what is the benefit of literature review

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• Literature Review: The What, Why and How-to Guide
• Introduction

Literature Review: The What, Why and How-to Guide — Introduction

• Getting Started
• How to Pick a Topic
• Strategies to Find Sources
• Evaluating Sources & Lit. Reviews
• Tips for Writing Literature Reviews
• Writing Literature Review: Useful Sites
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What are Literature Reviews?

So, what is a literature review? "A literature review is an account of what has been published on a topic by accredited scholars and researchers. In writing the literature review, your purpose is to convey to your reader what knowledge and ideas have been established on a topic, and what their strengths and weaknesses are. As a piece of writing, the literature review must be defined by a guiding concept (e.g., your research objective, the problem or issue you are discussing, or your argumentative thesis). It is not just a descriptive list of the material available, or a set of summaries." Taylor, D.  The literature review: A few tips on conducting it . University of Toronto Health Sciences Writing Centre.

Goals of Literature Reviews

What are the goals of creating a Literature Review?  A literature could be written to accomplish different aims:

• To develop a theory or evaluate an existing theory
• To summarize the historical or existing state of a research topic
• Identify a problem in a field of research 

Baumeister, R. F., & Leary, M. R. (1997). Writing narrative literature reviews .  Review of General Psychology , 1 (3), 311-320.

What kinds of sources require a Literature Review?

• A research paper assigned in a course
• A thesis or dissertation
• A grant proposal
• An article intended for publication in a journal

All these instances require you to collect what has been written about your research topic so that you can demonstrate how your own research sheds new light on the topic.

Types of Literature Reviews

What kinds of literature reviews are written?

Narrative review: The purpose of this type of review is to describe the current state of the research on a specific topic/research and to offer a critical analysis of the literature reviewed. Studies are grouped by research/theoretical categories, and themes and trends, strengths and weakness, and gaps are identified. The review ends with a conclusion section which summarizes the findings regarding the state of the research of the specific study, the gaps identify and if applicable, explains how the author's research will address gaps identify in the review and expand the knowledge on the topic reviewed.

• Example : Predictors and Outcomes of U.S. Quality Maternity Leave: A Review and Conceptual Framework:  10.1177/08948453211037398  

Systematic review : "The authors of a systematic review use a specific procedure to search the research literature, select the studies to include in their review, and critically evaluate the studies they find." (p. 139). Nelson, L. K. (2013). Research in Communication Sciences and Disorders . Plural Publishing.

• Example : The effect of leave policies on increasing fertility: a systematic review:  10.1057/s41599-022-01270-w

Meta-analysis : "Meta-analysis is a method of reviewing research findings in a quantitative fashion by transforming the data from individual studies into what is called an effect size and then pooling and analyzing this information. The basic goal in meta-analysis is to explain why different outcomes have occurred in different studies." (p. 197). Roberts, M. C., & Ilardi, S. S. (2003). Handbook of Research Methods in Clinical Psychology . Blackwell Publishing.

• Example : Employment Instability and Fertility in Europe: A Meta-Analysis:  10.1215/00703370-9164737

Meta-synthesis : "Qualitative meta-synthesis is a type of qualitative study that uses as data the findings from other qualitative studies linked by the same or related topic." (p.312). Zimmer, L. (2006). Qualitative meta-synthesis: A question of dialoguing with texts .  Journal of Advanced Nursing , 53 (3), 311-318.

• Example : Women’s perspectives on career successes and barriers: A qualitative meta-synthesis:  10.1177/05390184221113735

Literature Reviews in the Health Sciences

• UConn Health subject guide on systematic reviews Explanation of the different review types used in health sciences literature as well as tools to help you find the right review type
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What is the Purpose of a Literature Review?

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• 23rd October 2023

If you’re writing a research paper or dissertation , then you’ll most likely need to include a comprehensive literature review . In this post, we’ll review the purpose of literature reviews, why they are so significant, and the specific elements to include in one. Literature reviews can:

1. Provide a foundation for current research.

2. Define key concepts and theories.

3. Demonstrate critical evaluation.

4. Show how research and methodologies have evolved.

5. Identify gaps in existing research.

6. Support your argument.

Keep reading to enter the exciting world of literature reviews!

What is a Literature Review?

A literature review is a critical summary and evaluation of the existing research (e.g., academic journal articles and books) on a specific topic. It is typically included as a separate section or chapter of a research paper or dissertation, serving as a contextual framework for a study. Literature reviews can vary in length depending on the subject and nature of the study, with most being about equal length to other sections or chapters included in the paper. Essentially, the literature review highlights previous studies in the context of your research and summarizes your insights in a structured, organized format. Next, let’s look at the overall purpose of a literature review.

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Literature reviews are considered an integral part of research across most academic subjects and fields. The primary purpose of a literature review in your study is to:

Provide a Foundation for Current Research

Since the literature review provides a comprehensive evaluation of the existing research, it serves as a solid foundation for your current study. It’s a way to contextualize your work and show how your research fits into the broader landscape of your specific area of study.  

Define Key Concepts and Theories

The literature review highlights the central theories and concepts that have arisen from previous research on your chosen topic. It gives your readers a more thorough understanding of the background of your study and why your research is particularly significant .

Demonstrate Critical Evaluation 

A comprehensive literature review shows your ability to critically analyze and evaluate a broad range of source material. And since you’re considering and acknowledging the contribution of key scholars alongside your own, it establishes your own credibility and knowledge.

Show How Research and Methodologies Have Evolved

Another purpose of literature reviews is to provide a historical perspective and demonstrate how research and methodologies have changed over time, especially as data collection methods and technology have advanced. And studying past methodologies allows you, as the researcher, to understand what did and did not work and apply that knowledge to your own research.  

Identify Gaps in Existing Research

Besides discussing current research and methodologies, the literature review should also address areas that are lacking in the existing literature. This helps further demonstrate the relevance of your own research by explaining why your study is necessary to fill the gaps.

Support Your Argument

A good literature review should provide evidence that supports your research questions and hypothesis. For example, your study may show that your research supports existing theories or builds on them in some way. Referencing previous related studies shows your work is grounded in established research and will ultimately be a contribution to the field.  

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Ensure your literature review is polished and ready for submission by having it professionally proofread and edited by our expert team. Our literature review editing services will help your research stand out and make an impact. Not convinced yet? Send in your free sample today and see for yourself! 

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Literature Review: The What, Why and How-to Guide: Literature Reviews?

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What is a Literature Review?

So, what is a literature review .

"A literature review is an account of what has been published on a topic by accredited scholars and researchers. In writing the literature review, your purpose is to convey to your reader what knowledge and ideas have been established on a topic, and what their strengths and weaknesses are. As a piece of writing, the literature review must be defined by a guiding concept (e.g., your research objective, the problem or issue you are discussing, or your argumentative thesis). It is not just a descriptive list of the material available or a set of summaries." - Quote from Taylor, D. (n.d)."The Literature Review: A Few Tips on Conducting it".

• Citation: "The Literature Review: A Few Tips on Conducting it"

What kinds of literature reviews are written?

Each field has a particular way to do reviews for academic research literature. In the social sciences and humanities the most common are:

• Narrative Reviews: The purpose of this type of review is to describe the current state of the research on a specific research topic and to offer a critical analysis of the literature reviewed. Studies are grouped by research/theoretical categories, and themes and trends, strengths and weaknesses, and gaps are identified. The review ends with a conclusion section that summarizes the findings regarding the state of the research of the specific study, the gaps identify and if applicable, explains how the author's research will address gaps identify in the review and expand the knowledge on the topic reviewed.
• Book review essays/ Historiographical review essays : A type of literature review typical in History and related fields, e.g., Latin American studies. For example, the Latin American Research Review explains that the purpose of this type of review is to “(1) to familiarize readers with the subject, approach, arguments, and conclusions found in a group of books whose common focus is a historical period; a country or region within Latin America; or a practice, development, or issue of interest to specialists and others; (2) to locate these books within current scholarship, critical methodologies, and approaches; and (3) to probe the relation of these new books to previous work on the subject, especially canonical texts. Unlike individual book reviews, the cluster reviews found in LARR seek to address the state of the field or discipline and not solely the works at issue.” - LARR

What are the Goals of Creating a Literature Review?

• To develop a theory or evaluate an existing theory
• To summarize the historical or existing state of a research topic
• Identify a problem in a field of research 
• Baumeister, R.F. & Leary, M.R. (1997). "Writing narrative literature reviews," Review of General Psychology , 1(3), 311-320.

When do you need to write a Literature Review?

• When writing a prospectus or a thesis/dissertation
• When writing a research paper
• When writing a grant proposal

In all these cases you need to dedicate a chapter in these works to showcase what has been written about your research topic and to point out how your own research will shed new light into a body of scholarship.

Where I can find examples of Literature Reviews?

Note:  In the humanities, even if they don't use the term "literature review", they may have a dedicated  chapter that reviewed the "critical bibliography" or they incorporated that review in the introduction or first chapter of the dissertation, book, or article.

• UCSB electronic theses and dissertations In partnership with the Graduate Division, the UC Santa Barbara Library is making available theses and dissertations produced by UCSB students. Currently included in ADRL are theses and dissertations that were originally filed electronically, starting in 2011. In future phases of ADRL, all theses and dissertations created by UCSB students may be digitized and made available.

Where to Find Standalone Literature Reviews

Literature reviews are also written as standalone articles as a way to survey a particular research topic in-depth. This type of literature review looks at a topic from a historical perspective to see how the understanding of the topic has changed over time. 

• Find e-Journals for Standalone Literature Reviews The best way to get familiar with and to learn how to write literature reviews is by reading them. You can use our Journal Search option to find journals that specialize in publishing literature reviews from major disciplines like anthropology, sociology, etc. Usually these titles are called, "Annual Review of [discipline name] OR [Discipline name] Review. This option works best if you know the title of the publication you are looking for. Below are some examples of these journals! more... less... Journal Search can be found by hovering over the link for Research on the library website.

Social Sciences

• Annual Review of Anthropology
• Annual Review of Political Science
• Annual Review of Sociology
• Ethnic Studies Review

Hard science and health sciences:

• Annual Review of Biomedical Data Science
• Annual Review of Materials Science
• Systematic Review From journal site: "The journal Systematic Reviews encompasses all aspects of the design, conduct, and reporting of systematic reviews" in the health sciences.
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• What is a Literature Review? | Guide, Template, & Examples

What is a Literature Review? | Guide, Template, & Examples

Published on 22 February 2022 by Shona McCombes . Revised on 7 June 2022.

What is a literature review? A literature review is a survey of scholarly sources on a specific topic. It provides an overview of current knowledge, allowing you to identify relevant theories, methods, and gaps in the existing research.

There are five key steps to writing a literature review:

• Search for relevant literature
• Evaluate sources
• Identify themes, debates and gaps
• Outline the structure
• Write your literature review

A good literature review doesn’t just summarise sources – it analyses, synthesises, and critically evaluates to give a clear picture of the state of knowledge on the subject.

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Table of contents

Why write a literature review, 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, frequently asked questions about literature reviews, introduction.

• Quick Run-through
• Step 1 & 2

When you write a dissertation or thesis, you will have to conduct a literature review to situate your research within existing knowledge. The literature review gives you a chance to:

• Demonstrate your familiarity with the topic and scholarly context
• Develop a theoretical framework and methodology for your research
• Position yourself in relation to other researchers and theorists
• Show how your dissertation addresses a gap or contributes to a debate

You might also have to write a literature review as a stand-alone assignment. In this case, the purpose is to evaluate the current state of research and demonstrate your knowledge of scholarly debates around a topic.

The content will look slightly different in each case, but the process of conducting a literature review follows the same steps. We’ve written a step-by-step guide that you can follow below.

Prevent plagiarism, run a free check.

Writing literature reviews can be quite challenging! A good starting point could be to look at some examples, depending on what kind of literature review you’d like to write.

• Example literature review #1: “Why Do People Migrate? A Review of the Theoretical Literature” ( Theoretical literature review about the development of economic migration theory from the 1950s to today.)
• Example literature review #2: “Literature review as a research methodology: An overview and guidelines” ( Methodological literature review about interdisciplinary knowledge acquisition and production.)
• Example literature review #3: “The Use of Technology in English Language Learning: A Literature Review” ( Thematic literature review about the effects of technology on language acquisition.)
• Example literature review #4: “Learners’ Listening Comprehension Difficulties in English Language Learning: A Literature Review” ( Chronological literature review about how the concept of listening skills has changed over time.)

You can also check out our templates with literature review examples and sample outlines at the links below.

Download Word doc Download Google doc

Before you begin searching for literature, you need a clearly defined topic .

If you are writing the literature review section of a dissertation or research paper, you will search for literature related to your research objectives and questions .

If you are writing a literature review as a stand-alone assignment, you will have to choose a focus and develop a central question to direct your search. Unlike a dissertation research question, this question has to be answerable without collecting original data. You should be able to answer it based only on a review of existing publications.

Make a list of keywords

Start by creating a list of keywords related to your research topic. Include each of the key concepts or variables you’re interested in, and list any synonyms and related terms. You can add to this list if you discover new keywords in the process of your literature search.

• Social media, Facebook, Instagram, Twitter, Snapchat, TikTok
• Body image, self-perception, self-esteem, mental health
• Generation Z, teenagers, adolescents, youth

Search for relevant sources

Use your keywords to begin searching for sources. Some databases to search for journals and articles include:

• Your university’s library catalogue
• Google Scholar
• Project Muse (humanities and social sciences)
• Medline (life sciences and biomedicine)
• EconLit (economics)
• Inspec (physics, engineering and computer science)

You can use boolean operators to help narrow down your search:

Read the abstract to find out whether an article is relevant to your question. When you find a useful book or article, you can check the bibliography to find other relevant sources.

To identify the most important publications on your topic, take note of recurring citations. If the same authors, books or articles keep appearing in your reading, make sure to seek them out.

You probably won’t be able to read absolutely everything that has been written on the topic – you’ll have to evaluate which sources are most relevant to your questions.

For each publication, ask yourself:

• What question or problem is the author addressing?
• What are the key concepts and how are they defined?
• What are the key theories, models and methods? Does the research use established frameworks or take an innovative approach?
• What are the results and conclusions of the study?
• How does the publication relate to other literature in the field? Does it confirm, add to, or challenge established knowledge?
• How does the publication contribute to your understanding of the topic? What are its key insights and arguments?
• What are the strengths and weaknesses of the research?

Make sure the sources you use are credible, and make sure you read any landmark studies and major theories in your field of research.

You can find out how many times an article has been cited on Google Scholar – a high citation count means the article has been influential in the field, and should certainly be included in your literature review.

The scope of your review will depend on your topic and discipline: in the sciences you usually only review recent literature, but in the humanities you might take a long historical perspective (for example, to trace how a concept has changed in meaning over time).

Remember that you can use our template to summarise and evaluate sources you’re thinking about using!

Take notes and cite your sources

As you read, you should also begin the writing process. Take notes that you can later incorporate into the text of your literature review.

It’s important to keep track of your sources with references to avoid plagiarism . It can be helpful to make an annotated bibliography, where you compile full reference information and write a paragraph of summary and analysis for each source. This helps you remember what you read and saves time later in the process.

You can use our free APA Reference Generator for quick, correct, consistent citations.

To begin organising your literature review’s argument and structure, you need to understand the connections and relationships between the sources you’ve read. Based on your reading and notes, you can look for:

• Trends and patterns (in theory, method or results): do certain approaches become more or less popular over time?
• Themes: what questions or concepts recur across the literature?
• Debates, conflicts and contradictions: where do sources disagree?
• Pivotal publications: are there any influential theories or studies that changed the direction of the field?
• Gaps: what is missing from the literature? Are there weaknesses that need to be addressed?

This step will help you work out the structure of your literature review and (if applicable) show how your own research will contribute to existing knowledge.

• Most research has focused on young women.
• There is an increasing interest in the visual aspects of social media.
• But there is still a lack of robust research on highly-visual platforms like Instagram and Snapchat – this is a gap that you could address in your own research.

There are various approaches to organising the body of a literature review. You should have a rough idea of your strategy before you start writing.

Depending on the length of your literature review, you can combine several of these strategies (for example, your overall structure might be thematic, but each theme is discussed chronologically).

Chronological

The simplest approach is to trace the development of the topic over time. However, if you choose this strategy, be careful to avoid simply listing and summarising sources in order.

Try to analyse patterns, turning points and key debates that have shaped the direction of the field. Give your interpretation of how and why certain developments occurred.

If you have found some recurring central themes, you can organise your literature review into subsections that address different aspects of the topic.

For example, if you are reviewing literature about inequalities in migrant health outcomes, key themes might include healthcare policy, language barriers, cultural attitudes, legal status, and economic access.

Methodological

If you draw your sources from different disciplines or fields that use a variety of research methods , you might want to compare the results and conclusions that emerge from different approaches. For example:

• Look at what results have emerged in qualitative versus quantitative research
• Discuss how the topic has been approached by empirical versus theoretical scholarship
• Divide the literature into sociological, historical, and cultural sources

Theoretical

A literature review is often the foundation for a theoretical framework . You can use it to discuss various theories, models, and definitions of key concepts.

You might argue for the relevance of a specific theoretical approach, or combine various theoretical concepts to create a framework for your research.

Like any other academic text, your literature review should have an introduction , a main body, and a conclusion . What you include in each depends on the objective of your literature review.

The introduction should clearly establish the focus and purpose of the literature review.

If you are writing the literature review as part of your dissertation or thesis, reiterate your central problem or research question and give a brief summary of the scholarly context. You can emphasise the timeliness of the topic (“many recent studies have focused on the problem of x”) or highlight a gap in the literature (“while there has been much research on x, few researchers have taken y into consideration”).

Depending on the length of your literature review, you might want to divide the body into subsections. You can use a subheading for each theme, time period, or methodological approach.

As you write, make sure to follow these tips:

• Summarise and synthesise: give an overview of the main points of each source and combine them into a coherent whole.
• Analyse and interpret: don’t just paraphrase other researchers – add your own interpretations, discussing the significance of findings in relation to the literature as a whole.
• Critically evaluate: mention the strengths and weaknesses of your sources.
• Write in well-structured paragraphs: use transitions and topic sentences to draw connections, comparisons and contrasts.

In the conclusion, you should summarise the key findings you have taken from the literature and emphasise their significance.

If the literature review is part of your dissertation or thesis, reiterate how your research addresses gaps and contributes new knowledge, or discuss how you have drawn on existing theories and methods to build a framework for your research. This can lead directly into your methodology section.

A literature review is a survey of scholarly sources (such as books, journal articles, and theses) related to a specific topic or research question .

It is often written as part of a dissertation , thesis, research paper , or proposal .

There are several reasons to conduct a literature review at the beginning of a research project:

• To familiarise yourself with the current state of knowledge on your topic
• To ensure that you’re not just repeating what others have already done
• To identify gaps in knowledge and unresolved problems that your research can address
• To develop your theoretical framework and methodology
• To provide an overview of the key findings and debates on the topic

Writing the literature review shows your reader how your work relates to existing research and what new insights it will contribute.

The literature review usually comes near the beginning of your  dissertation . After the introduction , it grounds your research in a scholarly field and leads directly to your theoretical framework or methodology .

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Conducting a Literature Review

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The literature review is an integral part of any research project and is undertaken as a means of surveying what research has been conducted previously on a particular topic.

There are many reasons for conducting a literature review, but one of the primary reasons is to establish a base line of what is already known on a topic before exploring the topic any further. The review typically involves a search of any previously published or presented materials that might have relevance to a prospective new study.

If the point of a research project is solely to review what has already been written on a topic, the resulting article is termed a "survey of the literature" or a "literature survey" or even a "literature review." In this case, the article is complete in itself and does not delve into anything new regarding the topic. A literature survey might end with a discussion of what work is still needed to further develop knowledge of a particular topic, but it does not, itself, flesh out any of those ideas. Articles of this type can be highly beneficial to someone seeking to launch an original study; literature surveys have already laid some of the groundwork for a prospective researcher's own literature review.

When the survey serves as the initial step that precedes a further investigation of an idea or ideas about a topic, then that review of the literature sets the stage for the presentation of original research. Original research usually involves the selection of a methodology for examining a topic and may include the gathering of data that can be further analyzed to arrive at assumptions about the topic. Data may be derived from the examination of human subjects, from conducting surveys or assessments, from the study of particular species of plants or animals, from the systematic scientific measurement of any physical phenomena, from nearly anything that can be documented and analyzed. Again, the whole point of launching an original study is to learn something new about a topic. Research typically begins with what is known (the literature review) and progresses into analyzing, through the observation and analysis of data, what is yet to be known through further study.

Both the literature survey and the original study are considered academic articles, as opposed to popular articles. Both involve research in order to come to a better understanding of a topic.

• Literature Review Tutorial by American University Library
• The Literature Review: A Few Tips On Conducting It by University of Toronto
• Write a Literature Review by UC Santa Cruz University Library
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• What is a literature review?
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What is a Literature Review?

A literature or narrative review is a comprehensive review and analysis of the published literature on a specific topic or research question. The literature that is reviewed contains: books, articles, academic articles, conference proceedings, association papers, and dissertations. It contains the most pertinent studies and points to important past and current research and practices. It provides background and context, and shows how your research will contribute to the field. 

A literature review should: 

• Provide a comprehensive and updated review of the literature;
• Explain why this review has taken place;
• Articulate a position or hypothesis;
• Acknowledge and account for conflicting and corroborating points of view

From  S age Research Methods

Purpose of a Literature Review

A literature review can be written as an introduction to a study to:

• Demonstrate how a study fills a gap in research
• Compare a study with other research that's been done

Or it can be a separate work (a research article on its own) which:

• Organizes or describes a topic
• Describes variables within a particular issue/problem

Limitations of a Literature Review

Some of the limitations of a literature review are:

• It's a snapshot in time. Unlike other reviews, this one has beginning, a middle and an end. There may be future developments that could make your work less relevant.
• It may be too focused. Some niche studies may miss the bigger picture.
• It can be difficult to be comprehensive. There is no way to make sure all the literature on a topic was considered.
• It is easy to be biased if you stick to top tier journals. There may be other places where people are publishing exemplary research. Look to open access publications and conferences to reflect a more inclusive collection. Also, make sure to include opposing views (and not just supporting evidence).

Source: Grant, Maria J., and Andrew Booth. “A Typology of Reviews: An Analysis of 14 Review Types and Associated Methodologies.” Health Information & Libraries Journal, vol. 26, no. 2, June 2009, pp. 91–108. Wiley Online Library, doi:10.1111/j.1471-1842.2009.00848.x.

Meryl Brodsky : Communication and Information Studies

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For help in other subject areas, please see the guide to library specialists by subject .

Periodically, UT Libraries runs a workshop covering the basics and library support for literature reviews. While we try to offer these once per academic year, we find providing the recording to be helpful to community members who have missed the session. Following is the most recent recording of the workshop, Conducting a Literature Review. To view the recording, a UT login is required.

• October 26, 2022 recording
• Last Updated: Oct 26, 2022 2:49 PM
• URL: https://guides.lib.utexas.edu/literaturereviews

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Literature Review

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The purpose of a literature review is to collect relevant, timely research on your chosen topic, and synthesize it into a cohesive summary of existing knowledge in the field. This then prepares you for making your own argument on that topic, or for conducting your own original research.

Depending on your field of study, literature reviews can take different forms. Some disciplines require that you synthesize your sources topically, organizing your paragraphs according to how your different sources discuss similar topics. Other disciplines require that you discuss each source in individual paragraphs, covering various aspects in that single article, chapter, or book.

Within your review of a given source, you can cover many different aspects, including (if a research study) the purpose, scope, methods, results, any discussion points, limitations, and implications for future research. Make sure you know which model your professor expects you to follow when writing your own literature reviews.

Tip : Literature reviews may or may not be a graded component of your class or major assignment, but even if it is not, it is a good idea to draft one so that you know the current conversations taking place on your chosen topic. It can better prepare you to write your own, unique argument.

Benefits of Literature Reviews

• Literature reviews allow you to gain familiarity with the current knowledge in your chosen field, as well as the boundaries and limitations of that field.
• Literature reviews also help you to gain an understanding of the theory(ies) driving the field, allowing you to place your research question into context.
• Literature reviews provide an opportunity for you to see and even evaluate successful and unsuccessful assessment and research methods in your field.
• Literature reviews prevent you from duplicating the same information as others writing in your field, allowing you to find your own, unique approach to your topic.
• Literature reviews give you familiarity with the knowledge in your field, giving you the chance to analyze the significance of your additional research.

Choosing Your Sources

When selecting your sources to compile your literature review, make sure you follow these guidelines to ensure you are working with the strongest, most appropriate sources possible.

Topically Relevant

Find sources within the scope of your topic

Appropriately Aged

Find sources that are not too old for your assignment

Find sources whose authors have authority on your topic

Appropriately “Published”

Find sources that meet your instructor’s guidelines (academic, professional, print, etc.)

Tip:  Treat your professors and librarians as experts you can turn to for advice on how to locate sources. They are a valuable asset to you, so take advantage of them!

Organizing Your Literature Review

Synthesizing topically.

Some assignments require discussing your sources together, in paragraphs organized according to shared topics between them.

For example, in a literature review covering current conversations on Alison Bechdel’s  Fun Home , authors may discuss various topics including:

• her graphic style
• her allusions to various literary texts
• her story’s implications regarding LGBT experiences in 20 th  century America.

In this case, you would cluster your sources on these three topics. One paragraph would cover how the sources you collected dealt with Bechdel’s graphic style. Another, her allusions. A third, her implications.

Each of these paragraphs would discuss how the sources you found treated these topics in connection to one another. Basically, you compare and contrast how your sources discuss similar issues and points.

To determine these shared topics, examine aspects including:

• Definition of terms
• Common ground
• Issues that divide
• Rhetorical context

Summarizing Individually

Depending on the assignment, your professor may prefer that you discuss each source in your literature review individually (in their own, separate paragraphs or sections). Your professor may give you specific guidelines as far as what to cover in these paragraphs/sections.

If, for instance, your sources are all primary research studies, here are some aspects to consider covering:

• Participants
• Limitations
• Implications
• Significance

Each section of your literature review, in this case, will identify all of these elements for each individual article.

You may or may not need to separate your information into multiple paragraphs for each source. If you do, using proper headings in the appropriate citation style (APA, MLA, etc.) will help keep you organized.

If you are writing a literature review as part of a larger assignment, you generally do not need an introduction and/or conclusion, because it is embedded within the context of your larger paper.

If, however, your literature review is a standalone assignment, it is a good idea to include some sort of introduction and conclusion to provide your reader with context regarding your topic, purpose, and any relevant implications or further questions. Make sure you know what your professor is expecting for your literature review’s content.

Typically, a literature review concludes with a full bibliography of your included sources. Make sure you use the style guide required by your professor for this assignment.

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What is a literature review?

A literature review is an integrated analysis -- not just a summary-- of scholarly writings and other relevant evidence related directly to your research question.  That is, it represents a synthesis of the evidence that provides background information on your topic and shows a association between the evidence and your research question.

A literature review may be a stand alone work or the introduction to a larger research paper, depending on the assignment.  Rely heavily on the guidelines your instructor has given you.

Why is it important?

A literature review is important because it:

• Explains the background of research on a topic.
• Demonstrates why a topic is significant to a subject area.
• Discovers relationships between research studies/ideas.
• Identifies major themes, concepts, and researchers on a topic.
• Identifies critical gaps and points of disagreement.
• Discusses further research questions that logically come out of the previous studies.

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1. Choose a topic. Define your research question.

Your literature review should be guided by your central research question.  The literature represents background and research developments related to a specific research question, interpreted and analyzed by you in a synthesized way.

• Make sure your research question is not too broad or too narrow.  Is it manageable?
• Begin writing down terms that are related to your question. These will be useful for searches later.
• If you have the opportunity, discuss your topic with your professor and your class mates.

2. Decide on the scope of your review

How many studies do you need to look at? How comprehensive should it be? How many years should it cover? 

• This may depend on your assignment.  How many sources does the assignment require?

3. Select the databases you will use to conduct your searches.

Make a list of the databases you will search. 

Where to find databases:

• use the tabs on this guide
• Find other databases in the Nursing Information Resources web page
• More on the Medical Library web page
• ... and more on the Yale University Library web page

4. Conduct your searches to find the evidence. Keep track of your searches.

• Use the key words in your question, as well as synonyms for those words, as terms in your search. Use the database tutorials for help.
• Save the searches in the databases. This saves time when you want to redo, or modify, the searches. It is also helpful to use as a guide is the searches are not finding any useful results.
• Review the abstracts of research studies carefully. This will save you time.
• Use the bibliographies and references of research studies you find to locate others.
• Check with your professor, or a subject expert in the field, if you are missing any key works in the field.
• Ask your librarian for help at any time.
• Use a citation manager, such as EndNote as the repository for your citations. See the EndNote tutorials for help.

Review the literature

Some questions to help you analyze the research:

• What was the research question of the study you are reviewing? What were the authors trying to discover?
• Was the research funded by a source that could influence the findings?
• What were the research methodologies? Analyze its literature review, the samples and variables used, the results, and the conclusions.
• Does the research seem to be complete? Could it have been conducted more soundly? What further questions does it raise?
• If there are conflicting studies, why do you think that is?
• How are the authors viewed in the field? Has this study been cited? If so, how has it been analyzed?

Tips: 

• Review the abstracts carefully.  
• Keep careful notes so that you may track your thought processes during the research process.
• Create a matrix of the studies for easy analysis, and synthesis, across all of the studies.
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A Guide to Literature Reviews

Importance of a good literature review.

• Conducting the Literature Review
• Structure and Writing Style
• Types of Literature Reviews
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• Acknowledgements

A literature review is not only a summary of key sources, but  has an organizational pattern which combines both summary and synthesis, often within specific conceptual categories . A summary is a recap of the important information of the source, but a synthesis is a re-organization, or a reshuffling, of that information in a way that informs how you are planning to investigate a research problem. The analytical features of a literature review might:

• Give a new interpretation of old material or combine new with old interpretations,
• Trace the intellectual progression of the field, including major debates,
• Depending on the situation, evaluate the sources and advise the reader on the most pertinent or relevant research, or
• Usually in the conclusion of a literature review, identify where gaps exist in how a problem has been researched to date.

The purpose of a literature review is to:

• Place each work in the context of its contribution to understanding the research problem being studied.
• Describe the relationship of each work to the others under consideration.
• Identify new ways to interpret prior research.
• Reveal any gaps that exist in the literature.
• Resolve conflicts amongst seemingly contradictory previous studies.
• Identify areas of prior scholarship to prevent duplication of effort.
• Point the way in fulfilling a need for additional research.
• Locate your own research within the context of existing literature [very important].
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Lau F, Kuziemsky C, editors. Handbook of eHealth Evaluation: An Evidence-based Approach [Internet]. Victoria (BC): University of Victoria; 2017 Feb 27.

Handbook of eHealth Evaluation: An Evidence-based Approach [Internet].

Chapter 9 methods for literature reviews.

Guy Paré and Spyros Kitsiou .

9.1. Introduction

Literature reviews play a critical role in scholarship because science remains, first and foremost, a cumulative endeavour ( vom Brocke et al., 2009 ). As in any academic discipline, rigorous knowledge syntheses are becoming indispensable in keeping up with an exponentially growing eHealth literature, assisting practitioners, academics, and graduate students in finding, evaluating, and synthesizing the contents of many empirical and conceptual papers. Among other methods, literature reviews are essential for: (a) identifying what has been written on a subject or topic; (b) determining the extent to which a specific research area reveals any interpretable trends or patterns; (c) aggregating empirical findings related to a narrow research question to support evidence-based practice; (d) generating new frameworks and theories; and (e) identifying topics or questions requiring more investigation ( Paré, Trudel, Jaana, & Kitsiou, 2015 ).

Literature reviews can take two major forms. The most prevalent one is the “literature review” or “background” section within a journal paper or a chapter in a graduate thesis. This section synthesizes the extant literature and usually identifies the gaps in knowledge that the empirical study addresses ( Sylvester, Tate, & Johnstone, 2013 ). It may also provide a theoretical foundation for the proposed study, substantiate the presence of the research problem, justify the research as one that contributes something new to the cumulated knowledge, or validate the methods and approaches for the proposed study ( Hart, 1998 ; Levy & Ellis, 2006 ).

The second form of literature review, which is the focus of this chapter, constitutes an original and valuable work of research in and of itself ( Paré et al., 2015 ). Rather than providing a base for a researcher’s own work, it creates a solid starting point for all members of the community interested in a particular area or topic ( Mulrow, 1987 ). The so-called “review article” is a journal-length paper which has an overarching purpose to synthesize the literature in a field, without collecting or analyzing any primary data ( Green, Johnson, & Adams, 2006 ).

When appropriately conducted, review articles represent powerful information sources for practitioners looking for state-of-the art evidence to guide their decision-making and work practices ( Paré et al., 2015 ). Further, high-quality reviews become frequently cited pieces of work which researchers seek out as a first clear outline of the literature when undertaking empirical studies ( Cooper, 1988 ; Rowe, 2014 ). Scholars who track and gauge the impact of articles have found that review papers are cited and downloaded more often than any other type of published article ( Cronin, Ryan, & Coughlan, 2008 ; Montori, Wilczynski, Morgan, Haynes, & Hedges, 2003 ; Patsopoulos, Analatos, & Ioannidis, 2005 ). The reason for their popularity may be the fact that reading the review enables one to have an overview, if not a detailed knowledge of the area in question, as well as references to the most useful primary sources ( Cronin et al., 2008 ). Although they are not easy to conduct, the commitment to complete a review article provides a tremendous service to one’s academic community ( Paré et al., 2015 ; Petticrew & Roberts, 2006 ). Most, if not all, peer-reviewed journals in the fields of medical informatics publish review articles of some type.

The main objectives of this chapter are fourfold: (a) to provide an overview of the major steps and activities involved in conducting a stand-alone literature review; (b) to describe and contrast the different types of review articles that can contribute to the eHealth knowledge base; (c) to illustrate each review type with one or two examples from the eHealth literature; and (d) to provide a series of recommendations for prospective authors of review articles in this domain.

9.2. Overview of the Literature Review Process and Steps

As explained in Templier and Paré (2015) , there are six generic steps involved in conducting a review article:

• formulating the research question(s) and objective(s),
• searching the extant literature,
• screening for inclusion,
• assessing the quality of primary studies,
• extracting data, and
• analyzing data.

Although these steps are presented here in sequential order, one must keep in mind that the review process can be iterative and that many activities can be initiated during the planning stage and later refined during subsequent phases ( Finfgeld-Connett & Johnson, 2013 ; Kitchenham & Charters, 2007 ).

Formulating the research question(s) and objective(s): As a first step, members of the review team must appropriately justify the need for the review itself ( Petticrew & Roberts, 2006 ), identify the review’s main objective(s) ( Okoli & Schabram, 2010 ), and define the concepts or variables at the heart of their synthesis ( Cooper & Hedges, 2009 ; Webster & Watson, 2002 ). Importantly, they also need to articulate the research question(s) they propose to investigate ( Kitchenham & Charters, 2007 ). In this regard, we concur with Jesson, Matheson, and Lacey (2011) that clearly articulated research questions are key ingredients that guide the entire review methodology; they underscore the type of information that is needed, inform the search for and selection of relevant literature, and guide or orient the subsequent analysis. Searching the extant literature: The next step consists of searching the literature and making decisions about the suitability of material to be considered in the review ( Cooper, 1988 ). There exist three main coverage strategies. First, exhaustive coverage means an effort is made to be as comprehensive as possible in order to ensure that all relevant studies, published and unpublished, are included in the review and, thus, conclusions are based on this all-inclusive knowledge base. The second type of coverage consists of presenting materials that are representative of most other works in a given field or area. Often authors who adopt this strategy will search for relevant articles in a small number of top-tier journals in a field ( Paré et al., 2015 ). In the third strategy, the review team concentrates on prior works that have been central or pivotal to a particular topic. This may include empirical studies or conceptual papers that initiated a line of investigation, changed how problems or questions were framed, introduced new methods or concepts, or engendered important debate ( Cooper, 1988 ). Screening for inclusion: The following step consists of evaluating the applicability of the material identified in the preceding step ( Levy & Ellis, 2006 ; vom Brocke et al., 2009 ). Once a group of potential studies has been identified, members of the review team must screen them to determine their relevance ( Petticrew & Roberts, 2006 ). A set of predetermined rules provides a basis for including or excluding certain studies. This exercise requires a significant investment on the part of researchers, who must ensure enhanced objectivity and avoid biases or mistakes. As discussed later in this chapter, for certain types of reviews there must be at least two independent reviewers involved in the screening process and a procedure to resolve disagreements must also be in place ( Liberati et al., 2009 ; Shea et al., 2009 ). Assessing the quality of primary studies: In addition to screening material for inclusion, members of the review team may need to assess the scientific quality of the selected studies, that is, appraise the rigour of the research design and methods. Such formal assessment, which is usually conducted independently by at least two coders, helps members of the review team refine which studies to include in the final sample, determine whether or not the differences in quality may affect their conclusions, or guide how they analyze the data and interpret the findings ( Petticrew & Roberts, 2006 ). Ascribing quality scores to each primary study or considering through domain-based evaluations which study components have or have not been designed and executed appropriately makes it possible to reflect on the extent to which the selected study addresses possible biases and maximizes validity ( Shea et al., 2009 ). Extracting data: The following step involves gathering or extracting applicable information from each primary study included in the sample and deciding what is relevant to the problem of interest ( Cooper & Hedges, 2009 ). Indeed, the type of data that should be recorded mainly depends on the initial research questions ( Okoli & Schabram, 2010 ). However, important information may also be gathered about how, when, where and by whom the primary study was conducted, the research design and methods, or qualitative/quantitative results ( Cooper & Hedges, 2009 ). Analyzing and synthesizing data : As a final step, members of the review team must collate, summarize, aggregate, organize, and compare the evidence extracted from the included studies. The extracted data must be presented in a meaningful way that suggests a new contribution to the extant literature ( Jesson et al., 2011 ). Webster and Watson (2002) warn researchers that literature reviews should be much more than lists of papers and should provide a coherent lens to make sense of extant knowledge on a given topic. There exist several methods and techniques for synthesizing quantitative (e.g., frequency analysis, meta-analysis) and qualitative (e.g., grounded theory, narrative analysis, meta-ethnography) evidence ( Dixon-Woods, Agarwal, Jones, Young, & Sutton, 2005 ; Thomas & Harden, 2008 ).

9.3. Types of Review Articles and Brief Illustrations

EHealth researchers have at their disposal a number of approaches and methods for making sense out of existing literature, all with the purpose of casting current research findings into historical contexts or explaining contradictions that might exist among a set of primary research studies conducted on a particular topic. Our classification scheme is largely inspired from Paré and colleagues’ (2015) typology. Below we present and illustrate those review types that we feel are central to the growth and development of the eHealth domain.

9.3.1. Narrative Reviews

The narrative review is the “traditional” way of reviewing the extant literature and is skewed towards a qualitative interpretation of prior knowledge ( Sylvester et al., 2013 ). Put simply, a narrative review attempts to summarize or synthesize what has been written on a particular topic but does not seek generalization or cumulative knowledge from what is reviewed ( Davies, 2000 ; Green et al., 2006 ). Instead, the review team often undertakes the task of accumulating and synthesizing the literature to demonstrate the value of a particular point of view ( Baumeister & Leary, 1997 ). As such, reviewers may selectively ignore or limit the attention paid to certain studies in order to make a point. In this rather unsystematic approach, the selection of information from primary articles is subjective, lacks explicit criteria for inclusion and can lead to biased interpretations or inferences ( Green et al., 2006 ). There are several narrative reviews in the particular eHealth domain, as in all fields, which follow such an unstructured approach ( Silva et al., 2015 ; Paul et al., 2015 ).

Despite these criticisms, this type of review can be very useful in gathering together a volume of literature in a specific subject area and synthesizing it. As mentioned above, its primary purpose is to provide the reader with a comprehensive background for understanding current knowledge and highlighting the significance of new research ( Cronin et al., 2008 ). Faculty like to use narrative reviews in the classroom because they are often more up to date than textbooks, provide a single source for students to reference, and expose students to peer-reviewed literature ( Green et al., 2006 ). For researchers, narrative reviews can inspire research ideas by identifying gaps or inconsistencies in a body of knowledge, thus helping researchers to determine research questions or formulate hypotheses. Importantly, narrative reviews can also be used as educational articles to bring practitioners up to date with certain topics of issues ( Green et al., 2006 ).

Recently, there have been several efforts to introduce more rigour in narrative reviews that will elucidate common pitfalls and bring changes into their publication standards. Information systems researchers, among others, have contributed to advancing knowledge on how to structure a “traditional” review. For instance, Levy and Ellis (2006) proposed a generic framework for conducting such reviews. Their model follows the systematic data processing approach comprised of three steps, namely: (a) literature search and screening; (b) data extraction and analysis; and (c) writing the literature review. They provide detailed and very helpful instructions on how to conduct each step of the review process. As another methodological contribution, vom Brocke et al. (2009) offered a series of guidelines for conducting literature reviews, with a particular focus on how to search and extract the relevant body of knowledge. Last, Bandara, Miskon, and Fielt (2011) proposed a structured, predefined and tool-supported method to identify primary studies within a feasible scope, extract relevant content from identified articles, synthesize and analyze the findings, and effectively write and present the results of the literature review. We highly recommend that prospective authors of narrative reviews consult these useful sources before embarking on their work.

Darlow and Wen (2015) provide a good example of a highly structured narrative review in the eHealth field. These authors synthesized published articles that describe the development process of mobile health ( m-health ) interventions for patients’ cancer care self-management. As in most narrative reviews, the scope of the research questions being investigated is broad: (a) how development of these systems are carried out; (b) which methods are used to investigate these systems; and (c) what conclusions can be drawn as a result of the development of these systems. To provide clear answers to these questions, a literature search was conducted on six electronic databases and Google Scholar . The search was performed using several terms and free text words, combining them in an appropriate manner. Four inclusion and three exclusion criteria were utilized during the screening process. Both authors independently reviewed each of the identified articles to determine eligibility and extract study information. A flow diagram shows the number of studies identified, screened, and included or excluded at each stage of study selection. In terms of contributions, this review provides a series of practical recommendations for m-health intervention development.

9.3.2. Descriptive or Mapping Reviews

The primary goal of a descriptive review is to determine the extent to which a body of knowledge in a particular research topic reveals any interpretable pattern or trend with respect to pre-existing propositions, theories, methodologies or findings ( King & He, 2005 ; Paré et al., 2015 ). In contrast with narrative reviews, descriptive reviews follow a systematic and transparent procedure, including searching, screening and classifying studies ( Petersen, Vakkalanka, & Kuzniarz, 2015 ). Indeed, structured search methods are used to form a representative sample of a larger group of published works ( Paré et al., 2015 ). Further, authors of descriptive reviews extract from each study certain characteristics of interest, such as publication year, research methods, data collection techniques, and direction or strength of research outcomes (e.g., positive, negative, or non-significant) in the form of frequency analysis to produce quantitative results ( Sylvester et al., 2013 ). In essence, each study included in a descriptive review is treated as the unit of analysis and the published literature as a whole provides a database from which the authors attempt to identify any interpretable trends or draw overall conclusions about the merits of existing conceptualizations, propositions, methods or findings ( Paré et al., 2015 ). In doing so, a descriptive review may claim that its findings represent the state of the art in a particular domain ( King & He, 2005 ).

In the fields of health sciences and medical informatics, reviews that focus on examining the range, nature and evolution of a topic area are described by Anderson, Allen, Peckham, and Goodwin (2008) as mapping reviews . Like descriptive reviews, the research questions are generic and usually relate to publication patterns and trends. There is no preconceived plan to systematically review all of the literature although this can be done. Instead, researchers often present studies that are representative of most works published in a particular area and they consider a specific time frame to be mapped.

An example of this approach in the eHealth domain is offered by DeShazo, Lavallie, and Wolf (2009). The purpose of this descriptive or mapping review was to characterize publication trends in the medical informatics literature over a 20-year period (1987 to 2006). To achieve this ambitious objective, the authors performed a bibliometric analysis of medical informatics citations indexed in medline using publication trends, journal frequencies, impact factors, Medical Subject Headings (MeSH) term frequencies, and characteristics of citations. Findings revealed that there were over 77,000 medical informatics articles published during the covered period in numerous journals and that the average annual growth rate was 12%. The MeSH term analysis also suggested a strong interdisciplinary trend. Finally, average impact scores increased over time with two notable growth periods. Overall, patterns in research outputs that seem to characterize the historic trends and current components of the field of medical informatics suggest it may be a maturing discipline (DeShazo et al., 2009).

9.3.3. Scoping Reviews

Scoping reviews attempt to provide an initial indication of the potential size and nature of the extant literature on an emergent topic (Arksey & O’Malley, 2005; Daudt, van Mossel, & Scott, 2013 ; Levac, Colquhoun, & O’Brien, 2010). A scoping review may be conducted to examine the extent, range and nature of research activities in a particular area, determine the value of undertaking a full systematic review (discussed next), or identify research gaps in the extant literature ( Paré et al., 2015 ). In line with their main objective, scoping reviews usually conclude with the presentation of a detailed research agenda for future works along with potential implications for both practice and research.

Unlike narrative and descriptive reviews, the whole point of scoping the field is to be as comprehensive as possible, including grey literature (Arksey & O’Malley, 2005). Inclusion and exclusion criteria must be established to help researchers eliminate studies that are not aligned with the research questions. It is also recommended that at least two independent coders review abstracts yielded from the search strategy and then the full articles for study selection ( Daudt et al., 2013 ). The synthesized evidence from content or thematic analysis is relatively easy to present in tabular form (Arksey & O’Malley, 2005; Thomas & Harden, 2008 ).

One of the most highly cited scoping reviews in the eHealth domain was published by Archer, Fevrier-Thomas, Lokker, McKibbon, and Straus (2011) . These authors reviewed the existing literature on personal health record ( phr ) systems including design, functionality, implementation, applications, outcomes, and benefits. Seven databases were searched from 1985 to March 2010. Several search terms relating to phr s were used during this process. Two authors independently screened titles and abstracts to determine inclusion status. A second screen of full-text articles, again by two independent members of the research team, ensured that the studies described phr s. All in all, 130 articles met the criteria and their data were extracted manually into a database. The authors concluded that although there is a large amount of survey, observational, cohort/panel, and anecdotal evidence of phr benefits and satisfaction for patients, more research is needed to evaluate the results of phr implementations. Their in-depth analysis of the literature signalled that there is little solid evidence from randomized controlled trials or other studies through the use of phr s. Hence, they suggested that more research is needed that addresses the current lack of understanding of optimal functionality and usability of these systems, and how they can play a beneficial role in supporting patient self-management ( Archer et al., 2011 ).

9.3.4. Forms of Aggregative Reviews

Healthcare providers, practitioners, and policy-makers are nowadays overwhelmed with large volumes of information, including research-based evidence from numerous clinical trials and evaluation studies, assessing the effectiveness of health information technologies and interventions ( Ammenwerth & de Keizer, 2004 ; Deshazo et al., 2009 ). It is unrealistic to expect that all these disparate actors will have the time, skills, and necessary resources to identify the available evidence in the area of their expertise and consider it when making decisions. Systematic reviews that involve the rigorous application of scientific strategies aimed at limiting subjectivity and bias (i.e., systematic and random errors) can respond to this challenge.

Systematic reviews attempt to aggregate, appraise, and synthesize in a single source all empirical evidence that meet a set of previously specified eligibility criteria in order to answer a clearly formulated and often narrow research question on a particular topic of interest to support evidence-based practice ( Liberati et al., 2009 ). They adhere closely to explicit scientific principles ( Liberati et al., 2009 ) and rigorous methodological guidelines (Higgins & Green, 2008) aimed at reducing random and systematic errors that can lead to deviations from the truth in results or inferences. The use of explicit methods allows systematic reviews to aggregate a large body of research evidence, assess whether effects or relationships are in the same direction and of the same general magnitude, explain possible inconsistencies between study results, and determine the strength of the overall evidence for every outcome of interest based on the quality of included studies and the general consistency among them ( Cook, Mulrow, & Haynes, 1997 ). The main procedures of a systematic review involve:

• Formulating a review question and developing a search strategy based on explicit inclusion criteria for the identification of eligible studies (usually described in the context of a detailed review protocol).
• Searching for eligible studies using multiple databases and information sources, including grey literature sources, without any language restrictions.
• Selecting studies, extracting data, and assessing risk of bias in a duplicate manner using two independent reviewers to avoid random or systematic errors in the process.
• Analyzing data using quantitative or qualitative methods.
• Presenting results in summary of findings tables.
• Interpreting results and drawing conclusions.

Many systematic reviews, but not all, use statistical methods to combine the results of independent studies into a single quantitative estimate or summary effect size. Known as meta-analyses , these reviews use specific data extraction and statistical techniques (e.g., network, frequentist, or Bayesian meta-analyses) to calculate from each study by outcome of interest an effect size along with a confidence interval that reflects the degree of uncertainty behind the point estimate of effect ( Borenstein, Hedges, Higgins, & Rothstein, 2009 ; Deeks, Higgins, & Altman, 2008 ). Subsequently, they use fixed or random-effects analysis models to combine the results of the included studies, assess statistical heterogeneity, and calculate a weighted average of the effect estimates from the different studies, taking into account their sample sizes. The summary effect size is a value that reflects the average magnitude of the intervention effect for a particular outcome of interest or, more generally, the strength of a relationship between two variables across all studies included in the systematic review. By statistically combining data from multiple studies, meta-analyses can create more precise and reliable estimates of intervention effects than those derived from individual studies alone, when these are examined independently as discrete sources of information.

The review by Gurol-Urganci, de Jongh, Vodopivec-Jamsek, Atun, and Car (2013) on the effects of mobile phone messaging reminders for attendance at healthcare appointments is an illustrative example of a high-quality systematic review with meta-analysis. Missed appointments are a major cause of inefficiency in healthcare delivery with substantial monetary costs to health systems. These authors sought to assess whether mobile phone-based appointment reminders delivered through Short Message Service ( sms ) or Multimedia Messaging Service ( mms ) are effective in improving rates of patient attendance and reducing overall costs. To this end, they conducted a comprehensive search on multiple databases using highly sensitive search strategies without language or publication-type restrictions to identify all rct s that are eligible for inclusion. In order to minimize the risk of omitting eligible studies not captured by the original search, they supplemented all electronic searches with manual screening of trial registers and references contained in the included studies. Study selection, data extraction, and risk of bias assessments were performed inde­­pen­dently by two coders using standardized methods to ensure consistency and to eliminate potential errors. Findings from eight rct s involving 6,615 participants were pooled into meta-analyses to calculate the magnitude of effects that mobile text message reminders have on the rate of attendance at healthcare appointments compared to no reminders and phone call reminders.

Meta-analyses are regarded as powerful tools for deriving meaningful conclusions. However, there are situations in which it is neither reasonable nor appropriate to pool studies together using meta-analytic methods simply because there is extensive clinical heterogeneity between the included studies or variation in measurement tools, comparisons, or outcomes of interest. In these cases, systematic reviews can use qualitative synthesis methods such as vote counting, content analysis, classification schemes and tabulations, as an alternative approach to narratively synthesize the results of the independent studies included in the review. This form of review is known as qualitative systematic review.

A rigorous example of one such review in the eHealth domain is presented by Mickan, Atherton, Roberts, Heneghan, and Tilson (2014) on the use of handheld computers by healthcare professionals and their impact on access to information and clinical decision-making. In line with the methodological guide­lines for systematic reviews, these authors: (a) developed and registered with prospero ( www.crd.york.ac.uk/ prospero / ) an a priori review protocol; (b) conducted comprehensive searches for eligible studies using multiple databases and other supplementary strategies (e.g., forward searches); and (c) subsequently carried out study selection, data extraction, and risk of bias assessments in a duplicate manner to eliminate potential errors in the review process. Heterogeneity between the included studies in terms of reported outcomes and measures precluded the use of meta-analytic methods. To this end, the authors resorted to using narrative analysis and synthesis to describe the effectiveness of handheld computers on accessing information for clinical knowledge, adherence to safety and clinical quality guidelines, and diagnostic decision-making.

In recent years, the number of systematic reviews in the field of health informatics has increased considerably. Systematic reviews with discordant findings can cause great confusion and make it difficult for decision-makers to interpret the review-level evidence ( Moher, 2013 ). Therefore, there is a growing need for appraisal and synthesis of prior systematic reviews to ensure that decision-making is constantly informed by the best available accumulated evidence. Umbrella reviews , also known as overviews of systematic reviews, are tertiary types of evidence synthesis that aim to accomplish this; that is, they aim to compare and contrast findings from multiple systematic reviews and meta-analyses ( Becker & Oxman, 2008 ). Umbrella reviews generally adhere to the same principles and rigorous methodological guidelines used in systematic reviews. However, the unit of analysis in umbrella reviews is the systematic review rather than the primary study ( Becker & Oxman, 2008 ). Unlike systematic reviews that have a narrow focus of inquiry, umbrella reviews focus on broader research topics for which there are several potential interventions ( Smith, Devane, Begley, & Clarke, 2011 ). A recent umbrella review on the effects of home telemonitoring interventions for patients with heart failure critically appraised, compared, and synthesized evidence from 15 systematic reviews to investigate which types of home telemonitoring technologies and forms of interventions are more effective in reducing mortality and hospital admissions ( Kitsiou, Paré, & Jaana, 2015 ).

9.3.5. Realist Reviews

Realist reviews are theory-driven interpretative reviews developed to inform, enhance, or supplement conventional systematic reviews by making sense of heterogeneous evidence about complex interventions applied in diverse contexts in a way that informs policy decision-making ( Greenhalgh, Wong, Westhorp, & Pawson, 2011 ). They originated from criticisms of positivist systematic reviews which centre on their “simplistic” underlying assumptions ( Oates, 2011 ). As explained above, systematic reviews seek to identify causation. Such logic is appropriate for fields like medicine and education where findings of randomized controlled trials can be aggregated to see whether a new treatment or intervention does improve outcomes. However, many argue that it is not possible to establish such direct causal links between interventions and outcomes in fields such as social policy, management, and information systems where for any intervention there is unlikely to be a regular or consistent outcome ( Oates, 2011 ; Pawson, 2006 ; Rousseau, Manning, & Denyer, 2008 ).

To circumvent these limitations, Pawson, Greenhalgh, Harvey, and Walshe (2005) have proposed a new approach for synthesizing knowledge that seeks to unpack the mechanism of how “complex interventions” work in particular contexts. The basic research question — what works? — which is usually associated with systematic reviews changes to: what is it about this intervention that works, for whom, in what circumstances, in what respects and why? Realist reviews have no particular preference for either quantitative or qualitative evidence. As a theory-building approach, a realist review usually starts by articulating likely underlying mechanisms and then scrutinizes available evidence to find out whether and where these mechanisms are applicable ( Shepperd et al., 2009 ). Primary studies found in the extant literature are viewed as case studies which can test and modify the initial theories ( Rousseau et al., 2008 ).

The main objective pursued in the realist review conducted by Otte-Trojel, de Bont, Rundall, and van de Klundert (2014) was to examine how patient portals contribute to health service delivery and patient outcomes. The specific goals were to investigate how outcomes are produced and, most importantly, how variations in outcomes can be explained. The research team started with an exploratory review of background documents and research studies to identify ways in which patient portals may contribute to health service delivery and patient outcomes. The authors identified six main ways which represent “educated guesses” to be tested against the data in the evaluation studies. These studies were identified through a formal and systematic search in four databases between 2003 and 2013. Two members of the research team selected the articles using a pre-established list of inclusion and exclusion criteria and following a two-step procedure. The authors then extracted data from the selected articles and created several tables, one for each outcome category. They organized information to bring forward those mechanisms where patient portals contribute to outcomes and the variation in outcomes across different contexts.

9.3.6. Critical Reviews

Lastly, critical reviews aim to provide a critical evaluation and interpretive analysis of existing literature on a particular topic of interest to reveal strengths, weaknesses, contradictions, controversies, inconsistencies, and/or other important issues with respect to theories, hypotheses, research methods or results ( Baumeister & Leary, 1997 ; Kirkevold, 1997 ). Unlike other review types, critical reviews attempt to take a reflective account of the research that has been done in a particular area of interest, and assess its credibility by using appraisal instruments or critical interpretive methods. In this way, critical reviews attempt to constructively inform other scholars about the weaknesses of prior research and strengthen knowledge development by giving focus and direction to studies for further improvement ( Kirkevold, 1997 ).

Kitsiou, Paré, and Jaana (2013) provide an example of a critical review that assessed the methodological quality of prior systematic reviews of home telemonitoring studies for chronic patients. The authors conducted a comprehensive search on multiple databases to identify eligible reviews and subsequently used a validated instrument to conduct an in-depth quality appraisal. Results indicate that the majority of systematic reviews in this particular area suffer from important methodological flaws and biases that impair their internal validity and limit their usefulness for clinical and decision-making purposes. To this end, they provide a number of recommendations to strengthen knowledge development towards improving the design and execution of future reviews on home telemonitoring.

9.4. Summary

Table 9.1 outlines the main types of literature reviews that were described in the previous sub-sections and summarizes the main characteristics that distinguish one review type from another. It also includes key references to methodological guidelines and useful sources that can be used by eHealth scholars and researchers for planning and developing reviews.

Typology of Literature Reviews (adapted from Paré et al., 2015).

As shown in Table 9.1 , each review type addresses different kinds of research questions or objectives, which subsequently define and dictate the methods and approaches that need to be used to achieve the overarching goal(s) of the review. For example, in the case of narrative reviews, there is greater flexibility in searching and synthesizing articles ( Green et al., 2006 ). Researchers are often relatively free to use a diversity of approaches to search, identify, and select relevant scientific articles, describe their operational characteristics, present how the individual studies fit together, and formulate conclusions. On the other hand, systematic reviews are characterized by their high level of systematicity, rigour, and use of explicit methods, based on an “a priori” review plan that aims to minimize bias in the analysis and synthesis process (Higgins & Green, 2008). Some reviews are exploratory in nature (e.g., scoping/mapping reviews), whereas others may be conducted to discover patterns (e.g., descriptive reviews) or involve a synthesis approach that may include the critical analysis of prior research ( Paré et al., 2015 ). Hence, in order to select the most appropriate type of review, it is critical to know before embarking on a review project, why the research synthesis is conducted and what type of methods are best aligned with the pursued goals.

9.5. Concluding Remarks

In light of the increased use of evidence-based practice and research generating stronger evidence ( Grady et al., 2011 ; Lyden et al., 2013 ), review articles have become essential tools for summarizing, synthesizing, integrating or critically appraising prior knowledge in the eHealth field. As mentioned earlier, when rigorously conducted review articles represent powerful information sources for eHealth scholars and practitioners looking for state-of-the-art evidence. The typology of literature reviews we used herein will allow eHealth researchers, graduate students and practitioners to gain a better understanding of the similarities and differences between review types.

We must stress that this classification scheme does not privilege any specific type of review as being of higher quality than another ( Paré et al., 2015 ). As explained above, each type of review has its own strengths and limitations. Having said that, we realize that the methodological rigour of any review — be it qualitative, quantitative or mixed — is a critical aspect that should be considered seriously by prospective authors. In the present context, the notion of rigour refers to the reliability and validity of the review process described in section 9.2. For one thing, reliability is related to the reproducibility of the review process and steps, which is facilitated by a comprehensive documentation of the literature search process, extraction, coding and analysis performed in the review. Whether the search is comprehensive or not, whether it involves a methodical approach for data extraction and synthesis or not, it is important that the review documents in an explicit and transparent manner the steps and approach that were used in the process of its development. Next, validity characterizes the degree to which the review process was conducted appropriately. It goes beyond documentation and reflects decisions related to the selection of the sources, the search terms used, the period of time covered, the articles selected in the search, and the application of backward and forward searches ( vom Brocke et al., 2009 ). In short, the rigour of any review article is reflected by the explicitness of its methods (i.e., transparency) and the soundness of the approach used. We refer those interested in the concepts of rigour and quality to the work of Templier and Paré (2015) which offers a detailed set of methodological guidelines for conducting and evaluating various types of review articles.

To conclude, our main objective in this chapter was to demystify the various types of literature reviews that are central to the continuous development of the eHealth field. It is our hope that our descriptive account will serve as a valuable source for those conducting, evaluating or using reviews in this important and growing domain.

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• Cite this Page Paré G, Kitsiou S. Chapter 9 Methods for Literature Reviews. In: Lau F, Kuziemsky C, editors. Handbook of eHealth Evaluation: An Evidence-based Approach [Internet]. Victoria (BC): University of Victoria; 2017 Feb 27.
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• Concluding Remarks

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Dissertations - Skills Guide

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• Research Proposal
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• Primary Research

Literature Review

• Methodology
• Downloadable Resources
• Further Reading

What is it?

Literature reviews involve collecting information from literature that is already available, similar to a long essay. It is a written argument that builds a case from previous research (Machi and McEvoy, 2012). Every dissertation should include a literature review, but a dissertation as a whole can be a literature review. In this section we discuss literature reviews for the whole dissertation.

What are the benefits of a literature review?

There are advantages and disadvantages to any approach. The advantages of conducting a literature review include accessibility, deeper understanding of your chosen topic, identifying experts and current research within that area, and answering key questions about current research. The disadvantages might include not providing new information on the subject and, depending on the subject area, you may have to include information that is out of date.

How do I write it?

A literature review is often split into chapters, you can choose if these chapters have titles that represent the information within them, or call them chapter 1, chapter 2, ect. A regular format for a literature review is:

Introduction (including methodology)

This particular example is split into 6 sections, however it may be more or less depending on your topic.

Literature Reviews Further Reading

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Annotated Literature Review: Health Benefits of Urban Greenspace

Our Community Engagement Core partnered with the Arnold Arboretum in 2020 to produce an annotated literature review (120 pages) that outlines the various health benefits of urban greenspace.

EXECUTIVE SUMMARY

Goal: There is a significant body of research dating back many decades investigating the various health benefits of greenspace1, many of which can be categorized into measured and perceived mental, physical, or social benefits. In order to gain an understanding of this evidence base, a structured literature on health benefits of urban greenspace was conducted and relevant articles summarized.

Findings: There is a general consensus that urban greenspace influences human health in a positive manner, but in some cases, there was insufficient evidence to generalize about specific health outcomes including diabetes (Kondo et al., 2018), cancer (Kondo et al., 2018; Ekkel and Vries 2017) or birth outcomes (Kondo et al., 2018; Wolf et al., 2020; Fong et al., 2018; Ekkel and Vries 2017). Most original research studies utilized a cross-sectional study design (Kondo et al., 2018), with many researchers controlling for socio-economic status in their analyses (Wolf et al., 2020). In general, studies focused more on short-term health benefits of greenspace (e.g., improved blood pressure, stress reduction & cognitive performance) (Wolf et al., 2020). The lack of randomized control trials made it difficult to distinguish whether or not reported results were attributable to an intervention (i.e., introduction of physical activity) or to the urban greenspace itself, particularly in studies of short-term improvements in physical and psychological health (Saitta et al., 2019). Studies included in this review exhibited variation in sample size (e.g., eight to a combined 290+million) (Wolf et al., 2020; Twohig-Bennett et al., 2018), with the majority of studies having been conducted in Europe and the United States. The full range of the human life span has been represented in studies to-date: adults (71%) young adults (13%), children (13%) & older adults (3%) (Wolf et al., 2020). Measured outcomes have been shown to vary by geographical location and/or type of natural and built environment examined (Roberts et al., 2020). It is worth noting that few studies focused on health inequities or the impact or urban greenspace specifically on disadvantaged for vulnerable populations (Kondo et al., 2018).

Overall findings were positive associations between urban greenspace and attention, mood, and physical activity (Kondo et al., 2018) and negative associations between urban greenspace and mortality, short-term cardiovascular markers (e.g., heart rate, blood pressure) and violence (Kondo et al., 2018). Generally, exposure to greenspace resulted in improvement of overall well-being, reduced symptoms of depression, anxiety, attention deficit/hyperactivity disorder (Younan et al., 2016), and a boost in immune function (Capaldi et al., 2015; Rook 2013). Other findings of interest are presented below:

Mental Health Benefits:

Exposure to urban greenspace can mitigate psychological stress by providing opportunity for physical activity, social interaction, and engendering cognitive and physiological responses associated with stress reduction and attention restoration, which may be pronounced for urban populations (Mennis et al., 2018; Jennings et al., 2016; Knecht 2004) more so for Black, indigenous, or people of color, which are subject to additional contextual societal (e.g., systemic racism) and environmental factors (e.g., proximity to sources of air pollution or major roadways) (Mennis et al., 2018).

Study participants were better able to perform a test of working memory after walking through an arboretum compared to those who walked on roads with heavy traffic and those who walked through the arboretum had 20% improvement in working memory (Hall and Knuth 2019).

A 10-20% reduction in perceived risk of poor mental health, depression and/or anxiety and intake of medication was found per interquartile range increase in average NDVI around homes, suggesting that there are substantial mental health benefits from nearby urban greenspace (Nieuwenhuijsen et al., 2017).

1 It is important to note that while ‘greenspace’ may take on different meanings, the term has been used extensively to refer to areas or urban vegetation such as public and private parks, gardens, residential landscapes, urban forests or other municipal landscapes (Hall & Knuth 2019). Some studies focused on a specific type of green measure (e.g., tree canopy measure) or nature-immersive experience (e.g., outdoor education program intervention), but a common metric used to indicate amount of greenspace in a study area was normalized difference vegetation index NDVI) (Kondo et al., 2018). Outcomes can and have been shown to vary by type of greenspace analyzed (MacBride-Stewart et al., 2016).

Meta-analysis of studies showed that increased greenspace exposure was associated with decreased salivary cortisol, a marker of stress, with effect mean difference (EMD) -0.05 [95% confidence interval (CI) -0.07, 0.04] (Twohig- Bennett and Jones 2018).

Physiological measures of stress (e.g., electromyography, skin conductance response, pulse transit time, cardiac response, partial thromboplastin time) indicated quicker and more complete recovery in a natural environment, even when measured over 10-minute period, and initial few minutes of recovery showed parasympathetic response which slows heart rate, increases intestinal and gland activity, and relaxes muscles in the gastrointestinal tract, while no such response was evident for urban settings (Berto 2014).

Physical Health Benefits:

Lower body mass index (BMI) among adults was observed in higher greenspace neighborhoods with more destinations for walking than in less green neighborhoods (Tsai et al., 2016) and proximity and access to urban greenspaces have been linked to healthier weights and lower BMIs in children (Chawla 2015; Hall and Knuth 2019), while perceived lack of greenspace and playground space among pre-school children have been independently associated with being overweight (Douglas et al., 2017).

Increased greenspace exposure has been associated with heart rate [EMD -2.57 (95% CI -4.30, -0.83)], diastolic blood pressure [EMD -1.97 (95% CI -3.45, -0.19)], high-density lipoprotein (HDL) cholesterol [EMD -0.03 (95% CI -0.05, <-0.01)], low frequency heart rate variability (HRV) [EMD -0.06 (95% CI -0.08, -0.03)], increased high frequency HRV [EMD 91.87 (95% CI 50.92, 132.82)], and cardiovascular mortality [odds ratio (OR) 0.84 (95% CI 0.76, 0.93)] (Twohig-Bennett et al., 2018).

Walk in nature have positive short-term effects on cardiovascular system and as measured in hypertensive patients, walks in nature decreased serum levels associated with high blood pressure, including endothelin-1, homocysteine, renin, angiotensin II type 1 receptor, and angiotensin II type 2 receptor, suggesting that walks in nature lower blood pressure in young, middle-aged, and older adults (Hall and Knuth 2019).

Regular exposure to low concentrations of mixtures of natural compounds and toxins in natural environments confers pleotropic health benefits by inhibiting activities of interconnected cell-signaling systems (e.g., PI3K/Akt/mTORCI) and when overactive can lead to pathological processes resulting in cancer, diabetes, inflammation, immunosuppression, and/or neurodegenerative diseases (Nieuwenhuijsen et al., 2017).

Social Health Benefits:

Survey data revealed that across the United States, there is a significant positive relationship between attractive physical settings (e.g., trails, parks) and community satisfaction, encouraging social interactions across diverse populations, which can remedy decline of social relationships in urban areas (Jennings et al., 2016).

Participants from multiple studies reported that accessible, usable parks enabled social interaction and development of social skills in addition to exposing people without disabilities to those with disability to foster community learning and improve tolerance and acceptance in society, while at the same time empowering social confidence of people with disabilities (Saitta et al., 2019).

Urban greenery can help people develop a sense of community and neighborhood attachment, increase social contacts, and reduce feelings of social isolation (Nesbitt et al., 2017). Positive correlations between use of public urban greenspace and strength of neighborhood ties and sense of community have been reported, in addition to more deaths for older adult residents recorded in urban areas with low greenness (Douglas et al., 2017).

Health Benefits of Access:

Disadvantaged communities, children, older people and people with mental health problems and pregnant women usually have less access to urban greenspace compared to more affluent populations but may be the greatest beneficiaries, suggesting that provision of access in a safe manner is important for reducing health inequities and buffer effects of some stressors (Kruize et al., 2019; Gascon et al., 2015).

Distance to destination, suitability of infrastructure (e.g., walking paths), and safety are very important factors motivating people to visit urban greenspaces (Kruize et al., 2019; Saitta et al., 2019; Hartig et al., 2014), and factors such as encountering busy roads may deter use of greenspace (Lachowycz and Jones 2013; Lee and Maheswaran 2011).

Across North American cities, underprivileged populations have disproportionately less access to vegetation including greenspace than affluent groups, with disparities more pronounced on public versus private land (Hall and Knuth 2019).

In the United States, typical standard suggested for ‘walkable’ is a destination within 0.25 miles or 400 meters at most (suggested by Sturm & Cohen 2014 in Ekkel & Vries 2017), but it has been shown that a distance of 100 to 300 meters (Ekkel and Vries 2017) is the threshold distance after which use of greenspace declines rapidly. Reported mental health measured using MHI-5 tool was better among residents having access to a park within 400 meters compared to those at 800+ meters (Ekkel and Vries 2017).

In addition to measured and perceived mental, physical, and social health benefits from urban greenspace, there are other areas of research that offer important findings on additional health benefits from urban greenspace. These include some less tangible and therefore harder to measure aspects (e.g., spirituality, feelings of vitality) as well as restoration from such practices as the Japanese art of shinrin-yoku (translated into English as ‘forest bathing’). A few notable findings are included below:

Other Health Benefits:

Aspects of human-nature interaction important to well-being that are not well understood but may be important include sense of place, aesthetics and preference, spiritual beliefs (Dickinson and Hobbs 2017); these views could have an impact on the use of urban greenspace (Rakhshandehroo et al., 2015; Shanahan, Fuller et al., 2015).

Health benefits of greenspace found to be larger in some studies involving larger areas with more biodiversity compared to urban park environments (Roberts et al., 2019) and in studies including biodiversity as a measure of interest, it (biodiversity) has emerged as an important positive element for people using urban greenspaces (Carrus et al., 2015; Zhou and Rana 2012); variation in greenspace itself has important role in enhancing population health (Shanahan, Lin et al., 2015).

Functional magnetic resonance imaging (fMRI) scans showed that spending time in forest settings prompted the brain area activations related to involuntary attention and cognitive restoration and one study found that short 15- minute sessions of ‘forest bathing’ produced enhanced subjective feelings of vigor, recovery, and vitality (Wolf et al., 2020).

Conclusion: Urban greenspace is an important multi-faceted influence on the health of urban populations, with respect to mental, physical, social and other benefits. However, more research utilizing a randomized control trial approach is needed to best assess such health benefits, particularly with respect to specific types of greenspace or micro-environments (e.g., street tree canopy, arboreta, mixed use park). In addition, some research uncovered here has suggested that underrepresented and/or vulnerable social groups may benefit more from exposure and access to urban greenspaces, so further research in this area is needed to add to the current peer-reviewed literature evidence base. Accessibility to urban greenspace emerged as a recurring barrier for underrepresented populations, so attention to providing safe and inclusive accessible greenspace should be of priority for urban areas.

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• Management of systemic lupus erythematosus: a systematic literature review informing the 2023 update of the EULAR recommendations
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• http://orcid.org/0000-0002-8832-7475 Myrto Kostopoulou 1 ,
• http://orcid.org/0000-0002-9771-6667 Chetan B Mukhtyar 2 ,
• http://orcid.org/0000-0001-5299-1406 George Bertsias 3 , 4 ,
• http://orcid.org/0000-0002-9812-4671 Dimitrios T Boumpas 1 , 5 ,
• http://orcid.org/0000-0003-2696-031X Antonis Fanouriakis 1
• 1 Rheumatology and Clinical Immunology Unit, Attikon University Hospital , National and Kapodistrian University of Athens School of Medicine , Athens , Greece
• 2 Vasculitis Service, Rheumatology Department , Norfolk and Norwich University Hospital NHS Trust , Norwich , UK
• 3 Rheumatology and Clinical Immunology , University of Crete, School of Medicine , Heraklion , Greece
• 4 Laboratory of Autoimmunity and Inflammation , Institute of Molecular Biology and Biotechnology , Heraklion , Greece
• 5 Laboratory of Autoimmunity and Inflammation , Biomedical Research Foundation of the Academy of Athens , Athens , Greece
• Correspondence to Dr Antonis Fanouriakis, Rheumatology and Clinical Immunology Unit, "Attikon" University Hospital, National and Kapodistrian University of Athens School of Medicine, Athens, Greece; afanour{at}med.uoa.gr

Objectives To analyse the new evidence (2018–2022) for the management of systemic lupus erythematosus (SLE) to inform the 2023 update of the European League Against Rheumatism (EULAR) recommendations.

Methods Systematic literature reviews were performed in the Medline and the Cochrane Library databases capturing publications from 1 January 2018 through 31 December 2022, according to the EULAR standardised operating procedures. The research questions focused on five different domains, namely the benefit/harm of SLE treatments, the benefits from the attainment of remission/low disease activity, the risk/benefit from treatment tapering/withdrawal, the management of SLE with antiphospholipid syndrome and the safety of immunisations against varicella zoster virus and SARS-CoV2 infection. A Population, Intervention, Comparison and Outcome framework was used to develop search strings for each research topic.

Results We identified 439 relevant articles, the majority being observational studies of low or moderate quality. High-quality randomised controlled trials (RCTs) documented the efficacy of the type 1 interferon receptor inhibitor, anifrolumab, in non-renal SLE, and belimumab and voclosporin, a novel calcineurin inhibitor, in lupus nephritis (LN), when compared with standard of care. For the treatment of specific organ manifestations outside LN, a lack of high-quality data was documented. Multiple observational studies confirmed the beneficial effects of attaining clinical remission or low disease activity, reducing the risk for multiple adverse outcomes. Two randomised trials with some concerns regarding risk of bias found higher rates of relapse in patients who discontinued glucocorticoids (GC) or immunosuppressants in SLE and LN, respectively, yet observational cohort studies suggest that treatment withdrawal might be feasible in a subset of patients.

Conclusion Anifrolumab and belimumab achieve better disease control than standard of care in extrarenal SLE, while combination therapies with belimumab and voclosporin attained higher response rates in high-quality RCTs in LN. Remission and low disease activity are associated with favourable long-term outcomes. In patients achieving these targets, GC and immunosuppressive therapy may gradually be tapered. Cite Now

• Systemic Lupus Erythematosus
• Lupus Nephritis

Data availability statement

All data relevant to the study are included in the article or uploaded as online supplemental information.

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See:  http://creativecommons.org/licenses/by-nc/4.0/ .

https://doi.org/10.1136/ard-2023-225319

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WHAT IS ALREADY KNOWN ON THIS TOPIC

Since the 2019 European League Against Rheumatism (EULAR) recommendations for the management of systemic lupus erythematosus (SLE), several studies have been published providing data on alternative therapeutic options and treatment targets. A systematic literature review (SLR) focusing on recent advances was performed to inform the 2023 update of EULAR recommendations for the management of SLE.

WHAT THIS STUDY ADDS

In extrarenal disease, anifrolumab and belimumab were superior to standard of care treatment in a number of high-quality randomised controlled trials.

High-quality evidence points towards better efficacy of combination treatments with belimumab or voclosporin compared with standard of care in patients with lupus nephritis.

Both remission and low disease activity have been associated with lower risk of adverse outcomes in observational studies.

Although treatment discontinuation increases the risk of flares, successful glucocorticoid withdrawal was accomplished in patients with SLE in remission in several cohort studies.

HOW THIS STUDY MIGHT AFFECT RESEARCH, PRACTICE OR POLICY

This SLR provided a systematic update of current evidence regarding the management of patients with SLE, to inform the 2023 update of the EULAR recommendations.

Introduction

Management of systemic lupus erythematosus (SLE) is challenging, owing to the heterogeneity of disease phenotype, the variable severity of involvement even within the same organ manifestation, and the different efficacy of drugs in different patient subgroups and disease manifestations. 1 Patients with SLE will frequently require multiple drugs during the course of their disease to achieve and maintain sufficient control. To this end, it is important that recent years have witnessed significant progress in the form of introduction of new drugs to treat the disease. Anifrolumab, an anti-type 1 interferon receptor inhibitor, was approved in 2021 for the treatment of moderate-to-severe extrarenal SLE. 2 3 Belimumab and voclosporin (a novel calcineurin inhibitor (CNI)) were also approved by the European Medicines Agency in 2021 and 2022, respectively, for the treatment of lupus nephritis (LN), a cardinal manifestation of the disease affecting up to 40%–50% of patients, with significant impact on morbidity and survival. 4 5

These important advances provided the ground for an update of the European League Against Rheumatism (EULAR) recommendations for the management of SLE, which was published recently. 6 To this end, we performed structured systematic literature reviews (SLRs), aiming to update the evidence for the efficacy and safety of different therapies, as well as try to define the optimal therapy of different organ manifestations of the disease. The results of these SLRs were presented to the Task Force members during dedicated meetings to form the current evidence base, on which the formulation of the current recommendations was based. The current manuscript presents in detail the results of these SLRs.

We followed the standardised operating procedures for the development of EULAR-endorsed recommendations and employed the Appraisal of Guidelines Research and Evaluation instrument. Following assembly of the Task Force, the convenor (DTB), one methodologist (GB), one co-methodologist (CBM), and two fellows responsible for the SLR (AF and MK) created an outline of the proposed methodology, as well as the main research questions in the form of Population, Intervention, Comparison and Outcomes (PICOs), which were circulated among Task Force members. A Delphi-based methodology within the Task Force finally identified five research questions: (1) management of general and organ-specific SLE (divided in six subquestions regarding drug efficacy and safety in patients with active SLE, active mucocutaneous, musculoskeletal, haematological, neuropsychiatric and kidney involvement, respectively), (2) targets of treatment, (3) management of patients with SLE and antiphospholipid syndrome, (4) tapering/withdrawal of treatment in SLE and (5) efficacy and safety of vaccination against varicella zoster virus (VZV) reactivation and SARS-CoV2 infection (a generic SLR for infection risk and prevention in SLE was not performed, because there are specific EULAR recommendations on this topic). 7 Separate search strings were developed for each PICO (1–5), resulting in five separate SLRs (the six subquestions of PICO 1 (PICO 1a–f) were examined with a single search string) ( online supplemental file 1 and 2, tables S1.1–S1.10 ).

Supplemental material

Under the supervision of the methodologists, AF and MK performed the SLRs independently in two different databases (MEDLINE through PubMed and the Cochrane Library), with additional inclusion of Lancet Rheumatology (due to non-inclusion of the latter in PubMed). Since this was an update of the 2019 recommendations on general SLE, the current SLRs evaluated all English language publications published between January 2018 and December 2022. All study designs were included (meta-analyses, randomised controlled trials (RCTs), quasi-RCTs, cohort studies, case–control studies, cross–sectional studies) while narrative reviews, case series, case reports, conference abstracts, animal studies, trials in non-English language, trials with population<20 and trials on paediatric populations were excluded. In case a study was captured as an original publication and was also included in a meta-analysis, then only the meta-analysis data were used, to avoid duplicating the evidence from that particular study. Eligible studies were reviewed for snowball references and relevant articles, identified by manual search within the reference list of the originally retrieved publications, were also included. For each research question, a predefined extraction form was used to capture the population set, all relevant interventions, their duration of use, route of administration, dosage, follow-up time and the respective effect estimates, including incidence rate, mean difference, risk difference, correlation coefficient, odds ratio (OR) and relative risk. For each research question, results were synthesised and presented according to the interventions used and the respective outcomes.

Risk of bias (RoB) was assessed using the revised Cochrane Risk of Bias Assessment Tool for RCTs (ROB V.2), the Newcastle-Ottawa scale for observational studies, and the AMSTAR V.2 tool for meta-analyses ( online supplemental file 3 ). In case of disagreements, these were internally discussed until achievement of consensus, and one methodologist was involved when deemed necessary. A Preferred Reporting Items for Systematic Reviews and Meta-Analyses checklist was completed and has been submitted along with the manuscript.

We screened a total of 10 889 articles, of which 578 were selected for full-text review, and 439 were finally included for data extraction (see figure 1 for a detailed flow diagram of the selection process). The results below are presented in terms of general efficacy of drugs in SLE, followed by treatment of specific manifestations, with a focus on LN.

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Flow diagram of the study selection process.

Efficacy and safety of hydroxychloroquine (HCQ) in SLE

Between January 2018 and December 2022, a total of 39 studies (all observational) evaluated and confirmed the association of HCQ with various favourable outcomes ( online supplemental file 4, table S4.1 ). A total of 10 studies reported a negative association between HCQ use and mortality in SLE; a meta-analysis of 21 studies (26 037 patients) found a pooled HR 0.46 for death in patients with SLE receiving HCQ (consistent results in all geographic regions). 8 Fewer (or individual) studies showed a positive effect of HCQ on various outcomes (reduced rate of disease flares, thrombosis, osteonecrosis, infections, among others). Regarding safety of HCQ, the focus was on retinal toxicity. 9 10 The current SLRs identified 10 studies (mostly of poor or fair quality) ( table 1 ); two retrospective cohort studies of good quality (ie, lower RoB) reported retinopathy rates of 0.8% and 4.3%, respectively. Longer duration of HCQ intake and a higher cumulative dose were confirmed as risk factors for retinal toxicity. Regarding other safety issues, a concern for corrected QT (QTc) prolongation was raised when HCQ was used during the early phases of the COVID-19 pandemic; however, a total of six studies found no clinically relevant QTc prolongation with HCQ use.

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Prevalence of HCQ retinopathy in observational studies and associations

The recommended dose of 5 mg/kg in the 2023 recommendations was based on (1) an observational study of good quality, which calculated the threshold for an increased risk of flares near 5 mg/kg/day of HCQ dose, 11 (2) older evidence of good quality, suggesting that risk of toxicity is low for doses below 5 mg/kg real body weight 10 and (3) indirect evidence for a slightly increased risk of flares in patients who taper HCQ versus those who continue (see below, Safety of treatment tapering in SLE).

Efficacy and safety of glucocorticoids (GC) in SLE

Although GC are widely used in SLE, high-quality RCTs assessing the efficacy of different schemes and tapering strategies are still lacking. A single, retrospective study of good quality in 206 patients with LN found higher rates of 1-year complete response in patients who started with ≥40 mg/day compared with those who started with ≤30 mg/day, without increased risk for GC-related damage. 12 Two small RCTs (one with 32 and one with 20 patients, both with high RoB) compared different doses of GC with same background immunosuppression (cyclophosphamide (CYC) and mycophenolate mofetil (MMF), respectively) and found discordant results; one showed equal response rates and the other higher rates in the high-dose GC arm. 13 14

For safety, the SLRs identified a large number of studies examining different cut-offs of average prednisone doses in association with different adverse effects ( online supplemental file 4, tableS4.2 for association with infections and online supplemental table S4.3 for associations with other harms). Most studies pointed towards thresholds of mean 5–7.5 mg/day prednisone, associated with a variety of GC-related side effects in multivariable associations.

Efficacy and safety of immunosuppressive drugs in extrarenal SLE

Immunosuppressive therapies used to treat extrarenal manifestations of SLE include both conventional drugs (azathioprine (AZA), methotrexate (MTX), MMF, CNIs, among others), as well as biologic agents (approved therapies belimumab and anifrolumab, and drugs used off-label, such as rituximab (RTX)). During the period captured by the SLRs, no new head-to-head comparisons between conventional immunosuppressive drugs were identified, rather only limited observational studies (mainly of-low quality) reporting efficacy in selected manifestations (mainly LN). To this end, this part will focus on new data regarding approved biologics.

We retrieved a total of 53 publications of belimumab in SLE, published between 2018 and 2022 (among them, 6 RCTs, 7 open-label extensions of previous RCTs, 11 post hoc analyses of previously published RCTs, 7 meta-analyses and 18 real-world observational studies), overall confirming efficacy of the drug in extrarenal lupus. A Cochrane SLR including 6 RCTs of belimumab in SLE found belimumab to be associated with a pooled risk ratio of 1.33 (95% CI 1.22 to 1.45) and 1.59 (95% CI 1.17 to 2.15) for Safety of Estrogen in Lupus National Assessment—Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) reduction by four points and reduction of GC dose by 50%, respectively. 15 Importantly, after the publication of the 2019 recommendations, belimumab has been tested in phase III RCTs in specific ethnic/racial populations, the Efficacy and Safety of Belimumab in Black Race Patients with SLE (EMBRACE) RCT in 448 African-Americans, 16 and the Belimumab in Subjects with SLE-North East Asia (BLISS-NEA) in 707 patients from North-East Asia. 17 Although in both studies, SLE Responder Index (SRI)-4 responses at 52 weeks were higher with belimumab versus placebo, the EMBRACE did not reach statistical significance (SRI response at week 52 48.7% with belimumab versus 41.6% with placebo (OR 1.40, 95% CI 0.93 to 2.11)). On the contrary, in BLISS-NEA, more patients treated with belimumab were SRI-4 responders at week 52 (53.8% vs 40.1% with placebo, OR 1.99, 95% CI 1.40 to 2.82). Regarding safety of belimumab, a phase IV RCT (BASE, 4003 patients) designed to test safety issues, found slightly higher rates of serious depression (0.35% vs 0.05%; Δ 0.15%, 95% CI 0.02% to 0.58%), treatment-emergent suicidality (1.42% vs 1.16%; Δ 0.26%, 95% CI −0.44% to 0.96%) and sponsor-adjudicated serious suicide or self-injury (0.75% vs 0.25%; post hoc Δ 0.50%, 95% CI 0.06% to 0.94%) with belimumab compared with placebo. 18 Similarly, a pooled post hoc analysis of one phase II and five phase III RCTs of belimumab (total 4170 patients) reported that serious depression was more common with belimumab (0.2% vs 0.1%) although suicide/self-injury was similar (0.3% in each group). 19 Incidence of all other adverse events and mortality was also similar between belimumab and placebo.

In addition to the Treatment of Uncontrolled Lupus via the Interferon Pathway (TULIP) trials, the SLR retrieved a total of 17 publications related to the use of anifrolumab in SLE: 2 phase II RCTs (one was in LN), 2 open-label extension studies, 7 post hoc analyses of previous RCTs, and 4 meta-analyses. Despite the discordant SRI-4 data of the two TULIP trials, both studies found significantly greater British Isles Lupus Assessment Group (BILAG)-based Composite Lupus Assessment (BICLA) response rates with anifrolumab compared with placebo (pooled OR 2.25, 95% CI 1.72 to 2.95, in a meta-analysis). 20 A post hoc analysis of the TULIP trials found that anifrolumab was associated with lower annualised disease flare rates (rate ratio 0.75, 95% CI 0.60 to 0.95), prolonged time to first flare (HR 0.70, 95% CI 0.55 to 0.89) and fewer patients with ≥1 flare (Δ −9.3%, 95% CI −16.3% to −2.3%), compared to placebo. 21 Regarding GC-sparing potential, another post hoc analysis of both TULIP trials reported sustained reduction to ≤7.5 mg/day prednisone in patients on ≥10 mg/day at baseline in 50.5% for anifrolumab versus 31.8% for placebo (Δ 18.7%, p<0.001), 22 while the above-mentioned meta-analysis (including also the MUSE phase II study of the drug) calculated the respective pooled OR at 2.45 (95% CI 1.69 to 3.54) compared to placebo. 20 In terms of safety, in general, adverse events and serious adverse events were similar between anifrolumab and placebo in RCTs, with the exception of VZV infection; analysis of the TULIP trials found a higher incidence of VZV in anifrolumab-treated patients versus placebo (6.4% vs 1.4%), evident in both interferon-high and interferon-low patients, 22 and confirmed in meta-analyses. 20 23 On the other hand, in the long-term extension of the TULIP studies (placebo controlled, 369 patients), VZV rates by year decreased over time and were lower during the long-term extension period than during the first year of TULIP (6.8 for year 1, dropping to 2.9 in year 4). 24

In RCTs, both belimumab and anifrolumab showed better clinical responses in patients who had abnormal serological markers at baseline (low C3/C4 levels and/or high antidouble-stranded DNA antibodies). 22 25 26

Treatment of specific extrarenal manifestations of SLE

Subquestions 1b–1f of PICO 1 were focused on the efficacy of different immunosuppressive treatments in various organ manifestations of SLE (mucocutaneous, musculoskeletal, haematological, neuropsychiatric and kidney involvement). The results on LN are presented in a separate section. Regarding other manifestations, the SLRs confirmed the paucity of high-quality data for their treatment. For skin disease, belimumab and anifrolumab have documented efficacy in RCTs of their clinical programme; however, belimumab has used the skin component from BILAG, while the more recent TULIP trials of anifrolumab have used the skin-specific Cutaneous Lupus Activity and Damage Index (CLASI) ( table 2 ).

Efficacy of belimumab and anifrolumab on skin disease in SLE

A meta-analysis of six RCTs focusing on skin efficacy of belimumab found a pooled OR of clinical response (BILAG defined) at 52 weeks of 1.44 (95% CI 1.20 to 1.74, I 2 =0%). 27 Clinical response was first noted after 20 weeks of treatment (OR 1.35, 95% CI 1.01 to 1.81, I 2 =0%), sustained through 1 year. In addition, CLASI data for belimumab have been reported in three observational studies (including 62, 67 and 466 patients, respectively), all showing significant reductions from baseline, ranging from 4 to 6 units ( table 2 ). 28–30 Anifrolumab RCTs have used CLASI to assess response; post hoc analyses of both TULIP phase III and the phase II MUSE trial have shown percentage differences in CLASI-A 50 (ie, 50% reduction from baseline) response more than 20% from placebo, almost reaching 30% in MUSE. 22 31 32

Efficacy data on arthritis were more scarce, available only from RCT of belimumab and anifrolumab. The post hoc analysis of the TULIP studies found that anifrolumab was associated with greater percentage of patients achieving ≥50% reduction in active swollen and tender joints (treatment Δ: 12.6% (95% CI 2.4% to 22.9%)). 22 Significant reduction was also noted in a similar analysis of the MUSE phase II study (mean (SD) swollen and tender joint reductions –5.5 (6.3) vs –3.4 (5.9) for placebo, p=0.004). 32 For belimumab, only two small observational, uncontrolled studies (n=81 and 20, respectively) specifically reported a reduction in the number of swollen and tender joints. 33 34

The SLR retrieved very few studies regarding haematological and neuropsychiatric manifestations. For neuropsychiatric SLE (NPSLE), a single meta-analysis on the efficacy of RTX in refractory SLE (including NPSLE) reported a pooled complete response rate of 90% for neuropsychiatric manifestations (95% CI 53% to 99%). 35 No other relevant studies were identified. For immune cytopenias, post hoc analysis of the TULIP trials found a 25% difference in response rate in haematological manifestations, in favour of anifrolumab (56% vs 31% for placebo), but with no further details. 31 A similar analysis of the BLISS trials (published in 2012, thus not included in the current SLR) had not found a difference of belimumab over placebo for haematological manifestations.

Treatment of LN

The SLR identified 98 studies evaluating the efficacy and safety of various treatments in LN. These included 14 meta-analyses (1 of high quality, 9 of low or critically low quality and 4 network meta-analyses), 15 RCTs (5 of low RoB, 6 with some concerns and 4 with high RoB) and 69 studies with other study designs (2 open-label extension studies of RCTs, 2 post hoc studies, 1 integrated analysis and 64 observational studies including 8 prospective cohorts, 53 retrospective cohorts, 2 cross-sectional and 1 case–control study) and varied quality.

14 RCTs (5 head-to-head, 2 dose-comparison and 7 add-on vs placebo trials) involving 2099 LN patients evaluated the efficacy and safety of various drugs as initial treatments for LN ( table 3 ).

Efficacy of initial treatments for LN in RCTs 2018–2022

Regarding comparison of standard of care therapies (CYC and MMF), only two new RCTs, both in Asian LN populations, were identified from the SLR (one with high and one with low RoB). One small RCT of 49 LN patients with impaired kidney function (mean±SD baseline serum creatinine 1.58±1.38 mg/dL) showed similar efficacy between CYC (monthly pulses of 0.5–1 g/m 2 for 6 months) and low-dose MMF (1.5 g/day) after 24 weeks of treatment (19.0% vs 28.6%, p=0.572). 36 In a second RCT, a low versus high dose of intravenous CYC (low dose: six fortnightly intravenous CYC pulses of 500 mg, high dose: 4 weekly six cycles of 750 mg/m 2 ), both followed by AZA, were administered in 38 and 37 patients, respectively. After 52 weeks, patients in the high-dose group had significantly increased rates of complete/partial response (50% vs 73%, p=0.04) and fewer relapses (3% vs 24%, p=0.01) compared with the low-dose group, with no difference in infection rates and death. 37 Although this study was designated as low RoB, it was nevertheless open-label and the sample size was relatively small.

Five RCTs (2 with low RoB, 2 with some concerns and 1 with high RoB) explored the effect of CNIs, either as monotherapy or in combination with MMF, against CYC/MMF. 5 38–41 In an open-label non-inferiority (margin 15%) RCT of 299 LN patients, tacrolimus (TAC) was non-inferior to CYC in terms of complete and partial response after 24 weeks of treatment. When the individual components of response were investigated, TAC was associated with a significant decrease in estimated glomerular filtration rate (eGFR), counterbalanced by greater reductions in proteinuria compared with CYC. 38 Similarly, in another RCT of 83 patients with proliferative LN who received 1:1 TAC or MMF followed by AZA, both arms had comparable remission rates at 12 months (46.3% vs 57.1% p=0.3). 39 Regarding long-term outcomes, TAC was non-inferior to MMF in a study of 150 patients who were previously randomised to TAC or MMF as induction treatment and AZA as maintenance. 42 After 10 years, the TAC group had similar relapse rates compared with MMF and there was also no difference in a composite outcome (reduction in eGFR≥30%, chronic kidney disease stage 4/5 or death). As in the previous SLR, no RCT was identified assessing the role of CNI as monotherapy in proliferative LN in non-Asian populations. In a meta-analysis of trials in Asian populations, TAC outperformed CYC in terms of complete response (OR 2.41 95% CI 1.46 to 3.99, based on seven studies), but had a similar effect when compared with MMF (OR 0.95 95% CI 0.54 to 1.64, based on three studies). 43 Similar results were reported in two recent network meta-analyses. 44 45

Three RCTs investigated the efficacy of multitarget therapy (CNI in combination with MMF, two using voclosporin and one using TAC) compared with MMF or CYC, all pointing towards better response rates with the multitarget treatment. 5 40 41 In AURA-LV, a phase II multicentre RCT, 267 patients were randomised 1:1:1 to receive either voclosporin (23.7 or 39.5 mg, each two times per day) or placebo, in combination with MMF (2 g/day) and low dose GC. At 24 weeks, patients on low-dose voclosporin had significantly increased complete response rates (defined as urine protein-to-creatinine ratio (UPCr) <0.5 mg/mg, an eGFR>60 mL/min/1.73 m 2 or no decrease of ≥20% of baseline eGFR, no administration of rescue medication and no more than 10 mg prednisone equivalent per day for 3 or more consecutive days or for 7 or more days during weeks 44–52) compared with placebo (OR 2.03, 95% CI 1.01 to 4.05); in terms of safety, voclosporin was associated with higher rates of adverse events and death. 41 The AURORA trial was a phase III multicentre RCT involving 357 LN patients with class III, IV, V or mixed classes. Patients were randomly assigned to voclosporin (23.7 mg two times per day) or placebo in addition to 2 g/day of MMF and low-dose GCs and were followed for 52 weeks. Complete renal response (defined as in AURA-LV) was achieved in significantly more patients in the voclosporin group than placebo (41% vs 23%, OR 2.65 95% CI 1.64 to 4.27), while both groups had similar eGFR and safety profile during follow-up. Importantly, subgroup analysis showed no benefit from the introduction of voclosporin in class V or when the dose of MMF exceeded 2 g/day. 5 An integrated analysis of pooled data from phases II and III voclosporin trials, as well as a long-term extension study of the AURORA trial (the latter published after the completion of the present SLR) corroborated the previous findings in efficacy and safety. 46 47 In another small (n=56), open-label RCT with longer follow-up (72 weeks), combination treatment with TAC (0.06–0.08 mg/kg/day) and MMF (20–30 mg/kg/day) was superior to intravenous CYC (0.5–0.75 g/m monthly for 6 months) in terms of renal response (81.5% vs 57.7%, p<0.05) and kidney function (mean ± SD serum creatinine 56.7±32.1 vs 72.5±32.5, p 0.019). 40

Four RCTs evaluated the efficacy and safety of biologic agents added to background immunosuppressive therapy. Two phase III trials investigated the add-on effect of belimumab (one of low RoB and the other with some concerns), one phase II trial investigated the add-on effect of anifrolumab (RoB with some concerns) and another phase II RCT investigated the add-on effect of obinutuzumab (low RoB). In the Belimumab International Study in Lupus Nephritis (BLISS-LN), a phase III, double-blind, placebo-controlled trial, 448 patients were randomly assigned to intravenous belimumab (10 mg/kg/month) or placebo added to standard therapy (ie, six pulses of intravenous CYC 500 mg every 2 weeks followed by AZA, or MMF (3 g/day) plus GC 0.5–1 mg/kg/day as initial dose). 4 Patients were stratified according to induction treatment and race. The primary endpoint assessed at 104 weeks was the primary efficacy renal response (PERR) defined as UPCr≤0.7 g/g, eGFR no worse than 20% below the preflare value or at least 60 mL/min/1.73 m 2 and no use of rescue therapy. More patients in the belimumab group achieved PERR compared with placebo at 104 weeks (43% vs 32% OR 1.6 95%CI 1.0 to 2.3). 4 In a secondary analysis, patients with class 5 or with a UPCr>3 g/g did not benefit from the addition of belimumab, in terms of PERR. However, the risk of a 30% and 40% decline in eGFR and the risk of flare were significantly less in patients receiving belimumab. 48 The CALIBRATE study was a phase II open-label RCT in patients with refractory or relapsing LN, assessing the safety and potential benefit from the addition of belimumab to a background treatment of RTX and intravenous CYC. 49 Although the addition of belimumab did not increase adverse events, patients on belimumab and placebo had similar response rates (52% vs 41%, p=0.4). The phase II double-blinded TULIP-LN study randomised 147 patients with biopsy-proven proliferative LN in a 1:1:1 ratio to receive either monthly 300 mg of intravenous anifrolumab (basic regimen), 900 mg of intravenous anifrolumab for 3 doses and 300 mg thereafter (intensified regimen (IR)) or placebo on top of MMF (2 g/day) and GC. 50 The primary endpoint (change in UPCr at week 52 for combined anifrolumab vs placebo) was not met; however, when the two anifrolumab arms were analysed separately, more patients in the IR achieved complete response compared with placebo (45.5% and 31.1% respectively). Importantly, safety concerns were raised due to an increased incidence of VZV infection in the combined anifrolumab groups versus placebo (16.7% vs 8.2%). In another phase II RCT, 125 LN patients were randomly assigned to obinutuzumab, a humanised type 2 anti-CD20 monoclonal antibody, or placebo in addition to MMF and GC. 51 After 52 and 104 weeks significantly more patients in the obinutuzumab group achieved complete response (UPCr<0.5, normal renal function without worsening of baseline serum creatinine by >15% and inactive urinary sediment) compared with placebo (35% vs 23%, p=0.1 and 41% vs 23%, p=0.026, respectively).

This SLR identified only one trial (RoB with some concerns) that was specifically designed to compare different drugs as maintenance treatments. In this RCT, 215 patients with biopsy-proven LN who had previously received intravenous CYC plus GC and achieved remission were randomised 1:1 to leflunomide (20 mg/day) or AZA (100 mg/day) for 36 months. The primary endpoint, time to kidney flare, was similar between groups (16 vs 14 months, p=0.67), and there was no difference in safety profile. 52

Remission, low disease activity and associations with favourable outcomes in SLE

PICO 2 focused on the short-term and long-term benefits of attainment of treatment targets, both in extrarenal SLE and LN. The current SLR identified observational studies in which both remission (defined either per the recent Definition of Remission in SLE (DORIS) definition 53 or earlier definitions) and low disease activity (mainly defined as the lupus low disease activity state (LLDAS) 54 ) are associated with reduced risk for damage accrual ( table 4 ), as well as disease flares and other adverse sequelae (death, serious infections and hospitalisations, online supplemental table S4.4 ). In studies of good quality, range of OR for an increase in SDI were 0.49–0.75 for remission and 0.19–0.88 for LLDAS, versus patients not attaining these targets. Similarly, observational studies in LN examining the association between complete remission at variable time-points and favourable long-term kidney outcomes are shown in online supplemental table S4.5

Association of attainment of remission or LLDAS with risk for damage accrual

Safety of treatment tapering in SLE

PICO 4 addressed the issue of safety of tapering and/or withdrawal of immunosuppressive treatment in patients with SLE who have quiescent disease. Studies were categorised according to tapering of (1) GC, (2) immunosuppressive drugs and (3) antimalarials. For GC, a randomised study (CORTICOLUP) found higher rate of flares in patients with SLE on chronic prednisone 5 mg/day who discontinued GC, versus those who continued this dose. 55 A meta-analysis reported a pooled incidence of 24% (95% CI 21 to 27) and 13% (95% CI 8 to 18) for global and major flares, respectively, following GC withdrawal 56 ; a different meta-analysis focusing on risk factors found an increased risk for flare in serologically active, clinically quiescent disease after GC withdrawal (OR 1.78, 95% CI 1.00 to 3.15), while HCQ use trended towards decreased risk of flare, however results were not statistically significant (OR 0.50, 95% CI 0.23 to 1.07). Individual observational studies of the current SLR are shown in table 5 and support that gradual tapering to discontinuation of GC may be achieved without increasing the risk for flares, especially with slow tapering and long-standing remission prior to complete withdrawal (although most of these did not have a control patient group which did not discontinue GC).

Studies evaluating tapering and withdrawal of glucocorticoids in patients with SLE

Contrary to GC, although a similar RCT of withdrawal versus continuation has not been performed, discontinuation of antimalarials is more frequently associated with increased risk of flares. Four observational studies addressed this issue. Large observational studies from the multicentre Systemic Lupus International Collaborating Clinics (SLICC) cohort, 57 the Toronto Lupus cohort, 58 as well as five other SLE cohorts in Canada, 59 reported higher rates of disease flares in patients with SLE who stopped HCQ compared with patients who continued, with HR ranging from 1.56 57 to 2.30. 58 Tapering HCQ to a lower dose seems to be associated with a lower risk for flare, as patients in the Toronto cohort who tapered had significantly fewer flares versus abrupt discontinuation (45.9% vs 72.6%; p=0.01), 58 while the respective risk for flare in the SLICC study for those with HCQ dose reduction was 1.20 (95% CI 1.04 to 1.38) compared with patients who continued. 57

Finally, regarding withdrawal of synthetic immunosuppressive drugs, a limited number of studies have been published, mainly in LN. The Weaning of Immunosuppressive Therapy in Lupus Nephritis (WIN-Lupus) study randomised 96 patients with proliferative LN in remission after 2–3 years of immunosuppression to treatment discontinuation versus maintenance. 60 Relapses of LN (27.3% vs 12.5%), as well as severe disease flares (31.8% vs 12.5%), were significantly more common in the discontinuation group. An Italian uncontrolled observational study reported a 22.9% relapse rate (19/83 patients) in LN patients who discontinued immunosuppression. Antimalarial treatment and longer duration of remission (>3 years) at the time of therapy withdrawal were associated with lower risk of LN relapse. 61

Safety of herpes zoster and SARS-CoV2 vaccination in SLE

The final PICO focused on prevention of specific infections in SLE, namely VZV and COVID-19, rather than on general preventive measures for infections (vaccinations, etc), for which specific EULAR recommendations exist and are regularly updated. 7 These particular infections were chosen, because of the impact of zoster on patients with SLE (in view also of the potential increased risk with new therapies, such as interferon inhibitors), 62 and the public health problem imposed by the COVID pandemic, most obvious in populations with immunosuppression. 63

Regarding efficacy and safety of the zoster vaccine in patients with SLE, we identified three studies assessing the newer recombinant, adjuvanted vaccine (Shingrix) in patients with systemic autoimmune diseases, which also included a small subset with SLE. A study in 403 patients (16 with SLE) found a flare rate of 7.1% in the SLE group (all were mild), as well as one zoster breakthrough case. 64 Another study on 622 patients (24 with SLE) reported mild flares in 4/24 patients with SLE (17%), all treated only with GC. 65 The third, larger study, using two claims databases from the USA to estimate recombinant zoster vaccination among adults aged≥50 years with systemic autoimmune diseases and possible vaccine-related flares, found no statistically significant increase in flares for any autoimmune disease following either dose of recombinant vaccine (more than 4500 patients with SLE in the two databases, risk ratio for flare in the risk window vs control window 0.9–1.0 in this group). 66 Formerly, the live attenuated vaccine (Zostavax) was tested in a single, high-quality RCT in 90 quiescent patients with SLE (plus 10 healthy controls), testing VZV IgG reactivity and safety at 6 weeks. 67 Both anti-VZV IgG and T-cell spots increased significantly in herpes zoster-vaccinated patients, in a similar magnitude to healthy controls, while only two patients experienced a mild/moderate flare.

Regarding the immunogenicity and safety of SARS-CoV2 vaccination in patients with SLE, the SLR identified a significant number of studies ( online supplemental table S4.6 ). A meta-analysis, including 32 studies and 8269 patients in total, tested clinical effectiveness (ie, prevention from COVID-19), immunogenicity and safety, and found a pooled seropositivity rate 81.1% following various anti-SARS-CoV2 vaccine formulations (higher with mRNA vaccines), very rare severe adverse events (<1%), as well as a cumulative flare rate 5.5% 68 ; however, moderate or severe flares were reported only in 0%–2% of patients in all but one studies ( online supplemental table S4.6 ). Additionally, seven studies addressed the influence of concomitant or background immunosuppression on vaccine immunogenicity ( online supplemental table S4.7 ). As shown in these studies, concomitant use of MMF, RTX and possible GC was associated with lower patient ability to mount immune responses to SARS-CoV2 vaccination.

For the recent update of the EULAR recommendations for the management of SLE, we performed five different SLRs based on respective PICOs, to cover the most important aspects in the treatment of this challenging disease.

HCQ is the backbone treatment for all patients with SLE, while GC are still used in the majority of patients. The current SLR confirmed the beneficial effects of HCQ in lupus, ranging from prevention of infections or thrombosis to improved survival. Regarding retinal toxicity, although studies seem to converge to longer duration of use and higher cumulative dose as major risk factors for this complication, the actual rate of this complication had wide variation among studies, possibly in part due to different screening techniques used and definitions applied. We did not document other major safety signals. On the contrary, the current SLR confirmed the correlation of chronic GC use with multiple adverse outcomes in SLE (eg, susceptibility to infections, osteonecrosis, irreversible damage, among others). It should be noted that the recommended lowering of the maximum maintenance dose to 5 mg/day (instead of 7.5 mg/day) was not based on a randomised trial comparing the safety of these two different maintenance doses. Nevertheless, most observational studies that tested threshold daily prednisone doses in relation to adverse events pointed to the 5 mg/day, as well as to a stronger association with increasing doses (see table 1 ).

For the use of conventional and biologic immunosuppressive drugs in extrarenal SLE, the approved biologics anifrolumab and belimumab have proven efficacy in the form of high-quality RCTs with low RoB, compared with standard of care. Importantly, RCTs have become more elaborate in recent years, because in the anifrolumab studies, organ-specific endpoints, such as the CLASI and tender/swollen joint counts, were applied (belimumab studies had used SLEDAI and BILAG domains). RCTs are not available for conventional immunosuppressive agents in extrarenal SLE and are unlikely to be performed in the future due to the long experience with the everyday use of the drugs. Additionally, there are very few comparative studies between different immunosuppressive agents, (MTX, AZA, MMF, etc) all prior to the starting date of the current SLR.

Regarding the treatment of LN, equal efficacy of standard of care treatment, MMF and CYC, was again confirmed in additional comparative studies, mainly of low quality. More importantly, two high-quality RCTs with low RoB led to the approval of belimumab and voclosporin for the treatment of active LN. 4 5 These RCTs were the largest that have been performed in LN to date, and the BLISS-LN additionally used a novel response definition (PERR) and used an extended time-point at 2 years (all other RCTs of ‘induction’ therapies in LN have tested efficacy at 6 or 12 months). Post hoc analyses of both BLISS-LN and AURORA did not find a statistically significant benefit of any of the drugs in class 5 LN, but patients with this histologic class represented less than 20% of the study population in both studies; belimumab was also found to perform better in patients with baseline proteinuria less than 3 g/day.

For treatment targets of SLE, our SLR provided robust evidence for the positive association of remission and LLDAS with lower risk for multiple adverse outcomes, including damage ( table 4 ), flares, mortality and hospitalisation. Although the two states are comparable in terms of prognosis, data point towards slightly lower odds for damage accrual for remission over LLDAS; on the other hand, LLDAS is achieved more frequently than DORIS remission. The prognostic significance of both conditions has been tested in longitudinal cohorts of patients receiving routine care. Interestingly, a randomised trial has been designed to test whether a ‘treat-to-target’ approach aiming at remission or LLDAS confers additional benefit over standard of care. 69

Two randomised studies, CORTICOLUP and WIN-LUPUS, tested the discontinuation of prednisone (CORTICOLUP) and immunosuppressive agents (WIN-LUPUS) in extrarenal SLE and LN, respectively. 55 60 Although both studies found higher rates of relapse in patients that discontinued treatment, and withstanding their limitations (eg, CORTICOLUP was criticised for the abrupt—rather than more gradual—stopping of prednisone from 5 mg/day), they have opened the way for similar trials in SLE. A number of cohort studies have been reported with successful discontinuation, especially of GC, without an increased risk for flare in the majority of patients.

Some methodological considerations of our work merit explanation. Since high-quality studies are lacking for most organ manifestations of SLE, we adopted an inclusive approach during article screening and selection, in order to capture evidence from observational and non-controlled studies for topics where RCTs are absent or scarce. This led to inclusion of a large number of studies (n=439), many of which had limited contribution to the conclusions regarding drug efficacy for specific manifestations. This issue is particularly relevant for conventional immunosuppressive drugs, which are often used to treat extrarenal lupus manifestations, but lack support from randomised evidence. With improved trial design and approval of new drugs (mainly biologics), we anticipate that SLR for future updates of SLE recommendations will focus more on RCTs and high-quality observational studies with low RoB. Additionally, our SLR did not include the EMBASE database, and Medline was partially captured through PubMed. We acknowledge that this may have led to omission of some studies, nevertheless the multiple sources used for our SLR (PubMed, Cochrane, hand search of references of included studies) has reduced the possibility of leaving out significant studies.

In conclusion, the dedicated SLRs that supported the update of the EULAR recommendations for the management of SLE found high-quality data for the efficacy of biologic agents in treating the disease (anifrolumab and belimumab) and for the new treatment options in LN (RCT with low RoB for belimumab and voclosporin), but low-to-moderate quality concerning most other aspects of the disease. Additionally, treatment targets, such as remission and low disease activity, show a robust and consistent association with several favourable outcomes, supporting their establishment as the goal of therapy in SLE. Studies (some of them randomised) addressing the issue of treatment tapering in lupus patients in remission have also been published since the previous recommendations, following the paradigm of rheumatoid arthritis and spondylarthritis.

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Acknowledgments.

We wish to acknowledge the support of the EULAR Quality of Care Committee and express our sincere appreciation and gratitude to the EULAR Secretariat, especially Simona Lupatin, executive assistant and to Dora Togia for the outstanding organisation and coordination.

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Supplementary materials

Supplementary data.

This web only file has been produced by the BMJ Publishing Group from an electronic file supplied by the author(s) and has not been edited for content.

• Data supplement 1

Handling editor Kimme L Hyrich

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Contributors MK and AF drafted the manuscript, CBM, GB and DTB edited the manuscript, and AF provided the final version. AF acts as the guarantor responsible for the overall content of the manuscript.

Funding This study was supported by the European League Against Rheumatism (project number QoC015).

Competing interests AF reports honoraria and/or consulting fees from Lilly, Boehringer, Novartis, AbbVie, AstraZeneca, GSK, MSD, Pfizer, UCB, Amgen, Aenorasis, support for attending meetings from UCB. MK reports honoraria and/or consulting fees from GSK, participation in advisory boards from GSK, AstraZeneca, Amgen. GB reports grants from GSK, AstraZeneca, Pfizer, honoraria and/or consulting fees from Lilly, Aenorasis, Novartis, AstraZeneca, GSK, SOBI, Pfizer, participation in advisory boards from Novartis. DTB reports unrestricted investigational grants from GSK, honoraria and/or consulting fees from GSK, AstraZeneca, Pfizer. CBM declares no conflict of interest.

Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.

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Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.

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The effect of corporate risk management on cyber risk mitigation: Evidence from the insurance industry

• Published: 22 May 2024

Cite this article

• Kwangmin Jung   ORCID: orcid.org/0000-0002-5615-8865 1 ,
• Chanjin Kim 2 &
• Jiyeon Yun 3  

We examine how corporate risk management can be used to address a firm’s vulnerability to cyber risk. We use a large, novel dataset on cyber risk and corporate risk management to analyse US insurers’ cyber loss events during the period of 2000–2021. Our analysis includes information on whether insurers have implemented an enterprise risk management (ERM) programme and whether they report applying cyber risk management (CRM). The results illustrate that the implementation of CRM measures may have no significant effect on cyber risk mitigation. However, we determine that the likelihood (frequency) of a cyber loss event decreases by 3.9% (6.8%) as ERM programmes mature year on year. We also find that an insurer can benefit from implementing both CRM and ERM through a lowered event likelihood (frequency) of 3.8 percentage points on average (3.7 percentage points) per year compared to solely implementing an ERM programme.

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According to PwC’s 24th Annual Global CEO Survey in 2021, nearly half of respondents (47%) are extremely concerned about cyber risks. Higher response rates are observed in North America, Europe and Asia–Pacific (PwC 2021 ).

Note that following prior literature on ERM (see, e.g. Liebenberg and Hoyt 2003 ; Berry-Stölzle and Xu 2018 ), we use multiple terms interchangeably throughout the paper, to represent (1) the ERM system and (2) the action of implementing ERM. For the first case, ERM programme and ERM framework are used; for the second case, ERM adoption and ERM implementation are applied.

One may argue that there is an association between the ERM and CRM indicators. Our approaches to measuring an insurer’s ERM and CRM initiatives are heterogeneous in that CRM has been investigated through insurers’ financial reports, in which their CRM initiatives tend to be structurally described, whereas ERM has been studied with a keyword search that was proposed in the relevant literature. The search method for ERM has been discussed in the research thread in which the claim is made that the keywords used in such studies can cover the landscape of firms’ ERM implementations (see, e.g. Hoyt and Liebenberg 2011 ; Eckles et al. 2014 ; Eastman et al. 2023 ). Evidence that partially addresses the lack of a significant association between our ERM and CRM indicators can be found in Gatzert and Schubert ( 2022 ), where the impact of CRM, as defined in our study, is still statistically significant on firm value, as proxied by Tobin’s Q , without a loss of magnitude, even when the ERM measure defined similarly to that of Hoyt and Liebenberg ( 2011 ) is also considered (see Gatzert and Schubert 2022 , Table A9). Note that their results also show a statistically significant impact of ERM on Tobin’s Q .

Gatzert and Schubert ( 2022 ) engage in empirical studies to understand the cyber risk consciousness in the financial services industry in the U.S. and determine that U.S. insurers tend to have higher consciousness of cyber risks than U.S. banks. This implies that examining the insurance industry may be an optimal exploration of the effect of ERM programmes on CRM.

To reduce this gap, the National Institute of Standard and Technology (NIST) has provided guidelines to encourage firms to integrate cybersecurity risks into their ERM programmes (Stine et al. 2020 ).

Lechner and Gatzert ( 2018 ) examine all three strands of the ERM literature, and their results support the literature findings by showing the statistical significance of the impacts of firm specifics (e.g. firm size, industry sector or financial leverage) on ERM engagement and confirm the impact of ERM on firm value.

The proposed model of the study helps predict the frequency of cyberattacks by considering several corporate characteristic variables with a probit regression analysis, which is in line with our approach.

Gatzert and Schubert ( 2022 ) discuss firms having different levels of CRM implementation and that such differences can lead to heterogeneous reactions to cyber risks. Analysing firms’ financial reports, the authors categorise the levels of cyber risk postures into four types: (1) a limited action within the framework of operational risk management (referred to as CyberRM 1a); (2) the action of implementing a guideline or measure of CRM (referred to as CyberRM 1b); (3) the presence of a comprehensive framework for CRM (referred to as CyberRM 1c); and (4) no action taken for CRM (referred to as CyberRM 0). The authors find that the number of financial firms implementing the second level in their sample is approximately 73%, which is a much larger portion than the other types (4% for comprehensive framework, 5% for part of operational risk management and 18% for no action). This finding leads us to examine and compare the most used measure of CRM with that of ERM.

An alternative approach to measuring ERM quality is the use of Standard & Poor’s (S&P) published opinion on ERM practices. The rating of S&P offers information on how firms implement ERM, however, it does not address the entire landscape of ERM-running firms, which can result in selection bias (Hoyt and Liebenberg 2011 ). To ensure a consistent measure of ERM quality for all firms in our sample, we utilise age as a proxy for risk management maturity. That is, firms are expected to be able to better manage risks as their ERM programmes mature.

Anderson and Moore ( 2006 ) discuss information and communication systems (i.e. information security infrastructure) operating via organic connections of multiple systems. If one system is cyber-threatened, other connected systems can also be affected. In addition, they argue that many companies can be exposed to cyber risks if widely distributed software (e.g. Google Chrome, Microsoft Windows) comes under cyber threat. The authors point out that insurers may have difficulty in pricing cyber insurance due to such interconnectedness and the interdependence of cyber risks.

Kamiya et al. ( 2021 ) find that the impacts of corporate governance features, such as CEO–chair duality, the proportion of outside directors on the board and board size, are not statistically significant in predicting the likelihood of cyberattacks. Other studies have shown that corporate governance motives may also influence firm decisions to adopt ERM (see, e.g. Lundqvist 2015 ), implying that such motives can be inherent in the measure of ERM. In our case, the searched keywords are closely associated with corporate governance, for example, the presence of a Chief Risk Officer or Enterprise Risk Officer (see " Keyword search approach and data " section for more detail). We thus do not further control for corporate governance measures in this study.

This bias indicates that there may be omitted variable bias regarding the decision to adopt CRM and ERM in estimating Eqs. ( 1 )–( 3 ).

We incorporate these binary variables to control for external factors driving the adoption of CRM and ERM, which take a value of 1 in the years corresponding to each event and 0 otherwise.

SOX imposes stringent requirements on publicly traded firms for reporting, disclosure and internal controls and specifies penalties for non-compliance.

CISA provides the necessary infrastructure for companies to conduct CRM, thus facilitating cybersecurity management.

Since the probit model assumes that the error term follows a standard normal distribution, the Inverse Mills Ratio should be generated from the estimates of the probit model, and the logistic model cannot be utilised (Heckman 1979 ).

As described in " Literature review and hypothesis development " section, we adopt the definition of category 1b proposed by Gatzert and Schubert ( 2022 ) for our CRM dataset, since firms implementing this category address most cases. Given that information technology is currently used in a wide range of areas worldwide and in most industries, most companies consider CRM to some degree. Therefore, we seek evidence that illustrates insurers' interest in CRM through more specific expressions. We also exclude high-level definitions to distinguish from holistic and enterprise-level CRM. For the list of 188 words and phrases, refer to Gatzert and Schubert ( 2022 , Table 1 in Appendix A).

While building a reliable measure of ERM may be challenging (McShane et al. 2011 ), the keyword search method has been widely employed in the major strand of ERM research despite the possibility of firms underreporting this issue (see, e.g. Hoyt and Liebenberg 2011 ; Eckles et al. 2014 ; Lechner and Gatzert 2018 ; Gatzert and Schubert 2022 ). An alternative approach to measuring ERM is the use of S&P published opinions on ERM practices; however, this provides only a few cases, which can lead to selection bias (Hoyt and Liebenberg 2011 ). To ensure a consistent measure of ERM implementation, we utilise the key word search method.

Cyber loss events in our analysis indicate data breaches that contain privacy, sensitive and confidential data (primarily in the PRC dataset) as well as those that accrue legal liability due to cyber loss events, loss or damage to information assets, restitution, loss of recourse and write-down costs (provided in the SAS dataset). In this regard, our dataset handles a wider cyber loss landscape than that of Kamiya et al. ( 2021 ), who only use data breach events caused by cyberattacks.

Specifically, we follow the search and identification strategy of Eling and Wirfs ( 2019 ) to filter cyber cases. For more detail, see Eling and Wirfs ( 2019 , Appendix B), which describes the three criteria (critical asset, actor and outcome) associated with cyber risk.

Following Kamiya et al. ( 2021 ) who use the same cyber loss dataset, we do not consider the proportional hazards model in the probit model of the second stage due to the potential of multiple events occurring for the same insurer (i.e. doubly censored cases).

In line with previous studies (see, e.g. Hoyt and Liebenberg 2011 ; Grace et al. 2015 ; Gatzert and Schubert 2022 ), we restrict our sample to publicly traded insurance companies in the U.S. By focusing on publicly traded firms, we facilitate easier identification of CRM and ERM implementation through public disclosures and media coverage. There are several advantages to concentrating on the insurance sector. First, focusing on a single industry provides a uniform sample, thereby minimising heterogeneity and the potential differences observable from regulatory and industry effects. Second, we choose insurance companies rather than other corporations as they conduct business in risk management and are thus expected to quickly recognise the advantages of risk management frameworks, such as CRM and ERM, and implement them successfully. Finally, as the financial industry is subject to various regulations and supervision, we can generally assume a high level of transparency and quality of information on existing risks and risk management processes in annual reports and press releases.

We also check for the presence of multicollinearity between variables by looking at the correlation coefficients (see “ Appendix ”) and variance inflation factors (VIF). We find no evidence to show the violation of the classical assumption with low correlation, and the VIF is less than 10 in all cases.

On average, ERM or CRM adopters are larger, have a higher percentage of institutional ownership and have smaller stock return volatility from the prior year. We further find that ERM adopters have higher leverage, but CRM adopters have lower leverage.

The results of the Wald and F -tests support the suitability of all estimated coefficients in all columns.

We also consider a model using interaction variables between the binary of risk management activities (i.e. CRM, ERM and IRM) and firm size to verify the statistical significance of such variables. We find statistical evidence only for CRM, where the variables of risk management, size and their interaction are all significant. This case illustrates that large insurers with CRM implementation can reduce their cyber loss events; however, the size effect increasing the loss probability still dominates the amount of reduction.

We calculate the size of reduction in the loss probability with the parsimonious model incorporating significant variables, whose inputs are their median values to ensure robustness in the face of extreme cases. We compute the change in loss probability from the cumulative density function of the standard normal distribution in Eq. ( 7 ) for all two consecutive years of ERM age and take the average of the changes.

The size of reduction in loss frequency is derived from the transformation of Eq. ( 8 ), where we take the size of the decrease between 100% and the result of the exponential function applying to the estimated coefficient (i.e. \(1-{{\text{e}}}^{-0.070}\approx 0.068\) ).

The results of the log-likelihood ratio test confirm that the models that include the treatment variable have a higher explanatory power compared to those without it in all columns. The results of the Wald and F -tests confirm the suitability of the estimated coefficients shown in all columns.

Note that we find no statistical significance of the variables of industrial and international diversification regarding their impacts on cyber risk vulnerability. Specifically, we employ industrial and international diversification to control firm complexity and diversification (Hoyt and Liebenberg 2011 ), where industrial diversification indicates the number of different types of business segments and international diversification addresses whether to have positive sales outside of North America. Although insurers with either more business lines or internationally profitable business may face higher exposure to cyber risks, our results show no evidence for such a hypothesis in any of the model specifications on CRM, ERM and IRM.

We again take the parsimonious model with significant variables to calculate the size of the effect of the IRM implementation, as addressed in Footnote 28.

We use Eq. ( 8 ) to obtain the size of the decrease between 100% and the result of the exponential function applying to the estimated coefficient (i.e. \(1-{{\text{e}}}^{-0.111}\approx 0.105\) ).

As a robustness check for this finding, we test the models with the interaction term of ERM and CRM variables and identify the statistically significant effect of simultaneous risk management actions (ERM and CRM) on cyber risk mitigation. This result supports our main finding on the effect of the IRM and can be provided upon request.

As in the CRM and ERM effect models, the results of the log-likelihood ratio test again support the claim that models including the treatment variable have a higher explanatory power compared to those without in all columns. The results of the Wald and F -tests confirm the suitability of all estimated coefficients in all columns.

We further examine potential reverse causality by controlling a one-period lagged variable of cyber loss event (i.e. \({\mathrm{Cyber\, Event}}_{i,t-1}\) and \({\delta }_{i,t-1}\) in the formulas of " Model framework " section) in all models. We obtain identical results to those of our main findings by showing that the effects of ERM and IRM are statistically significant. These results can be provided upon request.

Logistic and probit regression approaches are both used to model a binary outcome to capture the probability of either value. The key difference between the two approaches is the type of link function for the mean of the dependent variable, where the logistic regression imposes a logit function and the probit model requires an inverse Gaussian under the assumption on the Gaussian as the underlying distribution (Long and Freese 2006 , Chap. 4).

This may lead to a potential measurement error in our dependent variable, which could result in a higher error variance. However, this potential error can be absorbed in the disturbance of the regression (Greene 2003 , p. 84).

US states have imposed data breach notification laws at different timepoints. Some states implemented such laws prior to 2006 and some have done so only within the last decade (Jung 2021 ). On the other hand, the general data protection regulation (GDPR) for data breach notification has been in effect in the EU since 2018, which can be expected to make extensive information on data breach events publicly available.

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Jung, K., Kim, C. & Yun, J. The effect of corporate risk management on cyber risk mitigation: Evidence from the insurance industry. Geneva Pap Risk Insur Issues Pract (2024). https://doi.org/10.1057/s41288-024-00326-z

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Gluten: A Benefit or Harm to the Body?

The quick answer is that it can be either, but it all depends on the individual.

What is Gluten?

Gluten is a protein naturally found in some  grains  including wheat, barley, and rye. It acts like a binder, holding food together and adding a “stretchy” quality—think of a pizza maker tossing and stretching out a ball of dough. Without gluten, the dough would rip easily.

Other grains that contain gluten are wheat berries, spelt, durum, emmer, semolina, farina, farro, graham, khorasan wheat, einkorn, and triticale (a blend of wheat and rye). Oats—though naturally gluten free—often contain gluten from cross-contamination when they are grown near, or  processed in the same facilities as the grains listed above. Gluten is also sold as wheat gluten, or seitan, a popular vegan high-protein food. Less obvious sources of gluten include soy sauce and modified food starch, however gluten-free options of these products are available and labeled as such to comply with the U.S. Food and Drug Administration’s gluten-free labeling rule.

Gluten and Health Benefits

Gluten is most often associated with wheat and wheat-containing foods that are abundant in our food supply. Negative media attention on wheat and gluten has caused some people to doubt its place in a healthful diet. There is little published research to support these claims; in fact published research suggests the opposite.

In a 2017 study of over 100,000 participants without celiac disease, researchers found no association between long-term dietary gluten consumption and heart disease risk. [1] In fact, the findings also suggested that non-celiac individuals who avoid gluten may increase their risk of heart disease, due to the potential for reduced consumption of whole grains.

• Many studies have linked whole grain consumption with improved health outcomes. For example, groups with the highest intakes of whole grains including wheat (2-3 servings daily) compared with groups eating the lowest amounts (less than 2 servings daily) were found to have significantly lower rates of heart disease and stroke, development of type 2 diabetes, and deaths from all causes. [2-5]

Gluten may also act as a prebiotic, feeding the “good” bacteria in our bodies. Arabinoxylan oligosaccharide is a prebiotic carbohydrate derived from wheat bran that has been shown to stimulate the activity of bifidobacteria in the colon. These bacteria are normally found in a healthy human gut. Changes in their amount or activity have been associated with gastrointestinal diseases including inflammatory bowel disease, colorectal cancer, and irritable bowel syndrome. [6,7]

When Gluten Is a Problem

What’s not great about gluten is that it can cause serious side effects in certain individuals. Some people react differently to gluten, where the body senses it as a toxin, causing one’s immune cells to overreact and attack it. If an unknowingly sensitive person continues to eat gluten, this creates a kind of battle ground resulting in inflammation. The side effects can range from mild (fatigue, bloating, alternating constipation and diarrhea) to severe (unintentional weight loss, malnutrition, intestinal damage) as seen in the autoimmune disorder celiac disease . Estimates suggest that 1 in 133 Americans has celiac disease, or about 1% of the population, but about 83% of them are undiagnosed or misdiagnosed with other conditions. [8,9] Research shows that people with celiac disease also have a slightly higher risk of osteoporosis and anemia (due to malabsorption of calcium and iron, respectively); infertility; nerve disorders; and in rare cases cancer. [10] The good news is that removing gluten from the diet may reverse the damage. A gluten-free diet is the primary medical treatment for celiac disease. However, understanding and following a strict gluten-free diet can be challenging, possibly requiring the guidance of a registered dietitian to learn which foods contain gluten and to ensure that adequate nutrients are obtained from gluten-free alternatives. Other conditions that may require the reduction or elimination of gluten in the diet include:

• Non-celiac gluten sensitivity, also referred to as gluten sensitive enteropathy (GSE) or gluten intolerance —An intolerance to gluten with similar symptoms as seen with celiac disease, but without the accompanying elevated levels of antibodies and intestinal damage. There is not a diagnostic test for GSE but is determined by persistent symptoms and a negative diagnostic celiac test.
• Wheat allergy —An allergy to one or more of the proteins (albumin, gluten, gliadin, globulin) found in wheat, diagnosed with positive immunoglobulin E blood tests and a food challenge. Compare this with celiac disease, which is a single intolerance to gluten. Symptoms range from mild to severe and may include swelling or itching of the mouth or throat, hives, itchy eyes, shortness of breath, nausea, diarrhea, cramps, and anaphylaxis. People who test negative for this condition may still have gluten sensitivity. This condition is most often seen in children, which most outgrow by adulthood.
• Dermatitis herpetiformis (DH) —A skin rash that results from eating gluten. It is an autoimmune response that exhibits itself as a persistent red itchy skin rash that may produce blisters and bumps. Although people with celiac disease may have DH, the reverse is not always true.

It is important to note that gluten is a problem only for those who react negatively to it, or test positive for celiac disease. Most people can and have eaten gluten most of their lives, without any adverse side effects.

Does gluten cause brain fog?

But does this side effect occur in people without a true gluten intolerance, and can the reverse be suggested in that the avoidance of gluten might sharpen the mind? A large cohort study disagrees. Almost 13,500 middle-aged women from the Nurses’ Health Study II without celiac disease were followed for 28 years to observe any potential links between gluten intake and mental ability. [15]   No significant differences were found in cognitive scores (measuring reaction time, attention, memory, etc.) comparing women with the highest and lowest gluten intakes. The lack of association remained even after excluding women with a dementia or cancer diagnosis.

Unless a person has diagnosed celiac disease, a wheat allergy, or a gluten sensitivity, current evidence does not support that eating gluten increases inflammation in the brain or negatively affects brain health.

What Is a “Gluten-Free Diet”?

This is essentially a diet that removes all foods containing or contaminated with gluten . However, since gluten-containing whole grains contain fiber and nutrients including B vitamins , magnesium , and iron , it’s important to make up for these missing nutrients. Along with consuming naturally gluten-free foods in their whole form like fruits , vegetables , legumes, nuts , seeds, fish, eggs , and poultry, the following whole grains are also inherently gluten-free:

• Brown, black, or red rice
• Gluten-free oats

It’s also key not to rely on processed gluten-free foods that may be high in calories, sugar, saturated fat, and sodium and low in nutrients, such as gluten-free cookies, chips, and other snack foods. Often, these foods are made with processed unfortified rice, tapioca, corn, or potato flours.

The gluten-free food industry has grown 136% from 2013 to 2015 with almost $12 billion in sales in 2015. Interestingly, studies show that people who do not have celiac disease are the biggest purchasers of gluten-free products. [11] Consumer surveys show that the top three reasons people select gluten-free foods are for “no reason,” because they are a “healthier option,” and for “digestive health.” [12] For those who are not gluten-intolerant, there is no data to show a specific benefit in following a gluten-free diet, particularly if processed gluten-free products become the mainstay of the diet. In fact, research following patients with celiac disease who change to a gluten-free diet shows an increased risk of obesity and metabolic syndrome. This could be partly due to improved intestinal absorption, but speculation has also focused on the low nutritional quality of processed gluten-free foods that may contain refined sugars and saturated fats and have a higher glycemic index. [13,14]

• Diet Review: Gluten-Free for Weight Loss
• Whole Grains
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• Liu S, Stampfer MJ, Hu FB, et al. Whole-grain consumption and risk of coronary heart disease: results from the Nurses’ Health Study. Am J Clin Nutr . 1999;70:412-9.
• Mellen PB, Walsh TF, Herrington DM. Whole grain intake and cardiovascular disease: a meta-analysis. Nutr Metab Cardiovasc Dis . 2008;18:283-90.
• de Munter JS, Hu FB, Spiegelman D, Franz M, van Dam RM. Whole grain, bran, and germ intake and risk of type 2 diabetes: a prospective cohort study and systematic review. PLoS Med . 2007;4:e261.
• Johnsen, N.F., et al. Whole-grain products and whole-grain types are associated with lower all-cause and cause-specific mortality in the Scandinavian HELGA cohort. British Journal of Nutrition , 114(4), 608-23.
• Neyrinck, A.M., et al. Wheat-derived arabinoxylan oligosaccharides with prebiotic effect increase satietogenic gut peptides and reduce metabolic endotoxemia in diet-induced obese mice. Nutr Diabetes . 2012 Jan; 2(1): e28.
• Tojo, R., et al. Intestinal microbiota in health and disease: role of bifidobacteria in gut homeostasis. World J Gastroenterol . 2014 Nov 7;20(41):15163-76.
• Beyond Celiac. Celiac Disease: Fast Facts https://www.beyondceliac.org/celiac-disease/facts-and-figures/ Accessed 4/1/2017.
• Riddle, M.S., Murray, J.A., Porter, C.K. The Incidence and Risk of Celiac Disease in a Healthy US Adult Population. Am J Gastroenterol . 2012;107(8):1248-1255.
• N., Freeman, H.J., Thomson, A.B.R. Celiac disease: Prevalence, diagnosis, pathogenesis and treatment. World J Gastroenterol . 2012 Nov 14; 18(42): 6036–6059.
• Topper A. Non-celiacs Drive Gluten-Free Market Growth. Mintel Group Ltd. Web. http://www.mintel.com/blog/food-market-news/gluten-free-consumption-trends . Accessed Mar 27, 2017.
• Reilly, N.R. The Gluten-Free Diet: Recognizing Fact, Fiction, and Fad. The Journal of Pediatrics. Volume 175, August 2016, pages 206–210.
• Tortora, R., et al. Metabolic syndrome in patients with celiac disease on a gluten-free diet. Aliment Pharmacol Ther . 2015 Feb;41(4):352-9.
• Kabbani, T.A., et al. Body mass index and the risk of obesity in coeliac disease treated with the gluten-free diet. Aliment Pharmacol Ther . 2012 Mar;35(6):723-9.
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