TABLE 2.
PRISMA-P 2015 Checklist (Moher et al., 2015). This checklist has been adapted for use with protocol submissions to Systematic Reviews from Table 3 in Moher D et al: Preferred reporting items for systematic review and meta-analysis protocols (PRISMA-P) 2015 statement. Systematic Reviews 2015 4:1.
| Section/topic | # | Checklist item | Information reported | Line number(s) | |
|---|---|---|---|---|---|
| Yes | No | ||||
| Administrative information | |||||
| Title | |||||
| Identification | 1a | Identify the report as a protocol of a systematic review | ⊠ | □ | 68–74 |
| Update | 1b | If the protocol is for an update of a previous systematic review, identify it as such | □ | □ | Not applicable |
| Registration | 2 | If registered, provide the name of the registry (e.g., PROSPERO) and registration number in the Abstract | □ | □ | Not applicable |
| Authors | |||||
| Contact | 3a | Provide the name, institutional affiliation, and e-mail address of all protocol authors; provide the physical mailing address of the corresponding author | ⊠ | □ | 4–9 |
| Contributions | 3b | Describe contributions of protocol authors and identify the guarantor of the review | □ | □ | Not applicable, only one author |
| Amendments | 4 | If the protocol represents an amendment of a previously completed or published protocol, identify it as such and list changes; otherwise, state a plan for documenting important protocol amendments | □ | □ | Not applicable |
| Support | |||||
| Sources | 5a | Indicate sources of financial or other support for the review | ⊠ | □ | 755 |
| Sponsor | 5b | Provide a name for the review funder and/or sponsor | □ | □ | Not applicable |
| Role of sponsor/funder | 5c | Describe roles of funder(s), sponsor(s), and/or institution(s), if any, in developing the protocol | □ | □ | Not applicable |
| Introduction | |||||
| Rationale | 6 | Describe the rationale for the review in the context of what is already known | ⊠ | □ | 14–63 |
| Objectives | 7 | Provide an explicit statement of the question(s) the review will address concerning participants, interventions, comparators, and outcomes (PICO) | ⊠ | □ | 64–66, Table 1 |
| METHODS | |||||
| Eligibility criteria | 8 | Specify the study characteristics (e.g., PICO, study design, setting, time frame) and report characteristics (e.g., years considered, language, publication status) to be used as criteria for eligibility for the review | ⊠ | □ | 68–96, Table 1 |
| Information sources | 9 | Describe all intended information sources (e.g., electronic databases, contact with study authors, trial registers, or other grey literature sources) with planned dates of coverage | ⊠ | □ | 69–70, 77–80 |
| Search strategy | 10 | The present draft of the search strategy is to be used for at least one electronic database, including planned limits, such that it could be repeated | ⊠ | □ | 68–96 |
| Study records | |||||
| Data management | 11a | Describe the mechanism(s) that will be used to manage records and data throughout the review | ⊠ | □ | 92–96 |
| Selection process | 11b | State the process that will be used for selecting studies (e.g., two independent reviewers) through each phase of the review (i.e., screening, eligibility, and inclusion in meta-analysis) | ⊠ | □ | 68–74, Table 1 |
| Data collection process | 11c | Describe the planned method of extracting data from reports (e.g., piloting forms, done independently, in duplicate), and processes for obtaining and confirming data from investigators | ⊠ | □ | 82–84 |
| Data items | 12 | List and define all variables for which data will be sought (e.g., PICO items, funding sources), any pre-planned data assumptions, and simplifications | ⊠ | □ | Table 1 |
| Outcomes and prioritization | 13 | List and define all outcomes for which data will be sought, including prioritization of main and additional outcomes, with rationale | ⊠ | □ | Table 1 |
| Risk of bias in individual studies | 14 | Describe anticipated methods for assessing the risk of bias of individual studies, including whether this will be done at the outcome or study level, or both; state how this information will be used in data synthesis | ⊠ | □ | 82–84 |
| DATA | |||||
| Synthesis | 15a | Describe criteria under which study data will be quantitatively synthesized | □ | ⊠ | — |
| 15b | If data are appropriate for quantitative synthesis, describe planned summary measures, methods of handling data, and methods of combining data from studies, including any planned exploration of consistency (e.g., I 2, Kendall’s tau) | — | |||
| 15c | Describe any proposed additional analyses (e.g., sensitivity or subgroup analyses, meta-regression) | □ | ⊠ | — | |
| 15d | If quantitative synthesis is not appropriate, describe the type of summary planned | ⊠ | □ | 92–96 | |
| Meta-bias(es) | 16 | Specify any planned assessment of meta-bias(es) (e.g., publication bias across studies, selective reporting within studies) | □ | ⊠ | — |
| Confidence in cumulative evidence | 17 | Describe how the strength of the body of evidence will be assessed (e.g., GRADE) | □ | ⊠ | — |