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Neal Haddaway

October 19th, 2020, 8 common problems with literature reviews and how to fix them.

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Literature reviews are an integral part of the process and communication of scientific research. Whilst systematic reviews have become regarded as the highest standard of evidence synthesis, many literature reviews fall short of these standards and may end up presenting biased or incorrect conclusions. In this post, Neal Haddaway highlights 8 common problems with literature review methods, provides examples for each and provides practical solutions for ways to mitigate them.

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Researchers regularly review the literature – it’s an integral part of day-to-day research: finding relevant research, reading and digesting the main findings, summarising across papers, and making conclusions about the evidence base as a whole. However, there is a fundamental difference between brief, narrative approaches to summarising a selection of studies and attempting to reliably and comprehensively summarise an evidence base to support decision-making in policy and practice.

So-called ‘evidence-informed decision-making’ (EIDM) relies on rigorous systematic approaches to synthesising the evidence. Systematic review has become the highest standard of evidence synthesis and is well established in the pipeline from research to practice in the field of health . Systematic reviews must include a suite of specifically designed methods for the conduct and reporting of all synthesis activities (planning, searching, screening, appraising, extracting data, qualitative/quantitative/mixed methods synthesis, writing; e.g. see the Cochrane Handbook ). The method has been widely adapted into other fields, including environment (the Collaboration for Environmental Evidence ) and social policy (the Campbell Collaboration ).

Despite the growing interest in systematic reviews, traditional approaches to reviewing the literature continue to persist in contemporary publications across disciplines. These reviews, some of which are incorrectly referred to as ‘systematic’ reviews, may be susceptible to bias and as a result, may end up providing incorrect conclusions. This is of particular concern when reviews address key policy- and practice- relevant questions, such as the ongoing COVID-19 pandemic or climate change.

These limitations with traditional literature review approaches could be improved relatively easily with a few key procedures; some of them not prohibitively costly in terms of skill, time or resources.

In our recent paper in Nature Ecology and Evolution , we highlight 8 common problems with traditional literature review methods, provide examples for each from the field of environmental management and ecology, and provide practical solutions for ways to mitigate them.

There is a lack of awareness and appreciation of the methods needed to ensure systematic reviews are as free from bias and as reliable as possible: demonstrated by recent, flawed, high-profile reviews. We call on review authors to conduct more rigorous reviews, on editors and peer-reviewers to gate-keep more strictly, and the community of methodologists to better support the broader research community. Only by working together can we build and maintain a strong system of rigorous, evidence-informed decision-making in conservation and environmental management.

Note: This article gives the views of the authors, and not the position of the LSE Impact Blog, nor of the London School of Economics. Please review our comments policy if you have any concerns on posting a comment below

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About the author

Neal Haddaway is a Senior Research Fellow at the Stockholm Environment Institute, a Humboldt Research Fellow at the Mercator Research Institute on Global Commons and Climate Change, and a Research Associate at the Africa Centre for Evidence. He researches evidence synthesis methodology and conducts systematic reviews and maps in the field of sustainability and environmental science. His main research interests focus on improving the transparency, efficiency and reliability of evidence synthesis as a methodology and supporting evidence synthesis in resource constrained contexts. He co-founded and coordinates the Evidence Synthesis Hackathon (www.eshackathon.org) and is the leader of the Collaboration for Environmental Evidence centre at SEI. @nealhaddaway

Why is mission creep a problem and not a legitimate response to an unexpected finding in the literature? Surely the crucial points are that the review’s scope is stated clearly and implemented rigorously, not when the scope was finalised.

Pingback: Quick, but not dirty – Can rapid evidence reviews reliably inform policy? | Impact of Social Sciences

#9. Most of them are terribly boring. Which is why I teach students how to make them engaging…and useful.

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Eight problems with literature reviews and how to fix them

Affiliations.

1 Mercator Research Institute on Climate Change and Global Commons, Berlin, Germany. [email protected].
2 Stockholm Environment Institute, Stockholm, Sweden. [email protected].
3 Africa Centre for Evidence, University of Johannesburg, Johannesburg, South Africa. [email protected].
4 College of Medicine and Health, Exeter University, Exeter, UK.
5 Department of Zoology, University of Cambridge, Cambridge, UK.
6 School of Biological Sciences, University of East Anglia, Norwich, UK.
7 Department of Biological Sciences, Royal Holloway University of London, Egham, UK.
8 Stockholm Environment Institute, Stockholm, Sweden.
9 Department of Zoology, University of Oxford, Oxford, UK.
10 Collaboration for Environmental Evidence, UK Centre, School of Natural Sciences, Bangor University, Bangor, UK.
11 Liljus ltd, London, UK.
12 Department of Forest Sciences, University of Helsinki, Helsinki, Finland.
13 Evidence Synthesis Lab, School of Natural and Environmental Sciences, University of Newcastle, Newcastle-upon-Tyne, UK.
PMID: 33046871
DOI: 10.1038/s41559-020-01295-x

Traditional approaches to reviewing literature may be susceptible to bias and result in incorrect decisions. This is of particular concern when reviews address policy- and practice-relevant questions. Systematic reviews have been introduced as a more rigorous approach to synthesizing evidence across studies; they rely on a suite of evidence-based methods aimed at maximizing rigour and minimizing susceptibility to bias. Despite the increasing popularity of systematic reviews in the environmental field, evidence synthesis methods continue to be poorly applied in practice, resulting in the publication of syntheses that are highly susceptible to bias. Recognizing the constraints that researchers can sometimes feel when attempting to plan, conduct and publish rigorous and comprehensive evidence syntheses, we aim here to identify major pitfalls in the conduct and reporting of systematic reviews, making use of recent examples from across the field. Adopting a 'critical friend' role in supporting would-be systematic reviews and avoiding individual responses to police use of the 'systematic review' label, we go on to identify methodological solutions to mitigate these pitfalls. We then highlight existing support available to avoid these issues and call on the entire community, including systematic review specialists, to work towards better evidence syntheses for better evidence and better decisions.

Environment
Research Design
Systematic Reviews as Topic*

Advantages and disadvantages of literature review

This comprehensive article explores some of the advantages and disadvantages of literature review in research. Reviewing relevant literature is a key area in research, and indeed, it is a research activity in itself. It helps researchers investigate a particular topic in detail. However, it has some limitations as well.

What is literature review?

In order to understand the advantages and disadvantages of literature review, it is important to understand what a literature review is and how it differs from other methods of research. According to Jones and Gratton (2009) a literature review essentially consists of critically reading, evaluating, and organising existing literature on a topic to assess the state of knowledge in the area. It is sometimes called critical review.

A literature review is a select analysis of existing research which is relevant to a researcher’s selected topic, showing how it relates to their investigation. It explains and justifies how their investigation may help answer some of the questions or gaps in the chosen area of study (University of Reading, 2022).

A literature review is a term used in the field of research to describe a systematic and methodical investigation of the relevant literature on a particular topic. In other words, it is an analysis of existing research on a topic in order to identify any relevant studies and draw conclusions about the topic.

A literature review is not the same as a bibliography or a database search. Rather than simply listing references to sources of information, a literature review involves critically evaluating and summarizing existing research on a topic. As such, it is a much more detailed and complex process than simply searching databases and websites, and it requires a lot of effort and skills.

Advantages of literature review

Information synthesis

A literature review is a very thorough and methodical exercise. It can be used to synthesize information and draw conclusions about a particular topic. Through a careful evaluation and critical summarization, researchers can draw a clear and comprehensive picture of the chosen topic.

Familiarity with the current knowledge

According to the University of Illinois (2022), literature reviews allow researchers to gain familiarity with the existing knowledge in their selected field, as well as the boundaries and limitations of that field.

Creation of new body of knowledge

One of the key advantages of literature review is that it creates new body of knowledge. Through careful evaluation and critical summarisation, researchers can create a new body of knowledge and enrich the field of study.

Answers to a range of questions

Literature reviews help researchers analyse the existing body of knowledge to determine the answers to a range of questions concerning a particular subject.

Disadvantages of literature review

Time consuming

As a literature review involves collecting and evaluating research and summarizing the findings, it requires a significant amount of time. To conduct a comprehensive review, researchers need to read many different articles and analyse a lot of data. This means that their review will take a long time to complete.

Lack of quality sources

Researchers are expected to use a wide variety of sources of information to present a comprehensive review. However, it may sometimes be challenging for them to identify the quality sources because of the availability of huge numbers in their chosen field. It may also happen because of the lack of past empirical work, particularly if the selected topic is an unpopular one.

Descriptive writing

One of the major disadvantages of literature review is that instead of critical appreciation, some researchers end up developing reviews that are mostly descriptive. Their reviews are often more like summaries of the work of other writers and lack in criticality. It is worth noting that they must go beyond describing the literature.

Key features of literature review

Clear organisation

A literature review is typically a very critical and thorough process. Universities usually recommend students a particular structure to develop their reviews. Like all other academic writings, a review starts with an introduction and ends with a conclusion. Between the beginning and the end, researchers present the main body of the review containing the critical discussion of sources.

No obvious bias

A key feature of a literature review is that it should be very unbiased and objective. However, it should be mentioned that researchers may sometimes be influenced by their own opinions of the world.

Proper citation

One of the key features of literature review is that it must be properly cited. Researchers should include all the sources that they have used for information. They must do citations and provide a reference list by the end in line with a recognized referencing system such as Harvard.

To conclude this article, it can be said that a literature review is a type of research that seeks to examine and summarise existing research on a particular topic. It is an essential part of a dissertation/thesis. However, it is not an easy thing to handle by an inexperienced person. It also requires a lot of time and patience.

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Neal Robert Haddaway works for the Stockholm Environment Institute and the Mercator Research Institute on Global Commons and Climate Change. He receives funding from the Alexander von Humboldt Foundation, Mistra, Formas, and Vinnova. He is also an honorary Research Associate at the Africa Centre for Evidence at the University of Johannesburg.

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Researchers regularly review the literature that’s generated by others in their field. This is an integral part of day-to-day research: finding relevant research, reading and digesting the main findings, summarising across papers, and making conclusions about the evidence base as a whole.

However, there is a fundamental difference between brief, narrative approaches to summarising a selection of studies and attempting to reliably, comprehensively summarise an evidence base to support decision-making in policy and practice.

So-called “evidence-informed decision-making” relies on rigorous systematic approaches to synthesising the evidence. Systematic review has become the highest standard of evidence synthesis. It is well established in the pipeline from research to practice in several fields including health , the environment and social policy . Rigorous systematic reviews are vital for decision-making because they help to provide the strongest evidence that a policy is likely to work (or not). They also help to avoid expensive or dangerous mistakes in the choice of policies.

But systematic review has not yet entirely replaced traditional methods of literature review. These traditional reviews may be susceptible to bias and so may end up providing incorrect conclusions. This is especially worrying when reviews address key policy and practice questions.

The good news is that the limitations of traditional literature review approaches could be improved relatively easily with a few key procedures. Some of these are not prohibitively costly in terms of skill, time or resources. That’s particularly important in African contexts, where resource constraints are a daily reality, but should not compromise the continent’s need for rigorous, systematic and transparent evidence to inform policy.

In our recent paper in Nature Ecology and Evolution , we highlighted eight common problems with traditional literature review methods. We gave examples for each problem, drawing from the field of environmental management and ecology. Finally, we outlined practical solutions.

These are the eight problems we identified in our paper .

First, traditional literature reviews can lack relevance. This is because limited stakeholder engagement can lead to a review that is of limited practical use to decision-makers.

Second, reviews that don’t publish their methods in an a priori (meaning that it is published before the review work begins) protocol may suffer from mission creep. In our paper we give the example of a 2019 review that initially stated it was looking at all population trends among insects. Instead, it ended up focusing only on studies that showed insect population declines. This could have been prevented by publishing and sticking to methods outlined in a protocol.

Third, a lack of transparency and replicability in the review methods may mean that the review cannot be replicated . Replicability is a central tenet of the scientific method.

Selection bias is another common problem. Here, the studies that are included in a literature review are not representative of the evidence base. A lack of comprehensiveness, stemming from an inappropriate search method, can also mean that reviews end up with the wrong evidence for the question at hand.

Traditional reviews may also exclude grey literature . This is defined as any document

produced on all levels of government, academics, business and industry in print and electronic formats, but which is not controlled by commercial publishers, i.e., where publishing is not the primary activity of the producing body.

It includes organisational reports and unpublished theses or other studies . Traditional reviews may also fail to test for evidence of publication bias; both these issues can result in incorrect or misleading conclusions. Another common error is to treat all evidence as equally valid. The reality is that some research studies are more valid than others. This needs to be accounted for in the synthesis.

Inappropriate synthesis is another common issue. This involves methods like vote-counting, which refers to tallying studies based on their statistical significance. Finally, a lack of consistency and error checking (as would happen when a reviewer works alone) can introduce errors and biases if a single reviewer makes decisions without consensus .

All of these common problems can be solved, though. Here’s how.

Stakeholders can be identified, mapped and contacted for feedback and inclusion without the need for extensive budgets. Best-practice guidelines for this process already exist .

Researchers can carefully design and publish an a priori protocol that outlines planned methods for searching, screening, data extraction, critical appraisal and synthesis in detail. Organisations like the Collaboration for Environmental Evidence have existing protocols from which people can draw.

Researchers also need to be explicit and use high-quality guidance and standards for review conduct and reporting . Several such standards already exist .

Another useful approach is to carefully design a search strategy with an info specialist; to trial the search strategy against a benchmark list; and to use multiple bibliographic databases, languages and sources of grey literature. Researchers should then publish their search methods in an a priori protocol for peer review.

Researchers should consider carefully planning and trialling a critical appraisal tool before starting the process in full, learning from existing robust critical appraisal tools . Critical appraisal is the carefully planned assessment of all possible risks of bias and possible confounders in a research study. Researchers should select their synthesis method carefully, based on the data analysed. Vote-counting should never be used instead of meta-analysis. Formal methods for narrative synthesis should be used to summarise and describe the evidence base.

Finally, at least two reviewers should screen a subset of the evidence base to ensure consistency and shared understanding of the methods before proceeding. Ideally, reviewers should conduct all decisions separately and then consolidate.

Collaboration

Collaboration is crucial to address the problems with traditional review processes. Authors need to conduct more rigorous reviews. Editors and peer reviewers need to gate-keep more strictly. The community of methodologists needs to better support the broader research community.

Working together, the academic and research community can build and maintain a strong system of rigorous, evidence-informed decision-making in conservation and environmental management – and, ultimately, in other disciplines.

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Published: 12 October 2020

Eight problems with literature reviews and how to fix them

Neal R. Haddaway ORCID: orcid.org/0000-0003-3902-2234 1 , 2 , 3 ,
Alison Bethel 4 ,
Lynn V. Dicks 5 , 6 ,
Julia Koricheva ORCID: orcid.org/0000-0002-9033-0171 7 ,
Biljana Macura ORCID: orcid.org/0000-0002-4253-1390 2 ,
Gillian Petrokofsky 8 ,
Andrew S. Pullin 9 ,
Sini Savilaakso ORCID: orcid.org/0000-0002-8514-8105 10 , 11 &
Gavin B. Stewart ORCID: orcid.org/0000-0001-5684-1544 12

Nature Ecology & Evolution volume 4 , pages 1582–1589 ( 2020 ) Cite this article

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An Author Correction to this article was published on 19 October 2020

This article has been updated

Traditional approaches to reviewing literature may be susceptible to bias and result in incorrect decisions. This is of particular concern when reviews address policy- and practice-relevant questions. Systematic reviews have been introduced as a more rigorous approach to synthesizing evidence across studies; they rely on a suite of evidence-based methods aimed at maximizing rigour and minimizing susceptibility to bias. Despite the increasing popularity of systematic reviews in the environmental field, evidence synthesis methods continue to be poorly applied in practice, resulting in the publication of syntheses that are highly susceptible to bias. Recognizing the constraints that researchers can sometimes feel when attempting to plan, conduct and publish rigorous and comprehensive evidence syntheses, we aim here to identify major pitfalls in the conduct and reporting of systematic reviews, making use of recent examples from across the field. Adopting a ‘critical friend’ role in supporting would-be systematic reviews and avoiding individual responses to police use of the ‘systematic review’ label, we go on to identify methodological solutions to mitigate these pitfalls. We then highlight existing support available to avoid these issues and call on the entire community, including systematic review specialists, to work towards better evidence syntheses for better evidence and better decisions.

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An amendment to this paper has been published and can be accessed via a link at the top of the paper.

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Haddaway, N. R. Open Synthesis: on the need for evidence synthesis to embrace Open Science. Environ. Evid. 7 , 26 (2018).

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Acknowledgements

We thank C. Shortall from Rothamstead Research for useful discussions on the topic.

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Neal R. Haddaway

Stockholm Environment Institute, Stockholm, Sweden

Neal R. Haddaway & Biljana Macura

Africa Centre for Evidence, University of Johannesburg, Johannesburg, South Africa

College of Medicine and Health, Exeter University, Exeter, UK

Alison Bethel

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Lynn V. Dicks

School of Biological Sciences, University of East Anglia, Norwich, UK

Department of Biological Sciences, Royal Holloway University of London, Egham, UK

Julia Koricheva

Department of Zoology, University of Oxford, Oxford, UK

Gillian Petrokofsky

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Andrew S. Pullin

Liljus ltd, London, UK

Sini Savilaakso

Department of Forest Sciences, University of Helsinki, Helsinki, Finland

Evidence Synthesis Lab, School of Natural and Environmental Sciences, University of Newcastle, Newcastle-upon-Tyne, UK

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Examples of literature reviews and common problems identified.

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Haddaway, N.R., Bethel, A., Dicks, L.V. et al. Eight problems with literature reviews and how to fix them. Nat Ecol Evol 4 , 1582–1589 (2020). https://doi.org/10.1038/s41559-020-01295-x

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Eight problems with literature reviews and how to fix them

Systemic reviews have been introduced as a more rigorous approach to synthesizing evidence, compared to traditional approaches, but their methods are often poorly applied. Using examples, this article aims to identify major pitfalls in the conduct and reporting of systematic reviews.

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Haddaway, N. R., Bethel, A., Dicks, L. V., Koricheva, J., Macura, B., Petrokofsky, G., Pullin, A. S., Savilaakso, S. and Stewart, G. B. (2020). Eight problems with literature reviews and how to fix them. Nature Ecology & Evolution. 1–8. DOI: 10.1038/s41559-020-01295-x

10.1038/s41559-020-01295-x

Despite the increasing popularity of systematic reviews in the environmental field, evidence synthesis methods continue to be poorly applied in practice, resulting in the publication of syntheses that are highly susceptible to bias. Recognizing the constraints that researchers can sometimes feel when attempting to plan, conduct and publish rigorous and comprehensive evidence syntheses, this article aims to identify major pitfalls in the conduct and reporting of systematic reviews, making use of recent examples from across the field.

Adopting a “critical friend” role in supporting would-be systematic reviews and avoiding individual responses to police use of the “systematic review” label, the authors go on to identify methodological solutions to mitigate these pitfalls. They then highlight existing support available to avoid these issues and call on the entire community, including systematic review specialists, to work towards better evidence syntheses for better evidence and better decisions.

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Primary Research

Literature Review

Methodology
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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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Next: Methodology >>
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Literature Reviews

What is a literature review?
Steps in the Literature Review Process
Define your research question
Determine inclusion and exclusion criteria
Choose databases and search
Review Results
Synthesize Results
Analyze Results
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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.

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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.

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Conducting a literature review: why do a literature review, why do a literature review.

How To Find "The Literature"
Found it -- Now What?

Besides the obvious reason for students -- because it is assigned! -- a literature review helps you explore the research that has come before you, to see how your research question has (or has not) already been addressed.

You identify:

core research in the field
experts in the subject area
methodology you may want to use (or avoid)
gaps in knowledge -- or where your research would fit in

It Also Helps You:

Publish and share your findings
Justify requests for grants and other funding
Identify best practices to inform practice
Set wider context for a program evaluation
Compile information to support community organizing

Great brief overview, from NCSU

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Strengths and Weaknesses of Systematic Reviews

Automate every stage of your literature review to produce evidence-based research faster and more accurately.

Systematic reviews are considered credible sources since they are comprehensive, reproducible, and precise in stating the outcomes. The type of review system used and the approach taken depend on the goals and objectives of the research. To choose the best-suited review system, researchers must be aware of the strengths and weaknesses of each one.

Let us now look at the strengths and limitations of systematic reviews.

Strengths Of Systematic Reviews

Systematic reviews have become increasingly popular owing to their transparency, accuracy, replicability, and reduced risk of bias. Some of the main benefits of systematic reviews are;

Specificity

Researchers can answer specific research questions of high importance. For example, the efficacy of a particular drug in the treatment of an illness.

Explicit Methodology

A systematic review requires rigorous planning. Each stage of the review is predefined to the last detail. The research question is formulated using the PICO (population, intervention, comparison, and outcome) approach. A strict eligibility criteria is then established for inclusion and exclusion criteria for selecting the primary studies for the review. Every stage of the systematic review methodology is pre-specified to the last detail and made publicly available, even before starting the review process. This makes all the stages in the methodology transparent and reproducible.

Reliable And Accurate Results

The results of a systematic review are either analyzed qualitatively and presented as a textual narrative or quantitatively using statistical methods such as meta-analyses and numeric effect estimates. The quality of evidence or the confidence in effect estimates is calculated using the standardized GRADE approach.

Comprehensive And Exhaustive

A systematic review involves a thorough search of all the available data on a certain topic. It is exhaustive and considers every bit of evidence in synthesizing the outcome. Primary sources for the review are collected from databases and multiple sources, such as blogs from pharmaceutical companies, unpublished research directly from researchers, government reports, and conference proceedings. These are referred to as grey literature. The search criteria and keywords used in sourcing are specific and predefined.

Reproducible

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Weaknesses Of Systematic Reviews

Although systematic reviews are robust tools in scientific research they are not immune to errors. They can be misleading, or even harmful if the data is inappropriately handled or if they are biased. Some of the limitations of systematic reviews include:

Mass Production

Due to the popularity systematic reviews have gained, they tend to be used more than required. The growth rate of systematic reviews has outpaced the growth rate of studies overall. This results in redundancy. For example, a survey published in the BMJ[1], included 73 randomly selected meta-analyses published in 2010 found that for two-thirds of these studies, there was at least one, and sometimes as many as 13, additional meta-analyses published on the same topic by early 2013.

Risk of Bias

Although systematic reviews have many advantages, they are also more susceptible to certain types of biases. A bias is a systematic or methodological error that causes misrepresentation of the study outcomes. As bias can appear at any stage, authors should be aware of the specific risks at each stage of the review process. Most of the known errors in systematic reviews arise in the selection and publication stages. The eligibility criterion in a systematic review helps to avoid selection bias. Poor study design and execution can also result in a biased outcome. It’s important to learn about the types of bias in systematic reviews .

Expressing Strong Opinions by Stealth

Selective outcome reporting is a major threat to a systematic review. The author or reviewer may decide to only report a selection of the statistically significant outcomes that suit his interest. The possibility of unfair or misleading interpretation of evidence outcomes in a systematic review can have serious implications.

Like any review system, systematic reviews have their advantages and disadvantages. Understanding them is essential to making a choice of which review system to use.

Overlapping meta-analyses on the same topic: survey of published studies. BMJ 2013; 347:f4501

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Published: 04 September 2016

Improving the peer review of narrative literature reviews

Jennifer A. Byrne 1 , 2

Research Integrity and Peer Review volume 1 , Article number: 12 ( 2016 ) Cite this article

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As the size of the published scientific literature has increased exponentially over the past 30 years, review articles play an increasingly important role in helping researchers to make sense of original research results. Literature reviews can be broadly classified as either “systematic” or “narrative”. Narrative reviews may be broader in scope than systematic reviews, but have been criticised for lacking synthesis and rigour. The submission of more scientific manuscripts requires more researchers acting as peer reviewers, which requires adding greater numbers of new reviewers to the reviewing population over time. However, whereas there are many easily accessible guides for reviewers of primary research manuscripts, there are few similar resources to assist reviewers of narrative reviews. Here, I summarise why literature reviews are valued by their diverse readership and how peer reviewers with different levels of content expertise can improve the reliability and accessibility of narrative review articles. I then provide a number of recommendations for peer reviewers of narrative literature reviews, to improve the integrity of the scientific literature, while also ensuring that narrative review articles meet the needs of both expert and non-expert readers.

Peer Review reports

Over the past 30 years, the size of the published scientific literature has expanded exponentially [ 1 ]. While it has been argued that this rate of expansion is unsustainable [ 2 ], underlying factors such as greater numbers of scientists and scientific journals [ 3 ] are unlikely to change in the short term. The submission of more manuscripts for publication requires more peer reviewers, yet the current demand for capable, available manuscript reviewers is not being met [ 3 ]. This has serious adverse consequences for the validity of published research and overall trust in science [ 3 ].

Review articles help both experts and non-experts to make sense of the increasing volume of original publications [ 4 , 5 ]. Busy clinicians have a particular reliance upon review articles, because of their constant need for reliable, up-to-date information, yet limited available time [ 6 ]. Literature reviews can also help other content experts such as researchers and policymakers to identify gaps in their own reading and knowledge. However, literature reviews are also sought by readers with little or no prior understanding of the reviewed topic, such as researchers seeking to rapidly triage results from high-throughput analyses and students for whom literature reviews can represent entry points into a new field. For the benefit of both expert and non-expert readers, it is essential that review articles accurately synthesise the relevant literature in a comprehensive, transparent and objective manner [ 7 , 8 ].

Numbers of review articles are increasing in fields where this has been measured [ 4 ], as is the diversity of review types published [ 9 , 10 ]. Although there are now many review sub-types that can be distinguished based upon the literature search, appraisal, synthesis and analysis methods used [ 9 , 10 ], review articles can be broadly classified as either “systematic” or “narrative” [ 5 , 11 ]. Systematic reviews take defined approaches to the identification and synthesis of study findings and include other review sub-types such as evidence maps [ 12 ]. The systematic review is considered to be the gold standard of evidence synthesis, but also carries the potential disadvantages of narrow scope [ 11 ], and requiring more time and resources to prepare and update [ 7 ]. Narrative reviews, also referred to as “traditional reviews” [ 5 ] and “literature reviews” [ 9 ], constitute the majority of review articles published in some fields [ 7 ]. Other review sub-types, such as rapid and scoping reviews also present information in a narrative format [ 9 ]. Narrative reviews have been criticised for rarely employing peer-reviewed methodologies, or duplicate curation of evidence [ 5 ], and for often failing to disclose study inclusion criteria [ 11 ]. Despite these limitations, narrative reviews remain frequent within the literature, as they offer breadth of literature coverage and flexibility to deal with evolving knowledge and concepts [ 11 ]. In this article, I will provide advice regarding the peer review of narrative reviews, and the advice presented aims to be broadly applicable. I will not attempt to provide advice regarding the peer review of systematic reviews [ 13 , 14 ].

Given the broad readership of literature reviews, content and methodology experts as well as reviewers with less directly relevant expertise can play important roles in the peer-review process [ 15 ]. Peer reviewers with related content expertise are best placed to assess the reliability of the information presented, while other reviewers can ensure that this information remains accessible to readers with different levels of prior knowledge. However, whereas there are easily accessible guides for reviewers of primary research manuscripts [ 16 , 17 ], there are few similar resources available for reviewers of literature reviews [ 15 , 18 ]. This article therefore proposes a number of recommendations for peer reviewers (Table 1 ) to ensure that narrative literature review articles make the best possible contributions to their fields, while also meeting their readers’ often diverse needs.

Ask whether the literature review justifies its place in the literature

Lower than expected ratios between numbers of original publications and review articles suggest excessive numbers of reviews in some fields, which may contribute to the very problem that review articles aim to solve [ 4 ]. With rapidly rising publication rates in many fields [ 2 ], even content-expert peer reviewers should check publication databases for similar and/or overlapping review articles as part of the peer-review process. Pre-empting such scrutiny, authors should clearly define the review’s scope and what it intends to achieve [ 8 ]. If there have been other recent reviews of the same or similar topics, the authors should explain how their manuscript is unique. This could be through combining literature from related fields, by updating existing reviews in light of new research evidence [ 8 ], or because published reviews may have been subject to bias. A clear definition of a review’s scope is a recognised tool to reduce evidence selection bias [ 19 ]. Review authors can also define their subject by referring to literature reviews of related topics that will not be explored in depth. These definitions and statements should form part of an overall narrative structure that helps readers to anticipate and understand the information presented [ 20 ].

Ask whether the literature searches conducted were clearly defined

A criticism frequently levelled at traditional or narrative reviews is that they do not always state or follow rules regarding literature searches [ 5 , 7 , 11 ]. Providing evidence that comprehensive literature searches have been conducted, preferably according to pre-defined eligibility criteria [ 19 ], increases confidence that the review’s findings and conclusions are reliable, and have not been subject to selection bias. Ideally, any literature search choices made by the authors should be clearly stated, transparent and reproducible [ 11 ].

Check for citation breadth and balance

Consider whether the authors have cited a comprehensive range of literature or whether they have tended to cite papers that support their own point of view. If there are important papers that have not been cited, suggest to the authors that these be added, and explain why. If only a limited number of articles can be cited due to the journal’s requirements, check that these studies are representative of those available.

Where possible, verify that information has been summarised correctly

Many different types of citation errors can be identified in the research literature [ 21 , 22 ], and these may occur regardless of the journal impact factor [ 22 ]. The increasing size and complexity of primary reports [ 3 ] also render data extraction and summary more challenging. Realistically, it is unlikely that individual peer reviewers will have detailed knowledge of any full review topic [ 19 ]. Nonetheless, if you are a content expert, take time to cross-reference at least some individual statements to citations, for the particular benefit of non-expert readers. If your level of expertise means that you are unable to verify the accuracy of particular sections of the review, you should indicate this to your editor. Peer reviewers can also ask about data extraction methods, if these were not described in the manuscript. Adopting systematic review practices, such as duplicate independent data extraction, or independent data extraction and validation, can reduce content errors and increase reliability [ 19 ].

Check that original references have been cited

Authors sometimes incorrectly cite original studies, both in original manuscripts and reviews [ 23 , 24 ]. While checking the content, ask whether descriptions of original findings were referenced accordingly, as opposed to being incorrectly attributed to reviews [ 23 ].

Consider how studies were critically evaluated

Beyond correct data summary, narrative literature reviews should include critical data appraisal and some level of data synthesis. How this should be done varies according to the review scope and methodology [ 9 , 10 , 19 ]. While some narrative reviews reasonably focus on breadth as opposed to depth of literature coverage [ 10 ], limited or poor data appraisal risks placing undue emphasis on poor quality research [ 9 ]. Evaluating at least some aspects of the methods used by individual studies can improve reliability [ 7 ]. Similarly, ask how the authors have interpreted conflicting findings or studies with apparently outlying results [ 9 , 11 ].

Evaluate whether tables/figures/diagrams support the text

While not all literature reviews need to include figures or tables, these can help to summarise findings and make key messages clearer. Some detailed information may be best presented in tables, with a shorter summary within the text. Tables can improve the availability of quantitative data for cross-checking, better demonstrate the results of qualitative or quantitative data synthesis, and reassure both peer reviewers and readers that comprehensive, objective analyses have been performed. If figures or tables are included, these need to be original; otherwise, the authors need to have obtained permission to reproduce these from an original source.

Consider whether the review will help someone entering the field

Literature reviews are not always read by subject experts, and it is important that the peer-review process considers this. Reviewers who are not direct content experts may valuably request clarification of nomenclature and/or historical issues that may have seemed too obvious for the authors to have explained. Summary diagrams suggested by peer reviewers may help make a literature review more accessible to a broader audience.

Ask whether the review expands the body of knowledge

Ultimately, the goal of a literature review should be to further the body of knowledge [ 18 ]. Extending or developing ideas is clearly a difficult task, and is often the weakest section of a review [ 25 ]. Consider therefore whether the authors have derived and clearly presented new ideas and/or new research directions from any identified knowledge gaps. Having read the manuscript with fresh eyes, peer reviewers may have valuable ideas to contribute.

Do not forget the rules for reviewing manuscripts in general

The review of literature reviews has some particular considerations, but all the usual manuscript review rules also apply, such as managing conflicts of interest and allocating appropriate time [ 16 , 17 ]. Try to separate the assessment of language and grammar from the more important assessment of scientific quality and remain aware that expert reviewers risk bringing their own biases to the peer-review process [ 15 ].

Conclusions

More quality peer reviewers are needed within the scientific community [ 3 ], including those with the capacity and confidence to review narrative literature reviews. Although it has been difficult to identify predictors of peer-reviewer performance and effective training methods, younger reviewer age has been reproducibly associated with better quality manuscript reviews [ 26 , 27 ]. This association suggests that peer reviewers should be recruited relatively early in their careers, and encouraged to participate widely in manuscript review. Associations between younger peer-reviewer age and better manuscript reviews may also highlight the need for regular training, to ensure that the peer-review community remains up-to-date regarding new approaches to editing or reviewing manuscripts. Indeed, a recent industry survey reported that over three quarters of researchers were interested in further reviewer training [ 28 ]. I therefore hope that this article will add to existing resources [ 29 ] to encourage less experienced peer reviewers to extend their efforts towards narrative literature reviews.

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Acknowledgements

I thank Dr Mona Shehata (Princess Margaret Cancer Centre, Toronto, Canada) for discussions, Ms Sarah Frost for critical reading, reviewers of this manuscript for many constructive comments, and reviewers of past publications for feedback which also contributed towards the development of this manuscript.

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JAB drafted, wrote and approved the final manuscript.

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The author declares that she has no competing interests.

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Molecular Oncology Laboratory, Children’s Cancer Research Unit, Kids Research Institute, The Children’s Hospital at Westmead, Locked Bag 4001, Westmead, 2145, NSW, Australia

Jennifer A. Byrne

The University of Sydney Discipline of Child and Adolescent Health, The Children’s Hospital at Westmead, Locked Bag 4001, Westmead, 2145, NSW, Australia

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Correspondence to Jennifer A. Byrne .

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Byrne, J.A. Improving the peer review of narrative literature reviews. Res Integr Peer Rev 1 , 12 (2016). https://doi.org/10.1186/s41073-016-0019-2

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DOI : https://doi.org/10.1186/s41073-016-0019-2

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Conducting a Literature Review

Benefits of conducting a literature review.

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While there might be many reasons for conducting a literature review, following are four key outcomes of doing the review.

Assessment of the current state of research on a topic . This is probably the most obvious value of the literature review. Once a researcher has determined an area to work with for a research project, a search of relevant information sources will help determine what is already known about the topic and how extensively the topic has already been researched.

Identification of the experts on a particular topic . One of the additional benefits derived from doing the literature review is that it will quickly reveal which researchers have written the most on a particular topic and are, therefore, probably the experts on the topic. Someone who has written twenty articles on a topic or on related topics is more than likely more knowledgeable than someone who has written a single article. This same writer will likely turn up as a reference in most of the other articles written on the same topic. From the number of articles written by the author and the number of times the writer has been cited by other authors, a researcher will be able to assume that the particular author is an expert in the area and, thus, a key resource for consultation in the current research to be undertaken.

Identification of key questions about a topic that need further research . In many cases a researcher may discover new angles that need further exploration by reviewing what has already been written on a topic. For example, research may suggest that listening to music while studying might lead to better retention of ideas, but the research might not have assessed whether a particular style of music is more beneficial than another. A researcher who is interested in pursuing this topic would then do well to follow up existing studies with a new study, based on previous research, that tries to identify which styles of music are most beneficial to retention.

Determination of methodologies used in past studies of the same or similar topics. It is often useful to review the types of studies that previous researchers have launched as a means of determining what approaches might be of most benefit in further developing a topic. By the same token, a review of previously conducted studies might lend itself to researchers determining a new angle for approaching research.

Upon completion of the literature review, a researcher should have a solid foundation of knowledge in the area and a good feel for the direction any new research should take. Should any additional questions arise during the course of the research, the researcher will know which experts to consult in order to quickly clear up those questions.

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Title: large language models for cyber security: a systematic literature review.

Abstract: The rapid advancement of Large Language Models (LLMs) has opened up new opportunities for leveraging artificial intelligence in various domains, including cybersecurity. As the volume and sophistication of cyber threats continue to grow, there is an increasing need for intelligent systems that can automatically detect vulnerabilities, analyze malware, and respond to attacks. In this survey, we conduct a comprehensive review of the literature on the application of LLMs in cybersecurity (LLM4Security). By comprehensively collecting over 30K relevant papers and systematically analyzing 127 papers from top security and software engineering venues, we aim to provide a holistic view of how LLMs are being used to solve diverse problems across the cybersecurity domain. Through our analysis, we identify several key findings. First, we observe that LLMs are being applied to a wide range of cybersecurity tasks, including vulnerability detection, malware analysis, network intrusion detection, and phishing detection. Second, we find that the datasets used for training and evaluating LLMs in these tasks are often limited in size and diversity, highlighting the need for more comprehensive and representative datasets. Third, we identify several promising techniques for adapting LLMs to specific cybersecurity domains, such as fine-tuning, transfer learning, and domain-specific pre-training. Finally, we discuss the main challenges and opportunities for future research in LLM4Security, including the need for more interpretable and explainable models, the importance of addressing data privacy and security concerns, and the potential for leveraging LLMs for proactive defense and threat hunting. Overall, our survey provides a comprehensive overview of the current state-of-the-art in LLM4Security and identifies several promising directions for future research.

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Radical Eyes for Equity: Another Cautionary Tale of Education Reform: “Improving Teaching Quality to Compensate for Socio-Economic Disadvantages: A Study of Research Dissemination Across Secondary Schools in England”

Reading Instruction
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Teacher Education, Quality, and Professional Development

Linked in her article for The Conversation is Sally Riordan’s “Improving teaching quality to compensate for socio-economic disadvantages: A study of research dissemination across secondary schools in England.”

This analysis is another powerful cautionary tale about education reform, notably the “science of reading” (SOR) movement sweeping across the US, mostly unchecked.

As I do a close reading of Riordan’s study, you should also note that the foundational failure of the SOR movement driving new and reformed reading legislation in states is that the main claims of the movement are dramatically oversimplified or misleading. I strongly recommend reviewing how these SOR claims are contradicted by a full examination of the research and science currently available on reading acquisition and teaching: Recommended: Fact-checking the Science of Reading, Rob Tierney and P David Pearson .

This close reading is intended to inform directly how and why SOR-based reading legislation is not only misguided but likely causing harm, notably as Riordan addresses, to the most vulnerable populations of students that education reform is often targeting.

First, here is an overview of Riordan’s study:

Similar to public, political, and educator beliefs in the US, “QFT [quality first teaching] is a commonly held belief amongst school staff” in the UK, Riordan found. In other words, despite evidence that student achievement is overwhelmingly linked to out-of-school factors , teacher quality and instructional practices are often the primary if not exclusive levers of education reform designed to closed so-called achievement gaps due to economic inequities.

This belief, however, comes with many problems:

Riordan’s analysis is incredibly important in terms of how the SOR movement and overly simplistic messaging (see Tierney and Pearson) have been translated into reductive legislation, adopting scripted curriculum, and banning or mandating practices that are not, in fact, supported by science or research .

Riordan identifies bureaucracy and simplistic messaging as the sources of implementation failure:

Nonetheless, “[t]his explicit demand [belief in QFT] is an example of the growing pressure on education practitioners to ensure their practices are supported by evidence (of many kinds),” Riordan explains, adding, “School staff believe that high-quality teaching reduces SED attainment gaps and that their belief is backed by research evidence.”

The research/science-to-instruction dynamic is often characterized by narrow citations or cherry-picking evidence : “Because school leaders cited the same references to research evidence to justify very different policies and practices, I conducted a review of the literature that led to these citations.”

One key problem is that while the evidence base may be narrow and “[a]lthough there is agreement that high-quality teaching is important to tackle SED, principles of QFT are nevertheless being implemented in a myriad of ways across secondary schools in England.”

In the US, many scholars have noted that the SOR movement uses “science” rhetoric but depends on anecdotes for evidence; and, in the UK:

Although many school staff (and particularly school leaders) are aware of the EEF resources and believe that there is evidence supporting principles of QFT, no interviewee described this evidence in any further detail. When asked why QFT works, staff reasoned intuitively. The line of reasoning that can be reconstructed from their replies is independent of the research evidence. …This intuitive argument, reasoned by school staff, is limited but I do not challenge its validity. The main point here is that this line of reasoning does not reflect the research evidence (which is described in detail below ‘The weakness of the evidence for QFT’). It is not the strength of the evidence base that has convinced school leaders to implement QFT practices. This highlights the importance of the psychological aspects of bringing research evidence to bear on practice. It also raises the possibility that a message was disseminated that was already widely believed. I turn to this bureaucratic concern next. Improving teaching quality to compensate for socio-economic disadvantages: A study of research dissemination across secondary schools in England

That intuitive urge , again, however, is linked to limited evidence: “Just five studies are being relied upon to disseminate the message that high-quality teaching is the most effective way to reduce SED attainment gaps.”

What may also be driving a misguided reform paradigm is convenience, or a lack of political imagination:

Evidence- or science-based reform, then, tends to be reduced to a “sham” (consider the misleading “miracle” rhetoric around Mississippi , also addressed in Tierney and Pearson):

The unintended consequence is a “misdirection of energy and time of school staff” driven by “pressure to conform to the policies promoted.”

Key to recognize is Riordan identifies that QFT reforms not only fail to close gaps but also cause harm: Some “attempts to improve the quality of teaching are contributing to a large attainment gap,” including: “It is by turning to a more refined measure of SED that we find evidence that the school’s innovations in teaching and learning over the last five years have benefitted its most affluent students most of all.”

Riordan’s conclusion is important and damning:

It has reviewed the wider picture in which school leaders are choosing to implement (or at least justifying the implementation of) particular practices based on a generic message instead of the specific research supporting those practices. The problem here is that the mechanisms operating to connect research with practice are too crude to acknowledge the richness and messiness of social science research. The message, ‘high-quality teaching is the most effective way to support students facing SED’, is too simple to be meaningful. Improving teaching quality to compensate for socio-economic disadvantages: A study of research dissemination across secondary schools in England

For the US, education reform broadly and the SOR movement can also be described as grounded in messages that are “too simple to be meaningful” and thus too simple to be effective and even likely to be harmful.

This blog post has been shared by permission from the author. Readers wishing to comment on the content are encouraged to do so via the link to the original post. Find the original post here:

The views expressed by the blogger are not necessarily those of NEPC.

P.L. Thomas

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An Appraisal

Alice Munro, a Literary Alchemist Who Made Great Fiction From Humble Lives

The Nobel Prize-winning author specialized in exacting short stories that were novelistic in scope, spanning decades with intimacy and precision.

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This black-and-white photo shows a smiling woman with short, thick dark hair sitting in a chair. The woman is wearing a loose fitting, short-sleeve white blouse, the fingers of her right hand holding the end of a long thing chain necklace that she is wearing around her neck. To the woman’s right, we can see part of a table lamp and the table it stands on, and, behind her, a dark curtain and part of a planter with a scraggly houseplant.

By Gregory Cowles

Gregory Cowles is a senior editor at the Book Review.

The first story in her first book evoked her father’s life. The last story in her last book evoked her mother’s death. In between, across 14 collections and more than 40 years, Alice Munro showed us in one dazzling short story after another that the humble facts of a single person’s experience, subjected to the alchemy of language and imagination and psychological insight, could provide the raw material for great literature.

And not just any person, but a girl from the sticks. It mattered that Munro, who died on Monday night at the age of 92, hailed from rural southwestern Ontario, since so many of her stories, set in small towns on or around Lake Huron, were marked by the ambitions of a bright girl eager to leave, upon whom nothing is lost. There was the narrator of “Boys and Girls,” who tells herself bedtime stories about a world “that presented opportunities for courage, boldness and self-sacrifice, as mine never did.” There was Rose, from “The Beggar Maid,” who wins a college scholarship and leaves her working-class family behind. And there was Del Jordan, from “Lives of Girls and Women” — Munro’s second book, and the closest thing she ever wrote to a novel — who casts a jaundiced eye on her town’s provincial customs as she takes the first fateful steps toward becoming a writer.

Does it seem reductive or limiting to derive a kind of artist’s statement from the title of that early book? It shouldn’t. Munro was hardly a doctrinaire feminist, but with implacable authority and command she demonstrated throughout her career that the lives of girls and women were as rich, as tumultuous, as dramatic and as important as the lives of men and boys. Her plots were rife with incident: the threatened suicide in the barn, the actual murder at the lake, the ambivalent sexual encounter, the power dynamics of desire. For a writer whose book titles gestured repeatedly at love (“The Progress of Love,” “The Love of a Good Woman,” “Hateship, Friendship, Courtship, Loveship, Marriage”), her narratives recoiled from sentimentality. Tucked into the stately columns of The New Yorker, where she was a steady presence for decades, they were far likelier to depict the disruptions and snowballing consequences of petty grudges, careless cruelties and base impulses: the gossip that mattered.

Munro’s stories traveled not as the crow flies but as the mind does. You got the feeling that, if the GPS ever offered her a shorter route, she would decline. Capable of dizzying swerves in a line or a line break, her stories often spanned decades with intimacy and sweep; that’s partly what critics meant when they wrote of the novelistic scope she brought to short fiction.

Her sentences rarely strutted or flaunted or declared themselves; but they also never clanked or stumbled — she was an exacting and precise stylist rather than a showy one, who wrote with steely control and applied her ambitions not to language but to theme and structure. (This was a conscious choice on her part: “In my earlier days I was prone to a lot of flowery prose,” she told an interviewer when she won the Nobel Prize in 2013. “I gradually learned to take a lot of that out.”) In the middle of her career her stories started to grow roomier and more contemplative, even essayistic; they could feel aimless until you approached the final pages and recognized with a jolt that they had in fact been constructed all along as intricately and deviously as a Sudoku puzzle, every piece falling neatly into place.

There was a signature Munro tone: skeptical, ruminative, given to a crucial and artful ambiguity that could feel particularly Midwestern. Consider “The Bear Came Over the Mountain,” which — thanks in part to Sarah Polley’s Oscar-nominated film adaptation, “ Away From Her ” (2006) — may be Munro’s most famous story; it details a woman’s descent into senility and her philandering husband’s attempt to come to terms with her attachment to a male resident at her nursing home. Here the husband is on a visit, confronting the limits of his knowledge and the need to make peace with uncertainty, in a characteristically Munrovian passage:

She treated him with a distracted, social sort of kindness that was successful in holding him back from the most obvious, the most necessary question. He could not demand of her whether she did or did not remember him as her husband of nearly 50 years. He got the impression that she would be embarrassed by such a question — embarrassed not for herself but for him. She would have laughed in a fluttery way and mortified him with her politeness and bewilderment, and somehow she would have ended up not saying either yes or no. Or she would have said either one in a way that gave not the least satisfaction.

Like her contemporary Philip Roth — another realist who was comfortable blurring lines — Munro devised multilayered plots that were explicitly autobiographical and at the same time determined to deflect or undermine that impulse. This tension dovetailed happily with her frequent themes of the unreliability of memory and the gap between art and life. Her stories tracked the details of her lived experience both faithfully and cannily, cagily, so that any attempt at a dispassionate biography (notably, Robert Thacker’s scholarly and substantial “Alice Munro: Writing Her Lives,” from 2005) felt at once invasive and redundant. She had been in front of us all along.

Until, suddenly, she wasn’t. That she went silent after her book “Dear Life” was published in 2012, a year before she won the Nobel, makes her passing now seem all the more startling — a second death, in a way that calls to mind her habit of circling back to recognizable moments and images in her work. At least three times she revisited the death of her mother in fiction, first in “The Peace of Utrecht,” then in “Friend of My Youth” and again in the title story that concludes “Dear Life”: “The person I would really have liked to talk to then was my mother,” the narrator says near the end of that story, in an understated gut punch of an epitaph that now applies equally well to Munro herself, but she “was no longer available.”

Gregory Cowles is the poetry editor of the Book Review and senior editor of the Books desk. More about Gregory Cowles

Open access
Published: 13 May 2024

High-dose naloxone formulations are not as essential as we thought

Paige M. Lemen 1 , 2 ,
Daniel P. Garrett 1 ,
Erin Thompson 3 ,
Megan Aho 3 ,
Christina Vasquez 3 , 4 &
Ju Nyeong Park 3 , 4

Harm Reduction Journal volume 21 , Article number: 93 ( 2024 ) Cite this article

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Naloxone is an effective FDA-approved opioid antagonist for reversing opioid overdoses. Naloxone is available to the public and can be administered through intramuscular (IM), intravenous (IV), and intranasal spray (IN) routes. Our literature review investigates the adequacy of two doses of standard IM or IN naloxone in reversing fentanyl overdoses compared to newer high-dose naloxone formulations. Moreover, our initiative incorporates the experiences of people who use drugs, enabling a more practical and contextually-grounded analysis. The evidence indicates that the vast majority of fentanyl overdoses can be successfully reversed using two standard IM or IN dosages. Exceptions include cases of carfentanil overdose, which necessitates ≥ 3 doses for reversal. Multiple studies documented the risk of precipitated withdrawal using ≥ 2 doses of naloxone, notably including the possibility of recurring overdose symptoms after resuscitation, contingent upon the half-life of the specific opioid involved. We recommend distributing multiple doses of standard IM or IN naloxone to bystanders and educating individuals on the adequacy of two doses in reversing fentanyl overdoses. Individuals should continue administration until the recipient is revived, ensuring appropriate intervals between each dose along with rescue breaths, and calling emergency medical services if the individual is unresponsive after two doses. We do not recommend high-dose naloxone formulations as a substitute for four doses of IM or IN naloxone due to the higher cost, risk of precipitated withdrawal, and limited evidence compared to standard doses. Future research must take into consideration lived and living experience, scientific evidence, conflicts of interest, and the bodily autonomy of people who use drugs.

Opioid use disorder affects more than 2.1 million individuals in the United States [ 1 ]. Persistent opioid use can leave individuals with opioid dependency resulting in daily opioid use, despite potential medical and social consequences, the most significant of which is overdose [ 2 , 3 ]. Opioid overdose occurs when opioids bind to and activate opioid receptors and suppress breathing rate below that which is required to maintain consciousness [ 4 ]. If suppression is continued for an extended time, health complications including death can occur.

Opioid overdose, however, is reversible if a bystander identifies an overdose in progress and administers naloxone hydrochloride (hereafter, naloxone) quickly [ 1 , 2 ]. Naloxone is an opioid antagonist medication with a stronger binding affinity for opioid receptors than heroin or fentanyl. When administered, it “knocks opioids off” the opioid receptors in the central or peripheral nervous system and binds without activation, thereby reversing both intentional (i.e. analgesia, euphoria) and unintentional (i.e. respiratory depression, coma) effects of the used opioid [ 3 , 4 ]. Naloxone administered by community members (bystanders, friends, family, etc.) has proven successful in reversing opioid overdoses in 75–100% of cases [ 5 ]. It is considered safe at the recommended doses to opioid-naive persons as well [ 5 ].

Naloxone is primarily available to the public through free community-based programs, though it is also available through provider prescriptions and as an over-the-counter medication at pharmacies. Community health workers, pharmacists, and medical professionals distributing naloxone often also provide training on overdose recognition and response, however, some organizations also incorporate a train-the-trainer model to enable community members to share these skills in their networks.

Community based overdose response can occur anywhere individuals use substances including private homes and public spaces (restaurants, shopping centers, laundromat, etc.) [ 6 ]. The currently recommended response protocol is a five step process: (1) checking for signs of opioid overdose, such as unconsciousness, slow or absent breathing, pale and clammy skin, and slow or no heartbeat, (2) calls emergency medical services (EMS) to ensure timely medical attention, (3) administer naloxone, (4) clear the airways to perform rescue breathing to help provide oxygen to the body, (5) administer additional naloxone if the individual does not regain consciousness and respiration [ 7 ]. An additional strategy to support someone experiencing overdose is to administer oxygen, however oxygen should not be used as the sole treatment method especially if breathing has ceased [ 8 , 9 , 10 ]. Many factors determine the amount of naloxone needed including type, amount, half-life and method of opioid use, tolerance levels, health status, and naloxone administration route [ 11 , 12 , 13 ].

While overdose detection and response is straightforward, the general population has an ingrained fear of and stigma towards PWUD. Many social and environmental factors contribute to the fear including lack of understanding, political beliefs, personal experiences, dissemination of misinformation, criminalization, and the ‘war on drugs’ mentality [ 14 , 15 , 16 ]. Oftentimes, individuals who use recreationally for personal, constructive purposes, and in a manner characterized by safety and responsibility, remain largely invisible within media representation and public forums [ 17 ]. Instead, the focus tends to prioritize individuals with SUD, those who overdose, or those solely in abstinence-based recovery. This biased depiction results in an altered portrayal of the effects and risks associated with recreational drug use [ 18 ] and provides opportunities for reinforcing racial, gender, and class stereotypes pertaining to drug users [ 18 , 19 ]. Misunderstandings and socially reinforced biases result in misunderstandings of and opposition towards harm reduction strategies [ 20 , 21 ]. In the context of naloxone, the misunderstandings can be seen in the altered portrayal of the effects and risks associated with naloxone use for overdose reversal [ 21 , 22 , 23 ]. It also results in sidelining of people with lived and living experience when exploring new developments regarding appropriate naloxone dose and administration.

Opioid use is a complex issue that is influenced by a variety of factors, such as social, economic, environmental, and other determinants of health. People who use drugs (PWUD) should not be delineated solely by their drug consumption, but rather recognized as multifaceted individuals with distinct requirements and aspirations. Therefore, adopting an impartial and non-judgmental approach is imperative when addressing the subject of drug use and, consequently, the application of naloxone.

Another consequence of the criminalization of non-prescribed opioid use is that it forces individuals who are dependent on opioids to use the unregulated illicit drug supply. Lack of regulatory standards results in a market fraught with impurities including both filler and undesired illicit substances. Notably, fentanyl has overtaken the heroin supply as the predominantly available opioid and has been found in non-opioid substance samples [ 24 , 25 , 26 ]. Fentanyl and its analogs are short acting opioids with exceptionally high potency when compared to other opioids like heroin and morphine [ 24 ]. Consequently, individuals who are exposed to fentanyl unintentionally or intentionally or at a higher purity level than anticipated are particularly vulnerable to overdose [ 27 ].

According to provisional data from the Centers for Disease Control and Prevention (CDC), there were more than 100,000 drug overdose deaths in the United States in 2021[ 28 ]. This concern for high overdose rates and drug poisoning severity provides theoretical justification for the proposal of higher doses of naloxone formulations. Nevertheless, this theoretical foundation lacks input from the ground level experts: PWUD, harm reduction workers, and other relevant groups possessing firsthand experience and direct involvement with drug users. These groups possess unique experiences and knowledge that most researchers and medical providers do not regularly have access to, including in the development of high-dose naloxone formulations.

Two previous literature reviews have been conducted on this topic: Moe and colleagues conducted a systematic review of overdoses (n = 26,660) in North America and Europe through 2018. They found that although higher initial and cumulative naloxone doses were being used by lay and healthcare responders for overdoses presumed to be fentanyl or another synthetic opioid, a cumulative total dose of 4 mg of naloxone (e.g., two doses of standard IN) was sufficient in 97% of presumed fentanyl/potent opioid cases [ 29 ]. Abdelal et al. [ 30 ] recently examined the use of two or more naloxone doses, however the authors received consultancy fees or stock options from Hika Pharmaceuticals, which manufactures the high-dose naloxone formulations product Kloxxado. The implementation of naloxone programs remains an imprecise science despite the reliability of naloxone in reversing opioid overdose. The emergence of newer formulations necessitates close examination of scientific research. Accordingly, this literature review aims to improve our understanding of how often more than two doses of IM and IN naloxone are needed to reverse a fentanyl overdose and whether promoting high-dose naloxone formulations is an optimal and necessary solution for community-led overdose response.

Naloxone options in the U.S.

There are currently three U.S. Food and Drug Administration (FDA)-approved administration routes of naloxone that are available: injectable intramuscular (IM), intravenous (IV), and intranasal spray (IN). Only IM and IN formulations are currently used in lay person response. Subcutaneous auto-injectors were used previously but have been discontinued [ 31 , 32 ]. IM naloxone solution has traditionally been provided in kits of two 1-mL vials containing a 0.4 mg/mL solution [ 33 ]. 10-mL vials containing 0.4 mg/mL are also available but are not readily accessible in IM naloxone kits provided to PWUD [ 34 , 35 ]. IN naloxone is also provided in two-unit kits with a 4 mg/0.1 ml naloxone solution pre-loaded into an atomizer that is ready to use intranasally. Regardless of the exact route of administration, naloxone can be easily administered by a lay bystander as an intervention for overdose [ 16 ].

The FDA has continued to support high-dose naloxone formulations (high-dose naloxone formulations) such as Kloxxado (double the dosage of standard IN) and Zimhi (25 times higher dose than generic IM) [ 17 ], despite the voiced concerns of harm reduction workers and others with lived experience of using naloxone to reverse an overdose [ 36 , 37 ]. This is in part due to concerns that the high potency of fentanyl could require higher doses of naloxone to be effective and the assumption that a single high dose formulation is preferred over multiple doses of the typical formulation. Having input on drug policy and research from people with lived and living experiences of drug use is invaluable because it provides a more comprehensive understanding of the complexities and realities of drug use. Inclusion results in policies and research that are informed by the perspectives and needs of those directly affected, leading to more effective and equitable outcomes [ 38 ]. However, the historical exclusion of these individuals can be attributed, in part, to the pervasive stigma surrounding drugs and PWUD [ 39 ].

The U.S. currently has seven overdose reversal products that contain naloxone described both below and in Table 1 .

Generic injectable naloxone is one of the most popular formulations supplied to PWUD [ 40 , 41 ]. It comes in 1 mL vials of 0.4 mg/mL concentration [ 33 ]. It can be utilized in any method of administration, including intramuscular (IM), and intravenous (IV) routes, as well as intranasally (IN) via an atomizer. NARCAN® Is the most well-known brand name for naloxone nasal spray. It comes with a 0.1 mL pre-packaged solution that contains 4 mg/0.1 mL of naloxone. This specific brand’s pre-packaged administration tool only allows for naloxone to be administered intranasally. The generic counterparts to NARCAN® are the Teva and Perrigo generic nasal sprays which have chemically identical active ingredients and concentrations. Kloxxado® is a newer naloxone nasal spray that also comes with double the dose of NARCAN. It comes with a 0.1 mL pre-packaged solution that contains 8 mg/0.1 mL of naloxone. Identical to NARCAN, this specific brand’s pre-packaged administration tool also only allows for naloxone to be administered intranasally. Zimhi is a brand name autoinjector that comes pre-loaded with 0.5 mL of 5 mg/0.5 mL naloxone. This syringe can only be administered intramuscularly (IM). Lastly, Amphastar® Prefilled Naloxone Syringes come in 2 mL, with 1 mg/mL naloxone. These prefilled syringes are also compatible with any method of administration, both nasal and injection routes. It is a recently approved IN naloxone formulation with a 4 mg/0.1 mL concentration. It is not yet widely available in the US.

In May 2023, the FDA approved Opvee®, a nasal spray version of nalmefene and the first alternative opioid antagonist indicated for opioid overdose reversal. The half-life of nalmefene is ~ 11 h, much longer than the 60- to 90-min half-life of naloxone [ 42 ]. Nalmefene may reverse opioid intoxication for longer than naloxone, which some view as a benefit over naloxone. However, its extended half-life presents the continued concern of placing opioid-dependent persons who overdose into precipitated opioid withdrawal for far longer than naloxone. Opvee was developed by Opiant Pharmaceuticals, which plans to release Opvee to the U.S. market as early as October 2023 [ 43 ]. Opiant also contributed to the development and manufacture of Narcan[ 44 ].

Bioavailability, referring to the proportion of a drug that is able to enter the body's circulation to have an active effect [ 45 ] and is a key consideration to take into account during discussions of naloxone dosing. It is used to approximate a drug’s effectiveness when taken by a patient. Factors that can affect bioavailability include the administration route (e.g. IN, IM, IV), drug form (e.g. tablet, liquid), and personal characteristics (e.g., age, weight, liver function).

The IN and IM administration routes are both commonly used by first responders in the community. They have bioavailability of 50% and 98% and a latency time to effectiveness of 15-min and 8-min, respectively [ 42 , 45 , 46 , 47 ]. The IV route is only used in inpatient medical settings and has a bioavailability of 100% with a 2-min latency to effect. The IV route is preferred by medical professionals as the dose can be tailored to each patient allowing for sufficient overdose reversal while minimizing the risk of withdrawal.

This study was conducted using the principles outlined by researchers with lived experience [ 38 , 48 ]. Tennessee Harm Reduction is a drug-user run community-based organization in rural West Tennessee focused on distributing naloxone, drug checking supplies, and safer use supplies to over 200 community members. The organization’s Director (second author) and Outreach Specialist (first author) initially connected with the third and senior authors at the Harm Reduction Innovation Lab to share their experiences, knowledge, and perspectives surrounding high-dose naloxone formulations. Through their work, DPG and PLM found that PWUD reported that IN naloxone seemed to cause worse precipitated withdrawal compared to IM naloxone and that it seemed to take longer to reverse the overdose. As a result, people giving or receiving naloxone became cautious about continuing to use it. Tennessee Harm Reduction’s client base have reported over 215 known overdose reversals, the majority of which (135) used IM naloxone first. About half of those only needed one dose and a further 40% required two doses with the remaining 10% having 3 or more doses administered. No unsuccessful overdose reversals have been reported. It is important to note that both time between doses and whether the administrator had proper training was not reported so it is unclear whether 3 or more doses were actually needed. High-dose naloxone formulations caused even worse symptoms of precipitated withdrawal. DPG also noted that newly available high-dose naloxone formulations cost between 2 to 10 times more than generic IM naloxone.

Given the limited resources allocated to harm reduction organizations, we saw a need to better understand whether adopting high-dose naloxone formulations would be beneficial. Through an unfunded partnership between Tennessee Harm Reduction and the Harm Reduction Innovation Lab, a search strategy was implemented between August 2022 and February 2023. Phrases included: “high-dose naloxone formulation”, “opioid overdose”, “naloxone dosage overdose”, “naloxone dosage”, “high dose naloxone”, “high dose naloxone opioid”, “naloxone dosing”, “naloxone formulation”, “high dose naloxone formulation”, “high-dose naloxone”, and “high-dosage naloxone”. A literature review was performed using search engines PubMed and Google Scholar to compile a collection of relevant scholarly works. We filtered for original peer-reviewed articles published between January 2012 to February 2023 when heroin and fentanyl became the leading cause of U.S. overdose death. We also conducted a Google search to gather information on each naloxone product and cited research. We reviewed the title and abstract of each article and excluded those that focused on unrelated concepts.

The remaining eligible articles were summarized by research assistants using a matrix developed by the study team. We extracted article characteristics, including support or opposition to high-dose naloxone formulations, any funding received, the authors’ employment/conflicts of interest, main findings, if more than two doses of naloxone were administered, and the stated advantages/disadvantages of high-dose naloxone formulations. The findings were discussed and organized into three topics as described below.

Given the number of articles funded by naloxone manufacturers or consultants paid by pharmaceutical companies, we decided to remove those articles and discuss them in a separate section in order to minimize bias.

We identified 23 articles eligible for inclusion (Fig. 1 ). Most articles were based on community-based response (N = 8) or medical response (N = 13) which included EMS response, hospitals, and outpatient settings. The 3 remaining articles focused on a combination of site types or police response. Most articles did not specify the brand of naloxone that was used but 2 explicitly focused on Narcan. The majority of the articles included multiple administration routes (N = 15) whereas 3 focused on intravenous, 1 on intramuscular, and 3 on intranasal. Two articles did not specify how naloxone was administered in the reported data. Additionally, no included articles noted whether oxygen was given to support overdose reversal and recovery despite that it has been shown to improve the success of naloxone [ 9 ].

Flow chart of all articles included

We coded each article as supportive of high-dose naloxone formulations (N = 7; 30%), unsupportive (N = 4; 17%), or neutral (N = 12; 52%) as seen in Table 2 . Notably, very few articles elicited the perspectives of PWUD. Six articles (25%) directly interviewed or surveyed PWUD. Common points of discussion identified in the articles included frequency of more than two doses, arguments supporting high-dose naloxone, and arguments against high-dose naloxone. Specific details of our synthesis are organized under these three overarching questions below.

Part one: how often are more than two standard doses of im or in naloxone needed to reverse a fentanyl overdose?

Relatively few papers have been published examining the number of doses of IM or IN naloxone needed to reverse an overdose. Supporters of high-dose naloxone formulations often reference a single nationwide study conducted from 2012 to 2015 [ 49 ], which reported a trend of Emergency Medical Service (EMS) providers needing to administer more doses per patient each year. However, this study is limited in its methodology as it fails to consider administration route, dose volume, and dose concentration. The omission results in uncertainty that is driving the need for more doses, an important factor to understand before changing dosing practices.

Other researchers report that there was an increase in the average dose provided by EMS. One Ohio-based study from 2014 and 2016 reported the average IV dose increased from 2 to 5 mg [ 50 ]. However, a study conducted in Pittsburgh from 2013–2016 found that less than 5% of overdoses required three or more doses of IM naloxone [ 51 ]. This was corroborated by a national study from 2018, though heroin not fentanyl was involved in the majority of these cases [ 52 ]. Similarly, only two percent of EMS responders in New Jersey reported requiring a third dose of IN naloxone after having a second dose administered by an advanced life support team [ 53 ]. A large study of New York police officers from 2015–2020 noted that an average of two doses of naloxone were administered to rescue individuals [ 54 ]. One survey-based study reported that 30% of participants living in regions with fentanyl epidemics used 3 or more doses of IN naloxone [ 11 ]. A randomized double-dummy controlled trial found that the risk of receiving additional doses was 19.4% higher in those given IN naloxone (1.4 mg/0.1 mL) compared to IM (0.8 mg/2 mL), and that IN naloxone was less efficient in bringing overdose patients back to spontaneous breathing within 10 min in the prehospital setting[ 55 ]. However, heroin was the suspected drug in 196 of the 201 participants analyzed.

Interestingly, a Morbidity and Mortality Weekly Report (MMWR) reported 83% of patients in Massachusetts required 3 or more doses of nasal naloxone to reverse a suspected fentanyl overdose [ 56 ]. A 2021 survey-based study out of Maryland indicated that 79% of participants administered 3 or more doses at their last witnessed overdose [ 57 ]. Case studies and hospital chart reports have recorded high doses (12–15 mg) of naloxone being administered for synthetic opioid overdoses [ 58 ]. More than two doses of naloxone were required to reverse two carfentanil overdoses, likely owing to the greater affinity of carfentanil for μ-receptors than naloxone [ 59 , 60 ]. μ-opioid receptors are one of the specific target sites in the body that naloxone binds to and blocks, effectively reversing the effects of opioid drugs [ 61 , 62 ].

An aforementioned rigorous systematic review by Moe and colleagues of overdoses (n = 26,660) from North America and Europe through 2018 found that less patients with presumed fentanyl/ultra-potent opioid exposure were revived using initial low doses (≤ 0.4 mg/ml) versus when heroin was presumed (57% vs. 80%) but they concluded that a cumulative dose of 4 mg (e.g., two standard doses of IN) was sufficient in 97% of presumed fentanyl/potent opioid cases [ 29 ].

In conclusion, although there have been greater doses used in clinical and community settings, evidence suggests that the vast majority of fentanyl overdoses can be reversed with standard dosing. However, overdoses involving carfentanil or other similarly potent synthetic analogs may require three or more doses. Two doses of IM naloxone (0.8 mg) have also been insufficient in reversing some fentanyl overdoses though such data are subject to the amount of fentanyl exposure [ 63 ]. Additionally, depending on the half life of the opioid used, an individual may fall back into an overdose after being revived due to naloxone’s half life of 30–90 min [ 64 ]. Given these facts, and the observation that three or more doses are already being used in the community, our recommendation is that four doses of IN or IM naloxone be provided to community members with clear education on the length of latency to effectiveness to optimize coverage. To determine whether high-dose naloxone formulations are an optimal solution we weigh the advantages and disadvantages of these formulations next.

Part two: what are the potential advantages of high-dose formulations?

There are many perceived benefits of high-dose naloxone formulations, though, in practice, the evidence base is underdeveloped. Given that the formulations currently approved have been relatively comparable in their concentration to others of the same administration route, much of the literature has focused on administering naloxone slowly over time (“titration”) rather than administering a single high-dose naloxone formulation. According to the small number of papers [ 46 , 65 ] on this topic, a high-dose naloxone formulation could theoretically result in a faster response and reduce the magnitude of the harmful non-fatal impacts of drug toxicity, including cognitive and physiologic issues, although this was not proven with real-world data. A high-dose naloxone formulation would improve reversal rates for overdoses involving carfentanil and other opioids that have a stronger μ-receptor affinity than fentanyl [ 59 ], though such experiences are relatively rare and localized. Interestingly, recent national study showed that almost half (48%) of people who had reversed an overdose with naloxone held no preference for, or were against, high-dose naloxone formulations, while over one third (36%) preferred a high-dose naloxone formulations to be made available [ 37 ].

Owing to the preconceived biases around drug use and naloxone by association, the need to carry fewer doses may help reduce experiences of stigma [ 11 ], while simultaneously providing more convenience in portability. Despite these potential benefits and community interest in high-dose naloxone formulations [ 37 ], we see many potential pitfalls of relying solely on them.

Part three: what are the potential disadvantages of high-dose formulations?

As discussed previously, prior literature suggests that, despite fentanyl poisoning becoming more prevalent, a standard dose can still be equally effective in many cases [ 36 , 51 , 66 , 67 , 68 ]. Below, we discuss further reasoning to not recommend high-dose naloxone formulations over standard dosing.

There is no pharmacological basis for high dose naloxone when it comes to fentanyl

In vivo, in the human brain, researchers have used a positron emission tomography (PET) scanner’s non-tomography positron detecting system to measure the dose–response curve of naloxone and found that ~ 13 μg/kg (0.013 mg/kg) of naloxone per kg of patient bodyweight was required to produce an estimated 50% receptor occupation when given intravenously[ 69 ]. In general, a drug typically needs to occupy a sufficient number of its target receptors to initiate the desired biological response. Studies have indicated that achieving approximately 50% receptor occupancy by naloxone is associated with its desired therapeutic effects in reversing opioid overdose [ 69 , 70 ]. This suggests that higher doses of naloxone may not be needed as long as 50% of the μ-opioid receptors are occupied. However, there are many factors that could affect level of occupancy such as route of administration and bioavailability [ 71 ].

A second pharmacokinetic consideration is the variable binding affinities of various opioids relative to the antagonistic effects of naloxone. Each opioid has a unique binding affinity (K i ) towards the μ-opioid receptors. Naloxone must have a lower K i , indicating a stronger binding affinity, to successfully reverse an overdose. Notably, morphine and fentanyl have similar K i values despite their vastly different potency levels demonstrating that potency does not always correlate with binding affinity [ 72 , 73 ]. Therefore, stronger analogs are not an indication of the need for high-dose naloxone formulations in the absence of binding affinity assessment.

While naloxone exhibits a relatively rapid and strong binding affinity to opioid receptors, the short duration of action means it is relatively quick to dissociate from the receptors [ 70 , 74 ]. For longer acting opioids, this means opioids may rebind causing a recurrence of respiratory depression. high-dose naloxone formulations have been found to make the effect last longer but doesn't change how quickly it works to reverse an overdose[ 75 ]. The duration of a drug's effects can vary depending on several factors, including the individual's tolerance, the method of administration, the dosage, and the purity of the drug. high-dose naloxone formulations may have an application for these longer-acting opioids and circumstances, but evidence is limited.

The risk of withdrawal from high-dose naloxone

As with any medication, there are potential risks associated with taking too much naloxone. The main risk of excessive naloxone dosing is that it can cause rapid-onset naloxone-induced withdrawal symptoms if a person has a high dependence to opioids [ 76 , 77 , 78 ]. Naloxone is effective at reversing overdose as it displaces opioids from the receptors without activating their sedative and respiratory depressant effects. The displacement effectively reverses the effects of the opioids and causes withdrawal even if opioids remain in the person's system [ 79 , 80 ]. This can include the well-known symptoms such as severe pain, agitation, muscle cramps, and nausea [ 81 ]. Additionally, precipitated withdrawal has serious symptoms, such as diarrhea, vomiting, myalgia, anxiety, and autonomic hyperactivity [ 82 ]. Additionally, in rare cases, naloxone can cause an allergic reaction, such as hives, difficulty breathing, or swelling of the face, lips, tongue, or throat [ 5 ]. Sequelae such as death, coma, and encephalopathy have been documented in association with these occurrences. Notably, such events have predominantly manifested in patients with pre-existing cardiovascular disorders or those concurrently administered medications with comparable adverse cardiovascular effects. However, establishing a definitive cause-and-effect relationship requires further investigation [ 83 ].

Due to these risks, the recommended dose for opioid reversal remains controversial. The aforementioned withdrawal risk can lead to hesitation among PWUD when encountering a potential overdose. They must quickly balance the potentially life threatening consequence of withholding the narcan with the ensuing implications of withdrawal. Namely, that the intense discomfort and cravings following withdrawal can lead to subsequent increased use and opioid seeking behaviors. Additionally, negative experiences related to overdose reversal may result in avoidance of treatment due to fears of having similar experiences in an already stressful medical setting. Finally, withdrawal can temporarily impair an individual's ability to carry out acts of daily living such as caring for oneself, attending work, or engaging in social activities. high-dose naloxone formulations are likely to intensify these drawbacks as administration to someone with high opioid dependence can lead to more intensified symptoms then the typical dose would as more opioids will be displaced with naloxone.

The need for respect, consent, and a voice in drug policy: ethical considerations

From a literal perspective, consent is the act of voluntarily agreeing to participate in something, such as a medical procedure, sexual activity, or research study. It is important because it ensures that individuals know and understand what they are agreeing to. Consent is a fundamental aspect of respecting individual autonomy and personal freedom and it is crucial for maintaining ethical standards in healthcare, research and interpersonal relationships.

In the context of an overdose, obtaining consent is not possible because the victim is unconscious. Unless the responder and person experiencing the overdose had discussed their preferences on how to handle such a situation before the overdose occurred, standard guidance should aim to do as little harm as possible. In such cases, it's also important to provide clear and accurate information and to respect their autonomy as much as possible after administration of naloxone when conscious.

Listening to PWUD is crucial in making informed decisions about increasing the dose formulation of naloxone. Those with lived and living experience have unique insight into the complexities of overdose and the effectiveness of naloxone. They can provide valuable information on how a higher dose formulation may impact their ability to respond to an overdose. Additionally, they can offer insight into other factors that may contribute to overdose, such as polysubstance use or lack of access to harm reduction services. By listening to those with lived and living experience, we can gain a better understanding of the challenges and barriers faced by PWUD and make more informed decisions about how to address overdose in a way that is effective, equitable, and inclusive.

Collaborating with PWUD is also an important aspect of practicing informed consent. By actively hearing their experiences and concerns, we can better understand their needs and preferences allowing us to provide care with respect and consideration of their unique circumstances. Individuals who use drugs have the right to make informed decisions about their healthcare and incorporating their preferences ensures they are empowered to make informed decisions about their healthcare. This can help build trust between healthcare providers and PWUD, leading to better health outcomes and more effective overdose prevention strategies. Conrarily, making decisions on naloxone dose, route of administration, and cost without including those who are directly impacted in the decision process violates their right to consent, erodes their trust and perpetuates the overdose epidemic.

Cost considerations

As shown in Table 1 , the costs of available naloxone formulations vary widely from $15-$40 per unit for the most affordable generic IM formulation to $131-$145 per unit for Zimhi high-dose IM auto injector and Kloxxado high-dose IN. As expected, generic formulations cost less than branded formulations with the IM and IN costing $15 and $20 at the lower cost range respectively. Notably, the two highest single dose formulations, Zimhi and Kloxxado, are also the most costly. Zimhi is 25 times stronger than generic IM naloxone and costs over 8 times the generic equivalent. Kloxxado is twice as strong as the generic IN formulation and costs about 5 times as much. Given that the majority of fentanyl overdoses studied only require two or three doses of standard IM or IN, high dose naloxone formulations with more than three times the dose within the same administration route category may not be a cost effective solution.

We aimed to understand whether two doses of IM/IN naloxone can effectively reverse fentanyl overdoses and whether newer high-dose formulations are an optimal and necessary solution. Our findings indicate that although two or more standard doses of naloxone have been administered in clinical and community settings, most fentanyl overdoses can be successfully reversed using two standard dosages of IN or IM. Overdoses involving carfentanil, a highly potent fentanyl analog, necessitate three or more doses for effective reversal; this may be due to carfentanil having a slower rate of opioid receptor dissociation [ 84 ]. However, carfentanil overdoses are relatively rare compared to fentanyl overdoses throughout the United States.

Although comparing formulations was beyond the scope of our review, we did note that in some cases, the administration of two IM naloxone doses (0.8 mg) has been insufficient in reversing a fentanyl overdose. However, the accuracy of this conclusion is contingent upon the quantity of fentanyl present in the drug samples consumed and the individual’s tolerance. For this reason, community-based programs that solely distribute IM naloxone could pre-emptively begin distributing four or more doses to all program participants. Given the well-established knowledge that overdose symptoms may recur after resuscitation, depending on the half-life of the specific opioid, keeping additional doses of naloxone on hand can be useful regardless of the formulation distributed.

Considering these findings and the current community practice of using multiple doses of standard IM and IN, we recommend providing, at minimum, four standard doses of IN or IM naloxone to each individual (i.e., two two-dose kits). This guarantees that administration can continue until the recipient achieves stability, ensuring appropriate intervals between each dose, and extra doses are on hand in case of carfentanil exposure or symptom recurrence. Given that some people who use fentanyl use multiple times per day, and some bystanders know multiple people who use fentanyl, providing an ample number of kits to potential bystanders is critical.

Higher-dosage formulations are unnecessary for fentanyl overdoses, and may also cause harm as evidenced by the risk of precipitated opioid withdrawal. While there is little evidence that high-dose naloxone formulations will be more effective for responding to fentanyl overdoses, high-dose naloxone formulations may elicit a faster overdose reversal rate for carfentanil overdoses compared to standard doses.

One barrier that remains in scaling up IM and IN naloxone is that only one brand of over-the-counter IN naloxone (Emergent) has been FDA approved. Approving generic naloxone and standard IM formulations will help speed up community-level naloxone coverage. Another barrier to carrying IM naloxone is that syringe possession remains illegal in some states.

Data limitations

Much of the literature supporting the use of high-dose naloxone formulations fails to take into consideration the expressed needs, barriers, and consent of PWUD, which may have significant implications for the ethical and effective implementation of such interventions. For these reasons, we encourage scientists, medical providers, and pharmaceutical companies to speak to PWUD and service providers (such as harm reduction workers or others working directly with drug users) when developing and testing new high-dose naloxone products. Providing the context to epidemiological and clinical data through lived experience is important because it allows for a more accurate interpretation of the results as well as a more realistic understanding of how naloxone formulary changes would impact PWUD. Without context, assumptions may be based on bias, or draw the wrong conclusions. We also noted that some studies were either conducted or funded by pharmaceutical companies who may have a conflict of interest in the study’s outcome.

Future studies and conclusions

The majority of the research conducted in the field of substance use has not been done in settings that accurately reflect the contexts in which PWUD experience an overdose and withdrawal symptoms. For example, there has been scientific debate on the role of non-opioid sedatives such as xylazine (a tranquilizer commonly used in veterinary medicine) and benzodiazepines (a central nervous system depressant) in overdose response[ 85 , 86 , 87 ]. We must communicate to the public that naloxone will not reverse the effects of these sedatives and additional medical intervention may be required to assist PWUD even after naloxone is administered. More studies that center the perspectives of PWUD are needed to optimize community bystander reversals especially in the era of xylazine and other contaminants.

In conclusion we did not find rigorous evidence to support the distribution of high-dose naloxone formulations compared to standard doses. Community programs should provide at least four doses of standard IM or IN (and more if possible) to each program participant to optimize naloxone coverage without sacrificing the physical and psychological wellbeing of PWUD.

Availability of data and materials

Data sharing is not applicable to this article as this is a literature review. However, Table 2 has been provided that lists all published research articles involved in the literature search for this review. The data referenced by Tennessee Harm Reduction are not publicly available because it was used only as observation. However, a summary of this data is available on the Tennessee Harm Reduction website and data from the corresponding author on reasonable request.

Abbreviations

Cardiopulmonary resuscitation

Emergency medical services

Federal drug administration

Intramuscular

Intravenous

Binding affinity

Morbidity and mortality weekly report

Positron emission tomography

People who use drugs

Substance abuse and mental health services administration

Substance use disorder

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Acknowledgements

We thank the volunteers from Tennessee Harm Reduction and the Harm Reduction Innovation Lab who supported this work.

MA is funded by the Karen T. Romer Undergraduate Teaching and Research Award at Brown University. ET and JNP are funded by the Center of Biomedical Research Excellence on Opioids and Overdose (P20GM125507) from the NIH. JNP serves as a technical consultant for a modeling project funded by the Food and Drug Administration (U01FD00745501) based at Harvard Medical School. Its contents are solely the responsibility of the authors and do not necessarily represent the official views of our funders.

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Lemen, P.M., Garrett, D.P., Thompson, E. et al. High-dose naloxone formulations are not as essential as we thought. Harm Reduct J 21 , 93 (2024). https://doi.org/10.1186/s12954-024-00994-z

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Why Systematic Review rather than Narrative Review?

1 Department of Psychiatry, The Catholic University of Korea College of Medicine, Seoul, Republic of Korea.

2 Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC, USA.

Sir: Recently review articles including systematic and narrative reviews have been significantly increasing in most psychiatric journals in the world alongside "Psychiatry Investigation (PI)". Since the launch of the "PI" at March 2004, there have been a number of review articles; indeed 54 papers were published as format of regular review papers or special articles in the "PI" from 2004 to 2014. However, of the 54 papers, only one review paper partially met the contemporary criteria of systematic review, otherwise were written as a format of narrative review for diverse topics such as epidemiological findings, concept and hypothesis of certain psychiatric disease, current understandings on certain disease, psychopharmacology, and treatment guidelines. This is unsatisfactory when reflecting the fact that systematic reviews have been rapidly and increasingly replacing traditional narrative (explicit) reviews as a standard platform of providing and updating currently available research findings as confident evidence. Most journals have started to change their policy in acceptance of review papers, they have been giving a priority to systematic review only as a regular review article and excluding narrative reviews, to provide the best evidence for all basic and clinical questions and further hypotheses. Of course, there should be Pros and Cons between systematic and narrative reviews; for instance, the major advantage of systematic reviews is that they are based on the findings of comprehensive and systematic literature searches in all available resources, with minimization of selection bias avoiding subjective selection bias, while narrative reviews, if they can be written experts in certain research area, can provide experts' intuitive, experiential and explicit perspectives in focused topics. 1

The absence of objective and systematic selection criteria in review method substantially results in a number of methodological shortcomings leading to clear bias of the author's interpretation and conclusions. Such differences are quite clear when referring to the review paper of Drs. Cipriani and Geddess, 2 where 7 narrative and 2 systematic reviews were compared and found that narrative reviews including same studies reached different conclusions against each other, indicating the difficulties of appraising and using narrative reviews to have conclusion on specific topic. Hence, narrative reviews may be evidence-based, but they are not truly useful as scientific evidence.

Even in reported as systematic review, it is also frequent that those papers are not true systematic review or they have certain bias in data search method and conclusions. For instance, due to lack of satisfactory pharmacotherapy for post-traumatic stress disorder (PTSD) and its frequent comorbid psychotic symptoms, a possible role of atypical antipsychotics (AAs) for PTSD has been consistently proposed. 3 In fact various AAs have demonstrated positive antidepressant and ant-anxiety effects in a number of small-scale, open-label studies (OLSs) or randomised, controlled clinical trials (RCTs). 4 In this context, a recent systematic review (4 olanzapine, 7 risperidone and 1 ziprasidone trials) by Wang et al. 5 has also suggested the positive prospect on the role of AAs for the treatment of PTSD; however, the review has a number of faulty and wrong selection of clinical trials data and interpretation of studies included in their review. The authors neglected wide range of clinical information such as patient characteristics (particularly, initial severity of disease), comorbidity issues, trial duration issues, trial design characteristics, primary endpoint difference, study sponsoring; that is, heterogeneity of clinical trials would substantially influence the quality and clinical implications of the study results. The basic problem of non-systematic search of data is that beneath the shining surface, it seems that the authors utilizing it often misunderstand the true value, underpinning meanings and correct nature of the data, or their true limitations and strengths, and they often go too far or short with the interpretation. 6 Indeed, the main conclusion of a narrative review may often be based on evidence, but such reviews themselves are not rigorous evidence since such reviews are too selective and thus little good quality information could be included. 2 In addition, I found one olanzapine trial was OLS but they included the study in the result (this is a mixture of data yielding a huge heterogeneity). 7 This clearly indicates they were not consistent in collection of the study for their review. Olanzapine has a lot of OLSs beyond the study, likewise other AAs also have a plenty of OLSs. Regarding an inclusion of OLSs for systematic reviews, an interesting metaanalyses are available on the role of olanzapine for adolescent bipolar disorder 8 and aripiprazole augmentation therapy 9 for depression. According to Pae et al. 9 the treatment effects were not significantly different between OLSs and RCTs in efficacy of aripiprazole augmentation for treating depression; the pooled effect size was statistically significant in both study design and also in a meta-analysis regression, study design was not a significant predictor of mean change in the primary endpoint, clearly indicating that OLSs are useful predictors of the potential safety and efficacy of a given compound. This finding was also supported by another meta-analysis. 8 Hence, the value of OLSs should be carefully re-evaluated for practical information source, development of new drugs or acquisition for new indications, and should not be neglected for data research, especially for narrative reviews. Furthermore, Dr. Wang et al. 5 did not include one important RCT; quetiapine has a RCT for PTSD, 10 which was presented in the thematic meeting of the CINP 2009. A 12-week RCT was conducted for 80 PTSD patients. Finally, Wang et al. 5 surprisingly did not present any effect size (ES) for studies, although such calculations are conventionally included in the review papers. Another critical example is Hickie and Rogers's review, 11 according to their article, agomelatine was efficacious antidepressant; however, subsequent researchers who avoided selection bias have clearly demonstrated its weak efficacy as an antidepressant. 12 Therefore, reflecting two review papers, 5 , 11 we can realize that inappropriate aggregation of studies may definitely bias conclusion. Hence, entire published and unpublished dataset should be considered in systematic review, especially, when clinical data is not sufficient and the medication has no officially approved indication by the regulatory agency.

To summarize, systematic review should include followings respecting recommendation from currently available systematic review guidelines (e.g., The Cochrane Library www.cochrane.org ); clear basic and clinical hypothesis, predefined protocol, designation of search resources, through data search (regardless of publication), transparent selection criteria, qualification of studies selected, synthesis of study data and information, relevant summary and conclusion. Table 1 compares systematic and narrative reviews ( Table 1 ). Since the evidence-based medicine is the current trend and also mandatory for establishment of heath policy, the PI should also turn to encourage submission of systematic reviews rather than narrative reviews.

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Acknowledgments

This work was supported by a grant of the Korean Health Technology R&D Project, Ministry of Health & Welfare, Republic of Korea (HI12C0003).

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Book Review: Anonymous public servants are the heart of George Stephanopoulos’ ‘Situation Room’

This cover image released by Grand Central Publishing shows “The Situation Room: The Inside Story of Presidents in Crisis” by George Stephanapoulos with Lisa Dickey. (Grand Central Publishing via AP)

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The biggest challenge for an author tackling the history of the Situation Room, the basement room of the White House where some of the biggest intelligence crises have been handled in recent decades, is the room itself. As a setting, it’s pretty underwhelming.

In “The Situation Room: The Inside Story of Presidents in Crisis,” George Stephanopoulos describes how the room — actually a series of rooms — for much of its history didn’t live up to its reputation in popular imagination or media. The centerpiece of it, as Stephanopoulos writes, had “all the charm of a cardboard box.”

But what keeps readers engaged in Stephanopoulos’ history isn’t any behind the scenes schematics or technology. This isn’t a Tom Clancy novel, though it moves along as briskly as one. Instead, it’s the stories Stephanopoulos and Lisa Dickey share of the normally nameless and faceless public servants, the duty officers who have staffed the center since its inception during John F. Kennedy’s presidency.

Stephanopoulos, a political commentator and ABC anchor who worked in the Clinton White House, wisely zeroes in on a single crisis during each of 12 presidencies during the Situation Room’s history. Along the way, he reveals much about the differing management styles of the nation’s presidents and offers plenty of interesting pieces of history.

This cover image released by Norton shows "This Strange Eventful History" by Claire Messud. (Norton via AP)

This includes the granular level of detail Lyndon B. Johnson sought in regular calls to the Situation Room late at night or early in the morning. The book offers a glimpse at the frenzied conversations that took place following Ronald Reagan’s shooting in 1981.

It should come as no surprise that the most riveting chapter centers around the moment that led to the most widely seen photo of the “Sit Room” — the killing of Osama bin Laden.

Stephanopoulos reveals that the photo — which showed former President Barack Obama in a cramped conference room receiving updates on the raid on the terrorist leader’s compound — could have looked a lot different. A larger room was available, but officials were worried about losing the audiovisual link if they tried moving it from the cramped room.

The duty officers whose stories are at the heart of the book are portrayed as apolitical figures, with one saying they “serve in silence.” Stephanopoulos’ book is a fitting tribute to them.

AP book reviews: https://apnews.com/hub/book-reviews

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Eight problems with literature reviews and how to fix them

Author: M Rahman

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Eight common problems with science literature reviews and how to fix them

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Eight problems with literature reviews and how to fix them

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Great brief overview, from NCSU

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Strengths and Weaknesses of Systematic Reviews

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Strengths Of Systematic Reviews

Specificity

Explicit Methodology

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Comprehensive And Exhaustive

Reproducible

Weaknesses Of Systematic Reviews

Mass Production

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Improving the peer review of narrative literature reviews

Ask whether the literature review justifies its place in the literature

Ask whether the literature searches conducted were clearly defined

Check for citation breadth and balance

Where possible, verify that information has been summarised correctly

Check that original references have been cited

Consider how studies were critically evaluated

Evaluate whether tables/figures/diagrams support the text

Consider whether the review will help someone entering the field

Ask whether the review expands the body of knowledge

Do not forget the rules for reviewing manuscripts in general