Article type
Year
Abstract
Background:
Reporting of child-centric systematic reviews (SRs) i.e., SRs including children, differs from adult SRs in several key aspects such as descriptions of child tailored interventions, justifiable comparators, valid outcomes and outcome measures, and separate synthesis for targeted pediatric age subgroups. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses – Protocol (PRISMA-P 2015) Statement and its corresponding statement for reports (PRISMA 2009) does not cover complexities associated with reporting SR in the pediatric population.
Objectives:
To develop PRISMA-P-C (Protocol for Children) and PRISMA-C (Report for Children) statements as extensions to the PRISMA-P and PRISMA Statements, respectively, tailored to the specific requirements of reporting protocols and reports of SRs and meta-analyses (MA) that include newborns, children and adolescents or mixed children and adult population.
Methods:
We developed this reporting guidance using the EQUATOR framework for health research reporting guidelines using the following steps: (1) a scoping review identified potential child-centric items; (2) a SR of child-centric SR protocols and reports published in Medline and Embase between 2010 to 2014 evaluated the clarity and transparency in reporting of child-centric modification and extension items and identified areas where reporting could be strengthened; (3) a web-based Delphi survey of researchers with experience in child-centric SRs contributed input on the inclusion and exclusion of potential reporting items; (4) an international face to face consensus meeting of researchers, clinicians, methodologists experienced in conducting child-centric SRs and MA, and journal editors.
Results:
The final PRISMA-P-C checklist features three new extension items to PRISMA-P for reporting child-centric SR and MA protocols: two items focus on rationale for a review in children and specification of eligibility criteria, respectively, asking explicit justifications for intervention, comparator and outcome for targeted pediatric age group; a separate data synthesis for adult and targeted pediatric age groups in “mixed” reviews. Wording in four PRISMA-P items is modified to specify review methods in targeted pediatric age subgroups. The PRISMA-C checklist adds seven extension items. These include a description of subgroup analyses for the targeted pediatric age group(s), justifications for intervention, comparator and outcome for these age group(s), justification for combining adult and pediatric data, if done, and appropriateness of outcome measures (i.e., validity, feasibility, reliability and responsiveness) for each of the targeted pediatric age group(s). Wording in eleven PRISMA items is modified. These extensions and modifications are integrated with the recent PRISMA 2020 statement.
Conclusions:
PRISMA-P-C and PRISMA-C provide guidelines for reporting protocols and reports of SRs and MA in newborns, children and adolescents including mixed adult and child reviews.
Patient or healthcare consumer involvement:
None.
Reporting of child-centric systematic reviews (SRs) i.e., SRs including children, differs from adult SRs in several key aspects such as descriptions of child tailored interventions, justifiable comparators, valid outcomes and outcome measures, and separate synthesis for targeted pediatric age subgroups. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses – Protocol (PRISMA-P 2015) Statement and its corresponding statement for reports (PRISMA 2009) does not cover complexities associated with reporting SR in the pediatric population.
Objectives:
To develop PRISMA-P-C (Protocol for Children) and PRISMA-C (Report for Children) statements as extensions to the PRISMA-P and PRISMA Statements, respectively, tailored to the specific requirements of reporting protocols and reports of SRs and meta-analyses (MA) that include newborns, children and adolescents or mixed children and adult population.
Methods:
We developed this reporting guidance using the EQUATOR framework for health research reporting guidelines using the following steps: (1) a scoping review identified potential child-centric items; (2) a SR of child-centric SR protocols and reports published in Medline and Embase between 2010 to 2014 evaluated the clarity and transparency in reporting of child-centric modification and extension items and identified areas where reporting could be strengthened; (3) a web-based Delphi survey of researchers with experience in child-centric SRs contributed input on the inclusion and exclusion of potential reporting items; (4) an international face to face consensus meeting of researchers, clinicians, methodologists experienced in conducting child-centric SRs and MA, and journal editors.
Results:
The final PRISMA-P-C checklist features three new extension items to PRISMA-P for reporting child-centric SR and MA protocols: two items focus on rationale for a review in children and specification of eligibility criteria, respectively, asking explicit justifications for intervention, comparator and outcome for targeted pediatric age group; a separate data synthesis for adult and targeted pediatric age groups in “mixed” reviews. Wording in four PRISMA-P items is modified to specify review methods in targeted pediatric age subgroups. The PRISMA-C checklist adds seven extension items. These include a description of subgroup analyses for the targeted pediatric age group(s), justifications for intervention, comparator and outcome for these age group(s), justification for combining adult and pediatric data, if done, and appropriateness of outcome measures (i.e., validity, feasibility, reliability and responsiveness) for each of the targeted pediatric age group(s). Wording in eleven PRISMA items is modified. These extensions and modifications are integrated with the recent PRISMA 2020 statement.
Conclusions:
PRISMA-P-C and PRISMA-C provide guidelines for reporting protocols and reports of SRs and MA in newborns, children and adolescents including mixed adult and child reviews.
Patient or healthcare consumer involvement:
None.