Seminar of Prof. Martin Kulldorff

Hi Folks,

this Friday Prof. Martin Kulldorff is our visiting speaker in the department seminar.
It will take place at 13:30, in our seminar room 2076 (ICEx). The title and abstract comes
next:



Continuous Sequential Statistical Analysis for Vaccine Safety Surveillance

During the last few years, the Maximized Sequential Probability Ratio Test (MaxSPRT)¹ has been used by the CDC sponsored Vaccine Safety Datalink project for near real-time vaccine safety surveillance^2-6. Using weekly data feeds of electronic health data from ten health insurance plans in the United States, surveillance has been or is being conducted for all recently approved vaccines, including e.g. Menactra for meningococcal disease, RotaTeq for rotavirus gastroenteritis, ProQuad for Measles-mumps, rubella and varicella; and MIV for H1N1 influenza.

We first give a brief background on the MaxSPRT and illustrate its use within the Vaccine Safety Datalink. In near real-time surveillance studies, there are several key design issues. For example, one can start the surveillance immediately after the first vaccine dose is given. Alternatively, the start may be delayed, either (A) until a fixed minimum number of vaccine doses have been given, or (B) until a fixed number of observed adverse events have been see. The critical values, statistical power and expected time to signal are obtained for the MaxSPRT under both of these scenarios and compared with the standard MaxSPRT without a delayed start. With option B, it is possible to reduce the expected time until a signal without any loss in overall statistical power. The same is not true for option A, which is not a recommended design, although it may be used if a delayed start is due to external logistical reasons not under the control of the investigators.

In conclusion, our research demonstrates the feasibility and usefulness of continuous sequential statistical methods for near real-time vaccine safety surveillance.

References:

1. Kulldorff M, Davis RL, Kolczak M, Lewis E, Lieu T, Platt R. A maximized sequential probability ratio test for drug and vaccine safety surveillance. Sequential Analysis, 2011, 30:58-78.

2. Lieu TA, Kulldorff M, Davis RL, Lewis EM, Weintraub E, Yih WK, Yin R, Brown JS, Platt R. Real-time vaccine safety surveillance for the early detection of adverse events. Medical Care, 2007, 45:S89-95.

3. Yih WK, Nordin JD, Kulldorff M, Lewis E, Lieu T, Shi P, Weintraub E. An assessment of the safety of adolescent and adult tetanus-diphtheria-acellular pertussis (Tdap) vaccine, using near real-time surveillance for adverse events in the Vaccine Safety Datalink. Vaccine, 2009, 27:4257-4262.

4. Belongia EA, Irving SA, Shui IM, Kulldorff M, Lewis E, Li R, Lieu TA, Weintraub E, Yih WK, Yin R, Baggs J, and the Vaccine Safety Datalink Investigation Group. Real-time surveillance to assess risk of intussusception and other adverse events after pentavalent, bovine-derived rotavirus vaccine. Pediatric Infectious Disease Journal, 2010, 29:1-5.

5. Greene SK, Kulldorff M, Lewis EM, Li R, Yin R, Weintraub ES, Fireman BH, Lieu TA, Nordin JD, Glanz JM, Baxter R, Jacobsen SJ, Broder KR, Lee GM. Near real-time surveillance for influenza vaccine safety: Proof-of-concept in the Vaccine Safety Datalink Project. American Journal of Epidemiology, 2010, 171:177-188.

6. Klein N, Fireman B, Yih WK, Lewis E, Kulldorff M, Ray P, Baxter R, Hambidge S, Nordin J, Naleway A, Belongia E, Lieu T, Baggs J, Weintraub E, for the Vaccine Safety Datalink. Measles-Mumps-Rubella-Varicella Combination Vaccine and the Risk of Febrile Seizures, Pediatrics, 2010, in press.

see you there!