Papers on the self-controlled case series method

About the method

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

Becker NG, Salim A and Kelman CW. Analysis of a potential trigger of an acute illness. Biostatistics 2006; 7(1):16-28. [abstract]

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. [abstract] [Accepted version, April 05]

Whitaker HJ. The self-controlled case series method: A way to study the relation between antipsychotics and stroke (Editorial). British Medical Journal 2008, 337(7670): 586-587.

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.

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.

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, accepted for publication. [Accepted version, July 11]

Comparisons with other methods

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]

Andrews NJ. Statistical assessment of the association between vaccination and rare adverse events post licensure. Vaccine 2002; 20: S49-S53. [abstract]

Farrington CP. Control without separate controls: Evaluation of vaccine safety using case-only methods. Vaccine 2004; 22: 2064-2070. [abstract]

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. [abstract]

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. [abstract]

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.

Extensions and additions

Vines SK and Farrington CP. Within-subject exposure dependency in case-crossover studies. Statistics in Medicine 2001; 20:3039-3049. [abstract]

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. [abstract]

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. [abstract]

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

Farrington CP and Whitaker HJ. Semiparametric analysis of case series data. Applied Statistics 2006; 55(5): 553-594. [abstract] [Accepted version, March 06]

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

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

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.

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.

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

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.

Kuhnert R, Hecker H, Poethko-Muller C, Schlaud M, Vennemann M, Whitaker HJ and Farrington CP. A Modied Self-Controlled Case Series Method to Examine Association Between Multi-dose Vaccinations and Death. Statistics in Medicine, 2011, 30(6), 666-677.

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.

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, accepted for publication. [Submitted version]

Published studies using the case series method


Farrington CP, Pugh S, Colville A, Flower A, Nash J, Morgan-Capner P, Rush M and Miller E. A new method for active surveillance of adverse events from diphtheria tetanus pertussis and measles mumps rubella vaccines. Lancet 1995; 345:567-569.

Taylor B, Miller E, Farrington CP, Petropoulos M-C, Favot-Mayaud I, Li J, Waight PA. Autism and measles, mumps and rubella vaccine: no epidemiological evidence for a causal association. Lancet 1999; 353:2026-2029.


Dourado I, Cunha S, Teixeira M de G, Farrington CP, Melo A, Lucena R, Barreto ML. An outbreak of aseptic meningitis associated with a Urabe-containing MMR mass vaccination campaign: implications for immunization programs. American Journal of Epidemiology 2000; 151:524-530.

Kramarz P, DeStefano F, Garguillo PM, Davis RL, Chen RT, Mullooly JP, Black SB, Shinefield MD, Bohlke K, Ward JI and Marcy MS. Does influenza vaccination exacerbate asthma? Archives of Family Medicine 2000; 9:617-623.


Miller E, Waight P, Farrington P, Stowe J, Taylor B. Idiopathic thrombocytopenic purpura and MMR vaccine. Archives of Disease in Childhood 2001; 84:227-229.

Andrews N, Miller E, Waight P, Farrington CP, Crowcroft N, Stowe J and Taylor B. Does oral polio vaccine cause intussusception in infants? Evidence from a sequence of three self-controlled case series studies in the United Kingdom. European Journal of Epidemiology 2001; 17:701-706.

Farrington CP, Miller E and Taylor B. MMR and autism: further evidence against a causal association. Vaccine 2001; 19:3632-3635.

Galindo Sardinas MA, Zambrano Cardenas A, Coutin Marie G, Santin Pena M, Alino Santiago M, Valcarcel Sanchez M, and Farrington CP. Lack of association between intussusception and oral polio vaccine in Cuban children. European Journal of Epidemiology 2001; 17:783-787.

Murphy TV, Garguillo PM, Massoudi MS, Nelson DB, Jumaan AO, Okoro CA, Zanardi LR, Setia S, Fair E, LeBaron CW, Wharton M and Livingood JR. Intussusception among infants given an oral rotavirus vaccine. New England Journal of Medicine 2001; 344:564-572.

Kramarz P, DeStefano F, Gargiullo PM, et al. Does influenza vaccination prevent asthma exacerbations in children? Journal of Pediatrics 2001; 138: 306-310.

Stowe J, Kafatos G, Andrews N, Miller E. Idiopathic thrombocytopenic purpura and the second dose of MMR. Archives of Disease in Childhood 2001; 93: 182-183.


Mullooly JP, Pearson J, Drew L, Schuler R, Maher J, Gargiullo P, De Stefano F, Chen R and the vaccine safety datalink working group. Wheezing lower respiratory disease and vaccination of full-term infants. Pharmacoepidemiology and Drug Safety 2002; 11:21-30.


Miller E, Andrews N, Waight P, Taylor B. Bacterial infections, immune overload, and MMR vaccine. Archives of Disease in Childhood 2003; 88:222-223.

Hubbard R, Farrington P, Smith C, Smeeth L and Tattersfield A. Exposure to tricyclic and selective serotonin reuptake inhibitor antidepressants and the risk of hip fracture. American Journal of Epidemiology 2003; 158:77-84.

Tata LJ, West J, Harrison T, Farrington P, Smith C, Hubbard R. Does influenza vaccination increase consultations, corticosteroid prescriptions or exacerbations in people with asthma or chronic obstructive pulmonary disease? Thorax 2003; 58:835-839.


Becker NG, Li Z and Kelman CW. The effect of transient exposures on the risk of an acute illness with low hazard rate. Biostatistics 2004; 5(2):239-248.

Mutsch M, Zhou W, Rhodes P, Bopp M, Chen RT, Linder T, Spyr C and Steffen R. Use of the inactivated intranasal influenza vaccine and the risk of bell's palsy in Switzerland. New England journal of medicine 2004; 350:896-903.

Smeeth L, Thomas SL, Hall AJ, Hubbard R, Farrington P and Vallance P. Risk of myocardial infarction and stroke after acute infection or vaccination. New England Journal of Medicine 2004; 351:2611-2618.


Miller E, Andrews N, Grant A, Stowe J and Taylor B. No evidence of an association between MMR vaccine and gait disturbance. Archives of Disease in Childhood 2005; 90:292-296.

Tata LJ, West J, Smith C, Farrington P, Card T, Smeeth L and Hubbard R. General population based study of the impact of tricyclic and selective serotonin reuptake inhibitor antidepressants on the risk of acute myocardial infarction. Heart 2005; 91(4):465-471.

Tata LJ, Fortun PJ, Hubbard RB, Smeeth L, Hawkey CJ, Smith CJP, Whitaker HJ, Farrington CP, Card TR and West J. Does concurrent prescription of selective serotonin reuptake inhibitors and non-steroidal anti-inflammatory drugs substantially increase the risk of upper gastrointestinal bleeding? Alimentary Pharmacology & Therapeutics 2005; 22(3):175-181.

Ali M, Do CG, Clemens JD, Park JK, Seidlein L, Truong MT, Vu TD, Le TH and Dang TC. The use of a computerized database to monitor vaccine safety in Viet Nam. Bulletin of the World Health Organization 2005; 83(8):604-610.

Hubbard R, Lewis S, Smith C, Godfrey C, Smeeth L, Farrington P and Britton J. Use of nicotine replacement therapy and the risk of acute myocardial infarction, stroke, and death. Tobacco Control 2005; 14(6):416-421.

Hubbard R, Lewis S, West J, Smith C, Godfrey C, Smeeth L, Farrington P and Britton J. Bupropion and the risk of sudden death: a self-controlled case-series analysis using The Health Improvement Network. Thorax 2005; 60(10): 848-850.


Smeeth L, Cook C, Thomas S, Hall AJ, Hubbard R and Vallance P. Risk of deep vein thrombosis and pulmonary embolism after acute infection in a community setting. The Lancet 2006; 367:1075-1079.

Cameron JC, Walsh D, Finlayson AR and Boyd JH. Oral polio vaccine and intussusception: A data linkage study using records for vaccination and hospitalization. American Journal of Epidemiology 2006; 163(6): 528-533.

Mullooly JP, Crane B and Chun C. Trivalent inactivated influenza vaccine safety in children: Assessing the contribution of telephone encounters. Vaccine 2006; 24(13): 2256-2263.

Hambidge SJ, Glanz JM, France EK, McClure D, Xu S, Yamasaki K, Jackson L, Mullooly JP, Zangwill KM, Marcy SM, Black SB, Lewis EM, Shinefield HR, Belongia E, Nordin J, Chen RT, Shay DK, Davis RL, DeStefano F and the Vaccine Safety Datalink Team. Safety of Trivalent Inactivated Influenza Vaccine in Children 6 to 23 Months Old. Journal of the American Medical Association 2006; 296(16): 1990-1997.

Game FL, Chipchase SY, Hubbard R, Burden RP and Jeffcoate WJ. Temporal association between the incidence of foot ulceration and the start of dialysis in diabetes mellitus. Nephrology Dialysis Transplantation 2006; 21 (11): 3207-3210.

Juurlink DN, Stukel TA, Kwong J, Kopp A, McGeer A, Upshur RE, Manuel DG, Moineddin R, Wilson K. Guillain-Barre syndrome after influenza vaccination in adults: A population-based study. Archives of Internal Medicine 2006; 166 (20): 2217-2221.

Hughes RA, Charlton J, Latinovic R and Gulliford MC. No association between immunization and Guillain-Barre syndrome in the United Kingdom. Archives of Internal Medicine 2006; 166: 1301-1304.

Stowe J, Andrews N, Wise L, Miller E. Bell’s Palsy and Parental Inactivated Influenza Vaccine. Human Vaccines 2006; 2:110-112.


Andrews N, Stowe J, Miller E and Taylor B. Post-licensure safety of the meningococcal group C conjugate vaccine. Human Vaccines 2007; 3(2): 59-63.

Miller E, Andrews N, Stowe J, Grant A, Waight P and Taylor B. Risks of convulsion and aseptic meningitis following measles-mumps-rubella vaccination in the United Kingdom. American Journal of Epidemiology 2007; 165(6): 704-709.

Ward KN, Bryant NJ, Andrews NJ, Bowley JS, Ohrling A, Verity CM, Ross EM, Miller E. Risk of serious neurologic disease after immunization of young children in Britain and Ireland. Pediatrics 2007; 120(2): 314-321.

Payne DC, Aranas A, McNeil MM, Duderstadt S and Rose CE. Concurrent vaccinations and US miliatary hospitalizations. Annals of Epidemiology 2007; 17(9): 697-703.

Hocine MN, Farrington CP, Touze E, Whitaker HJ, Fourrier A, Moreau T & Tubert-Bitter P. Hepatitis B vaccination and first central nervous system demyelinating events: reanalysis of a case-control study using the self-controlled case series method. Vaccine 2007; 25(31): 5938-5943.

Taylor B, Andrews N, Stowe J, Hamidi-Manesh L, Miller E. No increased risk of relapse after meningococcal C conjugate vaccine in nephrotic syndrome. Archives of Disease in Childhood 2007; 92: 887-889.

Burwen DR, La Voie L, Braun MM, Houck P, Hudson R, Ball R. Evaluating adverse events after vaccination in the Medicare population. Pharmacoepidemiology and Drug Safety 2007; 16: 753-761.


Stowe J, Kafatos G, Andrews N, Miller E. Idiopathic thrombocytopenic purpura and the second dose of MMR. Archives of Disease in Childhood 2008; 93(2): 182-183

France EK, Glanz J, Xu S, et al. Risk of immune thrombocytopenic purpura after measles-mumps-rubella immunization in children. Pediatrics 2008; 121: E687-E692.


Grosso A, Douglas I, Hingorani A, et al. Oral Bisphosphonates and Risk of Atrial Fibrillation and Flutter in Women: A Self-Controlled Case-Series Safety Analysis. Plos One 2009, 4(3):e4720.

Douglas IJ, Evans SJ, Pocock S, et al. The Risk of Fractures Associated with Thiazolidinediones: A Self-controlled Case-Series Study. Plos Medicine 2009, 6(9):e1000154.

Corrales-Medina VE, Fatemi O, Serpa J, Valayam J, Bozkurt B, Madjid M, Musher DM. The association between Staphylococcus aureus bacteremia and acute myocardial infarction. Scandinavian Journal of Infectious Diseases 2009, 41(6-7):511-514.

Corrales-Medina VF, Serpa J, Rueda AM, et al. Acute Bacterial Pneumonia is Associated With the Occurrence of Acute Coronary Syndromes. Medicine 2009, 88(3):154-159.

Gibson JE, Hubbard RB, Smith CJP, et al. Use of Self-controlled Analytical Techniques to Assess the Association Between Use of Prescription Medications and the Risk of Motor Vehicle Crashes. American Journal of Epidemiology 2009, 169(6): 761-768.

Naleway AL, Belongia EA, Donahue JG, Kieke BA, Glanz JM. Risk of immune hemolytic anemia in children following immunization. Vaccine 2009, 27: 7394-7397.

Stowe J, Andrews N, Taylor B, Miller E. No evidence of an increase of bacterial and viral infections following Measles, Mumps and Rubella vaccine. Vaccine 2009, 27: 1422-1425.

Zinman L, Thoma J, Kwong JC, Kopp A, Stukel TA, Juurlink DN. Safety of influenza vaccination in patients with myasthenia gravis: A population-based study. Muscle and Nerve 2009, 40: 947-951.


Greene SK, Kulldorff M, Lewis EM, et al. Near Real-Time Surveillance for Influenza Vaccine Safety: Proof-of-Concept in the Vaccine Safety Datalink Project. American Journal of Epidemiology 2010, 171(2):177-188.

Andrews N, Stowe J, Wise L, Miller E. Post-licensure comparison of the safety profile of diphtheria/tetanus/whole cell pertussis/haemophilus influenza type b vaccine and a 5-in-1 diphtheria/tetanus/acellular pertussis/haemophilus influenza type b/polio vaccine in the United Kingdom. Vaccine 2010, 28: 7215-7220.

Gold M, Dugdale S, Woodman RJ, McCaul KA. Use of the Australian Childhood Immunisation Register for vaccine safety data linkage. Vaccine 2010, 28: 4308-4311.

Huang WT, Gargiullo PM, Broder KR, et al. Lack of Association Between Acellular Pertussis Vaccine and Seizures in Early Childhood. Pediatrics 2010, 126: E263-E269.

Donaldson GC, Hurst JR, Smith CJ, Hubbard RB, Wedzicha JA. Increased risk of myocardial infarction and stroke following exacerbation of COPD. Chest 2010, 137 (5): 1091-1097.

Petersen, I., Gilbert, R., Evans, S., Ridolfi, A., Nazareth, I. Oral antibiotic prescribing during pregnancy in primary care: UK population-based study. Journal of Antimicrobial Chemotherapy 2010, 65 (10): 2238-2246.

Minassian C, D'Aiuto F, Hingorani AD, Smeeth L. Invasive dental treatment and risk for vascular events: A self-controlled case series. Annals of Internal Medicine 2010, 153 (8): 499-506.

Pratt NL, Roughead EE, Ramsay E, Salter A, Ryan P. Risk of hospitalization for stroke associated with antipsychotic use in the elderly: A self-controlled case series. Drugs and Aging 2010, 27 (11): 885-89.


Gwini SM, Coupland CAC, Siriwardena AN. The effect of influenza vaccination on risk of acute myocardial infarction: Self-controlled case-series study. Vaccine 2011, 29: 1145-1149.

Wilson K, Hawken S, Potter BK, Chakraborty P, Kwong J, Crowcroft N, Rothwell D, Manuel D. Patterns of emergency room visits, admissions and death following recommended pediatric vaccinations-A population based study of 969,519 vaccination events. Vaccine 2011 (Article in Press).

If you know of any other published studies using the self-controlled case series method we would appreciate it if you could contact us to let us know . Thanks!

The self-controlled case series method / Heather Whitaker / updated May 2011