Josephine van Dongen

Chapter 7 162 used within the RIVAR project. Exclusion criteria were: known hypersensitivity to the vaccine, severe diarrhea, previous intussusception or severe immunodeficiency. All hospitalized infants in a par ticipating hospital were screened and basic patient characteristics were entered into a digital Case Repor t Form (CRF). At the age of five months, the HRV immunization status was retrieved from medical records for all eligible infants and recorded in the CRF. A subset of eligible infants par ticipated in the before-after cohor t-study and was followed until 18 months of age for the occurrence of acute gastroenteritis. Implementation of a targeted rotavirus vaccination program Hospitals implemented the rotavirus vaccination program at different time points and entered the project one year prior to implementation of HRV (step wedged design). During a preparatory pre-implementation year the organizational and logistical infrastructure for patient selection and vaccine administration was set up in each hospital. Various educational activities targeting physicians and nurses were organized, such as group-presentations, e-learnings, and workshops. Nurses received practical tutorials for administration.We distributed pocket cards among medical doctors with eligibility criteria, (contra-) indications, the vaccination schedule and possible side effects of HRV. Posters and hand-outs were distributed to clinical wards and out- patient clinics highlighting key elements of the program. Shor tly before implementation, email newsletters were distributed to all HCP involved in the upcoming HRV implementation. The implementation of HRV was suppor ted by research personnel and -nurses. Administration of HRV first dose was scheduled during hospital stay or combined with a planned out-patient visit. The second dose of HRV was administered by parents at home, after they received instructions. Cold chain was guaranteed by a cooling device upon collection from the hospital. According to the product information, HRV can be administered in premature infants of at least 27 weeks gestation. However, national guidelines vary in their advice for HRV in these infants. Decisions about allowing administration of HRV on the in-patient-ward and to infants born before a gestational age of 27 weeks were left to the discretion of local policy in par ticipating hospitals. Regular audits were performed to guide the implementation throughout the project. Every two months the interim vaccination coverage was communicated to all hospitals.The program execution was discussed in order to identify improvements and caveats. Evaluation survey Among a sample of HCP and parents involved with rotavirus vaccination in the par ticipating hospitals we performed a survey to evaluate the implementation of the HRV program. The survey focused on study-specific and program specific themes. The themes were divided into: 1) rotavirus vaccination information provision, 2) program execution and 3) preference of rotavirus vaccination strategy. Information provision and execution were assessed using