The effect of chronic caffeine supplementation on endurance performance has been studied extensively in different populations. However, concurrent research on the effects of acute supplementation of caffeine on cardiorespiratory responses during endurance exercise in hot and humid conditions is unavailable
Source: Ping, WC, Keong, CC & Bandyopadhyay, A 2010, ‘Effects of acute supplementation of caffeine on cardiorespiratory responses during endurance running in a hot and humid climate’, Indian Journal of Medical Research, vol. 132, pp. 36–41. Used under a CC-BY-NC-SA licence.
Step two of writing a literature review is synthesis.
Synthesis describes combining separate components or elements to form a connected whole.
You will use the results of your analysis to find themes to build your literature review around. Each of the themes identified will become a subheading within the body of your literature review.
A good place to start when identifying themes is with the dependent variables (results/findings) that were investigated in the research studies.
Because all of the research articles you are incorporating into your literature review are related to your topic, it is likely that they have similar study designs and have measured similar dependent variables. Review the ‘Results’ column of your analysis grid. You may like to collate the common themes in a synthesis grid (see, for example Table 7.4 ).
Step three of writing a literature review is evaluation, which can only be done after carefully analysing your research papers and synthesising the common themes (findings).
During the evaluation stage, you are making judgements on the themes presented in the research articles that you have read. This includes providing physiological explanations for the findings. It may be useful to refer to the discussion section of published original investigation research papers, or another literature review, where the authors may mention tested or hypothetical physiological mechanisms that may explain their findings.
When the findings of the investigations related to a particular theme are inconsistent (e.g., one study shows that caffeine effects performance and another study shows that caffeine had no effect on performance) you should attempt to provide explanations of why the results differ, including physiological explanations. A good place to start is by comparing the methodologies to determine if there are any differences that may explain the differences in the findings (see the ‘Experimental design’ column of your analysis grid). An example of evaluation is shown in the examples that follow in this section, under ‘Running performance’ and ‘RPE ratings’.
When the findings of the papers related to a particular theme are consistent (e.g., caffeine had no effect on oxygen uptake in both studies) an evaluation should include an explanation of why the results are similar. Once again, include physiological explanations. It is still a good idea to compare methodologies as a background to the evaluation. An example of evaluation is shown in the following under ‘Oxygen consumption’.
Once you have completed the analysis, and synthesis grids and written your evaluation of the research papers , you can combine synthesis and evaluation information to create a paragraph for a literature review ( Figure 7.4 ).
The following paragraphs are an example of combining the outcome of the synthesis and evaluation stages to produce a paragraph for a literature review.
Note that this is an example using only two papers – most literature reviews would be presenting information on many more papers than this ( (e.g., 106 papers in the review article by Bain and colleagues discussed later in this chapter). However, the same principle applies regardless of the number of papers reviewed.
The next part of this chapter looks at the each section of a literature review and explains how to write them by referring to a review article that was published in Frontiers in Physiology and shown in Figure 7.1. Each section from the published article is annotated to highlight important features of the format of the review article, and identifies the synthesis and evaluation information.
In the examination of each review article section we will point out examples of how the authors have presented certain information and where they display application of important cognitive processes; we will use the colour code shown below:
This should be one paragraph that accurately reflects the contents of the review article.
The introduction should establish the context and importance of the review
The reference section provides a list of the references that you cited in the body of your review article. The format will depend on the journal of publication as each journal has their own specific referencing format.
It is important to accurately cite references in research papers to acknowledge your sources and ensure credit is appropriately given to authors of work you have referred to. An accurate and comprehensive reference list also shows your readers that you are well-read in your topic area and are aware of the key papers that provide the context to your research.
It is important to keep track of your resources and to reference them consistently in the format required by the publication in which your work will appear. Most scientists will use reference management software to store details of all of the journal articles (and other sources) they use while writing their review article. This software also automates the process of adding in-text references and creating a reference list. In the review article by Bain et al. (2014) used as an example in this chapter, the reference list contains 106 items, so you can imagine how much help referencing software would be. Chapter 5 shows you how to use EndNote, one example of reference management software.
Click the drop down below to review the terms learned from this chapter.
Copyright note:
Bain, A.R., Morrison, S.A., & Ainslie, P.N. (2014). Cerebral oxygenation and hyperthermia. Frontiers in Physiology, 5 , 92.
Pautasso, M. (2013). Ten simple rules for writing a literature review. PLoS Computational Biology, 9 (7), e1003149.
How To Do Science Copyright © 2022 by University of Southern Queensland is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License , except where otherwise noted.
Review the literature, write the literature review, further reading, learning objectives, attribution.
This guide is designed to:
A literature review is a summary and synthesis of scholarly research on a specific topic. It should answer questions such as:
The process of reviewing existing research allows you to fine-tune your research question and contextualize your own work. Preparing a literature review is a cyclical process. You may find that the research question you begin with evolves as you learn more about the topic.
Once you have defined your research question , focus on learning what other scholars have written on the topic.
In order to do a thorough search of the literature on the topic, define the basic criteria:
One strategy is to review bibliographies for sources that relate to your interest. For more on this technique, look at the tutorial on finding articles when you have a citation .
As you read sources, themes will emerge that will help you to organize the review. You can use a simple Synthesis Matrix to track your notes as you read. From this work, a concept map emerges that provides an overview of the literature and ways in which it connects. Working with Zotero to capture the citations, you build the structure for writing your literature review.
Citation | Concept/Theme | Main Idea | Notes 1 | Notes 2 | Gaps in the Research | Quotation | Page |
A key indicator for knowing when you are done is running into the same articles and materials. With no new information being uncovered, you are likely exhausting your current search and should modify search terms or search different catalogs or databases. It is also possible that you have reached a point when you can start writing the literature review.
These citation management tools also create citations, footnotes, and bibliographies with just a few clicks:
Zotero Tutorial
Endnote Tutorial
Your literature review should be focused on the topic defined in your research question. It should be written in a logical, structured way and maintain an objective perspective and use a formal voice.
Review the Summary Table you created for themes and connecting ideas. Use the following guidelines to prepare an outline of the main points you want to make.
The three elements of a literature review are introduction, body, and conclusion.
Introduction
This guide was designed to:
Content on this page adapted from:
Frederiksen, L. and Phelps, S. (2017). Literature Reviews for Education and Nursing Graduate Students. Licensed CC BY 4.0
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Use the "Literature Review Matrix Template" as a guideline to help you sort through your thoughts, note important points and think through the similarities and differences:
You are organizing the review by ideas and not by sources . The literature review is not just a summary of the already published works. Your synthesis should show how various articles are linked.
A summary table is also called a synthesis matrix. The table helps you organize and compare information for your systematic review, scholarly report, dissertation or thesis
Synthesis Matrix.
A summary table is also called a synthesis matrix . A summary table helps you record the main points of each source and document how sources relate to each other. After summarizing and evaluating your sources, arrange them in a matrix to help you see how they relate to each other, and apply to each of your themes or variables.
Faculty who typically guide students find it challenging to help students learn how to synthesize material (Blondy, Blakesless, Scheffer, Rubenfeld, Cronin, & Luster-Turner, 2016; Kearney, 2015) . Writers can easily summarize material but seem to struggle to adequately synthesize knowledge about their topic and express that in their writing. So, whether you are writing a student papers, dissertations, or scholarly report it is necessary to learn a few tips and tricks to organize your ideas.
Building a summary table and developing solid synthesis skills is important for nurses, nurse practitioners, and allied health researchers. Quality evidence-based practice initiatives and nursing care and medicine are based on understanding and evaluating the resources and research available, identifying gaps, and building a strong foundation for future work.
Good synthesis is about putting the data gathered, references read, and literature analyzed together in a new way that shows connections and relationships. ( Shellenbarger, 2016 ). The Merriam-Webster dictionary defines synthesis as something that is made by combining different things or the composition or combination of parts or elements so as to form a whole (Synthesis, n.d.).
In other words, building a summary table or synthesis matrix involves taking information from a variety of sources, evaluating that information and forming new ideas or insights in an original way. This can be a new and potentially challenging experience for students and researchers who are used to just repeating what is already in the literature.
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Research Tables and Synthesis Tables are useful tools for organizing and analyzing your research as you assemble your literature review. They represent two different parts of the review process: assembling relevant information and synthesizing it. Use a Research table to compile the main info you need about the items you find in your research -- it's a great thing to have on hand as you take notes on what you read! Then, once you've assembled your research, use the Synthesis table to start charting the similarities/differences and major themes among your collected items.
We've included an Excel file with templates for you to use below; the examples pictured on this page are snapshots from that file.
This is an example of a research table, in which you provide a basic description of the most important features of the studies, articles, and other items you discover in your research. The table identifies each item according to its author/date of publication, its purpose or thesis, what type of work it is (systematic review, clinical trial, etc.), the level of evidence it represents (which tells you a lot about its impact on the field of study), and its major findings. Your job, when you assemble this information, is to develop a snapshot of what the research shows about the topic of your research question and assess its value (both for the purpose of your work and for general knowledge in the field).
Think of your work on the research table as the foundational step for your analysis of the literature, in which you assemble the information you'll be analyzing and lay the groundwork for thinking about what it means and how it can be used.
This is an example of a synthesis table or synthesis matrix , in which you organize and analyze your research by listing each source and indicating whether a given finding or result occurred in a particular study or article ( each row lists an individual source, and each finding has its own column, in which X = yes, blank = no). You can also add or alter the columns to look for shared study populations, sort by level of evidence or source type, etc. The key here is to use the table to provide a simple representation of what the research has found (or not found, as the case may be). Think of a synthesis table as a tool for making comparisons, identifying trends, and locating gaps in the literature.
How do I know which findings to use, or how many to include? Your research question tells you which findings are of interest in your research, so work from your research question to decide what needs to go in each Finding header, and how many findings are necessary. The number is up to you; again, you can alter this table by adding or deleting columns to match what you're actually looking for in your analysis. You should also, of course, be guided by what's actually present in the material your research turns up!
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Learning objectives.
At the conclusion of this chapter, you will be able to:
7.1.1 putting the pieces together.
Combining separate elements into a whole is the dictionary definition of synthesis. It is a way to make connections among and between numerous and varied source materials. A literature review is not an annotated bibliography, organized by title, author, or date of publication. Rather, it is grouped by topic to create a whole view of the literature relevant to your research question.
Your synthesis must demonstrate a critical analysis of the papers you collected as well as your ability to integrate the results of your analysis into your own literature review. Each paper collected should be critically evaluated and weighed for “adequacy, appropriateness, and thoroughness” ( Garrard, 2017 ) before inclusion in your own review. Papers that do not meet this criteria likely should not be included in your literature review.
Begin the synthesis process by creating a grid, table, or an outline where you will summarize, using common themes you have identified and the sources you have found. The summary grid or outline will help you compare and contrast the themes so you can see the relationships among them as well as areas where you may need to do more searching. Whichever method you choose, this type of organization will help you to both understand the information you find and structure the writing of your review. Remember, although “the means of summarizing can vary, the key at this point is to make sure you understand what you’ve found and how it relates to your topic and research question” ( Bennard et al., 2014 ).
As you read through the material you gather, look for common themes as they may provide the structure for your literature review. And, remember, research is an iterative process: it is not unusual to go back and search information sources for more material.
At one extreme, if you are claiming, ‘There are no prior publications on this topic,’ it is more likely that you have not found them yet and may need to broaden your search. At another extreme, writing a complete literature review can be difficult with a well-trod topic. Do not cite it all; instead cite what is most relevant. If that still leaves too much to include, be sure to reference influential sources…as well as high-quality work that clearly connects to the points you make. ( Klingner, Scanlon, & Pressley, 2005 ).
Literature reviews can be organized sequentially or by topic, theme, method, results, theory, or argument. It’s important to develop categories that are meaningful and relevant to your research question. Take detailed notes on each article and use a consistent format for capturing all the information each article provides. These notes and the summary table can be done manually, using note cards. However, given the amount of information you will be recording, an electronic file created in a word processing or spreadsheet is more manageable. Examples of fields you may want to capture in your notes include:
Other fields that will be useful when you begin to synthesize the sum total of your research:
This short video demonstrates how a nursing researcher might create a summary table.
Summary tables can be organized by author or by theme, for example:
Author/Year | Research Design | Participants or Population Studied | Comparison | Outcome |
Smith/2010 | Mixed methods | Undergraduates | Graduates | Improved access |
King/2016 | Survey | Females | Males | Increased representation |
Miller/2011 | Content analysis | Nurses | Doctors | New procedure |
For a summary table template, see http://blogs.monm.edu/writingatmc/files/2013/04/Synthesis-Matrix-Template.pdf
An alternate way to organize your articles for synthesis it to create an outline. After you have collected the articles you intend to use (and have put aside the ones you won’t be using), it’s time to identify the conclusions that can be drawn from the articles as a group.
Based on your review of the collected articles, group them by categories. You may wish to further organize them by topic and then chronologically or alphabetically by author. For each topic or subtopic you identified during your critical analysis of the paper, determine what those papers have in common. Likewise, determine which ones in the group differ. If there are contradictory findings, you may be able to identify methodological or theoretical differences that could account for the contradiction (for example, differences in population demographics). Determine what general conclusions you can report about the topic or subtopic as the entire group of studies relate to it. For example, you may have several studies that agree on outcome, such as ‘hands on learning is best for science in elementary school’ or that ‘continuing education is the best method for updating nursing certification.’ In that case, you may want to organize by methodology used in the studies rather than by outcome.
Organize your outline in a logical order and prepare to write the first draft of your literature review. That order might be from broad to more specific, or it may be sequential or chronological, going from foundational literature to more current. Remember, “an effective literature review need not denote the entire historical record, but rather establish the raison d’etre for the current study and in doing so cite that literature distinctly pertinent for theoretical, methodological, or empirical reasons.” ( Milardo, 2015, p. 22 ).
As you organize the summarized documents into a logical structure, you are also appraising and synthesizing complex information from multiple sources. Your literature review is the result of your research that synthesizes new and old information and creates new knowledge.
Literature Reviews: Using a Matrix to Organize Research / Saint Mary’s University of Minnesota
Literature Review: Synthesizing Multiple Sources / Indiana University
Writing a Literature Review and Using a Synthesis Matrix / Florida International University
Sample Literature Reviews Grid / Complied by Lindsay Roberts
Select three or four articles on a single topic of interest to you. Then enter them into an outline or table in the categories you feel are important to a research question. Try both the grid and the outline if you can to see which suits you better. The attached grid contains the fields suggested in the video .
Author Date | Topic/Focus Purpose | Conceptual Theoretical Framework | Paradigm Methods | Context Setting Sample | Findings | Gaps |
Literature Reviews for Education and Nursing Graduate Students Copyright © by Linda Frederiksen is licensed under a Creative Commons Attribution 4.0 International License , except where otherwise noted.
A literature review is a summary of the existing knowledge and research on a particular subject. by identifying gaps in the literature, it provides a foundation for future research. as such, it’s a crucial first step in any research project..
A literature review serves several purposes:
Looking at existing examples of literature reviews is beneficial to get a clear understanding of what they entail. Find examples of a literature review by using an academic search engine (e.g. Google Scholar). As a starting point, search for your keyword or topic along with the term "literature review".
Identify the research question or topic, making it as narrow as possible. In this example of a literature review, we review the anxiolytic (anti-anxiety) activity of Piper methysticum , or Kava .
Let's walk through the steps in the process with this literature review example.
First, identify the research question or topic, making it as narrow as possible. In this literature review example, we're examining the effects of urbanization on the migration of birds.
Searching for relevant studies is arguably the most important aspect of the literature review.
Start by identifying keywords and phrases related to the topic and use them to search academic journals and databases ( Google Scholar , BASE , PubMed , etc.). For our example, you might start with "the effects of urbanization on bird migration", but after researching the field, discover that other terms like "avian migration" and "avian populations" are more commonly used.
Search for your keywords in Litmaps to find some initial articles to explore the field from. You can then use Litmaps to find additinal sources and curate a whole library of literature on your topic.
Search for your keywords in Litmaps, and select a starting article. This will return a visualization containing suggestions for relevant articles on your literature review topic. Review these to start curating your library.
Evaluate the relevance and quality of the sources found by reading abstracts of the most relevant articles. Additionally, consider the publication venue, year of publication and other salient measures to identify the reliability and relevance of the source.
Take notes on the key findings, methodologies, and theoretical frameworks used in the studies.
Use a research-friendly note-taking software, like Obsidian , that provide #tags to keep track of key concepts.
Organize the literature according to themes, subtopics, or categories, which will help outline the layout of the literature review.
Tag keywords using a tool like Obsidian to help organize papers into subtopics for the review.
Summarize and synthesize the findings from the sources analyzed. Start with an introduction that defines the research question, followed by the themes, subtopics, or categories identified. After that, provide a discussion or conclusion that addresses any gaps in the literature to motivate future research. Lastly, edit and revise your review to ensure it is well-structured, clear, and concise. The example below is from a review paper, which includes a table comparing the different sources evaluated. Such tables can be useful if you are conducting a comprehensive review.
If you're conducting a comprehensive review, you can include a table of sources reviewed in your process, like the one above from this publication .
Lastly, cite and reference the sources used in the literature review. Consider any referencing style requirements of the institution or journal you're submitting to. APA is the most common. However, you may need to familiarize yourself with other citation styles such as MLA, Chicago, or MHRA depending on your venue. See the image below for a literature review example APA of references. To cite references you've saved in Litmaps, you can move your saved articles from Litmaps to a reference manager (i.e. Zotero, Mendeley, EndNote, etc.) and then export their bibliography from there. Here's how to export articles from Litmaps.
Use a reference manager tool like Zotero to easily export which makes them easy to manage, like in this APA literature review example.
A successful literature review tells a brief story about the topic at hand and leaves the reader a clear notion of what has been covered. Most importantly, a literature review addresses any gaps in the field and frames newly presented research. Understand the key steps and look at literature review examples in order to create a high quality review.
Header image Forest & Kim Starr, used under Creative Commons BY 3.0
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Chapter 14: completing ‘summary of findings’ tables and grading the certainty of the evidence.
Holger J Schünemann, Julian PT Higgins, Gunn E Vist, Paul Glasziou, Elie A Akl, Nicole Skoetz, Gordon H Guyatt; on behalf of the Cochrane GRADEing Methods Group (formerly Applicability and Recommendations Methods Group) and the Cochrane Statistical Methods Group
Cite this chapter as: Schünemann HJ, Higgins JPT, Vist GE, Glasziou P, Akl EA, Skoetz N, Guyatt GH. Chapter 14: Completing ‘Summary of findings’ tables and grading the certainty of the evidence [last updated August 2023]. In: Higgins JPT, Thomas J, Chandler J, Cumpston M, Li T, Page MJ, Welch VA (editors). Cochrane Handbook for Systematic Reviews of Interventions version 6.5. Cochrane, 2024. Available from www.training.cochrane.org/handbook .
14.1.1 introduction to ‘summary of findings’ tables.
‘Summary of findings’ tables present the main findings of a review in a transparent, structured and simple tabular format. In particular, they provide key information concerning the certainty or quality of evidence (i.e. the confidence or certainty in the range of an effect estimate or an association), the magnitude of effect of the interventions examined, and the sum of available data on the main outcomes. Cochrane Reviews should incorporate ‘Summary of findings’ tables during planning and publication, and should have at least one key ‘Summary of findings’ table representing the most important comparisons. Some reviews may include more than one ‘Summary of findings’ table, for example if the review addresses more than one major comparison, or includes substantially different populations that require separate tables (e.g. because the effects differ or it is important to show results separately). In the Cochrane Database of Systematic Reviews (CDSR), all ‘Summary of findings’ tables for a review appear at the beginning, before the Background section.
Planning for the ‘Summary of findings’ table starts early in the systematic review, with the selection of the outcomes to be included in: (i) the review; and (ii) the ‘Summary of findings’ table. This is a crucial step, and one that review authors need to address carefully.
To ensure production of optimally useful information, Cochrane Reviews begin by developing a review question and by listing all main outcomes that are important to patients and other decision makers (see Chapter 2 and Chapter 3 ). The GRADE approach to assessing the certainty of the evidence (see Section 14.2 ) defines and operationalizes a rating process that helps separate outcomes into those that are critical, important or not important for decision making. Consultation and feedback on the review protocol, including from consumers and other decision makers, can enhance this process.
Critical outcomes are likely to include clearly important endpoints; typical examples include mortality and major morbidity (such as strokes and myocardial infarction). However, they may also represent frequent minor and rare major side effects, symptoms, quality of life, burdens associated with treatment, and resource issues (costs). Burdens represent the impact of healthcare workload on patient function and well-being, and include the demands of adhering to an intervention that patients or caregivers (e.g. family) may dislike, such as having to undergo more frequent tests, or the restrictions on lifestyle that certain interventions require (Spencer-Bonilla et al 2017).
Frequently, when formulating questions that include all patient-important outcomes for decision making, review authors will confront reports of studies that have not included all these outcomes. This is particularly true for adverse outcomes. For instance, randomized trials might contribute evidence on intended effects, and on frequent, relatively minor side effects, but not report on rare adverse outcomes such as suicide attempts. Chapter 19 discusses strategies for addressing adverse effects. To obtain data for all important outcomes it may be necessary to examine the results of non-randomized studies (see Chapter 24 ). Cochrane, in collaboration with others, has developed guidance for review authors to support their decision about when to look for and include non-randomized studies (Schünemann et al 2013).
If a review includes only randomized trials, these trials may not address all important outcomes and it may therefore not be possible to address these outcomes within the constraints of the review. Review authors should acknowledge these limitations and make them transparent to readers. Review authors are encouraged to include non-randomized studies to examine rare or long-term adverse effects that may not adequately be studied in randomized trials. This raises the possibility that harm outcomes may come from studies in which participants differ from those in studies used in the analysis of benefit. Review authors will then need to consider how much such differences are likely to impact on the findings, and this will influence the certainty of evidence because of concerns about indirectness related to the population (see Section 14.2.2 ).
Non-randomized studies can provide important information not only when randomized trials do not report on an outcome or randomized trials suffer from indirectness, but also when the evidence from randomized trials is rated as very low and non-randomized studies provide evidence of higher certainty. Further discussion of these issues appears also in Chapter 24 .
Several alternative standard versions of ‘Summary of findings’ tables have been developed to ensure consistency and ease of use across reviews, inclusion of the most important information needed by decision makers, and optimal presentation (see examples at Figures 14.1.a and 14.1.b ). These formats are supported by research that focused on improved understanding of the information they intend to convey (Carrasco-Labra et al 2016, Langendam et al 2016, Santesso et al 2016). They are available through GRADE’s official software package developed to support the GRADE approach: GRADEpro GDT (www.gradepro.org).
Standard Cochrane ‘Summary of findings’ tables include the following elements using one of the accepted formats. Further guidance on each of these is provided in Section 14.1.6 .
Ideally, ‘Summary of findings’ tables are supported by more detailed tables (known as ‘evidence profiles’) to which the review may be linked, which provide more detailed explanations. Evidence profiles include the same important health outcomes, and provide greater detail than ‘Summary of findings’ tables of both of the individual considerations feeding into the grading of certainty and of the results of the studies (Guyatt et al 2011a). They ensure that a structured approach is used to rating the certainty of evidence. Although they are rarely published in Cochrane Reviews, evidence profiles are often used, for example, by guideline developers in considering the certainty of the evidence to support guideline recommendations. Review authors will find it easier to develop the ‘Summary of findings’ table by completing the rating of the certainty of evidence in the evidence profile first in GRADEpro GDT. They can then automatically convert this to one of the ‘Summary of findings’ formats in GRADEpro GDT, including an interactive ‘Summary of findings’ for publication.
As a measure of the magnitude of effect for dichotomous outcomes, the ‘Summary of findings’ table should provide a relative measure of effect (e.g. risk ratio, odds ratio, hazard) and measures of absolute risk. For other types of data, an absolute measure alone (such as a difference in means for continuous data) might be sufficient. It is important that the magnitude of effect is presented in a meaningful way, which may require some transformation of the result of a meta-analysis (see also Chapter 15, Section 15.4 and Section 15.5 ). Reviews with more than one main comparison should include a separate ‘Summary of findings’ table for each comparison.
Figure 14.1.a provides an example of a ‘Summary of findings’ table. Figure 15.1.b provides an alternative format that may further facilitate users’ understanding and interpretation of the review’s findings. Evidence evaluating different formats suggests that the ‘Summary of findings’ table should include a risk difference as a measure of the absolute effect and authors should preferably use a format that includes a risk difference .
A detailed description of the contents of a ‘Summary of findings’ table appears in Section 14.1.6 .
Figure 14.1.a Example of a ‘Summary of findings’ table
Summary of findings (for interactive version click here )
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anyone taking a long flight (lasting more than 6 hours) international air travel compression stockings without stockings | ||||||
Outcomes | * (95% CI) | Relative effect (95% CI) | Number of participants (studies) | Certainty of the evidence (GRADE) | Comments | |
Assumed risk | Corresponding risk | |||||
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(DVT) | See comment | See comment | Not estimable | 2821 (9 studies) | See comment | 0 participants developed symptomatic DVT in these studies |
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| (0.04 to 0.26) | 2637 (9 studies) | ⊕⊕⊕⊕
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(0 to 3) | |||||
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(1 to 8) | |||||
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(2 to 15) |
(0.18 to 1.13) | 1804 (8 studies) | ⊕⊕⊕◯
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Post-flight values measured on a scale from 0, no oedema, to 10, maximum oedema | The mean oedema score ranged across control groups from
| The mean oedema score in the intervention groups was on average
(95% CI –4.9 to –4.5) | 1246 (6 studies) | ⊕⊕◯◯
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| See comment | See comment | Not estimable | 2821 (9 studies) | See comment | 0 participants developed pulmonary embolus in these studies |
| See comment | See comment | Not estimable | 2821 (9 studies) | See comment | 0 participants died in these studies |
| See comment | See comment | Not estimable | 1182 (4 studies) | See comment | The tolerability of the stockings was described as very good with no complaints of side effects in 4 studies |
*The basis for the is provided in footnotes. The (and its 95% confidence interval) is based on the assumed risk in the intervention group and the of the intervention (and its 95% CI). CI: confidence interval; RR: risk ratio; GRADE: GRADE Working Group grades of evidence (see explanations). |
a All the stockings in the nine studies included in this review were below-knee compression stockings. In four studies the compression strength was 20 mmHg to 30 mmHg at the ankle. It was 10 mmHg to 20 mmHg in the other four studies. Stockings come in different sizes. If a stocking is too tight around the knee it can prevent essential venous return causing the blood to pool around the knee. Compression stockings should be fitted properly. A stocking that is too tight could cut into the skin on a long flight and potentially cause ulceration and increased risk of DVT. Some stockings can be slightly thicker than normal leg covering and can be potentially restrictive with tight foot wear. It is a good idea to wear stockings around the house prior to travel to ensure a good, comfortable fit. Participants put their stockings on two to three hours before the flight in most of the studies. The availability and cost of stockings can vary.
b Two studies recruited high risk participants defined as those with previous episodes of DVT, coagulation disorders, severe obesity, limited mobility due to bone or joint problems, neoplastic disease within the previous two years, large varicose veins or, in one of the studies, participants taller than 190 cm and heavier than 90 kg. The incidence for the seven studies that excluded high risk participants was 1.45% and the incidence for the two studies that recruited high-risk participants (with at least one risk factor) was 2.43%. We have used 10 and 30 per 1000 to express different risk strata, respectively.
c The confidence interval crosses no difference and does not rule out a small increase.
d The measurement of oedema was not validated (indirectness of the outcome) or blinded to the intervention (risk of bias).
e If there are very few or no events and the number of participants is large, judgement about the certainty of evidence (particularly judgements about imprecision) may be based on the absolute effect. Here the certainty rating may be considered ‘high’ if the outcome was appropriately assessed and the event, in fact, did not occur in 2821 studied participants.
f None of the other studies reported adverse effects, apart from four cases of superficial vein thrombosis in varicose veins in the knee region that were compressed by the upper edge of the stocking in one study.
Figure 14.1.b Example of alternative ‘Summary of findings’ table
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children given antibiotics inpatients and outpatient probiotics no probiotics | ||||||
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Follow-up: 10 days to 3 months Children < 5 years |
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Due to risk of bias | Probably decreases the incidence of diarrhoea. | ||
1474 (7 studies) |
(0.29 to 0.55) |
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(6.5 to 12.2) |
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Children > 5 years |
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Due to risk of bias and imprecision | May decrease the incidence of diarrhoea. | ||
624 (4 studies) |
(0.53 to 1.21) |
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(5.9 to 13.6) |
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Follow-up: 10 to 44 days 1575 (11 studies) | - |
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Due to risk of bias and inconsistency | There may be little or no difference in adverse events. |
Follow-up: 10 days to 3 months 897 (5 studies) | - | The mean duration of diarrhoea without probiotics was | - |
(1.18 to 0.02 fewer days) | ⊕⊕⊝⊝
Due to imprecision and inconsistency | May decrease the duration of diarrhoea. |
Follow-up: 10 days to 3 months 425 (4 studies) | - | The mean stools per day without probiotics was | - |
(0.6 to 0 fewer) | ⊕⊕⊝⊝
Due to imprecision and inconsistency | There may be little or no difference in stools per day. |
*The basis for the (e.g. the median control group risk across studies) is provided in footnotes. The (and its 95% confidence interval) is based on the assumed risk in the comparison group and the of the intervention (and its 95% CI). confidence interval; risk ratio. | ||||||
Control group risk estimates come from pooled estimates of control groups. Relative effect based on available case analysis High risk of bias due to high loss to follow-up. Imprecision due to few events and confidence intervals include appreciable benefit or harm. Side effects: rash, nausea, flatulence, vomiting, increased phlegm, chest pain, constipation, taste disturbance and low appetite. Risks were calculated from pooled risk differences. High risk of bias. Only 11 of 16 trials reported on adverse events, suggesting a selective reporting bias. Serious inconsistency. Numerous probiotic agents and doses were evaluated amongst a relatively small number of trials, limiting our ability to draw conclusions on the safety of the many probiotics agents and doses administered. Serious unexplained inconsistency (large heterogeneity I = 79%, P value [P = 0.04], point estimates and confidence intervals vary considerably). Serious imprecision. The upper bound of 0.02 fewer days of diarrhoea is not considered patient important. Serious unexplained inconsistency (large heterogeneity I = 78%, P value [P = 0.05], point estimates and confidence intervals vary considerably). Serious imprecision. The 95% confidence interval includes no effect and lower bound of 0.60 stools per day is of questionable patient importance. |
The GRADE Working Group’s software, GRADEpro GDT ( www.gradepro.org ), including GRADE’s interactive handbook, is available to assist review authors in the preparation of ‘Summary of findings’ tables. GRADEpro can use data on the comparator group risk and the effect estimate (entered by the review authors or imported from files generated in RevMan) to produce the relative effects and absolute risks associated with experimental interventions. In addition, it leads the user through the process of a GRADE assessment, and produces a table that can be used as a standalone table in a review (including by direct import into software such as RevMan or integration with RevMan Web), or an interactive ‘Summary of findings’ table (see help resources in GRADEpro).
14.1.5.1 dichotomous outcomes.
‘Summary of findings’ tables should include both absolute and relative measures of effect for dichotomous outcomes. Risk ratios, odds ratios and risk differences are different ways of comparing two groups with dichotomous outcome data (see Chapter 6, Section 6.4.1 ). Furthermore, there are two distinct risk ratios, depending on which event (e.g. ‘yes’ or ‘no’) is the focus of the analysis (see Chapter 6, Section 6.4.1.5 ). In the presence of a non-zero intervention effect, any variation across studies in the comparator group risks (i.e. variation in the risk of the event occurring without the intervention of interest, for example in different populations) makes it impossible for more than one of these measures to be truly the same in every study.
It has long been assumed in epidemiology that relative measures of effect are more consistent than absolute measures of effect from one scenario to another. There is empirical evidence to support this assumption (Engels et al 2000, Deeks and Altman 2001, Furukawa et al 2002). For this reason, meta-analyses should generally use either a risk ratio or an odds ratio as a measure of effect (see Chapter 10, Section 10.4.3 ). Correspondingly, a single estimate of relative effect is likely to be a more appropriate summary than a single estimate of absolute effect. If a relative effect is indeed consistent across studies, then different comparator group risks will have different implications for absolute benefit. For instance, if the risk ratio is consistently 0.75, then the experimental intervention would reduce a comparator group risk of 80% to 60% in the intervention group (an absolute risk reduction of 20 percentage points), but would also reduce a comparator group risk of 20% to 15% in the intervention group (an absolute risk reduction of 5 percentage points).
‘Summary of findings’ tables are built around the assumption of a consistent relative effect. It is therefore important to consider the implications of this effect for different comparator group risks (these can be derived or estimated from a number of sources, see Section 14.1.6.3 ), which may require an assessment of the certainty of evidence for prognostic evidence (Spencer et al 2012, Iorio et al 2015). For any comparator group risk, it is possible to estimate a corresponding intervention group risk (i.e. the absolute risk with the intervention) from the meta-analytic risk ratio or odds ratio. Note that the numbers provided in the ‘Corresponding risk’ column are specific to the ‘risks’ in the adjacent column.
For the meta-analytic risk ratio (RR) and assumed comparator risk (ACR) the corresponding intervention risk is obtained as:
As an example, in Figure 14.1.a , the meta-analytic risk ratio for symptomless deep vein thrombosis (DVT) is RR = 0.10 (95% CI 0.04 to 0.26). Assuming a comparator risk of ACR = 10 per 1000 = 0.01, we obtain:
For the meta-analytic odds ratio (OR) and assumed comparator risk, ACR, the corresponding intervention risk is obtained as:
Upper and lower confidence limits for the corresponding intervention risk are obtained by replacing RR or OR by their upper and lower confidence limits, respectively (e.g. replacing 0.10 with 0.04, then with 0.26, in the example). Such confidence intervals do not incorporate uncertainty in the assumed comparator risks.
When dealing with risk ratios, it is critical that the same definition of ‘event’ is used as was used for the meta-analysis. For example, if the meta-analysis focused on ‘death’ (as opposed to survival) as the event, then corresponding risks in the ‘Summary of findings’ table must also refer to ‘death’.
In (rare) circumstances in which there is clear rationale to assume a consistent risk difference in the meta-analysis, in principle it is possible to present this for relevant ‘assumed risks’ and their corresponding risks, and to present the corresponding (different) relative effects for each assumed risk.
The risk difference expresses the difference between the ACR and the corresponding intervention risk (or the difference between the experimental and the comparator intervention).
For the meta-analytic risk ratio (RR) and assumed comparator risk (ACR) the corresponding risk difference is obtained as (note that risks can also be expressed using percentage or percentage points):
As an example, in Figure 14.1.b the meta-analytic risk ratio is 0.41 (95% CI 0.29 to 0.55) for diarrhoea in children less than 5 years of age. Assuming a comparator group risk of 22.3% we obtain:
For the meta-analytic odds ratio (OR) and assumed comparator risk (ACR) the absolute risk difference is obtained as (percentage points):
Upper and lower confidence limits for the absolute risk difference are obtained by re-running the calculation above while replacing RR or OR by their upper and lower confidence limits, respectively (e.g. replacing 0.41 with 0.28, then with 0.55, in the example). Such confidence intervals do not incorporate uncertainty in the assumed comparator risks.
Time-to-event outcomes measure whether and when a particular event (e.g. death) occurs (van Dalen et al 2007). The impact of the experimental intervention relative to the comparison group on time-to-event outcomes is usually measured using a hazard ratio (HR) (see Chapter 6, Section 6.8.1 ).
A hazard ratio expresses a relative effect estimate. It may be used in various ways to obtain absolute risks and other interpretable quantities for a specific population. Here we describe how to re-express hazard ratios in terms of: (i) absolute risk of event-free survival within a particular period of time; (ii) absolute risk of an event within a particular period of time; and (iii) median time to the event. All methods are built on an assumption of consistent relative effects (i.e. that the hazard ratio does not vary over time).
(i) Absolute risk of event-free survival within a particular period of time Event-free survival (e.g. overall survival) is commonly reported by individual studies. To obtain absolute effects for time-to-event outcomes measured as event-free survival, the summary HR can be used in conjunction with an assumed proportion of patients who are event-free in the comparator group (Tierney et al 2007). This proportion of patients will be specific to a period of time of observation. However, it is not strictly necessary to specify this period of time. For instance, a proportion of 50% of event-free patients might apply to patients with a high event rate observed over 1 year, or to patients with a low event rate observed over 2 years.
As an example, suppose the meta-analytic hazard ratio is 0.42 (95% CI 0.25 to 0.72). Assuming a comparator group risk of event-free survival (e.g. for overall survival people being alive) at 2 years of ACR = 900 per 1000 = 0.9 we obtain:
so that that 956 per 1000 people will be alive with the experimental intervention at 2 years. The derivation of the risk should be explained in a comment or footnote.
(ii) Absolute risk of an event within a particular period of time To obtain this absolute effect, again the summary HR can be used (Tierney et al 2007):
In the example, suppose we assume a comparator group risk of events (e.g. for mortality, people being dead) at 2 years of ACR = 100 per 1000 = 0.1. We obtain:
so that that 44 per 1000 people will be dead with the experimental intervention at 2 years.
(iii) Median time to the event Instead of absolute numbers, the time to the event in the intervention and comparison groups can be expressed as median survival time in months or years. To obtain median survival time the pooled HR can be applied to an assumed median survival time in the comparator group (Tierney et al 2007):
In the example, assuming a comparator group median survival time of 80 months, we obtain:
For all three of these options for re-expressing results of time-to-event analyses, upper and lower confidence limits for the corresponding intervention risk are obtained by replacing HR by its upper and lower confidence limits, respectively (e.g. replacing 0.42 with 0.25, then with 0.72, in the example). Again, as for dichotomous outcomes, such confidence intervals do not incorporate uncertainty in the assumed comparator group risks. This is of special concern for long-term survival with a low or moderate mortality rate and a corresponding high number of censored patients (i.e. a low number of patients under risk and a high censoring rate).
14.1.6.1 table title and header.
The title of each ‘Summary of findings’ table should specify the healthcare question, framed in terms of the population and making it clear exactly what comparison of interventions are made. In Figure 14.1.a , the population is people taking long aeroplane flights, the intervention is compression stockings, and the control is no compression stockings.
The first rows of each ‘Summary of findings’ table should provide the following ‘header’ information:
Patients or population This further clarifies the population (and possibly the subpopulations) of interest and ideally the magnitude of risk of the most crucial adverse outcome at which an intervention is directed. For instance, people on a long-haul flight may be at different risks for DVT; those using selective serotonin reuptake inhibitors (SSRIs) might be at different risk for side effects; while those with atrial fibrillation may be at low (< 1%), moderate (1% to 4%) or high (> 4%) yearly risk of stroke.
Setting This should state any specific characteristics of the settings of the healthcare question that might limit the applicability of the summary of findings to other settings (e.g. primary care in Europe and North America).
Intervention The experimental intervention.
Comparison The comparator intervention (including no specific intervention).
The rows of a ‘Summary of findings’ table should include all desirable and undesirable health outcomes (listed in order of importance) that are essential for decision making, up to a maximum of seven outcomes. If there are more outcomes in the review, review authors will need to omit the less important outcomes from the table, and the decision selecting which outcomes are critical or important to the review should be made during protocol development (see Chapter 3 ). Review authors should provide time frames for the measurement of the outcomes (e.g. 90 days or 12 months) and the type of instrument scores (e.g. ranging from 0 to 100).
Note that review authors should include the pre-specified critical and important outcomes in the table whether data are available or not. However, they should be alert to the possibility that the importance of an outcome (e.g. a serious adverse effect) may only become known after the protocol was written or the analysis was carried out, and should take appropriate actions to include these in the ‘Summary of findings’ table.
The ‘Summary of findings’ table can include effects in subgroups of the population for different comparator risks and effect sizes separately. For instance, in Figure 14.1.b effects are presented for children younger and older than 5 years separately. Review authors may also opt to produce separate ‘Summary of findings’ tables for different populations.
Review authors should include serious adverse events, but it might be possible to combine minor adverse events as a single outcome, and describe this in an explanatory footnote (note that it is not appropriate to add events together unless they are independent, that is, a participant who has experienced one adverse event has an unaffected chance of experiencing the other adverse event).
Outcomes measured at multiple time points represent a particular problem. In general, to keep the table simple, review authors should present multiple time points only for outcomes critical to decision making, where either the result or the decision made are likely to vary over time. The remainder should be presented at a common time point where possible.
Review authors can present continuous outcome measures in the ‘Summary of findings’ table and should endeavour to make these interpretable to the target audience. This requires that the units are clear and readily interpretable, for example, days of pain, or frequency of headache, and the name and scale of any measurement tools used should be stated (e.g. a Visual Analogue Scale, ranging from 0 to 100). However, many measurement instruments are not readily interpretable by non-specialist clinicians or patients, for example, points on a Beck Depression Inventory or quality of life score. For these, a more interpretable presentation might involve converting a continuous to a dichotomous outcome, such as >50% improvement (see Chapter 15, Section 15.5 ).
Review authors should provide up to three typical risks for participants receiving the comparator intervention. For dichotomous outcomes, we recommend that these be presented in the form of the number of people experiencing the event per 100 or 1000 people (natural frequency) depending on the frequency of the outcome. For continuous outcomes, this would be stated as a mean or median value of the outcome measured.
Estimated or assumed comparator intervention risks could be based on assessments of typical risks in different patient groups derived from the review itself, individual representative studies in the review, or risks derived from a systematic review of prognosis studies or other sources of evidence which may in turn require an assessment of the certainty for the prognostic evidence (Spencer et al 2012, Iorio et al 2015). Ideally, risks would reflect groups that clinicians can easily identify on the basis of their presenting features.
An explanatory footnote should specify the source or rationale for each comparator group risk, including the time period to which it corresponds where appropriate. In Figure 14.1.a , clinicians can easily differentiate individuals with risk factors for deep venous thrombosis from those without. If there is known to be little variation in baseline risk then review authors may use the median comparator group risk across studies. If typical risks are not known, an option is to choose the risk from the included studies, providing the second highest for a high and the second lowest for a low risk population.
For dichotomous outcomes, review authors should provide a corresponding absolute risk for each comparator group risk, along with a confidence interval. This absolute risk with the (experimental) intervention will usually be derived from the meta-analysis result presented in the relative effect column (see Section 14.1.6.6 ). Formulae are provided in Section 14.1.5 . Review authors should present the absolute effect in the same format as the risks with comparator intervention (see Section 14.1.6.3 ), for example as the number of people experiencing the event per 1000 people.
For continuous outcomes, a difference in means or standardized difference in means should be presented with its confidence interval. These will typically be obtained directly from a meta-analysis. Explanatory text should be used to clarify the meaning, as in Figures 14.1.a and 14.1.b .
For dichotomous outcomes, the risk difference can be provided using one of the ‘Summary of findings’ table formats as an additional option (see Figure 14.1.b ). This risk difference expresses the difference between the experimental and comparator intervention and will usually be derived from the meta-analysis result presented in the relative effect column (see Section 14.1.6.6 ). Formulae are provided in Section 14.1.5 . Review authors should present the risk difference in the same format as assumed and corresponding risks with comparator intervention (see Section 14.1.6.3 ); for example, as the number of people experiencing the event per 1000 people or as percentage points if the assumed and corresponding risks are expressed in percentage.
For continuous outcomes, if the ‘Summary of findings’ table includes this option, the mean difference can be presented here and the ‘corresponding risk’ column left blank (see Figure 14.1.b ).
The relative effect will typically be a risk ratio or odds ratio (or occasionally a hazard ratio) with its accompanying 95% confidence interval, obtained from a meta-analysis performed on the basis of the same effect measure. Risk ratios and odds ratios are similar when the comparator intervention risks are low and effects are small, but may differ considerably when comparator group risks increase. The meta-analysis may involve an assumption of either fixed or random effects, depending on what the review authors consider appropriate, and implying that the relative effect is either an estimate of the effect of the intervention, or an estimate of the average effect of the intervention across studies, respectively.
This column should include the number of participants assessed in the included studies for each outcome and the corresponding number of studies that contributed these participants.
Review authors should comment on the certainty of the evidence (also known as quality of the body of evidence or confidence in the effect estimates). Review authors should use the specific evidence grading system developed by the GRADE Working Group (Atkins et al 2004, Guyatt et al 2008, Guyatt et al 2011a), which is described in detail in Section 14.2 . The GRADE approach categorizes the certainty in a body of evidence as ‘high’, ‘moderate’, ‘low’ or ‘very low’ by outcome. This is a result of judgement, but the judgement process operates within a transparent structure. As an example, the certainty would be ‘high’ if the summary were of several randomized trials with low risk of bias, but the rating of certainty becomes lower if there are concerns about risk of bias, inconsistency, indirectness, imprecision or publication bias. Judgements other than of ‘high’ certainty should be made transparent using explanatory footnotes or the ‘Comments’ column in the ‘Summary of findings’ table (see Section 14.1.6.10 ).
The aim of the ‘Comments’ field is to help interpret the information or data identified in the row. For example, this may be on the validity of the outcome measure or the presence of variables that are associated with the magnitude of effect. Important caveats about the results should be flagged here. Not all rows will need comments, and it is best to leave a blank if there is nothing warranting a comment.
Detailed explanations should be included as footnotes to support the judgements in the ‘Summary of findings’ table, such as the overall GRADE assessment. The explanations should describe the rationale for important aspects of the content. Table 14.1.a lists guidance for useful explanations. Explanations should be concise, informative, relevant, easy to understand and accurate. If explanations cannot be sufficiently described in footnotes, review authors should provide further details of the issues in the Results and Discussion sections of the review.
Table 14.1.a Guidance for providing useful explanations in ‘Summary of findings’ (SoF) tables. Adapted from Santesso et al (2016)
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, Chi , Tau), or the overlap of confidence intervals, or similarity of point estimates. , describe it as considerable, substantial, moderate or not important. |
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14.2.1 the grade approach.
The Grades of Recommendation, Assessment, Development and Evaluation Working Group (GRADE Working Group) has developed a system for grading the certainty of evidence (Schünemann et al 2003, Atkins et al 2004, Schünemann et al 2006, Guyatt et al 2008, Guyatt et al 2011a). Over 100 organizations including the World Health Organization (WHO), the American College of Physicians, the American Society of Hematology (ASH), the Canadian Agency for Drugs and Technology in Health (CADTH) and the National Institutes of Health and Clinical Excellence (NICE) in the UK have adopted the GRADE system ( www.gradeworkinggroup.org ).
Cochrane has also formally adopted this approach, and all Cochrane Reviews should use GRADE to evaluate the certainty of evidence for important outcomes (see MECIR Box 14.2.a ).
MECIR Box 14.2.a Relevant expectations for conduct of intervention reviews
Assessing the certainty of the body of evidence ( ) | |
| GRADE is the most widely used approach for summarizing confidence in effects of interventions by outcome across studies. It is preferable to use the online GRADEpro tool, and to use it as described in the help system of the software. This should help to ensure that author teams are accessing the same information to inform their judgements. Ideally, two people working independently should assess the certainty of the body of evidence and reach a consensus view on any downgrading decisions. The five GRADE considerations should be addressed irrespective of whether the review includes a ‘Summary of findings’ table. It is helpful to draw on this information in the Discussion, in the Authors’ conclusions and to convey the certainty in the evidence in the Abstract and Plain language summary. |
Justifying assessments of the certainty of the body of evidence ( ) | |
| The adoption of a structured approach ensures transparency in formulating an interpretation of the evidence, and the result is more informative to the user. |
For systematic reviews, the GRADE approach defines the certainty of a body of evidence as the extent to which one can be confident that an estimate of effect or association is close to the quantity of specific interest. Assessing the certainty of a body of evidence involves consideration of within- and across-study risk of bias (limitations in study design and execution or methodological quality), inconsistency (or heterogeneity), indirectness of evidence, imprecision of the effect estimates and risk of publication bias (see Section 14.2.2 ), as well as domains that may increase our confidence in the effect estimate (as described in Section 14.2.3 ). The GRADE system entails an assessment of the certainty of a body of evidence for each individual outcome. Judgements about the domains that determine the certainty of evidence should be described in the results or discussion section and as part of the ‘Summary of findings’ table.
The GRADE approach specifies four levels of certainty ( Figure 14.2.a ). For interventions, including diagnostic and other tests that are evaluated as interventions (Schünemann et al 2008b, Schünemann et al 2008a, Balshem et al 2011, Schünemann et al 2012), the starting point for rating the certainty of evidence is categorized into two types:
There are many instances in which review authors rely on information from NRSI, in particular to evaluate potential harms (see Chapter 24 ). In addition, review authors can obtain relevant data from both randomized trials and NRSI, with each type of evidence complementing the other (Schünemann et al 2013).
In GRADE, a body of evidence from randomized trials begins with a high-certainty rating while a body of evidence from NRSI begins with a low-certainty rating. The lower rating with NRSI is the result of the potential bias induced by the lack of randomization (i.e. confounding and selection bias).
However, when using the new Risk Of Bias In Non-randomized Studies of Interventions (ROBINS-I) tool (Sterne et al 2016), an assessment tool that covers the risk of bias due to lack of randomization, all studies may start as high certainty of the evidence (Schünemann et al 2018). The approach of starting all study designs (including NRSI) as high certainty does not conflict with the initial GRADE approach of starting the rating of NRSI as low certainty evidence. This is because a body of evidence from NRSI should generally be downgraded by two levels due to the inherent risk of bias associated with the lack of randomization, namely confounding and selection bias. Not downgrading NRSI from high to low certainty needs transparent and detailed justification for what mitigates concerns about confounding and selection bias (Schünemann et al 2018). Very few examples of where not rating down by two levels is appropriate currently exist.
The highest certainty rating is a body of evidence when there are no concerns in any of the GRADE factors listed in Figure 14.2.a . Review authors often downgrade evidence to moderate, low or even very low certainty evidence, depending on the presence of the five factors in Figure 14.2.a . Usually, certainty rating will fall by one level for each factor, up to a maximum of three levels for all factors. If there are very severe problems for any one domain (e.g. when assessing risk of bias, all studies were unconcealed, unblinded and lost over 50% of their patients to follow-up), evidence may fall by two levels due to that factor alone. It is not possible to rate lower than ‘very low certainty’ evidence.
Review authors will generally grade evidence from sound non-randomized studies as low certainty, even if ROBINS-I is used. If, however, such studies yield large effects and there is no obvious bias explaining those effects, review authors may rate the evidence as moderate or – if the effect is large enough – even as high certainty ( Figure 14.2.a ). The very low certainty level is appropriate for, but is not limited to, studies with critical problems and unsystematic clinical observations (e.g. case series or case reports).
Figure 14.2.a Levels of the certainty of a body of evidence in the GRADE approach. *Upgrading criteria are usually applicable to non-randomized studies only (but exceptions exist).
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We now describe in more detail the five reasons (or domains) for downgrading the certainty of a body of evidence for a specific outcome. In each case, if no reason is found for downgrading the evidence, it should be classified as 'no limitation or not serious' (not important enough to warrant downgrading). If a reason is found for downgrading the evidence, it should be classified as 'serious' (downgrading the certainty rating by one level) or 'very serious' (downgrading the certainty grade by two levels). For non-randomized studies assessed with ROBINS-I, rating down by three levels should be classified as 'extremely' serious.
(1) Risk of bias or limitations in the detailed design and implementation
Our confidence in an estimate of effect decreases if studies suffer from major limitations that are likely to result in a biased assessment of the intervention effect. For randomized trials, these methodological limitations include failure to generate a random sequence, lack of allocation sequence concealment, lack of blinding (particularly with subjective outcomes that are highly susceptible to biased assessment), a large loss to follow-up or selective reporting of outcomes. Chapter 8 provides a discussion of study-level assessments of risk of bias in the context of a Cochrane Review, and proposes an approach to assessing the risk of bias for an outcome across studies as ‘Low’ risk of bias, ‘Some concerns’ and ‘High’ risk of bias for randomized trials. Levels of ‘Low’. ‘Moderate’, ‘Serious’ and ‘Critical’ risk of bias arise for non-randomized studies assessed with ROBINS-I ( Chapter 25 ). These assessments should feed directly into this GRADE domain. In particular, ‘Low’ risk of bias would indicate ‘no limitation’; ‘Some concerns’ would indicate either ‘no limitation’ or ‘serious limitation’; and ‘High’ risk of bias would indicate either ‘serious limitation’ or ‘very serious limitation’. ‘Critical’ risk of bias on ROBINS-I would indicate extremely serious limitations in GRADE. Review authors should use their judgement to decide between alternative categories, depending on the likely magnitude of the potential biases.
Every study addressing a particular outcome will differ, to some degree, in the risk of bias. Review authors should make an overall judgement on whether the certainty of evidence for an outcome warrants downgrading on the basis of study limitations. The assessment of study limitations should apply to the studies contributing to the results in the ‘Summary of findings’ table, rather than to all studies that could potentially be included in the analysis. We have argued in Chapter 7, Section 7.6.2 , that the primary analysis should be restricted to studies at low (or low and unclear) risk of bias where possible.
Table 14.2.a presents the judgements that must be made in going from assessments of the risk of bias to judgements about study limitations for each outcome included in a ‘Summary of findings’ table. A rating of high certainty evidence can be achieved only when most evidence comes from studies that met the criteria for low risk of bias. For example, of the 22 studies addressing the impact of beta-blockers on mortality in patients with heart failure, most probably or certainly used concealed allocation of the sequence, all blinded at least some key groups and follow-up of randomized patients was almost complete (Brophy et al 2001). The certainty of evidence might be downgraded by one level when most of the evidence comes from individual studies either with a crucial limitation for one item, or with some limitations for multiple items. An example of very serious limitations, warranting downgrading by two levels, is provided by evidence on surgery versus conservative treatment in the management of patients with lumbar disc prolapse (Gibson and Waddell 2007). We are uncertain of the benefit of surgery in reducing symptoms after one year or longer, because the one study included in the analysis had inadequate concealment of the allocation sequence and the outcome was assessed using a crude rating by the surgeon without blinding.
(2) Unexplained heterogeneity or inconsistency of results
When studies yield widely differing estimates of effect (heterogeneity or variability in results), investigators should look for robust explanations for that heterogeneity. For instance, drugs may have larger relative effects in sicker populations or when given in larger doses. A detailed discussion of heterogeneity and its investigation is provided in Chapter 10, Section 10.10 and Section 10.11 . If an important modifier exists, with good evidence that important outcomes are different in different subgroups (which would ideally be pre-specified), then a separate ‘Summary of findings’ table may be considered for a separate population. For instance, a separate ‘Summary of findings’ table would be used for carotid endarterectomy in symptomatic patients with high grade stenosis (70% to 99%) in which the intervention is, in the hands of the right surgeons, beneficial, and another (if review authors considered it relevant) for asymptomatic patients with low grade stenosis (less than 30%) in which surgery appears harmful (Orrapin and Rerkasem 2017). When heterogeneity exists and affects the interpretation of results, but review authors are unable to identify a plausible explanation with the data available, the certainty of the evidence decreases.
(3) Indirectness of evidence
Two types of indirectness are relevant. First, a review comparing the effectiveness of alternative interventions (say A and B) may find that randomized trials are available, but they have compared A with placebo and B with placebo. Thus, the evidence is restricted to indirect comparisons between A and B. Where indirect comparisons are undertaken within a network meta-analysis context, GRADE for network meta-analysis should be used (see Chapter 11, Section 11.5 ).
Second, a review may find randomized trials that meet eligibility criteria but address a restricted version of the main review question in terms of population, intervention, comparator or outcomes. For example, suppose that in a review addressing an intervention for secondary prevention of coronary heart disease, most identified studies happened to be in people who also had diabetes. Then the evidence may be regarded as indirect in relation to the broader question of interest because the population is primarily related to people with diabetes. The opposite scenario can equally apply: a review addressing the effect of a preventive strategy for coronary heart disease in people with diabetes may consider studies in people without diabetes to provide relevant, albeit indirect, evidence. This would be particularly likely if investigators had conducted few if any randomized trials in the target population (e.g. people with diabetes). Other sources of indirectness may arise from interventions studied (e.g. if in all included studies a technical intervention was implemented by expert, highly trained specialists in specialist centres, then evidence on the effects of the intervention outside these centres may be indirect), comparators used (e.g. if the comparator groups received an intervention that is less effective than standard treatment in most settings) and outcomes assessed (e.g. indirectness due to surrogate outcomes when data on patient-important outcomes are not available, or when investigators seek data on quality of life but only symptoms are reported). Review authors should make judgements transparent when they believe downgrading is justified, based on differences in anticipated effects in the group of primary interest. Review authors may be aided and increase transparency of their judgements about indirectness if they use Table 14.2.b available in the GRADEpro GDT software (Schünemann et al 2013).
(4) Imprecision of results
When studies include few participants or few events, and thus have wide confidence intervals, review authors can lower their rating of the certainty of the evidence. The confidence intervals included in the ‘Summary of findings’ table will provide readers with information that allows them to make, to some extent, their own rating of precision. Review authors can use a calculation of the optimal information size (OIS) or review information size (RIS), similar to sample size calculations, to make judgements about imprecision (Guyatt et al 2011b, Schünemann 2016). The OIS or RIS is calculated on the basis of the number of participants required for an adequately powered individual study. If the 95% confidence interval excludes a risk ratio (RR) of 1.0, and the total number of events or patients exceeds the OIS criterion, precision is adequate. If the 95% CI includes appreciable benefit or harm (an RR of under 0.75 or over 1.25 is often suggested as a very rough guide) downgrading for imprecision may be appropriate even if OIS criteria are met (Guyatt et al 2011b, Schünemann 2016).
(5) High probability of publication bias
The certainty of evidence level may be downgraded if investigators fail to report studies on the basis of results (typically those that show no effect: publication bias) or outcomes (typically those that may be harmful or for which no effect was observed: selective outcome non-reporting bias). Selective reporting of outcomes from among multiple outcomes measured is assessed at the study level as part of the assessment of risk of bias (see Chapter 8, Section 8.7 ), so for the studies contributing to the outcome in the ‘Summary of findings’ table this is addressed by domain 1 above (limitations in the design and implementation). If a large number of studies included in the review do not contribute to an outcome, or if there is evidence of publication bias, the certainty of the evidence may be downgraded. Chapter 13 provides a detailed discussion of reporting biases, including publication bias, and how it may be tackled in a Cochrane Review. A prototypical situation that may elicit suspicion of publication bias is when published evidence includes a number of small studies, all of which are industry-funded (Bhandari et al 2004). For example, 14 studies of flavanoids in patients with haemorrhoids have shown apparent large benefits, but enrolled a total of only 1432 patients (i.e. each study enrolled relatively few patients) (Alonso-Coello et al 2006). The heavy involvement of sponsors in most of these studies raises questions of whether unpublished studies that suggest no benefit exist (publication bias).
A particular body of evidence can suffer from problems associated with more than one of the five factors listed here, and the greater the problems, the lower the certainty of evidence rating that should result. One could imagine a situation in which randomized trials were available, but all or virtually all of these limitations would be present, and in serious form. A very low certainty of evidence rating would result.
Table 14.2.a Further guidelines for domain 1 (of 5) in a GRADE assessment: going from assessments of risk of bias in studies to judgements about study limitations for main outcomes across studies
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Low risk of bias | Most information is from results at low risk of bias. | Plausible bias unlikely to seriously alter the results. | No apparent limitations. | No serious limitations, do not downgrade. |
Some concerns | Most information is from results at low risk of bias or with some concerns. | Plausible bias that raises some doubt about the results. | Potential limitations are unlikely to lower confidence in the estimate of effect. | No serious limitations, do not downgrade. |
Potential limitations are likely to lower confidence in the estimate of effect. | Serious limitations, downgrade one level. | |||
High risk of bias | The proportion of information from results at high risk of bias is sufficient to affect the interpretation of results. | Plausible bias that seriously weakens confidence in the results. | Crucial limitation for one criterion, or some limitations for multiple criteria, sufficient to lower confidence in the estimate of effect. | Serious limitations, downgrade one level. |
Crucial limitation for one or more criteria sufficient to substantially lower confidence in the estimate of effect. | Very serious limitations, downgrade two levels. |
Table 14.2.b Judgements about indirectness by outcome (available in GRADEpro GDT)
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| Probably yes | Probably no | No | ||
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Intervention:
Yes | Probably yes | Probably no | No |
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Comparator:
Direct comparison:
Final judgement about indirectness across domains:
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Although NRSI and downgraded randomized trials will generally yield a low rating for certainty of evidence, there will be unusual circumstances in which review authors could ‘upgrade’ such evidence to moderate or even high certainty ( Table 14.3.a ).
Review authors should report the grading of the certainty of evidence in the Results section for each outcome for which this has been performed, providing the rationale for downgrading or upgrading the evidence, and referring to the ‘Summary of findings’ table where applicable.
Table 14.3.a provides a framework and examples for how review authors can justify their judgements about the certainty of evidence in each domain. These justifications should also be included in explanatory notes to the ‘Summary of Findings’ table (see Section 14.1.6.10 ).
Chapter 15, Section 15.6 , describes in more detail how the overall GRADE assessment across all domains can be used to draw conclusions about the effects of the intervention, as well as providing implications for future research.
Table 14.3.a Framework for describing the certainty of evidence and justifying downgrading or upgrading
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| Describe the risk of bias based on the criteria used in the risk-of-bias table. | Downgraded because of 10 randomized trials, five did not blind patients and caretakers. |
| Describe the degree of inconsistency by outcome using one or more indicators (e.g. I and P value), confidence interval overlap, difference in point estimate, between-study variance. | Not downgraded because the proportion of the variability in effect estimates that is due to true heterogeneity rather than chance is not important (I = 0%). |
| Describe if the majority of studies address the PICO – were they similar to the question posed? | Downgraded because the included studies were restricted to patients with advanced cancer. |
| Describe the number of events, and width of the confidence intervals. | The confidence intervals for the effect on mortality are consistent with both an appreciable benefit and appreciable harm and we lowered the certainty. |
| Describe the possible degree of publication bias. | 1. The funnel plot of 14 randomized trials indicated that there were several small studies that showed a small positive effect, but small studies that showed no effect or harm may have been unpublished. The certainty of the evidence was lowered. 2. There are only three small positive studies, it appears that studies showing no effect or harm have not been published. There also is for-profit interest in the intervention. The certainty of the evidence was lowered. |
| Describe the magnitude of the effect and the widths of the associate confidence intervals. | Upgraded because the RR is large: 0.3 (95% CI 0.2 to 0.4), with a sufficient number of events to be precise. |
| The studies show a clear relation with increases in the outcome of an outcome (e.g. lung cancer) with higher exposure levels. | Upgraded because the dose-response relation shows a relative risk increase of 10% in never smokers, 15% in smokers of 10 pack years and 20% in smokers of 15 pack years. |
| Describe which opposing plausible biases and confounders may have not been considered. | The estimate of effect is not controlled for the following possible confounders: smoking, degree of education, but the distribution of these factors in the studies is likely to lead to an under-estimate of the true effect. The certainty of the evidence was increased. |
Authors: Holger J Schünemann, Julian PT Higgins, Gunn E Vist, Paul Glasziou, Elie A Akl, Nicole Skoetz, Gordon H Guyatt; on behalf of the Cochrane GRADEing Methods Group (formerly Applicability and Recommendations Methods Group) and the Cochrane Statistical Methods Group
Acknowledgements: Andrew D Oxman contributed to earlier versions. Professor Penny Hawe contributed to the text on adverse effects in earlier versions. Jon Deeks provided helpful contributions on an earlier version of this chapter. For details of previous authors and editors of the Handbook , please refer to the Preface.
Funding: This work was in part supported by funding from the Michael G DeGroote Cochrane Canada Centre and the Ontario Ministry of Health.
Alonso-Coello P, Zhou Q, Martinez-Zapata MJ, Mills E, Heels-Ansdell D, Johanson JF, Guyatt G. Meta-analysis of flavonoids for the treatment of haemorrhoids. British Journal of Surgery 2006; 93 : 909-920.
Atkins D, Best D, Briss PA, Eccles M, Falck-Ytter Y, Flottorp S, Guyatt GH, Harbour RT, Haugh MC, Henry D, Hill S, Jaeschke R, Leng G, Liberati A, Magrini N, Mason J, Middleton P, Mrukowicz J, O'Connell D, Oxman AD, Phillips B, Schünemann HJ, Edejer TT, Varonen H, Vist GE, Williams JW, Jr., Zaza S. Grading quality of evidence and strength of recommendations. BMJ 2004; 328 : 1490.
Balshem H, Helfand M, Schünemann HJ, Oxman AD, Kunz R, Brozek J, Vist GE, Falck-Ytter Y, Meerpohl J, Norris S, Guyatt GH. GRADE guidelines: 3. Rating the quality of evidence. Journal of Clinical Epidemiology 2011; 64 : 401-406.
Bhandari M, Busse JW, Jackowski D, Montori VM, Schünemann H, Sprague S, Mears D, Schemitsch EH, Heels-Ansdell D, Devereaux PJ. Association between industry funding and statistically significant pro-industry findings in medical and surgical randomized trials. Canadian Medical Association Journal 2004; 170 : 477-480.
Brophy JM, Joseph L, Rouleau JL. Beta-blockers in congestive heart failure. A Bayesian meta-analysis. Annals of Internal Medicine 2001; 134 : 550-560.
Carrasco-Labra A, Brignardello-Petersen R, Santesso N, Neumann I, Mustafa RA, Mbuagbaw L, Etxeandia Ikobaltzeta I, De Stio C, McCullagh LJ, Alonso-Coello P, Meerpohl JJ, Vandvik PO, Brozek JL, Akl EA, Bossuyt P, Churchill R, Glenton C, Rosenbaum S, Tugwell P, Welch V, Garner P, Guyatt G, Schünemann HJ. Improving GRADE evidence tables part 1: a randomized trial shows improved understanding of content in summary of findings tables with a new format. Journal of Clinical Epidemiology 2016; 74 : 7-18.
Deeks JJ, Altman DG. Effect measures for meta-analysis of trials with binary outcomes. In: Egger M, Davey Smith G, Altman DG, editors. Systematic Reviews in Health Care: Meta-analysis in Context . 2nd ed. London (UK): BMJ Publication Group; 2001. p. 313-335.
Devereaux PJ, Choi PT, Lacchetti C, Weaver B, Schünemann HJ, Haines T, Lavis JN, Grant BJ, Haslam DR, Bhandari M, Sullivan T, Cook DJ, Walter SD, Meade M, Khan H, Bhatnagar N, Guyatt GH. A systematic review and meta-analysis of studies comparing mortality rates of private for-profit and private not-for-profit hospitals. Canadian Medical Association Journal 2002; 166 : 1399-1406.
Engels EA, Schmid CH, Terrin N, Olkin I, Lau J. Heterogeneity and statistical significance in meta-analysis: an empirical study of 125 meta-analyses. Statistics in Medicine 2000; 19 : 1707-1728.
Furukawa TA, Guyatt GH, Griffith LE. Can we individualize the 'number needed to treat'? An empirical study of summary effect measures in meta-analyses. International Journal of Epidemiology 2002; 31 : 72-76.
Gibson JN, Waddell G. Surgical interventions for lumbar disc prolapse: updated Cochrane Review. Spine 2007; 32 : 1735-1747.
Guyatt G, Oxman A, Vist G, Kunz R, Falck-Ytter Y, Alonso-Coello P, Schünemann H. GRADE: an emerging consensus on rating quality of evidence and strength of recommendations. BMJ 2008; 336 : 3.
Guyatt G, Oxman AD, Akl EA, Kunz R, Vist G, Brozek J, Norris S, Falck-Ytter Y, Glasziou P, DeBeer H, Jaeschke R, Rind D, Meerpohl J, Dahm P, Schünemann HJ. GRADE guidelines: 1. Introduction-GRADE evidence profiles and summary of findings tables. Journal of Clinical Epidemiology 2011a; 64 : 383-394.
Guyatt GH, Oxman AD, Kunz R, Brozek J, Alonso-Coello P, Rind D, Devereaux PJ, Montori VM, Freyschuss B, Vist G, Jaeschke R, Williams JW, Jr., Murad MH, Sinclair D, Falck-Ytter Y, Meerpohl J, Whittington C, Thorlund K, Andrews J, Schünemann HJ. GRADE guidelines 6. Rating the quality of evidence--imprecision. Journal of Clinical Epidemiology 2011b; 64 : 1283-1293.
Iorio A, Spencer FA, Falavigna M, Alba C, Lang E, Burnand B, McGinn T, Hayden J, Williams K, Shea B, Wolff R, Kujpers T, Perel P, Vandvik PO, Glasziou P, Schünemann H, Guyatt G. Use of GRADE for assessment of evidence about prognosis: rating confidence in estimates of event rates in broad categories of patients. BMJ 2015; 350 : h870.
Langendam M, Carrasco-Labra A, Santesso N, Mustafa RA, Brignardello-Petersen R, Ventresca M, Heus P, Lasserson T, Moustgaard R, Brozek J, Schünemann HJ. Improving GRADE evidence tables part 2: a systematic survey of explanatory notes shows more guidance is needed. Journal of Clinical Epidemiology 2016; 74 : 19-27.
Levine MN, Raskob G, Landefeld S, Kearon C, Schulman S. Hemorrhagic complications of anticoagulant treatment: the Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy. Chest 2004; 126 : 287S-310S.
Orrapin S, Rerkasem K. Carotid endarterectomy for symptomatic carotid stenosis. Cochrane Database of Systematic Reviews 2017; 6 : CD001081.
Salpeter S, Greyber E, Pasternak G, Salpeter E. Risk of fatal and nonfatal lactic acidosis with metformin use in type 2 diabetes mellitus. Cochrane Database of Systematic Reviews 2007; 4 : CD002967.
Santesso N, Carrasco-Labra A, Langendam M, Brignardello-Petersen R, Mustafa RA, Heus P, Lasserson T, Opiyo N, Kunnamo I, Sinclair D, Garner P, Treweek S, Tovey D, Akl EA, Tugwell P, Brozek JL, Guyatt G, Schünemann HJ. Improving GRADE evidence tables part 3: detailed guidance for explanatory footnotes supports creating and understanding GRADE certainty in the evidence judgments. Journal of Clinical Epidemiology 2016; 74 : 28-39.
Schünemann HJ, Best D, Vist G, Oxman AD, Group GW. Letters, numbers, symbols and words: how to communicate grades of evidence and recommendations. Canadian Medical Association Journal 2003; 169 : 677-680.
Schünemann HJ, Jaeschke R, Cook DJ, Bria WF, El-Solh AA, Ernst A, Fahy BF, Gould MK, Horan KL, Krishnan JA, Manthous CA, Maurer JR, McNicholas WT, Oxman AD, Rubenfeld G, Turino GM, Guyatt G. An official ATS statement: grading the quality of evidence and strength of recommendations in ATS guidelines and recommendations. American Journal of Respiratory and Critical Care Medicine 2006; 174 : 605-614.
Schünemann HJ, Oxman AD, Brozek J, Glasziou P, Jaeschke R, Vist GE, Williams JW, Jr., Kunz R, Craig J, Montori VM, Bossuyt P, Guyatt GH. Grading quality of evidence and strength of recommendations for diagnostic tests and strategies. BMJ 2008a; 336 : 1106-1110.
Schünemann HJ, Oxman AD, Brozek J, Glasziou P, Bossuyt P, Chang S, Muti P, Jaeschke R, Guyatt GH. GRADE: assessing the quality of evidence for diagnostic recommendations. ACP Journal Club 2008b; 149 : 2.
Schünemann HJ, Mustafa R, Brozek J. [Diagnostic accuracy and linked evidence--testing the chain]. Zeitschrift für Evidenz, Fortbildung und Qualität im Gesundheitswesen 2012; 106 : 153-160.
Schünemann HJ, Tugwell P, Reeves BC, Akl EA, Santesso N, Spencer FA, Shea B, Wells G, Helfand M. Non-randomized studies as a source of complementary, sequential or replacement evidence for randomized controlled trials in systematic reviews on the effects of interventions. Research Synthesis Methods 2013; 4 : 49-62.
Schünemann HJ. Interpreting GRADE's levels of certainty or quality of the evidence: GRADE for statisticians, considering review information size or less emphasis on imprecision? Journal of Clinical Epidemiology 2016; 75 : 6-15.
Schünemann HJ, Cuello C, Akl EA, Mustafa RA, Meerpohl JJ, Thayer K, Morgan RL, Gartlehner G, Kunz R, Katikireddi SV, Sterne J, Higgins JPT, Guyatt G, Group GW. GRADE guidelines: 18. How ROBINS-I and other tools to assess risk of bias in nonrandomized studies should be used to rate the certainty of a body of evidence. Journal of Clinical Epidemiology 2018.
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Deciding on the structure of your literature review should come towards the end of the literature review process – after you have collected and digested the literature, but before you start writing the chapter.
In other words, you need to first develop a rich understanding of the literature before you even attempt to map out a structure. There’s no use trying to develop a structure before you’ve fully wrapped your head around the existing research.
Equally importantly, you need to have a structure in place before you start writing , or your literature review will most likely end up a rambling, disjointed mess.
Importantly, don’t feel that once you’ve defined a structure you can’t iterate on it. It’s perfectly natural to adjust as you engage in the writing process. As we’ve discussed before , writing is a way of developing your thinking, so it’s quite common for your thinking to change – and therefore, for your chapter structure to change – as you write.
Like any other chapter in your thesis or dissertation, your literature review needs to have a clear, logical structure. At a minimum, it should have three essential components – an introduction , a body and a conclusion .
Let’s take a closer look at each of these.
Just like any good introduction, the introduction section of your literature review should introduce the purpose and layout (organisation) of the chapter. In other words, your introduction needs to give the reader a taste of what’s to come, and how you’re going to lay that out. Essentially, you should provide the reader with a high-level roadmap of your chapter to give them a taste of the journey that lies ahead.
Here’s an example of the layout visualised in a literature review introduction:
Your introduction should also outline your topic (including any tricky terminology or jargon) and provide an explanation of the scope of your literature review – in other words, what you will and won’t be covering (the delimitations ). This helps ringfence your review and achieve a clear focus . The clearer and narrower your focus, the deeper you can dive into the topic (which is typically where the magic lies).
Depending on the nature of your project, you could also present your stance or point of view at this stage. In other words, after grappling with the literature you’ll have an opinion about what the trends and concerns are in the field as well as what’s lacking. The introduction section can then present these ideas so that it is clear to examiners that you’re aware of how your research connects with existing knowledge .
The body of your literature review is the centre of your work. This is where you’ll present, analyse, evaluate and synthesise the existing research. In other words, this is where you’re going to earn (or lose) the most marks. Therefore, it’s important to carefully think about how you will organise your discussion to present it in a clear way.
The body of your literature review should do just as the description of this chapter suggests. It should “review” the literature – in other words, identify, analyse, and synthesise it. So, when thinking about structuring your literature review, you need to think about which structural approach will provide the best “review” for your specific type of research and objectives (we’ll get to this shortly).
There are (broadly speaking) three options for organising your literature review.
Organising the literature chronologically is one of the simplest ways to structure your literature review. You start with what was published first and work your way through the literature until you reach the work published most recently. Pretty straightforward.
The benefit of this option is that it makes it easy to discuss the developments and debates in the field as they emerged over time. Organising your literature chronologically also allows you to highlight how specific articles or pieces of work might have changed the course of the field – in other words, which research has had the most impact . Therefore, this approach is very useful when your research is aimed at understanding how the topic has unfolded over time and is often used by scholars in the field of history. That said, this approach can be utilised by anyone that wants to explore change over time .
For example , if a student of politics is investigating how the understanding of democracy has evolved over time, they could use the chronological approach to provide a narrative that demonstrates how this understanding has changed through the ages.
Here are some questions you can ask yourself to help you structure your literature review chronologically.
In some ways, chronology plays a part whichever way you decide to structure your literature review, because you will always, to a certain extent, be analysing how the literature has developed. However, with the chronological approach, the emphasis is very firmly on how the discussion has evolved over time , as opposed to how all the literature links together (which we’ll discuss next ).
The thematic approach to structuring a literature review means organising your literature by theme or category – for example, by independent variables (i.e. factors that have an impact on a specific outcome).
As you’ve been collecting and synthesising literature , you’ll likely have started seeing some themes or patterns emerging. You can then use these themes or patterns as a structure for your body discussion. The thematic approach is the most common approach and is useful for structuring literature reviews in most fields.
For example, if you were researching which factors contributed towards people trusting an organisation, you might find themes such as consumers’ perceptions of an organisation’s competence, benevolence and integrity. Structuring your literature review thematically would mean structuring your literature review’s body section to discuss each of these themes, one section at a time.
Here are some questions to ask yourself when structuring your literature review by themes:
PS – you can see an example of a thematically structured literature review in our literature review sample walkthrough video here.
The methodological option is a way of structuring your literature review by the research methodologies used . In other words, organising your discussion based on the angle from which each piece of research was approached – for example, qualitative , quantitative or mixed methodologies.
Structuring your literature review by methodology can be useful if you are drawing research from a variety of disciplines and are critiquing different methodologies. The point of this approach is to question how existing research has been conducted, as opposed to what the conclusions and/or findings the research were.
For example, a sociologist might centre their research around critiquing specific fieldwork practices. Their literature review will then be a summary of the fieldwork methodologies used by different studies.
Here are some questions you can ask yourself when structuring your literature review according to methodology:
Once you’ve completed the body section of your literature review using one of the structural approaches we discussed above, you’ll need to “wrap up” your literature review and pull all the pieces together to set the direction for the rest of your dissertation or thesis.
The conclusion is where you’ll present the key findings of your literature review. In this section, you should emphasise the research that is especially important to your research questions and highlight the gaps that exist in the literature. Based on this, you need to make it clear what you will add to the literature – in other words, justify your own research by showing how it will help fill one or more of the gaps you just identified.
Last but not least, if it’s your intention to develop a conceptual framework for your dissertation or thesis, the conclusion section is a good place to present this.
In the video below, we unpack a literature review chapter so that you can see an example of a thematically structure review in practice.
In this article, we’ve discussed how to structure your literature review for maximum impact. Here’s a quick recap of what you need to keep in mind when deciding on your literature review structure:
If you’re ready to get started, be sure to download our free literature review template to fast-track your chapter outline.
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Great work. This is exactly what I was looking for and helps a lot together with your previous post on literature review. One last thing is missing: a link to a great literature chapter of an journal article (maybe with comments of the different sections in this review chapter). Do you know any great literature review chapters?
I agree with you Marin… A great piece
I agree with Marin. This would be quite helpful if you annotate a nicely structured literature from previously published research articles.
Awesome article for my research.
I thank you immensely for this wonderful guide
It is indeed thought and supportive work for the futurist researcher and students
Very educative and good time to get guide. Thank you
Great work, very insightful. Thank you.
Thanks for this wonderful presentation. My question is that do I put all the variables into a single conceptual framework or each hypothesis will have it own conceptual framework?
Thank you very much, very helpful
This is very educative and precise . Thank you very much for dropping this kind of write up .
Pheeww, so damn helpful, thank you for this informative piece.
I’m doing a research project topic ; stool analysis for parasitic worm (enteric) worm, how do I structure it, thanks.
comprehensive explanation. Help us by pasting the URL of some good “literature review” for better understanding.
great piece. thanks for the awesome explanation. it is really worth sharing. I have a little question, if anyone can help me out, which of the options in the body of literature can be best fit if you are writing an architectural thesis that deals with design?
I am doing a research on nanofluids how can l structure it?
Beautifully clear.nThank you!
Lucid! Thankyou!
Brilliant work, well understood, many thanks
I like how this was so clear with simple language 😊😊 thank you so much 😊 for these information 😊
Insightful. I was struggling to come up with a sensible literature review but this has been really helpful. Thank you!
You have given thought-provoking information about the review of the literature.
Thank you. It has made my own research better and to impart your work to students I teach
I learnt a lot from this teaching. It’s a great piece.
I am doing research on EFL teacher motivation for his/her job. How Can I structure it? Is there any detailed template, additional to this?
You are so cool! I do not think I’ve read through something like this before. So nice to find somebody with some genuine thoughts on this issue. Seriously.. thank you for starting this up. This site is one thing that is required on the internet, someone with a little originality!
I’m asked to do conceptual, theoretical and empirical literature, and i just don’t know how to structure it
Asking questions are actually fastidious thing if you are not understanding anything fully, but this article presents good understanding yet.
thank you SOOO much it is really helpful ..
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A literature review is a document or section of a document that collects key sources on a topic and discusses those sources in conversation with each other (also called synthesis ). The lit review is an important genre in many disciplines, not just literature (i.e., the study of works of literature such as novels and plays). When we say “literature review” or refer to “the literature,” we are talking about the research ( scholarship ) in a given field. You will often see the terms “the research,” “the scholarship,” and “the literature” used mostly interchangeably.
There are a number of different situations where you might write a literature review, each with slightly different expectations; different disciplines, too, have field-specific expectations for what a literature review is and does. For instance, in the humanities, authors might include more overt argumentation and interpretation of source material in their literature reviews, whereas in the sciences, authors are more likely to report study designs and results in their literature reviews; these differences reflect these disciplines’ purposes and conventions in scholarship. You should always look at examples from your own discipline and talk to professors or mentors in your field to be sure you understand your discipline’s conventions, for literature reviews as well as for any other genre.
A literature review can be a part of a research paper or scholarly article, usually falling after the introduction and before the research methods sections. In these cases, the lit review just needs to cover scholarship that is important to the issue you are writing about; sometimes it will also cover key sources that informed your research methodology.
Lit reviews can also be standalone pieces, either as assignments in a class or as publications. In a class, a lit review may be assigned to help students familiarize themselves with a topic and with scholarship in their field, get an idea of the other researchers working on the topic they’re interested in, find gaps in existing research in order to propose new projects, and/or develop a theoretical framework and methodology for later research. As a publication, a lit review usually is meant to help make other scholars’ lives easier by collecting and summarizing, synthesizing, and analyzing existing research on a topic. This can be especially helpful for students or scholars getting into a new research area, or for directing an entire community of scholars toward questions that have not yet been answered.
Most lit reviews use a basic introduction-body-conclusion structure; if your lit review is part of a larger paper, the introduction and conclusion pieces may be just a few sentences while you focus most of your attention on the body. If your lit review is a standalone piece, the introduction and conclusion take up more space and give you a place to discuss your goals, research methods, and conclusions separately from where you discuss the literature itself.
Introduction:
Conclusion:
Lit reviews can take many different organizational patterns depending on what you are trying to accomplish with the review. Here are some examples:
Any lit review is only as good as the research it discusses; make sure your sources are well-chosen and your research is thorough. Don’t be afraid to do more research if you discover a new thread as you’re writing. More info on the research process is available in our "Conducting Research" resources .
As you’re doing your research, create an annotated bibliography ( see our page on the this type of document ). Much of the information used in an annotated bibliography can be used also in a literature review, so you’ll be not only partially drafting your lit review as you research, but also developing your sense of the larger conversation going on among scholars, professionals, and any other stakeholders in your topic.
Usually you will need to synthesize research rather than just summarizing it. This means drawing connections between sources to create a picture of the scholarly conversation on a topic over time. Many student writers struggle to synthesize because they feel they don’t have anything to add to the scholars they are citing; here are some strategies to help you:
The most interesting literature reviews are often written as arguments (again, as mentioned at the beginning of the page, this is discipline-specific and doesn’t work for all situations). Often, the literature review is where you can establish your research as filling a particular gap or as relevant in a particular way. You have some chance to do this in your introduction in an article, but the literature review section gives a more extended opportunity to establish the conversation in the way you would like your readers to see it. You can choose the intellectual lineage you would like to be part of and whose definitions matter most to your thinking (mostly humanities-specific, but this goes for sciences as well). In addressing these points, you argue for your place in the conversation, which tends to make the lit review more compelling than a simple reporting of other sources.
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Here are some examples of a literature review summary table: literature review summary table - with examples .
Researchers use literature review summary tables to organize a number of articles in a small space, based on selected criteria.
If you have the need to summarize and organize a lot of literature in a small space, you may want to ask your faculty whether a literature review summary table would be appropriate.
This resource and other tools can also be found in this library guide: Staying Organized & Keeping Track: Research Tools
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Synthesize: combine separate elements to form a whole.
A synthesis matrix helps you record the main points of each source and document how sources relate to each other.
After summarizing and evaluating your sources, arrange them in a matrix or use a citation manager to help you see how they relate to each other and apply to each of your themes or variables.
By arranging your sources by theme or variable, you can see how your sources relate to each other, and can start thinking about how you weave them together to create a narrative.
Download this free article summary table template.
When dealing with the literature, summarise the articles you read as you go along. This will ensure that you don't read and forget. Using the Article Summary Table template, you can neatly add a summary of each study to a table. This table is handy because you can easily refer to a specific article without searching through piles of pdfs.
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Literature reviews offer a critical synthesis of empirical and theoretical literature to assess the strength of evidence, develop guidelines for practice and policymaking, and identify areas for future research.1 It is often essential and usually the first task in any research endeavour, particularly in masters or doctoral level education. For effective data extraction and rigorous synthesis ...
Literature Review Matrix. As you read and evaluate your literature there are several different ways to organize your research. Courtesy of Dr. Gary Burkholder in the School of Psychology, these sample matrices are one option to help organize your articles. These documents allow you to compile details about your sources, such as the foundational ...
in the summary tables (see figure 1) demonstrates to. the readers that a robust method of data extraction and. synthesis has been followed. Tip 5: create your person alised template for lit ...
Examples of literature reviews. Step 1 - Search for relevant literature. Step 2 - Evaluate and select sources. Step 3 - Identify themes, debates, and gaps. Step 4 - Outline your literature review's structure. Step 5 - Write your literature review.
For example, for a review about the effectiveness of healthcare interven-tions, a literature summary table must include infor-mation about the intervention, its type, content timing, duration, setting, effectiveness, negative consequences, and receivers and implementers' experiences of its usage. Similarly, literature summary tables for articles
Literature Review Table. Literature Review Table Template. Peabody Librarians have created a sample literature review table to use to organize your research. Feel free to download this file and use or adapt as needed. << Previous: Literature Reviews Webinar Recording; Next: Writing Like an Academic >>
This video shows you exactly how to create a summary table for your research articles. It outlines what information should go in the table and provides helpf...
An example of a literature review is shown in Figure 7.1. ... This tool will allow you to create a concise summary of each research paper; see Table 7.1 for an example of an analysis grid. When filling in the grid, the aim is to draw out key aspects of each research paper.
When writing a literature review it is important to start with a brief introduction, followed by the text broken up into subsections and conclude with a summary to bring everything together. A summary table including title, author, publication date and key findings is a useful feature to present in your review (see Table 1 for an example). This ...
Structure. The three elements of a literature review are introduction, body, and conclusion. Introduction. Define the topic of the literature review, including any terminology. Introduce the central theme and organization of the literature review. Summarize the state of research on the topic. Frame the literature review with your research question.
The literature review is not just a summary of the already published works. Your synthesis should show how various articles are linked. Synthesis Matrix or Summary [Table Examples] Some students prefer to place the names of the authors across the top of the chart. Use what works best for you and your instructor or advisor.
Annotated Bibliographies. Annotated bibliographies can help you clearly see and understand the research before diving into organizing and writing your literature review. Although typically part of the "summarize" step of the literature review, annotations should not merely be summaries of each article - instead, they should be critical ...
This is an example of a research table, in which you provide a basic description of the most important features of the studies, articles, and other items you discover in your research.The table identifies each item according to its author/date of publication, its purpose or thesis, what type of work it is (systematic review, clinical trial, etc.), the level of evidence it represents (which ...
A literature review is not an annotated bibliography, organized by title, author, or date of publication. Rather, it is grouped by topic to create a whole view of the literature relevant to your research question. Figure 7.1. Your synthesis must demonstrate a critical analysis of the papers you collected as well as your ability to integrate the ...
Literature Review Example A literature review is a summary of the existing knowledge and research on a particular subject. By identifying gaps in the literature, it provides a foundation for future research. ... The example below is from a review paper, which includes a table comparing the different sources evaluated. Such tables can be useful ...
at each of these in turn.IntroductionThe first part of any literature review is a way of inviting your read. into the topic and orientating them. A good introduction tells the reader what the review is about - its s. pe—and what you are going to cover. It may also specifically tell you.
Some reviews may include more than one 'Summary of findings' table, for example if the review addresses more than one major comparison, or includes substantially different populations that require separate tables (e.g. because the effects differ or it is important to show results separately). ... Figure 14.1.a Example of a 'Summary of ...
See section 2.1 for further sou rces of information on GRADE and SoF tables, and section 2.2 for examples of CCCG reviews that include SoF tables. Creating a SoF: an overview A SoF table presents a summary of the main results of a review, together with an assessment of the quality of the evidence, in a highly standardised format.
Demonstrate your knowledge of the research topic. Identify the gaps in the literature and show how your research links to these. Provide the foundation for your conceptual framework (if you have one) Inform your own methodology and research design. To achieve this, your literature review needs a well-thought-out structure.
Writing a Literature Review. A literature review is a document or section of a document that collects key sources on a topic and discusses those sources in conversation with each other (also called synthesis). The lit review is an important genre in many disciplines, not just literature (i.e., the study of works of literature such as novels and ...
Here are some examples of a Literature Review Summary Table: Literature Review Summary Table - with examples . Researchers use literature review summary tables to organize a number of articles in a small space, based on selected criteria. If you have the need to summarize and organize a lot of literature in a small space, you may want to ask ...
Synthesis Matrix. A synthesis matrix helps you record the main points of each source and document how sources relate to each other. After summarizing and evaluating your sources, arrange them in a matrix or use a citation manager to help you see how they relate to each other and apply to each of your themes or variables. By arranging your ...
Download this FREE Article Summary Table template. When dealing with the literature, summarise the articles you read as you go along. This will ensure that you don't read and forget. Using the Article Summary Table template, you can neatly add a summary of each study to a table. This table is handy because you can easily refer to a specific ...