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Table 3 PRISMA-P (Preferred Reporting Items for Systematic review and Meta-Analysis Protocols) 2015 checklist: recommended items to address in a systematic review protocol* [29]

From: External validation of type 2 diabetes computer simulation models: definitions, approaches, implications and room for improvement—a protocol for a systematic review

Section and topic

Item No

Checklist item

PAGE NUMBER (SUBMITTED MANUSCRIPT) AND AUTHOR’S RESPONSE (KO)

ADMINISTRATIVE INFORMATION

 Title:

  Identification

1a

Identify the report as a protocol of a systematic review

See page 1, Title: External validation of type 2 diabetes computer simulation models: definitions, approaches, implications and room for improvement—a protocol for a systematic review

  Update

1b

If the protocol is for an update of a previous systematic review, identify as such

Not applicable

 Registration

2

If registered, provide the name of the registry (such as PROSPERO) and registration number

See page 2, Section: Systematic review registration: PROSPERO CRD42017069983.

 Authors:

  Contact

3a

Provide name, institutional affiliation, e-mail address of all protocol authors; provide physical mailing address of corresponding author

See page 1

Section: Author’s affiliations

  Contributions

3b

Describe contributions of protocol authors and identify the guarantor of the review

See page 13, Section: Authors’ contributions

  Amendments

4

If the protocol represents an amendment of a previously completed or published protocol, identify as such and list changes; otherwise, state plan for documenting important protocol amendments

See page 13, Section: Protocol amendments

 Support:

  Sources

5a

Indicate sources of financial or other support for the review

See page 13, Section: Funding

  Sponsor

5b

Provide name for the review funder and/or sponsor

Not applicable

  Role of sponsor or 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

See pages 2 and 4, Section: Background and Study objectives and rationale

 Objectives

7

Provide an explicit statement of the question(s) the review will address with reference to participants, interventions, comparators, and outcomes (PICO)

Not applicable

METHODS

 Eligibility criteria

8

Specify the study characteristics (such as PICO, study design, setting, time frame) and report characteristics (such as years considered, language, publication status) to be used as criteria for eligibility for the review

See page 5, Section: Eligibility criteria

 Information sources

9

Describe all intended information sources (such as electronic databases, contact with study authors, trial registers or other grey literature sources) with planned dates of coverage

See page 8, Section: Information Sources

 Search strategy

10

Present draft of search strategy to be used for at least one electronic database, including planned limits, such that it could be repeated

See Table 2. Search strategy for MEDLINE (via PubMed)

 Study records:

  Data management

11a

Describe the mechanism(s) that will be used to manage records and data throughout the review

See page 10, Section: Technical tools

  Selection process

11b

State the process that will be used for selecting studies (such as two independent reviewers) through each phase of the review (that is, screening, eligibility and inclusion in meta-analysis)

See page 10, Section: Study selection

  Data collection process

11c

Describe planned method of extracting data from reports (such as piloting forms, done independently, in duplicate), any processes for obtaining and confirming data from investigators

See page 11, Section: Data extraction

  Data items

12

List and define all variables for which data will be sought (such as PICO items, funding sources), any pre-planned data assumptions and simplifications

See Additional file 2

  Outcomes and prioritization

13

List and define all outcomes for which data will be sought, including prioritization of main and additional outcomes, with rationale

Not applicable

  Risk of bias in individual studies

14

Describe anticipated methods for assessing 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

Not applicable

  Data synthesis

15a

Describe criteria under which study data will be quantitatively synthesised

Not applicable

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 (such as I2, Kendall’s τ)

Not applicable

15c

Describe any proposed additional analyses (such as sensitivity or subgroup analyses, meta-regression)

Not applicable

15d

If quantitative synthesis is not appropriate, describe the type of summary planned

See page 12, Section: Data synthesis

  Meta-bias(es)

16

Specify any planned assessment of meta-bias(es) (such as publication bias across studies, selective reporting within studies)

Not applicable

  Confidence in cumulative evidence

17

Describe how the strength of the body of evidence will be assessed (such as GRADE)

Not applicable

  1. * It is strongly recommended that this checklist be read in conjunction with the PRISMA-P Explanation and Elaboration (cite when available) for important clarification on the items. Amendments to a review protocol should be tracked and dated. The copyright for PRISMA-P (including checklist) is held by the PRISMA-P Group and is distributed under a Creative Commons Attribution Licence 4.0