UID:
almahu_9949858846602882
Format:
1 online resource (80 pages)
Edition:
1st ed.
ISBN:
9789240029507
Note:
Intro -- Fig 1: Schematic representation of the risk and self-control intervals for adverse events with a risk interval from d0 to d7, a washout period of one week (d8-d14), and a self-control interval three times the length of the risk interval (d15-d38), where d -- Fig 2: Minimum number of cases required to reject the null hypothesis that the relative incidence of the AESI during the risk versus self-control interval is equal to 1. The probability of type-I error is set at 5%, the power at 80%, and the proportion of -- Fig 3: Summary of study flow and data collection for case-control studies -- Fig 4: Minimum number of cases required to detect odds ratios (ORs) from 2 to 5 for different levels of vaccination coverage, assuming a power of 80%, a probability of type-I error at 5%, and control-to-case ratio of 1:1, 2:1, 3:1 and 4:1. -- Table 1: Study sites with principal investigators and contact details -- Table 2: Minimum number of cases required to reject the null hypothesis that the relative incidence of AESI during risk versus self-control intervals is equal to 1. Probability of type-I error is set at 5%, power at 80%, and proportion of the total observ -- Table 3: Catchment area sizes required to detect a relative incidence of 2, 3, 4 or 5 for AESIs with annual background rates varying from 0.1-1000 per 100,000 people and a post-vaccination risk interval of 7 or 42 days, at different levels of vaccination -- Table 4: Minimum number of cases required to detect different odds ratios (ORs) for 25%, 50% and 75% vaccination coverage, assuming a power of 80%, a probability of type-I error at 5%, and a control-to-case ratio of 1:1, 2:1, 3:1 and 4:1.
,
Table 5: Catchment population required to detect an odds ratio (OR) of 2 to 5 for AESIs with known annual background rates varying from 0.1 to 1,000 per 100,000 people per year at three different levels of vaccination coverage (in controls), control-to-ca -- Table 6: Catchment population required to detect an odds ratio (OR) of 2 to 5, for AESIs with known annual background rates varying from 0.1 to 1,000 per 100,000 people per year at three different levels of vaccination coverage (in controls), and control- -- Table A1-1: Adverse events of special interest (AESI), their risk windows, and recommended study design. -- Table A2-1: Adverse events of special interest (AESI), and Brighton Collaboration (BC) case definitions (if available). -- 1. Contents -- 2. List of tables -- 3. List of figures -- 4. Protocol sign-off -- 5. Documentation of protocol amendments -- 6. Study team and responsibilities -- 6.1 Study team -- 6.2 Responsibilities -- 7. Abbreviations -- 8. Synopsis -- 9. Background and rationale -- 10. Objectives -- 10.1 Primary objective -- 11. Methods -- 11.1 Settings -- 11.2 Study sites -- 11.3 Study design -- 11.4 Self-controlled risk interval (SCRI) study -- 11.4.1 Study population -- 11.4.2 Study period -- 11.4.3 Study variables -- 11.4.4 Data sources -- 11.4.5 Study flow and data collection -- 11.4.6 Withdrawal from the study -- 11.4.7 Pregnancy -- 11.4.8 Sample size -- 11.4.9 Data analyses -- 11.5 Case-control study -- 11.5.1 Study population -- 11.5.2 Study period -- 11.5.3 Study variables -- 11.5.4 Controls -- 11.5.5 Other variables -- 11.5.6 Data sources -- 11.5.7 Study flow and data collection -- 11.5.8 Withdrawal from the study -- 11.5.9 Pregnancy -- 11.5.10 Sample size -- 11.5.11 Data analysis -- 12. Standardized analyses -- 12.1 Multi-site recruitment -- 12.2 Different COVID-19 vaccines -- 13. Data management.
,
13.1 Data entry using an electronic tool -- 13.1.1 Data security -- 13.2 Data transfer -- 13.3 Data retention and archiving -- 14. Quality assurance, monitoring and reporting -- 14.1 Monitoring -- 14.2 Periodic reporting -- 14.3 Final analyses and reporting -- 15. Study management -- 15.1 Data transfer -- 15.2 Data retention and archiving -- 15.3 National pharmacovigilance centre/AEFI committee/national immunization programme manager/dedicated scientific committee -- 15.4 Changes to the protocol -- 15.5 Management and reporting of adverse events and adverse reactions -- 16. Ethical considerations -- 16.1 Guiding principles -- 16.2 Respecting participants' autonomy -- 16.3 Participant confidentiality -- 16.4 Independent Ethics Committee/Institutional Review Board -- 17. Dissemination of study results -- 18. Study limitations -- 19. References -- 20. Annexes -- Annex 1 -- Adverse events of special interest -- Annex 2 -- Case definitions -- Annex 3 -- Catchment population calculation for SCRI study design -- Annex 4 -- Catchment population calculation for case-control study design -- Annex 5 -- Data dictionary -- Annex 6 -- Relationships between study tables -- Annex 7 -- Informed consent form.
Additional Edition:
Print version: Protocol Template to Be Used As Template for Observational Study Protocols for Sentinel Surveillance of Adverse Events of Special Interest (AESIs) after Vaccination with COVID-19 Vaccines Geneva : World Health Organization,c2021
Language:
English
Keywords:
Electronic books.
;
Electronic books.
URL:
Click here to view book
