title: Vaccines safety; effect of supervision or SMS on reporting rates of adverse events following immunization (AEFI) with meningitis vaccine (MenAfriVac™): a randomized controlled trial.
abstract: BACKGROUND
  To ensure vaccines safety, given the weaknesses of the national pharmacovigilance system in Cameroon, there is a need to identify effective interventions that can contribute to improving AEFI reporting.
  
  
  OBJECTIVE
  To assess the effect of: (i) sending weekly SMS, or (ii) weekly supervisory visits on AEFI reporting rate during a meningitis immunization campaign conducted in Cameroon in 2012 using the meningitis A conjugate vaccine (MenAfriVac™).
  
  
  METHODS
  Health facilities that met the inclusion criteria were randomly assigned to receive: (i) a weekly standardized SMS, (ii) a weekly standardized supervisory visits or (iii) no intervention. The primary outcome was the reported AEFI incidence rate from week 5 to 8 after the immunization campaign. Poisson regression model was used to estimate the effect of interventions after adjusting for health region, type of health facility, type and position of health workers as well as the cumulative number of AEFI reported from weeks 1 to 4.
  
  
  RESULTS
  A total of 348 (77.2%) of 451 health facility were included, and 116 assigned to each of three groups. The incidence rate of reported AEFI per 100 health facility per week was 20.0 (15.9-24.1) in the SMS group, 40.2 (34.4-46.0) in supervision group and 13.6 (10.1-16.9) in the control group. Supervision led to a significant increase of AEFI reporting rate compared to SMS [adjusted RR=2.1 (1.6-2.7); p<0.001] and control [RR=2.8(2.1-3.7); p<0.001)] groups. The effect of SMS led to some increase in AEFI reporting rate compared to the control group, but the difference was not statistically significant [RR=1.4(0.8-1.6); p=0.07)].
  
  
  CONCLUSIONS
  Supervision was more effective than SMS or routine surveillance in improving AEFI reporting rate. It should be part of any AEFI surveillance system. SMS could be useful in improving AEFI reporting rates but strategies need to be found to improve its effectiveness, and thus maximize its benefits.
authors.affiliation: Department of Biomedical Sciences, Faculty of Sciences, University of Dschang, Cameroon; Department of Epidemiology and Public Health, Swiss Tropical and Public Health Institute, Basel, Switzerland; Clinical Research Unit, Division of Health Operations Research, Ministry of Public Health, Cameroon. Electronic address: jateudj@yahoo.fr.
authors.forename: Jerome
authors.initials: J
authors.lastname: Ateudjieu
authors.affiliation: Institute of Social and Preventive Medicine, Faculty of Medicine, University of Geneva, Switzerland.
authors.forename: Beat
authors.initials: B
authors.lastname: Stoll
authors.affiliation: Biostatistics Unit, Department of Public Health, Faculty of Medicine & Biomedical Sciences, University of Yaounde I, Cameroon.
authors.forename: Georges
authors.initials: G
authors.lastname: Nguefack-Tsague
authors.affiliation: Department of Pharmacology Drugs and Laboratory, Ministry of Public Health, Cameroon.
authors.forename: Christoph
authors.initials: C
authors.lastname: Tchangou
authors.affiliation: Department of Epidemiology and Public Health, Swiss Tropical and Public Health Institute, Basel, Switzerland; Department of Ambulatory Care and Community Medicine-Infectious Disease Service, University Hospital, Lausanne, Switzerland.
authors.forename: Blaise
authors.initials: B
authors.lastname: Genton
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems / Q000458:organization & administration*; D002163:Cameroon; D006268:Health Facilities / Q000706:statistics & numerical data*; D006801:Humans; D022401:Meningococcal Vaccines / Q000009:adverse effects* / Q000627:therapeutic use; D017064:Process Assessment, Health Care; D060145:Text Messaging; D014611:Vaccination / Q000009:adverse effects; D018074:Vaccines, Conjugate / Q000009:adverse effects / Q000627:therapeutic use
chemical_list: C573970:MenAfriVac; D022401:Meningococcal Vaccines; D018074:Vaccines, Conjugate
keywords: AEFI surveillance; Cameroon; Immunization campaign; MenAfriVac™; Meningitis vaccine; SMS; supervision