Ivanova 2018.
Methods |
Study design: nationwide uncontrolled before‐and‐after study. National AFP surveillance data from 2006 to 2013. Virological testing in WHO‐accredited laboratories of faecal specimens adequately taken and handled. VAPP cases were identified through the acute flaccid paralysis surveillance system, classified by the National Expert Classification Committee Setting: Russian Federation Study dates: 1998 to 2014 |
|
Participants |
Participants: out of 6643 cases of AFP during the period 1998–2014, 127 cases were VAPP. 82 cases were observed in OPV recipients (rVAPP), whereas 45 cases were observed in non‐vaccinated contacts and classified as ‘contact VAPP’ (cVAPP). Age: the age of the patients varied from 1 month to 5.4 years (8.4 ± 8.1 months old). Children younger than 1 year constituted 74% of the group Sex: boys were dominant (80%) Ninety (70.9%) of the 127 VAPP patients were vaccinated against poliomyelitis. The majority of them (85.6%) had received one dose of OPV, while 10% had received two doses, 3.3% three doses, and 1.1% four doses. The time between OPV administration and the onset of paralysis was 20.9 8.7 days (ranging from 2 to 35 days). |
|
Interventions |
Before: exclusive use of OPV scheme OOOO (OPV at 6, 18, 20 months; 14 years) during the period 1998‐2007 After: Sequential scheme IIIOOOO ( IPV at 3, 4.5 months; OPV at 6, 18, 20 months; 14 years) during the period 2008‐2014. |
|
Outcomes |
Timing of outcome assessment: 10‐year period of tOPV use and a 7‐year period of the use of the sequential IPV–tOPV. Follow‐up: 10‐year period of tOPV use and a 7‐year period of the use of the sequential IPV–tOPV. |
|
Notes | The research was carried out with support from the Federal Budget of the Russian Federation allocated for the implementation of the Polio Eradication Programme in the Russian Federation, the WHO Polio Eradication Programme, the WHO Regional Office for Europe, and a Russian Science Foundation grant (project No.15‐15‐00147). The work of OEI, KLI, and APG were partially supported by Russian academic excellence project “5–100”. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
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: national AFP surveillance and virological testing of faecal specimens in WHO‐accredited laboratories adequately taken and handled |
UBA: follow‐up of professionals | Low risk | Comment: national AFP surveillance suggests a complete nationwide follow‐up. The follow‐up period was long enough. The AFP surveillance was unchanged from 2006 through to 2014. |
UBA: follow‐up of patients | Low risk | Comment: national AFP surveillance suggests a complete nationwide follow‐up. The follow‐up period was long enough. The AFP surveillance was unchanged from 2006 through to 2014. |
Conflict of interest | Low risk | Comment: the study was financed from the Russian Federation budget within the framework of the Program for eradication of poliomyelitis in the Russian Federation, WHO Polio eradication initiative, WHO's European Regional Bureau, Russian Foundation for Basic Research (project number 15‐15‐00147). |