Systematic Review and Meta-Analysis
PROTOCOL
How to use this protocol template:
1. The structure of this protocol template was developed in accordance with Preferred reporting
items for systematic review and meta-analysis protocols (PRISMA-P) 2015.
2. The instructions for each sections are in blue and dotted-underlined and will not be printed.
3. Further explanation for each sections can be sought in the supporting guidelines:
a. Cochrane Handbook for Systematic Reviews of Interventions
b. PRISMA-P 2015: elaboration and explanation
4. Please do not delete the instructions.
5. Always start typing your text in the given space, below the blue instructions.
6. After revising the protocol:
a. Please indicate the action on the revision history table below.
b. Please save the revised file under the different name according to its version. e.g.
“Protocol SR_v05” for version 5
CLINICAL EPIDEMIOLOGY AND EVIDENCE-BASED MEDICINE (CEEBM) UNIT, RSCM-FKUI
LANTAI 2 GEDUNG H RSCM, JL DIPONEGORO NO. 71, JAKARTA; T: (021) 3161760 | E: CE-EBM@CEEBM.ORG | W: WWW.CEEBM.ORG
Table of Contents
1. INTRODUCTION..........................................................................................................................3
1.1. Rationale...............................................................................................................................3
1.2. Objectives.............................................................................................................................3
2. METHODS.....................................................................................................................................3
2.1. Eligibility criteria..................................................................................................................3
2.1.1. Study designs..............................................................................................................3
2.1.2. Participants.................................................................................................................3
2.1.3. Interventions...............................................................................................................4
2.1.4. Comparators...............................................................................................................4
2.1.5. Outcomes....................................................................................................................4
2.1.6. Timing........................................................................................................................4
2.1.7. Setting........................................................................................................................5
2.1.8. Review eligibility criteria...........................................................................................5
2.2. Information sources..............................................................................................................5
2.3. Search strategy......................................................................................................................5
2.4. Study records........................................................................................................................6
2.4.1. Data management.......................................................................................................6
2.4.2. Selection process........................................................................................................6
2.4.3. Data collection process...............................................................................................6
2.5. Data items.............................................................................................................................7
2.6. Outcomes and prioritization..................................................................................................7
2.7. Risk of bias in individual studies..........................................................................................7
2.8. Data synthesis.......................................................................................................................8
2.9. Meta-bias(es)........................................................................................................................8
2.10. Confidence in cumulative estimate.......................................................................................8
3. REFERENCES...............................................................................................................................9
CLINICAL EPIDEMIOLOGY AND EVIDENCE-BASED MEDICINE (CEEBM) UNIT, RSCM-FKUI
LANTAI 2 GEDUNG H RSCM, JL DIPONEGORO NO. 71, JAKARTA; T: (021) 3161760 | E: CE-EBM@CEEBM.ORG | W: WWW.CEEBM.ORG
Systematic Review and Meta-Analysis Protocol Page |1
Title
Suggested format: [Intervention/s] for [Improving/Reducing/Increasing/etc.] [Clinical Outcome/s] in
[Problem/Population] in [Location/Situation]: A Systematic Review/Meta-Analysis
Support
This systematic review is supported by Clinical Epidemiology and Evidence-Based Medicine
(CEEBM) Unit, Faculty of Medicine Universitas Indonesia - Dr. Cipto Mangunkusumo Hospital.
Registration
In accordance with the Preferred reporting items for systematic review and meta-analysis protocols
(PRISMA-P) 2015 (PRISMA-P) guideline, our systematic review protocol was registered with the
International Prospective Register of Systematic Reviews (PROSPERO) (http://www.crd.york.ac.uk/
prospero/) on [registration date] and was last updated on [latest updated date] (registration number
[registration number])
CLINICAL EPIDEMIOLOGY AND EVIDENCE-BASED MEDICINE (CEEBM) UNIT, RSCM-FKUI
LANTAI 2 GEDUNG H RSCM, JL DIPONEGORO NO. 71, JAKARTA; T: (021) 3161760 | E: CE-EBM@CEEBM.ORG | W: WWW.CEEBM.ORG
Systematic Review and Meta-Analysis Protocol Page |2
Authors
Each person named as an author must make a substantial contribution to the conception and design of study, or analysis and interpretation of the data in the
review, drafting the review or commenting on it critically for intellectual content, and final approval of the document to be published
Institutional
No. Name E-mail address Contributions Signature**
Affiliation
1.
2.
3.
4.
5.
6.
*Mailing address of corresponding author:
**By signing this form, you accept responsibility for preparing, maintaining, publishing and updating the review according to the scientific standards
CLINICAL EPIDEMIOLOGY AND EVIDENCE-BASED MEDICINE (CEEBM) UNIT, RSCM-FKUI
LANTAI 2 GEDUNG H RSCM, JL DIPONEGORO NO. 71, JAKARTA; T: (021) 3161760 | E: CE-EBM@CEEBM.ORG | W: WWW.CEEBM.ORG
Systematic Review and Meta-Analysis Protocol Page |3
1. INTRODUCTION
1.1. Rationale
Describe the rationale for the review in the context of what is already known, what is unknown,
and what are the knowledge gaps. Refer to Cochrane Book page 56.
1.2. Objectives
Provide an explicit statement of the question(s) the review will address with reference to
participants, interventions, comparators, and outcomes (PICO). Refer to Cochrane Book page 57
and 84
2. METHODS
2.1. Eligibility criteria
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. Refer to Cochrane Book page 58 and 84.
Study characteristics:
2.1.1. Study designs
Eligible study designs should be stated here, along with any thresholds for inclusion based on the
conduct of the studies or their risk of bias. Refer to Cochrane Book page 90.
2.1.2. Participants
The diseases or conditions of interest should be described here, including any restrictions such as
diagnoses criteria, age groups and settings. Refer to Cochrane Book page 85.
CLINICAL EPIDEMIOLOGY AND EVIDENCE-BASED MEDICINE (CEEBM) UNIT, RSCM-FKUI
LANTAI 2 GEDUNG H RSCM, JL DIPONEGORO NO. 71, JAKARTA; T: (021) 3161760 | E: CE-EBM@CEEBM.ORG | W: WWW.CEEBM.ORG
Systematic Review and Meta-Analysis Protocol Page |4
2.1.3. Interventions
Interventions should be defined here. Restrictions on dose, frequency, intensity or duration
should be stated.
2.1.4. Comparators
Comparators should be defined here. Restrictions on dose, frequency, intensity or duration
should be stated. Refer to Cochrane Book page 86.
2.1.5. Outcomes
The review’s primary outcomes should normally reflect at least one potential benefit and at least
one potential area of harm, and should be as few as possible. It is normally expected that the
conclusions of the review will be based in large part on the effects of the interventions on these
outcomes. Non-primary outcomes (secondary outcomes) should be also be listed, if any. How the
outcomes will be collected should also be stated in this section. Refer to Cochrane Book page 87.
2.1.6. Timing
The time frames for follow up or the length of follow-up of outcomes should be defined here.
CLINICAL EPIDEMIOLOGY AND EVIDENCE-BASED MEDICINE (CEEBM) UNIT, RSCM-FKUI
LANTAI 2 GEDUNG H RSCM, JL DIPONEGORO NO. 71, JAKARTA; T: (021) 3161760 | E: CE-EBM@CEEBM.ORG | W: WWW.CEEBM.ORG
Systematic Review and Meta-Analysis Protocol Page |5
2.1.7. Setting
The setting in which the interventions are delivered should be defined here.
Report characteristics
2.1.8. Review eligibility criteria
Review eligibility criteria are likely to include geographical location, languages of publication,
publication status (such as inclusion of unpublished material or abstracts), and years of
publication. Inclusion or not of literature in multiple languages, unpublished data, or older data
can influence the effect estimates in meta-analyses. If it is planned to filter out (via search filter)
or exclude specific types of records (such as commentaries, letters, editorials, etc) during
screening, this should be stated.
2.2. Information sources
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. Refer to
Cochrane Book page 98.
2.3. Search strategy
Present draft of search strategy to be used for at least one electronic database, including planned
limits, such that it could be repeated. Refer to Cochrane Book page 128.
CLINICAL EPIDEMIOLOGY AND EVIDENCE-BASED MEDICINE (CEEBM) UNIT, RSCM-FKUI
LANTAI 2 GEDUNG H RSCM, JL DIPONEGORO NO. 71, JAKARTA; T: (021) 3161760 | E: CE-EBM@CEEBM.ORG | W: WWW.CEEBM.ORG
Systematic Review and Meta-Analysis Protocol Page |6
2.4. Study records
2.4.1. Data management
Describe the mechanism(s) that will be used to manage records and data throughout the review.
Refer to Cochrane Book page 142 and 182.
2.4.2. Selection process
State the process that will be used for selecting studies (such as two independent reviewers)
through each phase of the review (screening, eligibility, and inclusion in meta-analysis) along
with how any disagreements are resolved. Refer to Cochrane Book page 152.
2.4.3. Data collection process
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.
Whether data are extracted independently by more than one author should be stated, along with
how any disagreements are resolved. Refer to Cochrane Book page 156, 164, 170.
CLINICAL EPIDEMIOLOGY AND EVIDENCE-BASED MEDICINE (CEEBM) UNIT, RSCM-FKUI
LANTAI 2 GEDUNG H RSCM, JL DIPONEGORO NO. 71, JAKARTA; T: (021) 3161760 | E: CE-EBM@CEEBM.ORG | W: WWW.CEEBM.ORG
Systematic Review and Meta-Analysis Protocol Page |7
2.5. Data items
List and define all variables for which data will be sought (such as PICO items, funding sources)
and any pre-planned data assumptions and simplifications. Refer to Cochrane Book page 86.
2.6. Outcomes and prioritization
List and define all outcomes for which data will be sought, including prioritisation of main and
additional outcomes, with rationale. Refer to Cochrane Book page 161.
2.7. Risk of bias in individual studies
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. The tool(s) used should be described or
referenced, with an indication of how the results will be used in data synthesis and incorporated
into the interpretation of the results. Whether methods are applied independently by more than
one author should be stated, along with how any disagreements are resolved. Refer to Cochrane
Book page 190.
CLINICAL EPIDEMIOLOGY AND EVIDENCE-BASED MEDICINE (CEEBM) UNIT, RSCM-FKUI
LANTAI 2 GEDUNG H RSCM, JL DIPONEGORO NO. 71, JAKARTA; T: (021) 3161760 | E: CE-EBM@CEEBM.ORG | W: WWW.CEEBM.ORG
Systematic Review and Meta-Analysis Protocol Page |8
2.8. Data synthesis
Describe criteria under which study data will be quantitatively synthesised. If data are
appropriate for 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). The effect measures of choice should be stated. For example, odds ratio (OR),
risk ratio (RR) or risk difference (RD) for dichotomous data; mean difference (MD) or
standardized mean difference (SMD) for continuous data. Describe any proposed additional
analyses (e.g., sensitivity or subgroup analyses, meta-regression). If quantitative synthesis is not
appropriate, describe the type of summary planned. Refer to Cochrane Book page 244.
2.9. Meta-bias(es)
Specify any planned assessment of meta-bias(es) (such as publication bias across studies,
selective reporting within studies). Refer to Cochrane Book page 298.
2.10. Confidence in cumulative estimate
Describe how the strength of the body of evidence will be assessed (such as GRADE). Refer to
Cochrane Book page 335 and 360.
CLINICAL EPIDEMIOLOGY AND EVIDENCE-BASED MEDICINE (CEEBM) UNIT, RSCM-FKUI
LANTAI 2 GEDUNG H RSCM, JL DIPONEGORO NO. 71, JAKARTA; T: (021) 3161760 | E: CE-EBM@CEEBM.ORG | W: WWW.CEEBM.ORG
Systematic Review and Meta-Analysis Protocol Page |9
3. REFERENCES
CLINICAL EPIDEMIOLOGY AND EVIDENCE-BASED MEDICINE (CEEBM) UNIT, RSCM-FKUI
LANTAI 2 GEDUNG H RSCM, JL DIPONEGORO NO. 71, JAKARTA; T: (021) 3161760 | E: CE-EBM@CEEBM.ORG | W: WWW.CEEBM.ORG
