vaccine safety. Journal of Biopharmaceutical Statistics. 2016; 26: 686-693. DOI:10.1080/10543406.2015.1052819

Baker MA, Lieu TA, Li L, Hua W, Qiang Y, Kawai AT, Fireman BH, Martin DB and Nguyen MD. A vaccine study design selection framework for the postlicensure rapid immunization safety monitoring program. American Journal of Epidemiology. 2015; 181(8): 608-618. DOI:10.1093/aje/kwu322

McClure DL, Glanz JM, Xu S, Hambidge SJ, Mullooly JP, Baggs J. Comparison of epidemiologic methods for active surveillance of vaccine safety. Vaccine. 2008; 26(26): 3341-3345.

Whitaker HJ, Hocine MN and Farrington CP. On case-crossover methods for environmental time series data. Environmetrics. 2007; 18: 157-171. DOI:10.1002/env.809 [Accepted version, June 06]

Glanz JM, McClure DL, Xu S, Hambridge SJ, Lee M, Kolczak MS, Kleinman K, Mullooly JP and France EK. Four different study designs to evaluate vaccine safety were equally validated with contrasting limitations. Journal of Clinical Epidemiology. 2006; 59: 808-818. DOI:10.1016/j.jclinepi.2005.11.012

Smeeth L, Donnan PT and Cook DG. The use of primary case databases: case-control and case-only designs. Family Practice 2006; 23(5): 597-604. DOI:10.1093/fampra/cml025

Farrington CP, Nash J and Miller E. Case series analysis of adverse reactions to vaccines: a comparative evaluation. American Journal of Epidemiology 1996; 143: 1165-1173. Erratum 1998; 147: 93. [abstract]

Methodological papers and extensions

Ghebremichael-Weldeselassie Y, Whitaker HJ, Farrington CP. Spline-based self-controlled case series method. Statistics in Medicine. 2017; 36: 3022–3038. DOI:10.1002/sim.7311

Ghebremichael-Weldeselassie Y, Whitaker HJ, Douglas IJ, Smeeth L, Farrington CP. Self-controlled case series with multiple event types. Computational Statistics and Data Analysis.  2017; 113: 64-72. DOI:10.1016/j.csda.2016.10.010

Ghebremichael-Weldeselassie Y, Whitaker HJ, Farrington CP. Flexible modelling of vaccine effect in self-controlled case series models. Biometrical journal. 2016; 58(3): 607-622. DOI:10.1002/bimj.201400257

Moghaddass R, Rudin C, Madigan D. The factorized self-controlled case series method: An approach for estimating the effects of many drugs on many outcomes. Journal of Machine Learning Research. 2016; 17(185): 1-24.

Shaddox TR, Ryan PB, Schuemie MJ, Madigan D, Suchard MA. Hierarchical models for multiple, rare outcomes using massive observational healthcare databases. Statistical Analysis and Data Mining: The ASA Data Science Journal. 2016; 9(4): 260-268. DOI:10.1002/sam.11324

Schuemie MJ, Trifirò G, Coloma PM, Ryan PB, Madigan D. Detecting adverse drug reactions following long-term exposure in longitudinal observational data: The exposure-adjusted self-controlled case series. Statistical methods in medical research. 2016; 25(6), 2577-2592. DOI:10.1177/0962280214527531

Lee KJ, Carlin JB. Fractional polynomial adjustment for time-varying covariates in a self-controlled case series analysis. Statistics in Medicine. 2014; 33(1): 105-116. DOI:10.1002/sim.5911

Xu S, Newcomer S, Nelson J, Qian L, Mcclure D, Pan Y, Zeng C, Glanz J. Signal detection of adverse events with imperfect confirmation rates in vaccine safety studies using self-controlled case series design. Biometrical Journal. 2014; 56: 513-525. DOI:10.1002/bimj.201300012

Weldeselassie YG, Whitaker HJ, Farrington CP. Self-controlled case series method with smooth age effect. Statistics in Medicine. 2014; 33(4): 639-649. DOI:10.1002/sim.5949

Mohammed SM, Dalrymple LS, Şentürk D and Nguyen DV. Design considerations for case series models with exposure onset measurement error. Statistics in Medicine. 2013; 32: 772–786. DOI:10.1002/sim.5552

Mohammed SM, Dalrymple LS, Şentürk D. and Nguyen DV. Naive hypothesis testing for case series analysis with time-varying exposure onset measurement error: inference for infection-cardiovascular risk in patients on dialysis. Biometrics. 2013; 69: 520–529. DOI:10.1111/biom.12033

Quantin CE, Benzenine E, Velten M, Huet F, Farrington CP, Tubert-Bitter P. Self-Controlled Case Series and Misclassification Bias Induced by Case Selection From Administrative Hospital Databases: Application to Febrile Convulsions in Pediatric Vaccine Pharmacoepidemiology. American Journal of Epidemiology. 2013; 178(12), 1731–1739. DOI:10.1093/aje/kwt207

Simpson SE, Madigan D, Zorych I, Schuemie MJ, Ryan PB, Suchard MA. Multiple Self-Controlled Case Series for Large Scale Longitudinal Observational Databases. Biometrics. 2013; 69(4): 893-902. DOI:10.1111/biom.12078

Simpson SE. A positive event dependence model for self-controlled case series with applications in postmarketing surveillance. Biometrics. 2013; 69(1): 128-136. DOI:10.1111/j.1541-0420.2012.01795.x

Escolano S, Hill C, Tubert-Bitter P. A new self-controlled case series method for analyzing spontaneous reports of adverse events after vaccination. American Journal of Epidemiology. 2013; 178: 1496-1504. DOI:10.1093/aje/kwt128

Xu S, Hambidge SJ, Mcclure DL, Daley MF, Glanz JM. A scan statistic for identifying optimal risk windows in vaccine safety studies using self-controlled case series design. Statistics in Medicine. 2013; 32: 3290-3299. DOI:10.1002/sim.5733

Mohammed SM, Sentürk D, Dalrymple LS, Nguyen DV. Measurement error case series models with application to infection-cardiovascular risk in older patients on dialysis. Journal of the American Statistical Association. 2012; 107(500): 1310-1323.  DOI:10.1080/01621459.2012.695648

Kuhnert R, Hecker H, Poethko-Muller C, Schlaud M, Vennemann M, Whitaker HJ and Farrington CP. A modified self-controlled case series method to examine association between multi-dose vaccinations and death. Statistics in Medicine. 2011; 30(6), 666-677. DOI:10.1002/sim.4120

Xu S, Zhang L, Nelson JC, Zeng C, Mullooly J, McClure D and Glanz J. Identifying optimal risk windows for self-controlled case series studies of vaccine safety. Statistics in Medicine. 2011; 30: 742-752. DOI:10.1002/sim.4125

Farrington CP, Anaya K, Whitaker HJ, Hocine MN, Douglas I, Smeeth L. Self-controlled case series analysis with event-dependent observation periods. Journal of the American Statistical Association. 2011; 106(494): 417–426. [Submitted version] DOI:10.1198/jasa.2011.ap10108

Farrington CP, Hocine MN. Within-individual dependence in self-controlled case series models for recurrent events. Journal of the Royal Statistical Society series C. 2010; 59: 457-475. DOI:10.1111/j.1467-9876.2009.00703.x

Hocine MN, Musonda P, Andrews NJ and Farrington CP. Sequential case series for pharmacovigilance. Journal of the Royal Statistical Society series A. 2009; 172: 213-236. DOI:10.1111/j.1467-985X.2008.00555.x

Farrington CP, Whitaker HJ and Hocine MN. Case series analysis for censored, perturbed or curtailed post-event exposures. Biostatistics. 2009; 10(1): 3-16. DOI:10.1093/biostatistics/kxn013

Musonda P, Hocine MN, Andrews NJ and Farrington CP. Monitoring vaccine safety using case series CUSUM charts. Vaccine. 2008; 26(42): 5358-5367. DOI:10.1016/j.vaccine.2008.08.010

Musonda P, Hocine MN, Whitaker HJ and Farrington CP. Self-controlled case series analyses: small sample performance. Computational Statistics and Data Analysis. 2008; 52(4): 1942-1957. DOI:10.1016/j.csda.2007.06.016

Li B and Huang X. Existence and uniqueness of relative incidence estimates in case-series analysis. Computational Statistics and Data Analysis. 2006; 50: 1807-1817. DOI:10.1016/j.csda.2005.02.002

Musonda P, Farrington CP and Whitaker HJ. Sample sizes for self-controlled case series studies. Statistics in Medicine. 2006; 25(15): 2618-2631. DOI:10.1002/sim.2477 [Accepted version, Nov 05]

Farrington CP and Whitaker HJ. Semiparametric analysis of case series data. Applied Statistics. 2006; 55(5): 553-594. DOI:10.1111/j.1467-9876.2006.00554.x [Accepted version, March 06]

Musonda P. The self-controlled case series method: performance and design in studies of vaccine safety. PhD Thesis, The Open University, December 2006. [Thesis]

Hocine M, Guillemot D, Tubert-Bitter P and Moreau T. Testing independence between two Poisson-generated multinomial variables in case-series and cohort studies. Statistics in Medicine. 2005; 24:4035-4044. DOI:10.1002/sim.2413


The self-controlled case series method / Heather Whitaker / updated August 2017