Kapusinszky 2010.
Methods |
Study design: nationwide uncontrolled before‐and‐after study Setting: Hungary National AFP surveillance data from 1992 to 2006. Type 3 polioviruses isolated from the stools of patients with onset of AFP were recovered from archived specimens at the National Institute of Public Health, Budapest, Hungary. Study dates: 1959 to 1992 |
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Participants |
Participants: Out of all vaccinated Hungarian children, 90 cases of vaccine‐associated paralytic poliomyelitis (VAPP) were reported, 52 of which were associated with Sabin 3‐related virus (76% of VAPP cases with virologic data). Age: range = 1 to 54 months (mean = 15.6 months, median = 9 months) |
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Interventions |
Before (from 1959 to 1992, duration 396 months) O: (mOPV1, mOPV2, mOPV3) separated by 6 weeks at age 2‐38 months After (from 1992 to 2006, duration 168 months) IOOOOO: IPV at 3 months, 5 tOPV |
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Outcomes |
Follow‐up: 15 years |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | |
ITS/UBA: blinded assessment of primary outcome(s) | Unclear risk | Comment: AFP and virological testing are objective outcomes; however, VAPP requires interpretation. |
ITS/UBA: reliable primary outcome measure(s) | Low risk | Comment: In Hungary, the surveillance of AFP continued permanently with high standards. Additianalyy, there was a molecular characterization of poliovirus isolates from children who contracted VAPP. |
UBA: follow‐up of professionals | Low risk | Comment: national AFP surveillance suggests a complete nationwide follow‐up. The follow‐up period was long enough. |
UBA: follow‐up of patients | Low risk | Comment: national AFP surveillance suggests a complete nationwide follow‐up. The follow‐up period was long enough. |
Conflict of interest | Unclear risk | Comment: supported by the RiViGene Project (Genomic inventory, forensic markers, and assessment of potential therapeutic and vaccine targets for viruses relevant in biological crime and terrorism; Contract number: SSPE‐CT‐2005‐022639) |