EDITORIAL

Review Protocols

Érica Brandão de Moraes1,2

1 Aurora de Afonso Costa Nursing School, Fluminense Federal University, Niterói, RJ, Brazil

2 Brazilian Center for Evidence-Based Health Care: JBI Excellence Center (JBI Brazil), São Paulo, SP, Brazil

Systematic and scoping reviews are complex studies, as they involve the development of several stages with independent evaluation by at least two reviewers and use of data automation software programs, in addition to the methodological rigor that must be adopted to obtain a good quality review.

For these reviews there are published guidelines recommended by international organizations such as the Joanna Briggs Institute (JBI) and Cochrane. The guidelines undergo periodic updates and are available free of charge for consultation in their online versions on the websites (https://jbi-global-.wiki.refined.site/space/MANUAL; https://training.cochrane.org/handbook). Both organizations have a collaborating center in Brazil and offer professional improvement courses (https://brazil.cochrane.org/; http://www.ee.usp.br/jbibrasil/).

Scoping reviews are a type of synthesis of diverse evidence aimed at systematically identifying and mapping the range of evidence available on a given topic, field, concept or question, oftentimes regardless of the source (that is, primary research studies, reviews, non-empirical evidence) either within or between specific contexts(1). With the objective of differentiating scoping from systematic reviews, a number of methodologists grouped the purpose of scoping reviews into six broad indications, namely: identifying the types of evidence available on a given field; clarifying the main concepts/definitions in the literature; exploring how the research study on a given topic or field is conducted; identifying the main characteristics or factors related to a concept; acting as precursors of systematic reviews; and identifying and analyzing knowledge gaps(2).

In turn, systematic reviews aim at identifying, evaluating and synthesizing all the diverse evidence meeting the eligibility criteria specified to answer a specific research question. The researchers that conduct systematic reviews employ explicit and systematic methods that are selected with the objective of minimizing biases, in order to produce more reliable findings ​so as to ground decision-making processes(3). The main objectives are as follows: confirming the current practice/addressing any variation/identifying new practices; identifying and investigating conflicting results; producing statements to guide decision-making processes; and identifying and reporting areas for future research studies(4).

JBI uses the term “systematic” for various types of reviews, such as qualitative, effectiveness, text and opinion, prevalence and incidence, economic evidence, etiology and risk, mixed-methods, diagnostic test precision, and measuring properties(5). Currently, Cochrane recommends qualitative, intervention, diagnostic test, prognosis and methodology systematic reviews(3).

The main differences between systematic and scoping reviews are the critical evaluation of the studies, the possibility for synthesis analyses, and the generation of evaluation summaries regarding the methodological quality of the findings(4). In both types of review it is necessary to develop a review protocol, which must be prospectively registered, even with the possibility of being published in a journal.

Before initiating a review, either systematic or scoping, the guidelines instruct that a previous search for registries and reviews is conducted. The authors should ask themselves the following question: Is there any review or protocol registered in this area of interest? Even if preliminary, the search must be conducted in some databases and registry sites. The search for protocols can also be performed, more specifically, in journals devoted to publishing review protocols. In Brazil, OBJN stands out as a search site for protocols in journals. If there are protocols and reviews on the theme chosen, the authors should ask themselves the following question: Is there any aspect that differentiates the proposed review from what is already registered or published? Or is there any time gap that justifies a new review? (6)

One of the fundamental characteristics of a good quality review, either systematic or scoping, is the development of a review protocol, previously elaborated and which defines the main objectives, characteristics of the review project, and the analyses planned for the review. As minimum requirements, a review protocol must contain the following: Context and reason for the review, including what is already known about the topic, and a previous search for similar reviews in order to justify conduction of the review; Citation of the guideline that will be adopted in conducting the review; Clear research question aligned with the review objective; Search strategy proposed; Details of all the sites to be researched, including databases and gray literature sources; The inclusion criteria of the studies (with detailed information about what will be considered in each item of the research question, in addition to the types of evidence included in the review); How data selection and extraction will be performed (independent reviewers and methods to solve disagreements between the reviewers); Presenting the data that will be extracted in the data extraction instrument; and Details on how the results will be presented. The approaches proposed for writing the results, how they will be presented(2,3).

In the case of systematic review protocols, two additional items should also be considered: The process and the instruments to assess risk of bias and methodological quality of the studies; Appropriate, feasible and reasonable details about the anticipated meta-analysis (pre-planned) must be specified, such as: meta-analysis model, effect size to be used, tests to assess heterogeneity of the studies, and possibility of subgroup analyses(3).

It is noted that registration constitutes a recommended stage in the COCHRANE and JBI guidelines, and it is applied both for systematic and for scoping reviews. Registration is defined as the action of including diverse information about a research project (in this case a review) in a database before its initiation; in other words, it is a prospective registration(7). Registration avoids duplicity of reviews by different groups of authors. In order to register a protocol, the authors should include a predefined set of items in the platform. It is important to follow the recommendations contained in the guideline corresponding to the type of review chosen and search the registration criteria for each platform.

OBJN emphasizes that the studies belonging to this category must follow high methodological rigor and be registered in the International Prospective Register of Systematic Reviews – PROSPERO for systematic reviews (https://www.crd.york.ac.uk/prospero/); and, for scoping reviews, the authors are encouraged to register their protocol in Open Science Framework – OSF (https://osf.io/). The registration number is to be reported in the manuscript. The manuscripts must follow the checklist contained in the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols – PRISMA-P statement (https://www.equator-network.org/reporting-guidelines/prisma-protocols/) and, for scoping reviews, the one included in PRISMA-ScR (https://www.equator-network.org/reporting-guidelines/prisma-scr/).

Publication of the review protocol in the scientific journal should be considered by the authors. Any protocol written before the review must ensure that the review methods are transparent and reproducible, and adherence to the pre-specified research plan should help avoid biases in conduction of the review(8). Some international journals accept the publication of review protocols and, among the journals indexed in databases in Brazil, OBJN is a pioneer in the publication of such protocols. OBJN accepts submissions of systematic and scoping review protocols in a section devoted to this type of study, in addition to publication of an exclusive annual supplement for review protocols. The protocols must follow the journal's formatting standards and contain up to 3,000 words (https://objn.uff.br/wp-content/uploads/sites/408/2022/08/Standards-and-Instructions-Manual-OBJN-2022_EN.pdf). Such fact reflects a major advancement for improving the quality of systematic and scoping reviews, as many methodological inconsistencies are detected during peer review while evaluating protocols submitted to the journal.

REFERENCES

1. Munn Z, Pollock D, Khalil H, Alexander L, Mclnerney P, Godfrey CM, et al. What are scoping reviews? Providing a formal definition of scoping reviews as a type of evidence synthesis. JBI Evidence Synthesis. 2022;20(4):950-2. https://doi.org/10.11124/jbies-21-00483. PMid:35249995

2. Peters MDJ, Godfrey C, McInerney P, Munn Z, Tricco AC, Khalil H. Chapter 11: Scoping Reviews (2020 version). In: Aromataris E, Munn Z, editors. JBI Manual for Evidence Synthesis [Internet]. Adelaide (AUS): JBI; 2020 [cited 2022 jun 06]. Available from: https://synthesismanual.jbi.global. https://doi.org/10.46658/JBIMES-20-12

3. Higgins JP, Thomas J, Chandler J, Cumpston M, Li T, Page MJ, et al. Cochrane Handbook for Systematic Reviews of Interventions  version 6.3. 2022 [updated 2022 feb; cited 2022 jun 06]. Available from: www.training.cochrane.org/handbook

4. Munn Z, Peters MDJ, Stern C, Tufanaru C, McArthur A, Aromataris E. Systematic review or scoping review? Guidance for authors when choosing between a systematic or scoping review approach. BMC Med Res Methodol. 2018;18(1):143. https://doi.org/10.1186/s12874-018-0611-x. PMid:30453902

5. Santos WMD, Secoli SR, Püschel VAA. The Joanna Briggs Institute approach for systematic reviews. Rev Lat Am Enfermagem. 2018 Nov 14;26:e3074. https://doi.org/10.1590/1518-8345.2885.3074. PMid:30462787

6. Pollock D, Davies EL, Peters MDJ, Tricco AC, Alexander L, McInerney P, et al. Undertaking a scoping review: A practical guide for nursing and midwifery students, clinicians, researchers, and academics. J Adv Nurs. 2021;77(4):2102-13. https://doi.org/10.1111/jan.14743. PMid:33543511

7. Pieper D, Rombey T. Where to prospectively register a systematic review. Syst Rev. 2022;11(1):8. https://doi.org/10.1186/s13643-021-01877-1. PMid:34998432

8. Stewart L, Moher D, Shekelle P. Why prospective registration of systematic reviews makes sense. Syst Rev. 2012;1:7. https://doi.org/10.1186/2046-4053-1-7. PMid:22588008