Table 1 Potential modification and extension items beyond the current PRISMA-P and PRISMA for child-centric systematic reviews

Title

1

Identify the report as a systematic review, meta-analysis, or both for pediatric population as a focus of review with age group stated, if applicable.

Structured summary

2

Provide a structured summary including, as applicable: background; objectives; data sources; study eligibility criteria, including specifying targeted pediatric age groups, interventions; primary and secondary outcomes, study appraisal and synthesis methods; results; limitations; conclusions and implications of key findings; systematic review registration number.

2a. If a systematic review includes both adults and children, describe a subgroup analysis for the pediatric population(s) in the methods and results of the abstract

2b. Abstract report broad search strategy related to pediatric population

2c. Abstract describes applicability or limits of applicability of results to the pediatric group and sub-group(s)

Rationale

3

Describe the rationale for the review in the context of what is already known.

3a. Describe potential for extrapolation of evidence from adult data, or why extrapolation is not considered possible

3b. Describe any hypotheses that relate to particular pediatric population or pediatric subgroups.

Objectives

4

Provide an explicit statement of questions being addressed with reference to targeted pediatric age group(s), interventions, comparisons, outcomes, and study design (PICOS).

Protocol and registration

5

Indicate if a review protocol exists, if and where it can be accessed (e.g., Web address), and, if available, provide registration information including registration number.

Eligibility criteria

6

Specify study characteristics (e.g., PICOS, length of follow-up) and report characteristics (e.g., years considered, language, publication status) used as criteria for eligibility, giving rationale.

6a. Participants: Justify the eligible pediatric age range and age group(s) selected for the systematic review, addressing potential age related differences in intervention effects

6b1. Intervention: Justify an intervention for pediatric age range and age groups

6b2. Provide rationale for extrapolation or manipulation of adult intervention, if any

6c. Comparison: Explanation for a choice of comparison group and, if applicable, evidence for active comparator (for systematic reviews of RCTs) or standard of care for pediatric population and/or sub-groups

6d1. Outcomes: State all short and long term outcomes addressed for pediatric population and define them in detail. State whether they were primary/main or secondary/additional outcomes

6d2. Outcomes: Explain the clinical relevance of the selected outcomes (benefits and harms) for the pre-specified pediatric age group(s)

6d3. Outcomes: Explain the validity, feasibility and responsiveness of the outcome measures for the pre-specified pediatric age group(s)

Information sources

7

Describe all information sources (e.g., databases with dates of coverage, contact with study authors to identify additional studies) in the search and date last searched.

Search

8

Present full electronic search strategy for at least one database, including any limits used, such that it could be repeated.

8a. Describe the broad search strategy and terms (including database specific MeSH terms for pediatric population) used to address the pediatric population

8b. Describe any tested pediatric search filters used in the systematic review including sensitivity and precision of the search filters for retrieving child health systematic reviews

Study selection

9

State the process for selecting studies (i.e., screening, eligibility, included in systematic review, and, if applicable, included in the meta-analysis).

Data collection process

10

Describe method of data extraction from reports (e.g., piloted forms, independently, in duplicate) and any processes for obtaining and confirming data from investigators.

Data items

11

List and define all variables for which data were sought (e.g., PICOS, funding sources) and any assumptions and simplifications made.

Risk of bias in individual studies

12

Describe methods used for assessing risk of bias of individual studies (including specification of whether this was done at the study or outcome level), and how this information is to be used in any data synthesis.

12a. For each included trial in a systematic review, indicate (a plan to include) the source of financial support (such as Government, Academia or Industry), if any, for the trial(s).

Summary measures

13

State the principal summary measures (e.g., risk ratio, difference in means).

Synthesis of results

14

Describe the methods of handling data and combining results of studies, if done, including measures of consistency (e.g., I²) for each meta-analysis.

14a. Describe how studies (that include both adult and pediatric population but) without separate subgroup analysis for pediatric population were dealt in the analysis (where applicable)

Risk of bias across studies

15

Specify any assessment of risk of bias that may affect the cumulative evidence (e.g., publication bias, selective reporting within studies).

Additional analyses

16

Describe methods of additional analyses (e.g., sensitivity or subgroup analyses targeted pediatric age group(s), meta-regression), if done, indicating which were pre-specified.

Study selection

17

Give numbers of studies screened, assessed for eligibility, and included in the review, with reasons for exclusions at each stage, ideally with a flow diagram.

Study characteristics

18

For each study, present characteristics for which data were extracted (e.g., study size, PICOS, follow-up period) and provide the citations.

18a. Provide sample size of pediatric group and sub-groups (if applicable) for each study

Risk of bias within studies

19

Present data on risk of bias of each study and, if available, any outcome level assessment (see item 12).

Results of individual studies

20

For all outcomes considered (benefits or harms), present, for each study: (a) simple summary data for each intervention group (b) effect estimates and confidence intervals, ideally with a forest plot.

Synthesis of results

21

Present results of each meta-analysis done, including confidence intervals and measures of consistency.

21a. Report the numbers of included studies with pediatric participants and, where applicable, report the number of events and total pediatric population on which the result synthesis is based.

21b. Provide a description of the direction and size of effect in terms meaningful to those who would put findings into practice in a pediatric population.

Risk of bias across studies

22

Present results of any assessment of risk of bias across studies (see Item 15).

Additional analysis

23

Give results of additional analyses, if done (e.g., sensitivity or subgroup analyses for targeted pediatric age group(s), meta-regression [see Item 16]).

Summary of evidence

24

Summarize the main findings including the strength of evidence for each main outcome; consider their relevance to key groups (e.g., healthcare providers, users e.g., children and/or their parents, and policy makers).

Limitations

25

Discuss limitations at study and outcome level (e.g., risk of bias), and at review-level (e.g., incomplete retrieval of identified research, reporting bias), including any limitations arising from pediatric studies that were not available.

Conclusions

26

Provide a general interpretation of the results in the context of other evidence (e.g., evidence from adult studies, preclinical studies and studies based on routinely collected data e.g. Electronic health Record data or Registry data), and implications for future research.

26a. Provide extent and limits of applicability of the synthesised evidence to pediatric population of interest and describe the evidence and logic underlying those judgements.

26b. Provide implication for research, practice, or policy related to pediatric population where relevant (e.g., types of research needed to address unanswered question in the pediatric population).

26c. Provide a general interpretation of the results in the context of other evidence (e.g., evidence from adult studies, observational studies, and pre-clinical studies). Provide implications for future research, practice, or policy related to the targeted pediatric age group(s).

Funding

27

Describe sources of funding for the systematic review and other support (e.g., supply of data); role of funders for the systematic review.