Systematic Review Protocol
Protocols set out the plans for the conduct of CEE Systematic Reviews or Systematic Maps. They are a requirement of CEE registration and should be submitted in advance of conducting the review. Full details of the rationale and purpose of protocols and guidelines for their development can be found at http://www.environmentalevidence.org/information-for-authors. You should read this carefully when planning your review and writing your protocol.
Note that Environmental Evidence now considers it mandatory for all submitting authors to complete the relevant ROSES forms as part of their submission to demonstrate that they have included all relevant methodological details in their documents. The ROSES forms should be uploaded along with the submitted manuscript as a supplementary file. Failure to do so could result in your manuscript being returned before review. Templates for ROSES forms can be accessed here. ROSES templates should always be downloaded from the ROSES website as it contains most up-to-date templates. Please note the formatting of your submission should follow our guidelines and not the ROSES template.
IMPORTANT: COMMITMENT TO REGISTER AND PUBLISH WITH CEE. By publishing your protocol in this journal you are registering with CEE your intent to conduct, and submit to this journal for publication, a CEE Systematic Review. Please confirm that you and your co-authors are aware of and agree with this commitment when you submit by using the following words in your covering letter – ‘The authors hereby submit our protocol for publication in Environmental Evidence. By doing so we register with CEE our intent to conduct and submit to this journal a full and original systematic review report for publication and archiving in the CEE library’.
Protocols should normally be no longer than 8000 words (including references but excluding appendices and additional files).
Preparing your manuscript
The information below details the section headings that you should include in your manuscript and what information should be within each section.
Please note that your manuscript must include a 'Declarations' section including all of the subheadings (please see below for more information).
This should state the title of the article. The title should normally be the same or very similar to the review question, for example:
- What is the effectiveness of intervention A in producing change in subject B?
- What is the impact of factor X on subject Y?
The title should also indicate that it is a systematic review protocol, for example:
- What is the effectiveness of intervention A in producing change in subject B? A systematic review protocol.
- What is the impact of factor X on subject Y? A systematic review protocol.
The full names, institutional addresses, and email addresses for all authors must be included on the title page. The corresponding author should also be indicated.
The abstract should not exceed 350 words and must be structured into the following separate sections: Background, the context and purpose of the review, including the review question; Methods, how the review will be conducted and the outputs that are expected.
Three to ten keywords representing the main content of the article should be given. Please avoid repeating words that are already in the title.
This section should be written in a way that is accessible to readers without specialist knowledge in that area and must clearly state - and, if helpful, illustrate - the background to the review and its aims. You should indicate why this study is necessary and what it aims to contribute to the field. The role of commissioners and other stakeholders in the formulation of the question should be described and explained. It should logically lead the reader to the primary question stated in the next section.
Objective of the Review
You should describe the primary question and secondary questions when applicable. The primary question is the main question of the review and should be the same or very similar to the protocol title. The secondary questions are usually linked to possible subgroup analyses. This section may also present definitions of the primary question components (e.g. the subject, intervention and outcome measure) but see ‘study eligibility criteria’ below.
Searching for articles
Here the proposed searches are described in sufficient detail so as to be repeatable. The following subsections are a guide to the detail required on what will be searched and how the search will be conducted.
- Search languages
- Search strings for each of the search conducted provided in a supplementary file (search strings refer to combinations of terms using Boolean characters).
- Estimating the comprehensiveness of the search (e.g. a list of benchmark articles)
- Publication Databases to be searched
- Internet searches to be conducted
- Specialist searches - Searches for grey literature: stakeholder contacts, searches of organisational websites. Describe use of specific search terms or strings, filtering or limitations.
- Supplementary searches such as bibliographical searches, hand searches, public calls for literature and literature provided directly by stakeholders
Article screening and study eligibility criteria
Describe the methodology for eligibility screening including:
- Title, abstract and full text screening methodology
- Test(s) for consistency checking of decision regarding inclusion/exclusion, at title, abstract, full-text level between two or more reviewers. Include information on estimated number or proportion of titles/abstracts/full-text that will be used for consistency checking
Describe the role of systematic reviewers (who have also authored articles to be considered within the review) in decisions regarding inclusion or study validity assessment of their own work.
Provide explanation about the rationale you propose to include/exclude articles so that this stage is transparent and replicable by any external reader. Your eligibility criteria should be based on the following aspects:
- Eligible populations or subjects
- Eligible intervention(s) or exposure(s)
- Eligible comparator(s) (if appropriate)
- Eligible outcomes
- Eligible types of study design
Please state clearly that you will provide a list of articles excluded at full text with reasons for exclusion.
Study validity assessment
Describe here the approach you propose to use to critically appraise and assess validity of included studies. This will normally include a checklist of study validity criteria. Describe how the information from critical appraisal will be used in synthesis and how repeatability of critical appraisal of study validity will be tested.
Data coding and extraction strategy
Describe here how you will collect and record qualitative and/or quantitative outcome data and associated meta-data from eligible studies. This will normally include a data coding and extraction spreadsheet or checklist. Describe how the repeatability of this process will be tested. Describe process for obtaining and confirming missing or unclear information or data from authors. Please state that your extracted data records will be made available as additional files.
Potential effect modifiers/reasons for heterogeneity
Provide a list of those effect modifiers to be coded and considered in the review and details of how the list was compiled (including consultation of external experts). The list should not be exhaustive but a short list of those variables thought to be most important and amenable to analysis.
Data synthesis and presentation
Describe here the methods you might use to synthesise the collected qualitative and/or quantitative data and justify your methodological choice. Preferred methodology should be stated in sufficient detail for reviewers to comment. Describe also any subsequent manipulation of the data set (e.g. sub-group analysis, sensitivity analysis). Describe planned methods for examining the possible influence of publication bias on the synthesis. If all studies may not be selected for synthesis explain criteria for selection (e.g. incomplete or missing information). Narrative synthesis should always be attempted. Describe methods to be used for narratively synthesising the evidence base in the form of descriptive statistics, tables (including any map databases) and figures.
All manuscripts must contain the following sections under the heading 'Declarations':
- Ethics approval and consent to participate
- Consent for publication
- Availability of data and material
- Competing interests
- Authors' contributions
- Authors' information (optional)
Please see below for details on the information to be included in these sections.
If any of the sections are not relevant to your manuscript, please include the heading and write 'Not applicable' for that section.
Ethics approval and consent to participate
Manuscripts reporting studies involving human participants, human data or human tissue must:
- include a statement on ethics approval and consent (even where the need for approval was waived)
- include the name of the ethics committee that approved the study and the committee’s reference number if appropriate
Studies involving animals must include a statement on ethics approval.
See our editorial policies for more information.
If your manuscript does not report on or involve the use of any animal or human data or tissue, please state “Not applicable” in this section.
Consent for publication
If your manuscript contains any individual person’s data in any form (including any individual details, images or videos), consent for publication must be obtained from that person, or in the case of children, their parent or legal guardian. All presentations of case reports must have consent for publication.
You can use your institutional consent form or our consent form if you prefer. You should not send the form to us on submission, but we may request to see a copy at any stage (including after publication).
See our editorial policies for more information on consent for publication.
If your manuscript does not contain data from any individual person, please state “Not applicable” in this section.
Availability of data and materials
All manuscripts must include an ‘Availability of data and materials’ statement. Data availability statements should include information on where data supporting the results reported in the article can be found including, where applicable, hyperlinks to publicly archived datasets analysed or generated during the study. By data we mean the minimal dataset that would be necessary to interpret, replicate and build upon the findings reported in the article. We recognise it is not always possible to share research data publicly, for instance when individual privacy could be compromised, and in such instances data availability should still be stated in the manuscript along with any conditions for access.
Data availability statements can take one of the following forms (or a combination of more than one if required for multiple datasets):
- The datasets generated and/or analysed during the current study are available in the [NAME] repository, [PERSISTENT WEB LINK TO DATASETS]
- The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.
- All data generated or analysed during this study are included in this published article [and its supplementary information files].
- The datasets generated and/or analysed during the current study are not publicly available due [REASON WHY DATA ARE NOT PUBLIC] but are available from the corresponding author on reasonable request.
- Data sharing is not applicable to this article as no datasets were generated or analysed during the current study.
- The data that support the findings of this study are available from [third party name] but restrictions apply to the availability of these data, which were used under license for the current study, and so are not publicly available. Data are however available from the authors upon reasonable request and with permission of [third party name].
- Not applicable. If your manuscript does not contain any data, please state 'Not applicable' in this section.
More examples of template data availability statements, which include examples of openly available and restricted access datasets, are available here.
BioMed Central also requires that authors cite any publicly available data on which the conclusions of the paper rely in the manuscript. Data citations should include a persistent identifier (such as a DOI) and should ideally be included in the reference list. Citations of datasets, when they appear in the reference list, should include the minimum information recommended by DataCite and follow journal style. Dataset identifiers including DOIs should be expressed as full URLs. For example:
Hao Z, AghaKouchak A, Nakhjiri N, Farahmand A. Global integrated drought monitoring and prediction system (GIDMaPS) data sets. figshare. 2014. http://dx.doi.org/10.6084/m9.figshare.853801
With the corresponding text in the Availability of data and materials statement:
The datasets generated during and/or analysed during the current study are available in the [NAME] repository, [PERSISTENT WEB LINK TO DATASETS].[Reference number]
All financial and non-financial competing interests must be declared in this section.
See our editorial policies for a full explanation of competing interests. If you are unsure whether you or any of your co-authors have a competing interest please contact the editorial office.
Please use the authors initials to refer to each authors' competing interests in this section.
If you do not have any competing interests, please state "The authors declare that they have no competing interests" in this section.
All sources of funding for the research reported should be declared. The role of the funding body in the design of the study and collection, analysis, and interpretation of data and in writing the manuscript should be declared.
The individual contributions of authors to the manuscript should be specified in this section. Guidance and criteria for authorship can be found in our editorial policies.
Please use initials to refer to each author's contribution in this section, for example: "FC analyzed and interpreted the patient data regarding the hematological disease and the transplant. RH performed the histological examination of the kidney, and was a major contributor in writing the manuscript. All authors read and approved the final manuscript."
Please acknowledge anyone who contributed towards the article who does not meet the criteria for authorship including anyone who provided professional writing services or materials.
Authors should obtain permission to acknowledge from all those mentioned in the Acknowledgements section.
See our editorial policies for a full explanation of acknowledgements and authorship criteria.
If you do not have anyone to acknowledge, please write "Not applicable" in this section.
Group authorship (for manuscripts involving a collaboration group): if you would like the names of the individual members of a collaboration Group to be searchable through their individual PubMed records, please ensure that the title of the collaboration Group is included on the title page and in the submission system and also include collaborating author names as the last paragraph of the “Acknowledgements” section. Please add authors in the format First Name, Middle initial(s) (optional), Last Name. You can add institution or country information for each author if you wish, but this should be consistent across all authors.
Please note that individual names may not be present in the PubMed record at the time a published article is initially included in PubMed as it takes PubMed additional time to code this information.
This section is optional.
You may choose to use this section to include any relevant information about the author(s) that may aid the reader's interpretation of the article, and understand the standpoint of the author(s). This may include details about the authors' qualifications, current positions they hold at institutions or societies, or any other relevant background information. Please refer to authors using their initials. Note this section should not be used to describe any competing interests.
Endnotes should be designated within the text using a superscript lowercase letter and all notes (along with their corresponding letter) should be included in the Endnotes section. Please format this section in a paragraph rather than a list.
Examples of the Vancouver reference style are shown below.
See our editorial policies for author guidance on good citation practice
Web links and URLs: All web links and URLs, including links to the authors' own websites, should be given a reference number and included in the reference list rather than within the text of the manuscript. They should be provided in full, including both the title of the site and the URL, as well as the date the site was accessed, in the following format: The Mouse Tumor Biology Database. http://tumor.informatics.jax.org/mtbwi/index.do. Accessed 20 May 2013. If an author or group of authors can clearly be associated with a web link, such as for weblogs, then they should be included in the reference.
Example reference style:
Article within a journal
Smith JJ. The world of science. Am J Sci. 1999;36:234-5.
Article within a journal (no page numbers)
Rohrmann S, Overvad K, Bueno-de-Mesquita HB, Jakobsen MU, Egeberg R, Tjønneland A, et al. Meat consumption and mortality - results from the European Prospective Investigation into Cancer and Nutrition. BMC Medicine. 2013;11:63.
Article within a journal by DOI
Slifka MK, Whitton JL. Clinical implications of dysregulated cytokine production. Dig J Mol Med. 2000; doi:10.1007/s801090000086.
Article within a journal supplement
Frumin AM, Nussbaum J, Esposito M. Functional asplenia: demonstration of splenic activity by bone marrow scan. Blood 1979;59 Suppl 1:26-32.
Book chapter, or an article within a book
Wyllie AH, Kerr JFR, Currie AR. Cell death: the significance of apoptosis. In: Bourne GH, Danielli JF, Jeon KW, editors. International review of cytology. London: Academic; 1980. p. 251-306.
OnlineFirst chapter in a series (without a volume designation but with a DOI)
Saito Y, Hyuga H. Rate equation approaches to amplification of enantiomeric excess and chiral symmetry breaking. Top Curr Chem. 2007. doi:10.1007/128_2006_108.
Complete book, authored
Blenkinsopp A, Paxton P. Symptoms in the pharmacy: a guide to the management of common illness. 3rd ed. Oxford: Blackwell Science; 1998.
Doe J. Title of subordinate document. In: The dictionary of substances and their effects. Royal Society of Chemistry. 1999. http://www.rsc.org/dose/title of subordinate document. Accessed 15 Jan 1999.
Healthwise Knowledgebase. US Pharmacopeia, Rockville. 1998. http://www.healthwise.org. Accessed 21 Sept 1998.
Supplementary material/private homepage
Doe J. Title of supplementary material. 2000. http://www.privatehomepage.com. Accessed 22 Feb 2000.
Doe, J: Title of preprint. http://www.uni-heidelberg.de/mydata.html (1999). Accessed 25 Dec 1999.
Doe, J: Trivial HTTP, RFC2169. ftp://ftp.isi.edu/in-notes/rfc2169.txt (1999). Accessed 12 Nov 1999.
ISSN International Centre: The ISSN register. http://www.issn.org (2006). Accessed 20 Feb 2007.
Dataset with persistent identifier
Zheng L-Y, Guo X-S, He B, Sun L-J, Peng Y, Dong S-S, et al. Genome data from sweet and grain sorghum (Sorghum bicolor). GigaScience Database. 2011. http://dx.doi.org/10.5524/100012.
Figures, tables and additional files
See General formatting guidelines for information on how to format figures, tables and additional files.
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61 days to first decision for reviewed manuscripts only
53 days to first decision for all manuscripts
165 days from submission to acceptance
32 days from acceptance to publication
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