Treatment, laboratory, and data collection requirements for CONSA
| Standard clinical care . | Program site requirements for clinical care . |
|---|---|
| Medication use | Prompt availability and ability to administer/prescribe the principal drugs scheduled in the protocol, including penicillin and folic acid, once diagnosis of SCD is confirmed. |
| Immunization standard | An established Essential Programme on Immunization (EPI) must include administration of 2 vaccinations: pneumococcal (PCV-10 and PCV-13) or PPV-23, if the other pneumococcal vaccines are not available; and Hib. |
| Immunization requirement | CONSA participants from countries that do not operate EPI or have an EPI, which does not include the required vaccines identified in the requirement above, must demonstrate capacity to ensure that all patients will receive all required vaccinations within the appropriate timeline by an alternate mechanism. |
| Data system requirement | Ability to participate in the consortium’s data reporting system with a designated data manager and reliable Internet capabilities onsite. |
| National approvals for human participant research and other regulatory authorities | Approval by the institutional ethics committee (eg, institutional review board) and other local/national authorities (if necessary) to capture patient data in the consortium’s data reporting system and enroll patients into the registry trial. |
| Clinical care program | Established clinical care program for children with SCD that includes at least 1 pediatric SCD clinic or pediatric hematology clinic per week with personnel dedicated to the care of pediatric patients with SCD. |
| Catchment area | All CONSA participants must establish a proposed catchment area under the protocol and provide a plan to screen all babies within the designated area. CONSA participants must describe how they plan to enroll all babies with SCD into the protocol and patient registry. |
| Malaria prophylaxis | Malaria prophylaxis in the form of ITNs and/or standard recommended chemoprophylaxis must be provided to new or expectant mothers free-of-charge by the public health system of the country of the CONSA participant. If this is not ensured by the national public health system, the CONSA participant must show that ITNs and/or antimalarial chemoprophylaxis can be provided for free to families of all patients. |
| Laboratory and sampling | Screening, laboratory, and diagnostic requirements |
| Personnel compliance | Personnel at the referral laboratory must be in compliance with national regulations regarding laboratory certification and be willing to participate in the consortium-approved QA program. |
| Staffing for sample collection | Personnel must be trained to gather blood spots via filter paper cards from newborns in accordance with the protocol guidelines (supplemental Appendix 1). |
| Sample collection | Blood sample collection via heel prick should be obtained by 6 weeks of life, either in hospital when the baby is born or at the first neonatal care visit following birth (ie, first vaccination appointment). |
| Sample collection and laboratory materials | Logistics (availability of filter paper cards, gloves, lancets, shipping methods, etc) necessary for timely collection and shipment of screening samples to the referral laboratory. |
| Laboratory capacity for screening and diagnosis | A referral laboratory that can perform the initial screening test and confirmation tests via IEF and report results to the referring institution within 2 weeks of receipt of blood samples. |
| Additional requirements | |
| Family education and counseling | Each CONSA participant must have adequate family education and counseling services for families of babies enrolled in the consortium protocol. |
| Database requirements | Completion of the CRF for each clinical visit in the consortium database shortly after each visit. |
| Standard clinical care . | Program site requirements for clinical care . |
|---|---|
| Medication use | Prompt availability and ability to administer/prescribe the principal drugs scheduled in the protocol, including penicillin and folic acid, once diagnosis of SCD is confirmed. |
| Immunization standard | An established Essential Programme on Immunization (EPI) must include administration of 2 vaccinations: pneumococcal (PCV-10 and PCV-13) or PPV-23, if the other pneumococcal vaccines are not available; and Hib. |
| Immunization requirement | CONSA participants from countries that do not operate EPI or have an EPI, which does not include the required vaccines identified in the requirement above, must demonstrate capacity to ensure that all patients will receive all required vaccinations within the appropriate timeline by an alternate mechanism. |
| Data system requirement | Ability to participate in the consortium’s data reporting system with a designated data manager and reliable Internet capabilities onsite. |
| National approvals for human participant research and other regulatory authorities | Approval by the institutional ethics committee (eg, institutional review board) and other local/national authorities (if necessary) to capture patient data in the consortium’s data reporting system and enroll patients into the registry trial. |
| Clinical care program | Established clinical care program for children with SCD that includes at least 1 pediatric SCD clinic or pediatric hematology clinic per week with personnel dedicated to the care of pediatric patients with SCD. |
| Catchment area | All CONSA participants must establish a proposed catchment area under the protocol and provide a plan to screen all babies within the designated area. CONSA participants must describe how they plan to enroll all babies with SCD into the protocol and patient registry. |
| Malaria prophylaxis | Malaria prophylaxis in the form of ITNs and/or standard recommended chemoprophylaxis must be provided to new or expectant mothers free-of-charge by the public health system of the country of the CONSA participant. If this is not ensured by the national public health system, the CONSA participant must show that ITNs and/or antimalarial chemoprophylaxis can be provided for free to families of all patients. |
| Laboratory and sampling | Screening, laboratory, and diagnostic requirements |
| Personnel compliance | Personnel at the referral laboratory must be in compliance with national regulations regarding laboratory certification and be willing to participate in the consortium-approved QA program. |
| Staffing for sample collection | Personnel must be trained to gather blood spots via filter paper cards from newborns in accordance with the protocol guidelines (supplemental Appendix 1). |
| Sample collection | Blood sample collection via heel prick should be obtained by 6 weeks of life, either in hospital when the baby is born or at the first neonatal care visit following birth (ie, first vaccination appointment). |
| Sample collection and laboratory materials | Logistics (availability of filter paper cards, gloves, lancets, shipping methods, etc) necessary for timely collection and shipment of screening samples to the referral laboratory. |
| Laboratory capacity for screening and diagnosis | A referral laboratory that can perform the initial screening test and confirmation tests via IEF and report results to the referring institution within 2 weeks of receipt of blood samples. |
| Additional requirements | |
| Family education and counseling | Each CONSA participant must have adequate family education and counseling services for families of babies enrolled in the consortium protocol. |
| Database requirements | Completion of the CRF for each clinical visit in the consortium database shortly after each visit. |