systematic literature review registration

Systematic Reviews: Protocol & Registration

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Protocol & registration: PRISMA Item 24

Prior to publication of your review, you might publish a protocol, which documents the key points of your systematic review in progress. A protocol should include a conceptual discussion of the problem and include the following:

• Rationale, background
• Potential contribution of the review to clinical decision making
• Is there enough relevant literature to merit a systematic review/meta-analysis of studies
• Inclusion/exclusion criteria
• PICOS of interest (Population, Intervention, Comparison, Outcomes, Study types to be reviewed)
• Sources you will use to search the literature (& search syntax if possible)
• Screening methods
• Data extraction methods
• Methods to assess for bias
• Contact details

The PRISMA group has devised a checklist of items to include in a systematic review protocol. An explanation of the items is on the PRISMA Protocols webpage.

If you are undertaking a lengthy systematic review (1-2 years or more), it is an especially good idea to register the protocol in a registry like the  PROSPERO database or in OSF , so it can then be peer reviewed and to reduce unnecessary duplication of effort among researchers. If your review protocol has been registered you must indicate where it can be accessed, i.e. give the registration number & web address, or describe if you have had the protocol looked over by others e.g. AHRQ or people in your institution. 

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Register your Protocol

Evidence synthesis guide : register your protocol.

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“Prospective registration of systematic reviews promotes transparency, helps reduce potential for bias and serves to avoid unintended duplication of reviews. Registration offers advantages to many stakeholders in return for modest additional effort from the researchers registering their reviews.” 1

Registration Platforms

• PROSPERO Note: Prospero does not accept scoping review protocols
• Joanna Briggs Institute (JBI)
• Open Science Framework (OSF)
• protocols.io
• Research Registry

References & Recommended Reading

1.         Stewart L, Moher D, Shekelle P. Why prospective registration of systematic reviews makes sense. Systematic reviews. 2012;1:7.

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

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Systematic Reviews: Registration

• Record Keeping
• Developing Searches
• Deduplication
• Screening Sources
• Registration
• Data Extraction
• Useful Links
• Compiled Resources

Why Register a Systematic Review?

Registering a systematic review is an important process that provides significant benefits to individual researchers and the academic community. The following are several of those benefits ( https://www.crd.york.ac.uk/PROSPERO/#aboutpage) :

Provides a comprehensive listing of systematic reviews registered at inception

Avoids duplication

Counters publication bias

Safeguards against reporting biases by revealing any differences between the methods or outcomes reported in the published review and those planned in the registered protocol

Identifies whether there are any reviews already underway that address the topic of interest

Systematic Review Registries

PROSPERO is the most well-known systematic review registry, but there are others.

PROSPERO: https://www.crd.york.ac.uk/prospero/

PROSPERO is an international database of prospectively registered systematic reviews in health and social care, welfare, public health, education, crime, justice, and international development, where there is a health related outcome. Key features from the review protocol are recorded and maintained as a permanent record. PROSPERO aims to provide a comprehensive listing of systematic reviews registered at inception to help avoid duplication and reduce opportunity for reporting bias by enabling comparison of the completed review with what was planned in the protocol.

Campbell Collaboration: https://onlinelibrary.wiley.com/page/journal/18911803/homepage/submit-a-proposal

The Campbell Collaboration is an international network publishing high quality, transparent and policy-relevant evidence synthesis and maps in the social sectors. These are published in Campbell Systematic Reviews, an open-access journal, which is a member of the Centre for Open Science Registered Reports, thus adheres to peer review and publication of the planned methods as a protocol to minimize bias.

Cochrane: https://work.cochrane.org/registering-new-title

Cochrane is an independent international not-for-profit organization, dedicated to making up-to-date, accurate information about the effects of healthcare readily available worldwide. It produces and disseminates systematic reviews of healthcare interventions and promotes the search for evidence in the form of clinical trials and other studies of interventions.

OSF Registries: https://osf.io/registries

Created by the Center for Open Science , OSF Registries is a scholarly repository built for sharing, searching, and aggregating registrations of research. Using OSF Registries, researchers can create robust, timestamped registrations of research projects, or discover existing registrations on OSF and across connected registries like ClinicalTrials.gov, Research Registry, and more.

How to Register a Systematic Review in PROSPERO

PROSPERO is an international database of prospectively registered systematic reviews in health and social care. Key features from the review protocol are recorded and maintained as a permanent record. Systematic reviews should be registered at inception (i.e. at the protocol stage) to help avoid unplanned duplication and to enable comparison of reported review methods with what was planned in the protocol ( http://www.prisma-statement.org/Protocols/Registration ). The PROSPERO site indicates that " most registrants complete the form in 60 minutes or les s," but that is very optimistic. Plan on giving yourself plenty of time to complete the registration.

PROSPERO assists:

Researchers by allowing them to comply with PRISMA, providing a public record of their planned methods and raising awareness of their review. Use of the unique registration number allows them to track subsequent use of their review and monitor impact.

Commissioners and funders by allowing them to identify ongoing and unpublished reviews addressing their topic of interest, thereby helping avoid unplanned duplication.

Peer reviewers by allowing comparison of manuscript findings with the review protocol.

Journal Editors by providing a safeguard against reporting biases and providing access to key protocol features that they can utilize in the peer review process, where appropriate.

Guideline developers by providing information about forthcoming reviews which may assist in planning and timing of guideline development.

The public by providing free and open access to information about ongoing systematic reviews, by encouraging transparency in the systematic review process, by helping ensure that health and social care decisions that may affect them are known to be based on good quality systematic review evidence, and by helping to avoid wasting money on unintended duplication of effort.

Requirements for registration:

A full protocol should be ready before registering with PROSPERO.

Submissions must be made before data extraction commences.

Registration forms must be complete.

Submissions must be in English (search strategies and protocols attached to a record may be in any language).

PROSPERO does not accept:

Systematic reviews without an outcome of clear relevance to the health of humans.

Scoping reviews.

Literature reviews that use a systematic search but not a systematic synthesis of the results or outcome.

Systematic reviews assessing sports performance as an outcome.

Methodological reviews that assess ONLY the quality of reporting.

Other considerations:

Cochrane protocols are automatically uploaded- To avoid duplication of records, Cochrane protocols should not be registered separately with PROSPERO.

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The Whats and Whys of Protocols

Systematic reviews and scoping reviews should have a protocol which helps to plan and outline the study methodology. The protocol should include:

• the rationale for the review
• key questions broken into PICO (or other structured research question) components
• inclusion/exclusion criteria
• literature searches for published/unpublished literature
• data abstraction/data management
• assessment of methodological quality/risk of bias of individual studies (not required for scoping reviews)
• data synthesis
• grading the evidence for each key question

Why should complete a protocol?

• A protocol is your planning document and roadmap for the project. It allows you to complete a systematic review efficiently and accurately, ensures greater understanding among team members, and makes writing the manuscript far easier.
• Many journals now require submitted systematic reviews to have registered protocols.
• The PRISMA Reporting Standard lists information about the systematic review protocol as an "essential element" (PRISMA 2020 Item 24)
• The Cochrane Handbook, The Institute of Medicine Standards, and others, all list completing a protocol as one of the important steps to a successful systematic review.
• Best practices in systematic reviews: the importance of protocols & registration
• Planning a systematic review? Think protocols

Writing a Protocol

Protocol templates:

• PRISMA for systematic review protocols (PRISMA-P) Checklist and explanation of what should be included in a systematic review protocol.
• The PROSPERO systematic review protocol template
• OSF Scoping Review Protocol Template and Guidance Document "The Guidance document is intended to be used in tandem with the Scoping Review Protocol Template. The Guidance document includes tips, examples, and details about each section of the protocol. The Template includes headings and subheadings to use to structure the protocol (e.g., which order to present the information, what level of detail, etc.).”
• JBI scoping review protocol template

Resources to help authors prepare a protocol for a systematic or scoping review:

• Institute of Medicine – Standards for Systematic Reviews - Section 2.6
• The Cochrane Handbook - Section ii.1.4
• JBI Manual for Evidence Synthesis - Section 1.3 (Systematic reviews) & 11.2 (Scoping reviews)

Where to Register a Protocol

After you write the protocol, you should register it with a review registry. There are numerous review registries available, such as PROSPERO or OSF. Registration is free and open to anyone undertaking systematic reviews. Some journals also publish systematic review protocols.

• PROSPERO A registry for systematic review protocols
• How to register with PROSPERO

OSF can be used to pre-register a systematic or scoping review protocol and to share documents such as a citation management library, search strategies, and data extraction forms. Unlike other registries, evidence synthesis author teams do not submit their protocols for review by an editorial board before they are accepted and pre-registered on OSF. Instead, create your own pre-registration.

• How to create an OSF registration
• OSF Registrations Form

Scoping reviews may not be registered with PROSPERO.  Currently, they can be registered with the Open Science Framework or Figshare.

Publishing a Protocol

• BioMed Central Protocols BioMed Central will consider protocols of any type of research for publication, following the standard peer review.
• BMJ Open BMJ Open "will consider publishing without peer review protocols that have formal ethical approval and funding from a recognized, open access advocating research-funding body". Otherwise, protocols are peer reviewed.
• JBI Evidence Synthesis Like systematic reviews, scoping review protocols can be published in some journals.
• Systematic Reviews, a BioMed Central journal This open access title publishes protocols of systematic reviews broadly related to health sciences.
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Systematic reviews for health: registering a protocol.

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Registering Your Protocol

It is a good idea to register your protocol in a publicly accessible way. This will help avoid other people completing a review on your topic. Similarly, before you start doing a systematic review, it's worth checking the different registries that nobody else has already registered a protocol on the same topic.

This page lists mains sources of registered protocols.

For an overview of the characteristics of each register, check out Table 1 of this article:

Pieper, D., & Rombey, T. (2022). Where to prospectively register a systematic review. Systematic Reviews , 11 (1), 8. https://doi.org/10.1186/s13643-021-01877-1 

This is an open access article.

PROSPERO is an international database of prospectively registered systematic reviews, rapid reviews and umbrella reviews in health and social care, welfare, public health, education, crime, justice, and international development, where there is a health related outcome. Key features from the review protocol are recorded and maintained as a permanent record.

PROSPERO does not accept registrations for scoping reviews or literature scans; it also often has a backlog.

Open Science Framework is a good alternative.

Open Science Framework

The Open Science Framework  is a free and open source project management tool that supports researchers throughout their entire project life cycle. It has been developed by the Center for Open Science with a mission is to increase openness, integrity, and reproducibility of research.

Amongst other initiatives, it offers preregistration - you can specify your research plan in advance of your study and submit to to a registry.

• OSF - Create a Preregistration

Cochrane Library of Systematic Reviews

The Cochrane Library is a database that contain different types of high-quality, independent evidence to inform healthcare decision-making. Search the Cochrane Library for any published protocols or reviews related to your topic of interest before you propose and register a new review .

Inplasy is an international platform to register systematic review and meta-analysis protocols. Registration attracts a small fee, processing time is max. 48 hours and protocols get a DOI.

Learn about step-by-step protocol registration  or browse registered protocols. 

Research Registry

The Research Registry offers registration for all types of research studies, from case reports to observational/interventional studies to systematic reviews and meta-analyses.

Whilst the focus in the past has been on registering randomised controlled trials (RCTs), there has been tremendous growth in observational studies (case series, cohort, case-control, cross-sectional, etc), many of which are not registered.  Whilst some trial registries do allow for the registration of observational studies, only a small fraction are actually registered.  

JBI  is recognized as a global leader in evidence-based healthcare. The Institute and its collaborating entities promote and support the synthesis, transfer and utilization of evidence through identifying feasible, appropriate, meaningful and effective healthcare practices to assist in the improvement of healthcare outcomes globally.

The JBI EBP database is a comprehensive range of resources including over 3,000 records across seven publication types: Evidence Summaries, Evidence-Based Recommended Practices, Best Practice Information Sheets, Systematic Reviews, Consumer Information Sheets, Systematic Review Protocols, and Technical Reports.

• JBI Systematic Review Register

Need More Help? Book a consultation with a  Learning and Research Librarian  or contact  [email protected] .

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Proposals to conduct new Cochrane reviews

Proposals for Cochrane reviews are handled in Editorial Manager by the Proposal Manager, Evidence Pipeline team and topic experts. 

Review proposal forms  are provided to authors in Editorial Manager: Information for Authors. Authors are also informed of the proposal process on the Cochrane Library  Information for authors  page.

The Editorial Manager Knowledge Base  contains information on 

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PROSPERO is an online database led by the Centre for Reviews and Dissemination, University of York. It is free to search and open for free registration to anyone undertaking a systematic review with a health-related outcome.

Previously, all protocols for Cochrane reviews of interventions and of diagnostic test accuracy published from 1 October 2013 were automatically added to PROSPERO at title registration stage. The automatic functionality ceased in April 2020 and there is no timeline for a fix. Authors can register their reviews independently on PROSPERO, but not via the previous Cochrane pathway.

Back to  Pre-publication processes   •  EGR homepage

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Systematic Review Protocols and Protocol Registries

Systematic review protocols.

• a good systematic review can start with a protocol - it can serve as a road map for your review
• a protocol specifies the objectives, methods, and outcomes of primary interest of the systematic review
• a protocol promotes transparency of methods
• allows your peers to review how you will extract information to quantitavely summarize your outcome data

About Systematic Review Protocol Registries

• Various protocol registries exists
• Anyone can register their protocol
• Registering your protocol is helpful to establish that your group is doing this review
• Registering increases potential communication with interested researchers
• Registering may reduce the risk of multiple reviews addressing the same question
• Registering may provide greater transparency when updating a systematic review

Protocol Reporting Guidelines

• MECIR (Methodological Expectations for Cochrane Intervention Reviews) Manual  - guidelines on reporting protocols for Cochrane Intervention reviews
• PRISMA-P  - (PRISMA (Preferred Reporting Items for Systematic Reviews) for systematic review protocols

Systematic Review/Protocol Registries

• Campbell Collaboration  - produces systematic reviews of the effects of social interventions
• Cochrane Collaboration  - international organization, produces and disseminates systematic reviews of health care interventions
• PROSPERO  -international prospective register of systematic reviews

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Systematic Reviews: Home

Created by health science librarians.

• Systematic review resources

What is a Systematic Review?

A simplified process map, how can the library help, publications by hsl librarians, systematic reviews in non-health disciplines, resources for performing systematic reviews.

• Step 1: Complete Pre-Review Tasks
• Step 2: Develop a Protocol
• Step 3: Conduct Literature Searches
• Step 4: Manage Citations
• Step 5: Screen Citations
• Step 6: Assess Quality of Included Studies
• Step 7: Extract Data from Included Studies
• Step 8: Write the Review

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  Request a systematic or scoping review consultation

A systematic review is a literature review that gathers all of the available evidence matching pre-specified eligibility criteria to answer a specific research question. It uses explicit, systematic methods, documented in a protocol, to minimize bias , provide reliable findings , and inform decision-making.  ¹  

There are many types of literature reviews.

Before beginning a systematic review, consider whether it is the best type of review for your question, goals, and resources. The table below compares a few different types of reviews to help you decide which is best for you. 

• Scoping Review Guide For more information about scoping reviews, refer to the UNC HSL Scoping Review Guide.

• UNC HSL's Simplified, Step-by-Step Process Map A PDF file of the HSL's Systematic Review Process Map.
• Text-Only: UNC HSL's Systematic Reviews - A Simplified, Step-by-Step Process A text-only PDF file of HSL's Systematic Review Process Map.

The average systematic review takes 1,168 hours to complete. ¹   A librarian can help you speed up the process.

Systematic reviews follow established guidelines and best practices to produce high-quality research. Librarian involvement in systematic reviews is based on two levels. In Tier 1, your research team can consult with the librarian as needed. The librarian will answer questions and give you recommendations for tools to use. In Tier 2, the librarian will be an active member of your research team and co-author on your review. Roles and expectations of librarians vary based on the level of involvement desired. Examples of these differences are outlined in the table below.

• Request a systematic or scoping review consultation

The following are systematic and scoping reviews co-authored by HSL librarians.

Only the most recent 15 results are listed. Click the website link at the bottom of the list to see all reviews co-authored by HSL librarians in PubMed

Researchers conduct systematic reviews in a variety of disciplines.  If your focus is on a topic outside of the health sciences, you may want to also consult the resources below to learn how systematic reviews may vary in your field.  You can also contact a librarian for your discipline with questions.

• EPPI-Centre methods for conducting systematic reviews The EPPI-Centre develops methods and tools for conducting systematic reviews, including reviews for education, public and social policy.

Environmental Topics

• Collaboration for Environmental Evidence (CEE) CEE seeks to promote and deliver evidence syntheses on issues of greatest concern to environmental policy and practice as a public service

Social Sciences

• Siddaway AP, Wood AM, Hedges LV. How to Do a Systematic Review: A Best Practice Guide for Conducting and Reporting Narrative Reviews, Meta-Analyses, and Meta-Syntheses. Annu Rev Psychol. 2019 Jan 4;70:747-770. doi: 10.1146/annurev-psych-010418-102803. A resource for psychology systematic reviews, which also covers qualitative meta-syntheses or meta-ethnographies
• The Campbell Collaboration

Social Work

Software engineering

• Guidelines for Performing Systematic Literature Reviews in Software Engineering The objective of this report is to propose comprehensive guidelines for systematic literature reviews appropriate for software engineering researchers, including PhD students.

Sport, Exercise, & Nutrition

• Application of systematic review methodology to the field of nutrition by Tufts Evidence-based Practice Center Publication Date: 2009
• Systematic Reviews and Meta-Analysis — Open & Free (Open Learning Initiative) The course follows guidelines and standards developed by the Campbell Collaboration, based on empirical evidence about how to produce the most comprehensive and accurate reviews of research

• Systematic Reviews by David Gough, Sandy Oliver & James Thomas Publication Date: 2020

Updating reviews

• Updating systematic reviews by University of Ottawa Evidence-based Practice Center Publication Date: 2007
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Where to prospectively register a systematic review

Dawid pieper.

1 Faculty of Health Sciences Brandenburg, Brandenburg Medical School (Theodor Fontane), Institute for Health Services and Health System Research, Rüdersdorf, Germany

2 Center for Health Services Research, Brandenburg Medical School (Theodor Fontane), Rüdersdorf, Germany

Tanja Rombey

3 Department of Health Care Management, Technische Universität Berlin, Berlin, Germany

Associated Data

All data generated or analyzed during this study are included in this published article.

Prospective registration aims to reduce bias in the conduct and reporting of research and to increase transparency. In addition, prospective registration of systematic reviews is argued to help preventing unintended duplication, thereby reducing research waste. PROSPERO was launched in 2011 as the first prospective register for systematic reviews. While it has long been the only option to prospectively register systematic reviews, recently there have been new developments. Our aim was to identify and characterize current options to prospectively register a systematic review to assist review authors in choosing a suitable register.

To identify systematic review registers, we independently performed internet searches in January 2021 using keywords related to systematic reviews and prospective registration. “Registration” was defined as the process of entering information about a planned systematic review into a database before starting the systematic review process. We collected data on the characteristics of the identified registries and contacted the responsible party of each register for verification of the data related to their registry.

Overall, we identified five options to prospectively register a systematic review: PROSPERO, the Registry of Systematic Reviews/Meta-Analyses in Research Registry, and INPLASY, which are specific to systematic reviews, and the Open Science Framework Registries and protocols.io, which represent generic registers open to any study type. Detailed information on each register is presented in tables in the main text. Regarding the systematic-review-specific registries, authors have to trade-off between the costs of registration and the processing time of their registration record. All registers provide an option to search for systematic reviews already registered in the register. However, it is unclear how useful these search functions are.

Authors can prospectively register their systematic review in five registries, which come with different characteristics and features. The research community should discuss fair and sustainable financing models for registers that are not operated by for-profit organizations.

The purpose of prospective registration of systematic reviews

Prospective registration is a means to publish details about a research project before its commencement thus allowing evidence users to assess whether all steps of the research have been performed and reported as planned, or not. The overall aim is to reduce bias in the conduct and reporting of research and to increase transparency. The Declaration of Helsinki states that “[e]very research study involving human subjects must be registered in a publicly accessible database before recruitment of the first subject” [ 1 ]. In addition, prospective registration is legally required in the United States and Europe for some types of clinical trials [ 2 , 3 ]. However, neither these laws nor the Declaration of Helsinki apply to the literature-based study type of systematic reviews. Nevertheless, one could argue that prospective registration is just as important for systematic reviews for they usually play an even greater role in evidence-based decision-making in clinical practice and health policy than single clinical trials [ 4 ]. In addition to reducing bias and increasing transparency, prospective registration of systematic reviews may prevent unintended duplication, thereby reducing research waste [ 5 , 6 ].

Organizations conducting or commissioning systematic reviews related to health, such as Cochrane or the Joanna Briggs Institute (JBI), have their own databases of ongoing and published reviews. However, these databases are restricted to systematic reviews performed within these organizations. Thus, the idea of creating an independent registry of systematic reviews was proposed in January 2010 [ 7 ]. Following the establishment of a minimum dataset for prospective registration of systematic reviews [ 8 ], PROSPERO, the first international prospective register of systematic reviews, has been launched in February 2011. Nowadays, prospective registration of systematic reviews has been widely established and it is estimated that one third of systematic reviews published in 2018 were registered in PROSPERO [ 9 ].

From the viewpoint of authors, registers for systematic reviews need two main characteristics:

• Offering the service to prospectively register a systematic review
• Providing an oversight of all registered systematic reviews, including a search function

While the first one is obvious, the second one is particularly important when it comes to reducing unintended duplication of systematic reviews. All researchers intending to perform a systematic review should first search bibliographic databases and registers for systematic reviews on the same or similar research questions to avoid conducting duplicate reviews, which is already a major problem [ 10 , 11 ].

Although PROSPERO has long been the only option to prospectively register systematic reviews, there recently have been new developments. Our aim was to identify and characterize current options to prospectively register a systematic review and thereby to assist review authors in choosing a suitable register.

In this context, we define “prospective registration” as the action of entering information about a research project (here: a systematic review) into a database before its commencement. Usually, there is a pre-defined set of items the submitting authors are required to enter upon submission, such as the title, authors, aspects of the planned methods, and contact details. The depth of information is often left up to the authors, however. Prospective registration ought to be differentiated from publishing a manuscript for a protocol. Protocols are typically published as a stand-alone peer-reviewed article in a journal, as a registered report, or on a preprint server. The first two options have the advantage that the protocol manuscripts (unlike registration records and preprints) undergo peer-review which resembles a form of quality assurance. Furthermore, it can be assumed that journal publications have a high visibility as they are indexed in electronic databases.

We only considered registers for prospective registration of systematic reviews. Registers of completed systematic reviews, such as the Center on Knowledge Translation for Disability and Rehabilitation Research (KTDRR) Registry of Systematic Reviews [ 12 ], or KSR Evidence [ 13 ] are not further considered. Furthermore, we did not consider registers that are not universally open to all authors, such as the options offered by Cochrane, the Campbell Collaboration, the Agency for Healthcare Research and Quality (AHRQ), the JBI, or the Best Evidence Medical Education (BEME) Collaboration.

Overview of current options to prospectively register a systematic review

To identify systematic review registers, the two authors independently performed internet searches in generic search engines (Google, DuckDuckGo) using keywords related to systematic reviews and prospective registration in January 2021. Furthermore, experts from the authors’ wider research network were contacted about their knowledge of further systematic review registers. We collected data on the registries identified in the previous step and organized the data in structured tables. Categories were developed deductively by the two authors. Regular meetings were held between the authors to agree on the categories. This process was informed by relevant literature, including several works of the authors. Following data collection, we contacted the responsible party of each register in April 2021 for verification of the data we had collected with regard to their registry.

Overall, we describe five options to prospectively register a systematic review: PROSPERO, the Registry of Systematic Reviews/Meta-Analyses in Research Registry, and INPLASY, which are specific to systematic reviews, and Open Science Framework (OSF) Registries and protocols.io, which present generic registers open to any study type. OSF registries specifically focuses on preregistration of studies, while the OSF in general is a project management tool for researchers with various functions, for example storing and publishing data. The key characteristics of these registers are reported in Table  1 . Data have been verified for all registers except OSF Registries (no response received). At the end of the article, in addition to the five registries, other options are described for how and where to prospectively and transparently determine one’s planned methods.

Characteristics of the identified registers

PROSPERO seems to be the most prominent option by far, as indicated by their high number of registrations. However, this popularity also seems to have led to increased turn-around times. While there is no information on the overall processing time in PROSPERO, there is some evidence that it may take up to several months [ 14 ]. It can be assumed that in particular the assessment of submissions for eligibility and completeness take time. Such checks are also performed in Research Registry and INPLASY. However, registration records become immediately visible in Research Registry as submissions are assessed after registration, while INPLASY promises a fast turn-around time taking no longer than 48 hours. Although fast turn-around times are highly appreciated by authors [ 15 , 16 ], they come at the price of a having to pay a fee for the services offered by Research Registry and INPLASY. This might be problematic for systematic reviews without specific funding. Submissions to OSF Registries or protocols.io are not formally assessed, but these registers are also free of charge. Another advantage of both is that they offer services to share the data collected as part of the systematic review.

The three registers specific to systematic reviews have a given structure consisting of 24–28 mandatory fields. In OSF Registries, users can select from different registration forms or chose “Open-Ended-Registration” and provide a narrative summary of their systematic review registration. All registers can be searched for systematic reviews already registered in the register. PROSPERO offers most search tools, including use of Medical Subject Headings. However, it has previously been reported that PROSPERO’s search function is suboptimal [ 17 ]. It is unclear how well the search functions of the remaining registers exactly work, but one could argue that more sophisticated search functions must be implemented to facilitate efficient searches as the number of registrations increases. In a perfect world, the search functions should be similar as in bibliographic databases. Authors’ contact details are provided in the three systematic-review-specific registers, but not in OSF Registries and protocols.io. PROSPERO, OSF Registries and protocols.io enable version tracking, and INPLASY, OSF Registries and protocols.io provide Digital Object Identifiers (DOIs) for registrations. Authors should note that there are differences between the registries with respect to their eligibility criteria. For example, PROSPERO only accepts reviews including at least one direct health-related outcome. Further information on the identified registers can be found in Table  2 .

Further information on the identified registers

Additional options to prospectively and transparently determine one’s planned methods

In addition to publishing a protocol and registering a systematic review in one of the five registers described above, we identified further options for prospectively reporting one’s planned methods. However, we do not consider them as registers (see definition above).

First, there are online open access data repositories allowing users to upload time-stamped, version-tracked files with a DOI. These services can be used to upload protocol documents, but also any other type of data associated with a research project. Examples include the OSF (open source; https://osf.io/ ), Figshare (commercial; https://figshare.com/ ), or Zenodo (open source;funded by CERN, OpenAIRE and the European Union; https://zenodo.org/ ). Using OSF and Zenodo is suggested as an option in the updated Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) 2020 explanation and elaboration (Box 6) [ 29 ]. Recently, the PreregRS template for preregistering research syntheses was published, which aims to guide researchers in preparing a file that can be uploaded to such repositories [ 30 ]. More data repositories can be found by searching re3data.org, a registry of research data repositories. One option specifically for systematic reviews is the Systematic Review Data Repository by the AHRQ [ 31 ]. Second, we identified a pre-registration service called AsPredicted by the Penn Wharton Credibility Lab [ 32 ]. AsPredicted allows users to create a time-stamped PDF with the planned methods that can be shared selectively via a unique URL, but which remains private until an author makes it public. Third, we identified the Collaborative Approach to Meta-Analysis and Review of Animal Data from Experimental Studies (CAMARADES) by the Preclinical Systematic Review & Meta-analysis Facility (SyRF) [ 33 ]. SyRF shared protocols of systematic reviews of animal studies in in a standardized way on the CAMARADES website until 2018. Afterwards, the service was stopped, as systematic reviews of animal studies relevant to human health can nowadays be registered in PROSPERO. However, SyRF will continue to host systematic review protocols submitted previously [ 34 ]. Last, we also identified registration records for systematic reviews in ClinicalTrials.gov [ 35 , 36 ]. While ClinicalTrials.gov aligns with our definition of a register, we did not consider it in our overview as it clearly has a different purpose, i.e., the prospective registration of clinical trials.

The five identified registers have different characteristics and features which authors may want to consider when choosing a suitable register for their next systematic review. It seems that, among the systematic-review-specific registries, authors have to trade-off between the costs of registration and the processing time. While being the costliest, Research Registry is also the fastest register as records are published immediately. PROSPERO is used widely and is free of charge, but as PROSPERO receives funding from the United Kingdom (UK) National Institute for Health Research (NIHR), registrations from the UK are prioritized. While this is understandable, it may be problematic for users from outside the UK. Furthermore, there is a potential risk that funding will be discontinued at some point as it has previously been the case with the National Health Service Economic Evaluation Database and the Database of Abstracts of Reviews of Effects that were also hosted by the CRD and funded through the UK NIHR [ 37 ]. Thus, it seems to be necessary to discuss alternative financing schemes for registries, which are both fair and sustainable. However, this is also so case for clinical trials registers. Originally, it has been discussed to include a systematic review registry in clinical trials registries to use existing technology and resources efficiently and promote collaboration among trialists and reviewers [ 7 ].

Limitations

We identified several options to prospectively register a systematic review. While there are also important points regarding systematic review registers from a meta-perspective, this commentary is written from an author perspective. Furthermore, it is possible that we missed other available options and thus encourage others to share further options for the prospective registration of systematic reviews with us.

We identified five registries where authors can prospectively register their systematic review, three of which are systematic-review-specific and two generic ones. These registries come with different characteristics and features, for example in terms of the costs of registration, turn-around times, and funding/business model. For registers that are not operated for-profit, e.g., PROSPERO, the research community should discuss fair and sustainable financing models to ensure long-term access and performance.

Acknowledgements

We would like to thank Connor Evans from PROSPERO, Riaz Agha from Research Registry, João Vitor Canellas from INPLASY, and Emma Ganley from protocols.io for verifying the data related to their registry.

Abbreviations

Authors’ contributions

DP and TR were equally involved in the conception and design of the work and the acquisition and interpretation of data. DP has drafted the work and TR has substantively revised it. Both authors approved the submitted version and agree to be personally accountable for the work.

Open Access funding enabled and organized by Projekt DEAL. There was no funding for the conduct of this study.

Availability of data and materials

Declarations.

Not applicable.

DP and TR declare to have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

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A systematic literature review of the clinical and socioeconomic burden of bronchiectasis

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Background The overall burden of bronchiectasis on patients and healthcare systems has not been comprehensively described. Here, we present the findings of a systematic literature review that assessed the clinical and socioeconomic burden of bronchiectasis with subanalyses by aetiology (PROSPERO registration: CRD42023404162).

Methods Embase, MEDLINE and the Cochrane Library were searched for publications relating to bronchiectasis disease burden (December 2017–December 2022). Journal articles and congress abstracts reporting on observational studies, randomised controlled trials and registry studies were included. Editorials, narrative reviews and systematic literature reviews were included to identify primary studies. PRISMA guidelines were followed.

Results 1585 unique publications were identified, of which 587 full texts were screened and 149 were included. A further 189 citations were included from reference lists of editorials and reviews, resulting in 338 total publications. Commonly reported symptoms and complications included dyspnoea, cough, wheezing, sputum production, haemoptysis and exacerbations. Disease severity across several indices and increased mortality compared with the general population was reported. Bronchiectasis impacted quality of life across several patient-reported outcomes, with patients experiencing fatigue, anxiety and depression. Healthcare resource utilisation was considerable and substantial medical costs related to hospitalisations, treatments and emergency department and outpatient visits were accrued. Indirect costs included sick pay and lost income.

Conclusions Bronchiectasis causes significant clinical and socioeconomic burden. Disease-modifying therapies that reduce symptoms, improve quality of life and reduce both healthcare resource utilisation and overall costs are needed. Further systematic analyses of specific aetiologies and paediatric disease may provide more insight into unmet therapeutic needs.

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Bronchiectasis imposes a significant clinical and socioeconomic burden on patients, their families and employers, and on healthcare systems. Therapies that reduce symptoms, improve quality of life and reduce resource use and overall costs are needed. https://bit.ly/4bPCHlp

• Introduction

Bronchiectasis is a heterogeneous chronic respiratory disease clinically characterised by chronic cough, excessive sputum production and recurrent pulmonary exacerbations [ 1 ], and radiologically characterised by the abnormal widening of the bronchi [ 2 ]. Bronchiectasis is associated with several genetic, autoimmune, airway and infectious disorders [ 3 ]. Regardless of the underlying cause, the defining features of bronchiectasis are chronic airway inflammation and infection, regionally impaired mucociliary clearance, mucus hypersecretion and mucus obstruction, as well as progressive structural lung damage [ 4 , 5 ]. These features perpetuate one another in a “vicious vortex” leading to a decline in lung function, pulmonary exacerbations and associated morbidity, mortality and worsened quality of life [ 4 , 5 ]. Bronchiectasis can be further categorised into several infective and inflammatory endotypes and is associated with multiple comorbidities and underlying aetiologies [ 6 ].

Bronchiectasis has been described as an emerging global epidemic [ 7 ], with prevalence and incidence rates increasing worldwide [ 8 – 12 ]. The prevalence of bronchiectasis, as well as of the individual aetiologies, varies widely across geographic regions [ 13 ]. In Europe, the reported prevalence ranges from 39.1 (females) and 33.3 (males) cases per 100 000 inhabitants in Spain and 68 (females) and 65 (males) cases per 100 000 inhabitants in Germany, to as high as 566 cases (females) and 486 cases (males) per 100 000 inhabitants in the UK [ 10 – 12 ]. In the US, the average overall prevalence was reported to be 139 cases per 100 000 [ 14 ], in Israel, the prevalence was reported to be 234 cases per 100 000 [ 15 ], and in China the prevalence was reported to be 174 per 100 000 [ 8 ]. Studies show that bronchiectasis prevalence increases with age [ 14 ]. This may increase the socioeconomic impact of bronchiectasis on countries with disproportionately higher number of older citizens. Large registry studies in patients with bronchiectasis have been published from the US (Bronchiectasis Research Registry) [ 16 ], Europe and Israel (European Multicentre Bronchiectasis Audit and Research Collaboration (EMBARC)); the largest and most comprehensive report available to date) [ 17 ], India (EMBARC-India) [ 18 , 19 ], Korea (Korean Multicentre Bronchiectasis Audit and Research Collaboration) [ 20 ] and Australia (Australian Bronchiectasis Registry) [ 21 ].

Although there are currently no approved disease-modifying therapies for bronchiectasis [ 4 ], comprehensive clinical care recommendations for the management of patients with bronchiectasis have been published [ 22 , 23 ]. However, the burden that bronchiectasis imposes on patients and their families, as well as on healthcare systems, payers and employers, remains poorly understood. No review to date has used a systematic method to evaluate the overall disease burden of bronchiectasis. This is the first systematic literature review aimed at investigating and synthesising the clinical and socioeconomic burden of bronchiectasis. A better understanding of the overarching burden of bronchiectasis, both overall and by individual aetiologies and associated diseases, will highlight the need for new therapies and assist healthcare systems in planning care and required resources.

The protocol of this systematic review was registered on PROSPERO (reference number: CRD42023404162).

Search strategy

This systematic literature review was conducted according to the Preferred Reporting Items for Systematic Review and Meta-Analyses (PRISMA) guidelines [ 24 ]. Embase, MEDLINE and the Cochrane Library were searched for studies related to the clinical and socioeconomic burden of bronchiectasis (noncystic fibrosis bronchiectasis (NCFBE) and cystic fibrosis bronchiectasis (CFBE)) using the search terms available in supplementary table S1 . Articles written in English and published over a 5-year period (December 2017–December 2022) were included.

Selection criteria

The following article types reporting on prospective and retrospective observational studies, registry studies and randomised controlled trials (only baseline data extracted) were included: journal articles, preprints, research letters, conference proceedings, conference papers, conference abstracts, meeting abstracts and meeting posters. Reviews, literature reviews, systematic reviews and meta-analyses, as well as editorials, commentaries, letters and letters to the editor, were included for the purpose of identifying primary studies. A manual search of references cited in selected articles was performed and references were only included if they were published within the 5 years prior to the primary article being published.

Screening and data extraction

A reviewer screened all titles and abstracts to identify publications for full-text review. These publications then underwent full-text screening by the same reviewer for potential inclusion. A second reviewer independently verified the results of both the title/abstract screen and the full-text screen. Any discrepancies were resolved by a third independent reviewer. Data relating to aetiology, symptoms, disease severity, exacerbations, lung function, infection, comorbidities, patient-reported outcomes (PROs), exercise capacity, mortality, impact on family and caregivers, healthcare resource utilisation (HCRU), treatment burden, medical costs, and indirect impacts and costs, as well as data relating to the patient population, study design, sample size and country/countries of origin, were extracted from the final set of publications into a standardised Excel spreadsheet by one reviewer. Studies were grouped based on the burden measure, and aggregate data (range of reported values) were summarised in table or figure format. For the economic burden section, costs extracted from studies reporting in currencies other than the euros were converted to euros based on the average exchange rate for the year in which the study was conducted.

Data from patients with specific bronchiectasis aetiologies and in children (age limits varied from study to study and included upper age limits of 15, 18, 19 and 20 years) were reported separately, where available. As literature relating to NCFBE and CFBE is generally distinct, any data related to CFBE are reported separately in the tables and text. We conducted subanalyses of key disease burden indicators, in which we extracted data from multicentre studies or those with a sample size >1000 subjects, to try to identify estimates from the most representative datasets. These data from larger and multicentre studies are reported in square brackets in tables 1 – 3 and supplementary tables S2–S7 , where available.

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Prevalence and severity of bronchiectasis symptoms overall, in children, during exacerbations and in individual bronchiectasis aetiologies

Patient-reported outcome scores in patients with bronchiectasis overall and in individual bronchiectasis aetiologies

Healthcare resource utilisation (HCRU) in patients with bronchiectasis overall and in individual bronchiectasis aetiologies

Given the nature of the data included in this systematic literature review (that is, a broad range of patient clinical and socioeconomic characteristics rather than the outcome(s) of an intervention), in addition to the broad range of study types included, meta-analyses to statistically combine data of similar studies were not deemed appropriate and therefore not performed.

Summary of included studies

A total of 1834 citations were retrieved from the Embase, MEDLINE and Cochrane Library databases, of which 1585 unique citations were identified. Abstract/title screening led to the inclusion of 587 citations for full-text screening. Following full-text screening, 149 primary citations and 110 literature reviews, systematic reviews and meta-analyses as well as editorials and letters to the editor remained. From the reference lists of these 110 citations, a further 189 primary citations were identified. These articles were only included if 1) the primary articles contained data relating to the burden of bronchiectasis and 2) the primary articles were published within the 5 years prior to the original article's publication date. In total, 338 publications were considered eligible and included in this review ( supplementary figure S1 ). This included 279 journal articles, 46 congress abstracts and 13 letters to the editor or scientific/research letters. The results are summarised in the sections below. For the results from individual studies, including a description of the patient population, study design, sample size and country/countries of origin, please see the supplemental Excel file .

The most frequently reported aetiologies included post-infectious, genetic (primary ciliary dyskinesia (PCD), alpha-1 antitrypsin deficiency (AATD) and cystic fibrosis (CF)), airway diseases (COPD and asthma), allergic bronchopulmonary aspergillosis (ABPA), aspiration and reflux-related, immunodeficiency and autoimmune aetiologies ( supplementary figure S2 ). However, in up to 80.7% of adult cases and 53.3% of paediatric cases, the aetiology was not determined (referred to as “idiopathic bronchiectasis”) ( supplementary figure S2 ). When limited to larger or multicentre studies, the frequency of idiopathic bronchiectasis ranged from 11.5 to 66.0% in adults and from 16.5 to 29.4% in children. Further details and additional aetiologies can be seen in the supplemental Excel file .

Clinical burden

Symptom burden and severity.

Commonly reported symptoms in patients with bronchiectasis included cough, sputum production, dyspnoea, wheezing and haemoptysis, with these symptoms more prevalent in adults compared with children ( table 1 ). Other reported symptoms included chest discomfort, pain or tightness (both generally and during an exacerbation), fever and weight loss in both adults and children, and fatigue, tiredness or asthenia, appetite loss, and sweating in adults. In children, respiratory distress, hypoxia during an exacerbation, sneezing, nasal and ear discharge, thriving poorly including poor growth and weight loss, exercise intolerance, malaise, night sweats, abdominal pain, recurrent vomiting, and diarrhoea were reported ( supplemental Excel file ). Classic bronchiectasis symptoms such as sputum production (range of patients reporting sputum production across all studies: 22.0–92.7%) and cough (range of patients reporting cough across all studies: 24.0–98.5%) were not universally reported ( table 1 ).

In a study comparing bronchiectasis (excluding CFBE) in different age groups (younger adults (18–65 years), older adults (66–75 years) and elderly adults (≥76 years) [ 63 ]), no significant differences across age groups were reported for the presence of cough (younger adults: 73.9%; older adults: 72.8%; elderly adults: 72.9%; p=0.90), sputum production (younger adults: 57.8%; older adults: 63.8%; elderly adults: 6.0%; p=0.16) or haemoptysis (younger adults: 16.5%; older adults: 19.3%; elderly adults: 16.3%; p=0.47).

Disease severity

Disease severity was reported according to several measures including the bronchiectasis severity index (BSI), the forced expiratory volume in 1 s (FEV 1 ), Age, Chronic Colonisation, Extension, Dyspnoea (FACED) score and the Exacerbations-FACED (E-FACED) score, all of which are known to be associated with future exacerbations, hospitalisations and mortality ( supplementary table S2 and the supplemental Excel file ). Up to 78.7, 41.8 and 40.8% of patients with bronchiectasis reported severe disease according to the BSI, FACED score and E-FACED score, respectively ( supplementary table S2 ). In most studies, severity scores were greater among people with bronchiectasis secondary to COPD or post-tuberculosis (TB) than idiopathic bronchiectasis ( supplementary table S2 ). No data relating to disease severity were reported for CFBE specifically.

Exacerbations

The number of exacerbations experienced by patients with bronchiectasis in the previous year, per year and during follow-up are presented in figure 1 . For further details, please see the supplemental Excel file . Two studies reported exacerbation length in patients with bronchiectasis; this ranged from 11 to 16 days (both small studies; sample sizes of 191 and 32, respectively) [ 25 , 64 ]. A study in children with NCFBE reported a median of one exacerbation in the previous year. Additionally, the same study reported that 31.1% of children with bronchiectasis experienced ≥3 exacerbations per year [ 65 ].

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Range of bronchiectasis exacerbations in the previous year, per year and in the first and second years of follow-up. # : Two studies reported significant differences in the number of exacerbations experienced in the previous year across individual aetiologies. Study 1 [ 90 ]: Patients with idiopathic bronchiectasis had significantly fewer exacerbations in the previous year compared with other aetiologies (primary ciliary dyskinesia (PCD), COPD and post-infectious) (p<0.021). Study 2 [ 33 ]: significant difference between post-tuberculosis (TB) bronchiectasis (mean: 2.8) and other aetiologies excluding idiopathic bronchiectasis (mean: 1.7) (p<0.05).

Lung function

Reduced lung function was reported across several different measures in adults and children with bronchiectasis overall, including FEV 1 (absolute values and % predicted), forced vital capacity (FVC; absolute values and % pred) and lung clearance index (adults only) ( supplementary table S3 and the supplemental Excel file ). In most studies, lung function was lowest among people with post-TB bronchiectasis and bronchiectasis secondary to COPD or PCD ( supplementary table S2 ). Additional measures of lung function are detailed in the supplemental Excel file . Lung clearance index, considered more sensitive than spirometry to early airway damage, was elevated in two studies in adults with bronchiectasis, with a range of 9.0–12.8 (normal: 6–7 or less) [ 66 , 67 ].

In a study comparing bronchiectasis (people with CFBE excluded) in different age groups, elderly adults (≥76 years) had significantly lower FEV 1 % pred (median: 67) compared with both younger (18–65 years; median: 78) and older adults (66–75 years; median: 75) (p<0.017 for both comparisons) [ 63 ]. FVC % pred was found to be significantly lower in elderly adults (mean: 65) compared with both younger adults (median: 78) and older adults (median: 75) (p<0.017 for both comparisons) [ 63 ].

Chronic infection with at least one pathogen was reported in 22.3–79.6% of patients with bronchiectasis, although each study defined chronic infection differently (number of studies: 20). When limited to larger or multicentre studies, chronic infection with at least one pathogen was reported in 10.7–54.5% of patients with bronchiectasis (number of studies: 12). In two studies in NCFBE, significant differences in the proportion of patients chronically infected with at least one pathogen were reported across aetiologies (p<0.001 for both studies) [ 68 , 69 ]. Patients with post-infectious (other than TB) bronchiectasis (34.9%) [ 68 ] and patients with PCD-related bronchiectasis (68.3%) [ 69 ] had the highest prevalence of chronic infection.

The most commonly reported bacterial and fungal pathogens are shown in supplementary table S4 . The two most common bacterial pathogens were Pseudomonas ( P .) aeruginosa and Haemophilus ( H. ) influenzae . In several studies, more patients with PCD, TB and COPD as the aetiology of their bronchiectasis reported infection with P. aeruginosa . Additionally, in one study, significantly more children with CFBE had P. aeruginosa infection compared with children with NCFBE [ 70 ]. Further details and additional pathogens are reported in the supplemental Excel file .

Diversity of the sputum microbiome was assessed in two studies. In the first study in people with bronchiectasis (people with CFBE excluded), reduced microbiome alpha diversity (defined as the relative abundance of microbial species within a sample), particularly associated with Pseudomonas or Proteobacteria dominance, was associated with greater disease severity, increased frequency and severity of exacerbations, and a higher risk of mortality [ 71 ]. In the second study (unknown whether people with CFBE were excluded), a lower Shannon–Wiener diversity index (a measure of species diversity, with lower scores indicating lower diversity) score was associated with multiple markers of disease severity, including a higher BSI score (p=0.0003) and more frequent exacerbations (p=0.008) [ 72 ].

In a study comparing bronchiectasis (people with CFBE excluded) in different age groups (younger adults: 18–65 years; older adults: 66–75 years; elderly adults: ≥76 years) [ 63 ], chronic infection with H. influenzae was reported in 18.3% of younger adults, 12.8% of older adults and 8.8% of elderly adults, and chronic infection with Streptococcus ( Str. ) pneumoniae was reported in 5.3% of younger adults, 2.8% of older adults and 1.3% of elderly adults. For both of the above, the prevalence was significantly higher in younger adults compared with elderly adults (p<0.017 for both comparisons). However, no significant differences across age groups were reported for P. aeruginosa , Moraxella catarrhalis or Staphylococcus ( Sta .) aureus chronic infection.

P. aeruginosa infection was significantly associated with reduced FEV 1 [ 73 ], more severe disease [ 74 ], more frequent exacerbations [ 35 , 49 , 75 , 76 ], increased hospital admissions, reduced quality of life based on St. George's Respiratory Questionnaire (SGRQ) and increased and 4-year mortality [ 49 , 76 ]. Additionally, in a study reporting healthcare use and costs in the US between 2007–2013, healthcare costs and hospitalisation costs were found to be increased in patients infected with P. aeruginosa ($56 499 and $41 972 more than patients not infected with P. aeruginosa , respectively) [ 77 ]. In the same study, HCRU was also higher in patients infected with P. aeruginosa (fivefold increase in the number of hospitalisations and 84% more emergency department (ED) visits compared with patients not infected with P. aeruginosa ) [ 77 ].

Comorbidities

The most frequently reported comorbidities included cardiovascular (including heart failure, cerebrovascular disease and hypertension), respiratory (including asthma, COPD and sinusitis), metabolic (including diabetes and dyslipidaemia), malignancy (including haematological and solid malignancies), bone and joint-related (including osteoporosis and rheumatological disease), neurological (including anxiety and depression), renal, hepatic, and gastrointestinal comorbidities ( supplementary table S5 ). No data relating to comorbidities were reported for CFBE specifically. For further details and additional comorbidities, please see the supplemental Excel file .

In a study comparing bronchiectasis (people with CFBE excluded) in different age groups (younger adults: 18–65 years; older adults: 66–75 years; elderly adults: ≥76 years), younger adults had a significantly lower prevalence of diabetes compared with older adults, a significantly lower prevalence of stroke compared with elderly adults and a significantly lower prevalence of heart failure, solid tumours and renal failure compared with both older and elderly adults (p<0.0017 for all comparisons). Additionally, the prevalence of COPD was significantly lower in both younger and older adults compared with elderly adults (p<0.017) [ 63 ]. In studies reporting in children with bronchiectasis, the prevalence of comorbid asthma ranged from 22.2 to 25.8% [ 65 , 78 ] and the prevalence of sinusitis was reported to be 12.7% in a single study [ 79 ].

Charlson comorbidity index (CCI)

CCI scores can range from 0 to 37, with higher scores indicating a decreased estimate of 10-year survival. In this review, CCI scores ranged from 0.7 to 6.6 in studies reporting means (number of studies: 7). In one study, adults with bronchiectasis (people with CFBE excluded) who experienced ≥2 exacerbations per year were found to have significantly higher CCI scores (3.3) compared with patients who experienced less than two exacerbations per year (2.2) (p=0.001) [ 35 ]. In another study in adults with bronchiectasis (people with CFBE excluded), CCI scores increased significantly with increasing disease severity, with patients with mild (FACED score of 0–2), moderate (FACED score of 3–4) and severe (FACED score of 5–7) bronchiectasis reporting mean CCI scores of 3.9, 5.7 and 6.3, respectively [ 80 ]. No CCI scores were reported for CFBE specifically.

Prevalence of comorbidities in patients with bronchiectasis compared with control individuals

Several studies reported a higher prevalence of cardiovascular comorbidities. such as heart failure [ 81 ], stroke [ 82 , 83 ] and hypertension [ 82 – 84 ] in patients with bronchiectasis compared with a matched general population or healthy controls. Conversely, several additional studies reported no significant differences [ 81 , 85 , 86 ]. Two large studies reported an increased prevalence of diabetes in patients with bronchiectasis compared with nonbronchiectasis control groups [ 83 , 84 ]; however, three additional smaller studies reported no significant differences [ 81 , 82 , 86 ]. The prevalence of gastro–oesophageal reflux disease was found to be significantly higher in patients with bronchiectasis compared with matched nonbronchiectasis controls in one study [ 87 ], but no significant difference was reported in a second study [ 85 ]. Both anxiety and depression were found to be significantly more prevalent in patients with bronchiectasis compared with matched healthy controls in one study [ 55 ]. Lastly, two large studies reported an increased prevalence of asthma [ 84 , 87 ] and five studies reported a significantly higher prevalence of COPD [ 81 , 82 , 84 , 85 , 87 ] in patients with bronchiectasis compared with matched nonbronchiectasis controls or the general population. A smaller study reported conflicting evidence whereby no significant difference in the prevalence of asthma in patients with bronchiectasis compared with matched controls was reported [ 85 ].

Socioeconomic burden

Patient-reported outcomes.

Health-related quality of life (HRQoL), fatigue, anxiety and depression were reported across several PRO measures and domains. The most frequently reported PROs are discussed in further detail in the sections below ( table 2 ). Further details and additional PROs can be seen in the supplemental Excel file .

In a study comparing bronchiectasis (people with CFBE excluded) in different age groups (younger adults: 18–65 years; older adults: 66–75 years; elderly adults: ≥76 years), the median SGRQ total score was significantly higher in elderly adults (50.8) compared with younger adults (36.1), indicating a higher degree of limitation (p=0.017) [ 63 ].

In a study that reported Leicester Cough Questionnaire (LCQ) scores in men and women with bronchiectasis (people with CFBE excluded) separately, women had significantly lower LCQ total scores (14.9) when compared with men (17.5) (p=0.006), indicating worse quality of life [ 88 ]. Additionally, women had significantly lower scores across all three LCQ domains (p=0.014, p=0.005 and p=0.011 for physical, psychological and social domains, respectively) [ 88 ].

Exercise capacity

Exercise capacity in patients with bronchiectasis was reported using walking tests namely the 6-minute walk test (6MWT) and the incremental shuttle walk test (ISWT) ( supplementary table S6 ). The 6MWT data from patients with bronchiectasis generally fell within the normal range for healthy people; however, the ISWT data was below the normal range for healthy people ( supplementary table S6 ). Studies also reported on daily physical activity, daily sedentary time and number of steps per day in patients with bronchiectasis, and in children specifically ( supplementary table S6 ). No data relating to disease severity were reported for CFBE specifically. Further details can be seen in the supplemental Excel file .

Exercise capacity in patients with bronchiectasis compared with control individuals

In one study, the ISWT distance was reported to be significantly lower in patients with NCFBE compared with healthy controls (592.6 m versus 882.9 m; difference of ∼290 m; p<0.001) [ 89 ]. Additionally, patients with bronchiectasis spent significantly less time on activities of moderate and vigorous intensity compared with healthy controls (p=0.030 and 0.044, respectively) [ 89 ]. Lastly, a study reported that patients with NCFBE had a significantly lower step count per day compared with healthy controls (p<0.001) [ 89 ].

Mortality rate during study period

Mortality ranged from 0.24 to 67.6%; however, it should be noted that the study duration differed across studies. When limited to larger or multicentre studies, the mortality rate ranged from 0.24 to 28.1%. One study reported more deaths in patients with NCFBE (9.1%; 5.9-year mean follow-up period) compared with patients without bronchiectasis (0.8%; 5.4-year mean follow-up period) [ 84 ]. In one study, significantly more patients with COPD-related bronchiectasis died (37.5%) compared with other aetiologies (19.0%) (3.4-year mean follow-up period; p<0.001). After adjusting for several factors, multivariate analysis showed that the diagnosis of COPD as the primary cause of bronchiectasis increased the risk of death by 1.77 compared with the patients with other aetiologies [ 41 ]. Similarly, in another study, COPD-associated bronchiectasis was associated with higher mortality (55%) in multivariate analysis as compared with other aetiologies (rheumatic disease: 20%; post-infectious: 16%; idiopathic: 14%; ABPA: 13%; immunodeficiency: 11%) (hazard ratio 2.12, 95% CI 1.04–4.30; p=0.038; 5.2-year median follow-up period) [ 90 ].

Mortality rates by year

The 1-, 2-, 3-, 4- and 5-year mortality rates in patients with bronchiectasis (people with CFBE excluded, unless unspecified) ranged from 0.0 to 12.3%, 0.0 to 13.0%, 0.0 to 21.0%, 5.5 to 39.1% and 12.4 to 53.0%, respectively (number of studies: 9, 4, 7, 1 and 4, respectively). When limited to larger or multicentre studies, the 1-, 2-, 3- and 5-year mortality rates ranges were 0.4–7.9%, 3.9–13.0%, 3.7–21.0% and 12.4–53.0% (no 4-year mortality data from larger or multicentre studies). No data relating to mortality rates were reported for CFBE specifically.

Two studies reported mortality rate by bronchiectasis aetiology (people with CFBE excluded). In the first study, no significant difference in the 4-year mortality rate was reported across aetiologies (p=0.7; inflammatory bowel disease: 14.3%; post-TB: 13.4%; rheumatoid arthritis: 11.4%; idiopathic or post-infectious: 10.1%; ABPA: 6.1%; other aetiologies: 6.1%) [ 49 ]. In the second study, patients with post-TB bronchiectasis had a significantly higher 5-year mortality rate (30.0%) compared with patients with idiopathic bronchiectasis (18.0%) and other aetiologies (10.0%) (p<0.05 for both comparisons) [ 32 ].

In-hospital and intensive care unit mortality

In-hospital mortality ranged from 2.9 to 59.3% in patients with bronchiectasis (people with CFBE excluded, unless unspecified) hospitalised for an exacerbation or for other reasons (number of studies: 7). When limited to larger or multicentre studies, in-hospital mortality rate was reported in only one study (33.0%). One study reported mortality in bronchiectasis patients admitted to a tertiary care centre according to aetiology; in-hospital mortality was highest in patients with post-pneumonia bronchiectasis (15.8%), followed by patients with idiopathic (7.1%) and post-TB (2.6%) bronchiectasis. No deaths were reported in patients with COPD, ABPA or PCD aetiologies [ 42 ]. Intensive care unit mortality was reported in two studies and ranged from 24.6 to 36.1% [ 62 , 91 ]. No data relating to mortality rates were reported for CFBE specifically.

Impact on family and caregivers

Only two studies discussed the impact that having a child with bronchiectasis has on parents/caregivers. In the first study, parents of children with bronchiectasis (not specified whether children with CFBE were excluded) were more anxious and more depressed according to both the Hospital Anxiety and Depression Scale (HADS) and the Centre of Epidemiological Studies depression scale, compared with parents of children without any respiratory conditions (both p<0.001; sample size of 29 participants) [ 53 ]. In the second study, parents or carers of children with bronchiectasis (multicentre study with a sample size of 141 participants; children with CFBE excluded) were asked to vote for their top five greatest concerns or worries; the most common worries or concerns that were voted for by over 15% of parents were “impact on his/her adult life in the future, long-term effects, normal life” (29.8%), “ongoing declining health” (25.5%), “the cough” (24.8%), “impact on his/her life now as a child (play, development)” (24.1%), “lack of sleep/being tired” (24.1%), “concerns over aspects of antibiotic use” (22.7%), “missing school or daycare” (17.7%) and “breathing difficulties/shortness of breath” (16.3%) [ 92 ].

HCRU in terms of hospitalisations, ED visits, outpatient visits and length of stay overall and by bronchiectasis aetiology are reported in table 3 . No data relating to HCRU were reported for CFBE specifically.

In a study in children with bronchiectasis (children with CFBE excluded), 30.0% of children were hospitalised at least once in the previous year [ 65 ]. The median number of hospitalisations per year was 0 (interquartile range: 0–1) [ 65 ]. In another study, the mean length of hospital stay for children with bronchiectasis was 6.7 days (standard deviation: 4.8 days) [ 93 ]. In a study comparing bronchiectasis (people with CFBE excluded) in different age groups, significantly more elderly adults (≥76 years; 26.0%) were hospitalised at least once during the first year of follow-up compared with younger adults (18–65 years; 17.0%) and older adults (66–75 years; 17.0%) (p<0.017 for both comparisons) [ 63 ]. Additionally, length of stay was found to be significantly longer in male patients (mean: 17.6 days) compared with female patients (mean: 12.5 days) (p=0.03) [ 94 ].

HCRU in patients with bronchiectasis compared with control individuals

Length of stay was found to be 38% higher in patients with bronchiectasis (mean: 15.4 days; people with CFBE excluded) compared with patients with any other respiratory illness (mean: 9.6 days) (p<0.001) [ 94 ]. In a study reporting on HCRU in patients with bronchiectasis (people with CFBE excluded) over a 3-year period (Germany; 2012–2015) [ 85 ], a mean of 24.7 outpatient appointments per patient were reported; there was no significant difference in the number of outpatient appointments between patients with bronchiectasis and matched controls (patients without bronchiectasis matched by age, sex and distribution, and level of comorbidities) (mean: 23.4) (p=0.12). When assessing specific outpatient appointments over the 3-year period, patients with bronchiectasis attended a mean of 9.2 general practitioner appointments, 2.9 radiology appointments, 2.5 chest physician appointments and 0.8 cardiologist appointments. Patients with bronchiectasis had significantly fewer general practitioner appointments compared with matched controls (mean: 9.8) (p=0.002); however, they had significantly more radiology appointments (mean for matched controls: 2.3) and chest physician appointments (mean for matched controls: 1.4) compared with matched controls (p<0.001 for both comparisons).

Hospital admission rates

In England, Wales and Northern Ireland, the crude hospital admission rate in 2013 was 88.4 (95% CI 74.0–105.6) per 100 000 person-years [ 91 ]. In New Zealand (2008–2013), the crude and adjusted hospital admission rates were 25.7 and 20.4 per 100 000 population, respectively [ 95 ]. Lastly, in Australia and New Zealand (2004–2008) the hospital admission rate ranged from 0.7 to 2.9 per person-year [ 96 ]. In all of the abovementioned studies, people with CFBE were excluded.

Treatment burden

In two studies, the percentage of patients with bronchiectasis receiving any respiratory medication at baseline ranged from 60.8 to 85.7% [ 97 , 98 ]. Additionally, in a study comparing healthcare costs in patients with bronchiectasis before and after confirmation of P. aeruginosa infection, mean pharmacy visits in the year preceding diagnosis were reported to be 23.2; this increased significantly by 56.5% to 36.2 in the year post-diagnosis (p<0.0001) [ 99 ]. In another study, patients with bronchiectasis were prescribed a mean of 12 medications for bronchiectasis and other comorbidities [ 100 ]. In all of the abovementioned studies, people with CFBE were excluded. The most frequently reported respiratory treatments can be seen in supplementary table S7 . These included antibiotics (including macrolides), corticosteroids, bronchodilators, mucolytics and oxygen. No treatment data were reported for CFBE specifically. Other respiratory treatments included saline, anticholinergics and leukotriene receptor antagonists ( supplemental Excel file ).

In studies reporting in children with bronchiectasis, 23.9% of children were receiving any bronchodilator at baseline [ 101 ], 9.0–21.7% of children were receiving inhaled corticosteroids (ICS) at baseline [ 101 , 102 ], 4.3% of children were receiving oral corticosteroids at baseline [ 101 ] and 12.1% of children were receiving long-term oxygen therapy [ 103 ].

Medical and nonmedical indirect impacts and costs

Medical costs for bronchiectasis included overall costs, hospitalisation costs, ED visits and outpatient visit costs and costs of treatment; indirect impacts and costs included sick leave and sick pay, missed work and income loss for caregivers, and missed school or childcare for children ( table 4 and the supplemental Excel file ). People with CFBE were excluded from all of the studies in table 4 below. In studies reporting in currencies other than the €, costs were converted to € based on the average exchange rate for the year in which the study was conducted.

Bronchiectasis-related medical costs and indirect impacts and costs (individual studies)

No review to date has systematically evaluated the overall disease burden of bronchiectasis. Here, we present the first systematic literature review that comprehensively describes the clinical and socioeconomic burden of bronchiectasis overall and across individual aetiologies and associated diseases. A total of 338 publications were included in the final analysis. Together, the results indicate that the burden of clinically significant bronchiectasis on patients and their families, as well as on healthcare systems, is substantial, highlighting the urgent need for new disease-modifying therapies for bronchiectasis.

Bronchiectasis is associated with genetic, autoimmune, airway and infectious disorders. However, in many patients with bronchiectasis, an underlying aetiology cannot be identified (idiopathic bronchiectasis) [ 1 , 3 , 4 ]. This is supported by the results of this systematic literature review, in which up to 80.7% of patients were reported to have idiopathic bronchiectasis. The results are in line with those reported in a systematic literature review of bronchiectasis aetiology conducted by G ao et al. [ 13 ] (studies from Asia, Europe, North and South America, Africa and Oceania included) in which an idiopathic aetiology was reported in approximately 45% of patients with bronchiectasis, with a range of 5–82%. The maximum of 80.7% of patients with idiopathic bronchiectasis identified by this systematic literature review is much higher than in the recent report on the disease characteristics of the EMBARC where idiopathic bronchiectasis was the most common aetiology and reported in only ∼38% of patients with bronchiectasis [ 17 ]. This highlights the importance of sample size and geographic variation (80.7% reported from a single-country study with a small sample size versus ∼38% reported from a continent-wide study with a large sample size). Nevertheless, identifying the underlying aetiology is a recommendation of bronchiectasis guidelines as this can considerably alter the clinical management and prognosis [ 23 , 110 ]. Specific therapeutic interventions may be required for specific aetiologies, such as ICS for people with asthma-related bronchiectasis, antifungal treatment for those with ABPA-associated bronchiectasis and immunoglobulin replacement therapy for those with common variable immunodeficiency-related bronchiectasis [ 23 , 111 ]. Indeed, an observational study has shown that identification of the underlying aetiology affected management in 37% of people with bronchiectasis [ 112 ]. Future studies to determine the impact of identifying the underlying aetiology on management and prognosis are needed to fully understand its importance.

Patients with bronchiectasis experienced a significant symptom burden, with dyspnoea, cough, wheezing, sputum production and haemoptysis reported most commonly. These symptoms were also reported in children with bronchiectasis at slightly lower frequencies. Dealing with bronchiectasis symptoms are some of the greatest concerns from a patient's perspective. In a study assessing the aspects of bronchiectasis that patients found most difficult to deal with, sputum, dyspnoea and cough were the first, fifth and sixth most common answers, respectively [ 113 ]. Some aetiologies were reported to have a higher prevalence of certain symptoms. For example, in single studies, patients with PCD-related bronchiectasis were found to have a significantly higher prevalence of cough and wheezing [ 39 ], patients with COPD-related bronchiectasis were found to have a significantly higher prevalence of sputum production [ 41 ], and patients with post-TB bronchiectasis were found to have a higher prevalence of haemoptysis [ 30 ] compared with other aetiologies. Together, these results highlight the need for novel treatments that reduce the symptom burden of bronchiectasis. They also highlight the importance of teaching patients to perform and adhere to regular nonpharmacological interventions, such as airway clearance using physiotherapy techniques, which have been shown to improve cough-related health status and chronic sputum production [ 110 ]. Future studies assessing when airway clearance techniques should be started, and which ones are the most effective, are a research priority [ 113 ].

The burden of exacerbations in patients with bronchiectasis was high, with patients experiencing three or more exacerbations in the previous year (up to 73.6%), per year (up to 55.6%) or in the first year of follow-up (up to 32.4%). Few studies reported significant differences between aetiologies. Importantly, exacerbations are the second-most concerning aspect of bronchiectasis from the patient's perspective [ 113 ]. Patients with frequent exacerbations have more frequent hospitalisations and increased 5-year mortality [ 114 ] and exacerbations are also associated with poorer quality of life [ 114 , 115 ]. Therefore, prevention of exacerbations is of great importance in the management of bronchiectasis [ 116 ]. The exact cause of exacerbations in bronchiectasis (believed to be multifactorial) is not fully understood due a lack of mechanistic studies [ 116 ]. Future studies into the causes and risk factors for exacerbations [ 113 ] may lead to improvements in their prevention.

Many patients with bronchiectasis, including children, experienced chronic infections with bacterial pathogens such as P. aeruginosa , H. influenzae , Sta. aureus and Str. pneumoniae as well as non-tuberculous mycobacteria. Importantly, P. aeruginosa infection was significantly associated with more severe disease, reduced lung function and quality of life, and increased exacerbations, hospital admission, morality, HCRU and healthcare costs. Due to the clear and consistent association between P. aeruginosa and poor outcomes, patients with chronic P. aeruginosa colonisation should be considered to be at a higher risk of bronchiectasis-related complications [ 110 ]. Additionally, regular sputum microbiology screening should be performed in people with clinically significant bronchiectasis to detect new isolation of P. aeruginosa [ 110 ]; in which case, patients should be offered eradication antibiotic treatment [ 23 ]. Eradication of P. aeruginosa is not only of clinical importance, but also of economic importance due to the associated HCRU and healthcare costs. As such, a better understanding of the key factors leading to P. aeruginosa infection is a priority for future research [ 113 ].

Bronchiectasis markedly impacted HRQoL across several PROs including the SGRQ, Quality of Life–Bronchiectasis score, LCQ, COPD Assessment Test and Bronchiectasis Health Questionnaire. In children with bronchiectasis, significantly lower quality of life (according to the Paediatric Quality of Life Inventory score) compared with age-matched controls was reported [ 53 ]. The majority of studies reporting HRQoL in individual aetiologies and associated diseases either reported in a single aetiology, did not perform any statistical analyses to compare aetiologies, or reported no significant differences across aetiologies. Patients also experienced mild-to-moderate anxiety and depression according to the HADS-Anxiety, HADS-Depression and 9-question Patient Health Questionnaire scores, with very limited data reported in individual aetiologies. When compared with healthy controls, anxiety and depression were found to be significantly more prevalent in patients with bronchiectasis [ 55 ]. Additionally, exercise capacity was reduced, with patients with bronchiectasis reported to spend significantly less time on activities of moderate and vigorous intensity and have a significantly lower step count per day compared with healthy controls [ 89 ]. Improvements in anxiety, depression and exercise capacity are important priorities for people with bronchiectasis; in a study assessing the aspects of bronchiectasis that patients found most difficult to manage, “not feeling fit for daily activities”, anxiety and depression were the fourth, eighth and ninth most common answers, respectively [ 113 ].

The studies relating to HCRU and costs in this review were heterogeneous in terms of methodology, time period, country and currency, making them challenging to compare. Nevertheless, this study found that HCRU was substantial, with patients reporting a maximum of 1.3 hospitalisation, 1.3 ED and 21.0 outpatient visits per year. Length of stay was found to be significantly longer in patients with bronchiectasis compared with patients with any other respiratory illness in one study [ 91 ]. In another study, patients with bronchiectasis reported significantly more specialist appointments (radiologist appointments and chest physician appointments) compared with matched controls [ 85 ]. Patients with bronchiectasis also experienced a significant treatment burden, with up to 36.4, 58.0 and 83.0% of patients receiving long-term inhaled antibiotics, oral antibiotics and macrolides, respectively, up to 80.4% receiving long-term ICS and up to 61.7% and 81.4% receiving long-term long-acting muscarinic antagonists and long-acting beta agonists, respectively. Wide ranges of treatment use were reported in this study, which may reflect geographic variation in treatment patterns. Heterogeneous treatment patterns across Europe were observed in the EMBARC registry data with generally higher medication use in the UK and Northern/Western Europe and lower medication use in Eastern Europe (inhaled antibiotics: 1.8–8.9%; macrolides: 0.9–24.4%; ICS: 37.2–58.5%; long-acting beta agonists: 42.7–52.8%; long-acting muscarinic antagonists: 26.5–29.8%) [ 17 ]. Similarly, data from the Indian bronchiectasis registry indicate that the treatment of bronchiectasis in India is also diverse [ 19 ]. Furthermore, in a comparison of the European and Indian registry data, both long-term oral and inhaled antibiotics were more commonly used in Europe compared with India [ 19 ].

Cost varied widely across studies. However, patients, payers and healthcare systems generally accrued substantial medical costs due to hospitalisations, ED visits, outpatient visits, hospital-in-the-home and treatment-related costs. Other medical costs incurred included physiotherapy and outpatient remedies (including breathing or drainage techniques), outpatient medical aids (including nebulisers and respiration therapy equipment) and the cost of attending convalescence centres. Only one study compared the medical costs in patients with bronchiectasis and matched controls (age, sex and comorbidities) and found that patients with bronchiectasis had significantly higher total direct medical expenditure, hospitalisation costs, treatment costs for certain medications and costs associated with outpatient remedies and medical aids [ 85 ]. Bronchiectasis was also associated with indirect impacts and costs, including sick leave, sick pay and income lost due to absenteeism and missed work, and lost wages for caregivers of patients with bronchiectasis. Children with bronchiectasis also reported absenteeism from school or childcare.

Our findings regarding HRCU and costs in bronchiectasis are mirrored by a recent systematic literature review by R oberts et al . [ 117 ] estimating the annual economic burden of bronchiectasis in adults and children over the 2001–2022 time period. R oberts et al . [ 117 ] found that annual total healthcare costs per adult patient ranged from €3027 to €69 817 (costs were converted from USD to € based on the average exchange rate in 2021), predominantly driven by hospitalisation costs. Likewise, we report annual costs per patient ranging from €218 to €51 033, with annual hospital costs ranging from €1215 to €27 612 (adults and children included) ( table 4 ). Further, R oberts et al . [ 117 ] reports a mean annual hospitalisation rate ranging from 0.11 to 2.9, which is similar to our finding of 0.03–1.3 hospitalisations per year ( table 3 ). With regard to outpatient visits, R oberts et al . [ 117 ] reports a mean annual outpatient respiratory physician attendance ranging from 0.83 to 6.8 visits, whereas we report a maximum of 21 visits per year ( table 3 ). It should be noted, however, that our value is not restricted to visits to a respiratory physician. With regard to indirect annual costs per adult patient, R oberts et al . [ 117 ] reports a loss of income because of illness of €1109–€2451 (costs were converted from USD to € based on the average exchange rate in 2021), whereas we report a figure of ∼€1410 ( table 4 ). Finally, burden on children is similarly reported by us and R oberts et al . [ 117 ], with children missing 12 days of school per year per child ( table 4 ).

Limitations of this review and the existing literature

Due to the nature of this systematic literature review, no formal statistical analyses or formal risk of bias assessments were performed.

Several limitations within the existing literature were identified. Firstly, the vast majority of studies reported patients with NCFBE overall, with limited availability of literature reporting on individual aetiologies and associated disease. Furthermore, where this literature was available, it was limited to a handful of individual aetiologies and associated diseases, and in many of these studies, no statistical analyses to compare different aetiologies and associated disease were performed. Additionally, the methods used to determine aetiologies within individual studies may have differed. Literature on NCFBE and CFBE has traditionally been very distinct; as such, most of the studies included in this review have excluded people with CF. As the general term “CF lung disease” was not included in our search string in order to limit the number of hits, limited data on CFBE are included in this review. Bronchiectasis remains largely under-recognised and underdiagnosed, thus limiting the availability of literature. There is a particular knowledge gap with respect to paediatric NCFBE; however, initiatives such as the Children's Bronchiectasis Education Advocacy and Research Network (Child-BEAR-Net) ( www.improvebe.org ) are aiming to create multinational registries for paediatric bronchiectasis.

There were variations in the amount of literature available for the individual burdens. While there was more literature available on the clinical burden of bronchiectasis, economic data (related to both medical costs and indirect costs) and data on the impact of bronchiectasis on families and caregivers, were limited. Additionally, cost comparisons across studies and populations were difficult due to differences in cost definitions, currencies and healthcare systems.

Sample sizes of the studies included in this systematic literature review varied greatly, with the majority of studies reporting on a small number of participants. Furthermore, many of the studies were single-centre studies, thus limiting the ability to make generalisations about the larger bronchiectasis population, and cross-sectional, thus limiting the ability to assess the clinical and socioeconomic burden of bronchiectasis over a patient's lifetime. Furthermore, there may be potential sex/gender bias in reporting that has not been considered in this systematic literature review.

Finally, for many of the reported outcomes, data varied greatly across studies, with wide estimates for the frequency of different aetiologies and comorbidities as well as disease characteristics such as exacerbations and healthcare costs noted. This reflects the heterogeneity of both the study designs (including sample size and inclusion and exclusion criteria) and the study populations themselves. Additionally, the use of non-standardised terms across articles posed a limitation for data synthesis. Systematic collection of standardised data across multiple centres, with standardised inclusion and exclusion criteria such as that being applied in international registries, is likely to provide more accurate estimates than those derived from small single-centre studies.

• Conclusions

Collectively, the evidence identified and presented in this systematic literature review show that bronchiectasis imposes a significant clinical and socioeconomic burden on patients and their families and employers, as well as on healthcare systems. Disease-modifying therapies that reduce symptoms, improve quality of life, and reduce both HCRU and overall costs are urgently needed. Further systematic analyses of the disease burden of specific bronchiectasis aetiologies and associated disease (particularly PCD-, COPD- and post-TB-associated bronchiectasis, which appear to impose a greater burden in some aspects) and paediatric bronchiectasis (the majority of data included in this study were obtained from adults) may provide more insight into the unmet therapeutic needs for these specific patient populations.

Questions for future research

Further research into the clinical and socioeconomic burden of bronchiectasis for individual aetiologies and associated diseases is required.

• Supplementary material

Supplementary Material

Please note: supplementary material is not edited by the Editorial Office, and is uploaded as it has been supplied by the author.

Supplementary figures and tables ERR-0049-2024.SUPPLEMENT

Supplementary Excel file ERR-0049-2024.SUPPLEMENT

• Acknowledgements

Laura Cottino, PhD, of Nucleus Global, provided writing, editorial support, and formatting assistance, which was contracted and funded by Boehringer Ingelheim.

Provenance: Submitted article, peer reviewed.

Conflict of interest: The authors meet criteria for authorship as recommended by the International Committee of Medical Journal Editors (ICMJE). J.D. Chalmers has received research grants from AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline, Gilead Sciences, Grifols, Novartis, Insmed and Trudell, and received consultancy or speaker fees from Antabio, AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, Insmed, Janssen, Novartis, Pfizer, Trudell and Zambon. M.A. Mall reports research grants paid to their institution from the German Research Foundation (DFG), German Ministry for Education and Research (BMBF), German Innovation Fund, Vertex Pharmaceuticals and Boehringer Ingelheim; consultancy fees from AbbVie, Antabio, Arrowhead, Boehringer Ingelheim, Enterprise Therapeutics, Kither Biotec, Prieris, Recode, Santhera, Splisense and Vertex Pharmaceuticals; speaker fees from Vertex Pharmaceuticals; and travel support from Boehringer Ingelheim and Vertex Pharmaceuticals. M.A. Mall also reports advisory board participation for AbbVie, Antabio, Arrowhead, Boehringer Ingelheim, Enterprise Therapeutics, Kither Biotec, Pari and Vertex Pharmaceuticals and is a fellow of ERS (unpaid). P.J. McShane is an advisory board member for Boehringer Ingelheim's Airleaf trial and Insmed's Aspen trial. P.J. McShane is also a principal investigator for clinical trials with the following pharmaceutical companies: Insmed: Aspen, 416; Boehringer Ingelheim: Airleaf; Paratek: oral omadacycline; AN2 Therapeutics: epetraborole; Renovian: ARINA-1; Redhill; Spero; and Armata. K.G. Nielsen reports advisory board membership for Boehringer Ingelheim. M. Shteinberg reports having received research grants from Novartis, Trudell Pharma and GlaxoSmithKline; travel grants from Novartis, Actelion, Boehringer Ingelheim, GlaxoSmithKline and Rafa; speaker fees from AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline, Insmed, Teva, Novartis, Kamada and Sanofi; and advisory fees (including steering committee membership) from GlaxoSmithKline, Boehringer Ingelheim, Kamada, Syncrony Medical, Zambon and Vertex Pharmaceuticals. M. Shteinberg also reports data and safety monitoring board participation for Bonus Therapeutics, Israel and is an ERS Task Force member on bronchiectasis guideline development. S.D. Sullivan has participated in advisory boards for Boehringer Ingelheim and has research grants from Pfizer, Bayer and GlaxoSmithKline. S.H. Chotirmall is on advisory boards for CSL Behring, Boehringer Ingelheim and Pneumagen Ltd, served on a data and safety monitoring board for Inovio Pharmaceuticals Inc., and has received personal fees from AstraZeneca and Chiesi Farmaceutici.

Support statement: This systematic literature review was funded by Boehringer Ingelheim International GmbH. The authors did not receive payment related to the development of the manuscript. Boehringer Ingelheim was given the opportunity to review the manuscript for medical and scientific accuracy as well as intellectual property considerations. Funding information for this article has been deposited with the Crossref Funder Registry .

• Received March 8, 2024.
• Accepted June 4, 2024.
• Copyright ©The authors 2024

This version is distributed under the terms of the Creative Commons Attribution Licence 4.0.

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• Published: 03 September 2024

A systematic review and quality appraisal of guidelines and recommendations for home enteral tube feeding in adults

• Andriana Korai   ORCID: orcid.org/0000-0001-5537-1931 1 , 2   na1 ,
• Isabella Thomson 1 , 2   na1 ,
• Sharon Carey   ORCID: orcid.org/0000-0003-4155-5240 1 , 3 &
• Margaret Allman-Farinelli 1 , 2  

European Journal of Clinical Nutrition ( 2024 ) Cite this article

Metrics details

• Health policy

Home Enteral Tube Feeding (HETF) is a viable option for people within primary care settings when oral intake is insufficient to meet nutritional needs. As HETF is not a risk-free therapy, guidelines exist to enable its safe provision. This review aims to summarise existing guidelines and their recommendations pertaining to the provision of HETF and appraise their methodological quality. A systematic review was conducted according to the Cochrane Handbook for Systematic Reviews, PRISMA-checklist and a 2019 methodological guide specific to the review of clinical practice guidelines (PROSPERO registration: CRD42023456223). Records were sourced from five bibliographical databases (Medline, Embase, PsychINFO, Scopus, Cinahl) and the grey literature (64 websites, seven guideline repositories). The AGREE-II tool was applied to eligible guidelines. The recommendations of guidelines meeting a predetermined threshold score (domain 3 ‘rigour of development’ score >70%) were extracted, grouped, and assessed using the AGREE-REX tool. A total of 2707 records were screened with 15 guidelines meeting eligibility criteria. The median (IQR) overall AGREE-II score (/7) of all guidelines was 3 (3–5) and only 3/15 guidelines achieved a domain 3 score >70%. The median (IQR) overall AGREE-REX score was 33% (26–37%). No recommendation group achieved a domain score above 70%. No guideline or recommendation group was suggested for use without modification. Key limitations included suboptimal stakeholder involvement and implementability, and lack of methodological transparency. Current HETF guidelines inadequately align with methodological standards. This review highlights key areas HETF guideline developers should consider to create more relevant and implementable guidelines.

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Introduction.

Enteral nutrition (EN) enables optimisation or preservation of nutritional status in individuals with malnutrition or risk thereof and with compromised oral intake. Indications for the initiation of EN may include increased nutritional requirements, gastrointestinal tract malignancies, reduced nutrient absorption due to inflammatory conditions or swallowing difficulties arising from neurological disorders [ 1 ]. EN is mostly administered through nasoenteric or the stomal route, where percutaneous feeding devices can be inserted endoscopically, radiographically, or surgically [ 2 , 3 ]. While EN can be provided across the continuum of care, home enteral tube feeding (HETF) specifically involves delivering liquid nutrition via one of these routes within a domiciliary care setting [ 4 ]. While the cost-effectiveness of HETF compared to treatment in hospital has not been thoroughly evaluated, cost savings analyses have shown savings in HETF sub-groups, and across the care continuum in England of up to £65,484,550 for all forms of nutrition support inclusive of HETF [ 5 , 6 ].

Attempts have been made to estimate the global point prevalence of people receiving HETF through large-scale surveys and retrospective studies as national registries are limited [ 7 ]. In the last five years, national prevalence has only been reported in Australia and New Zealand (234 HETF patients per million) and Poland has reported total HETF cases, although both used clinician-administered surveys which are prone to underestimation [ 7 , 8 ]. Challenges with provision of HETF have been reported internationally in terms of clinical complications, funding and organisation of services, supply of consumables and research and development [ 9 , 10 ]. This is reflected in the significant variability noted in the provision of care to HETF patients on a national and global level [ 7 , 11 ]. The need for comprehensive clinical guidelines which additionally address barriers and facilitators to providing optimal care to this population group have been advocated [ 11 ]. Guidelines from well-known professional societies and government agencies have widespread use by clinicians caring for people receiving HETF [ 12 , 13 ], however, all available guidelines have not previously been collated or assessed for their quality.

Multiple standards and guidance for development of high-quality clinical practice guidelines exist [ 14 ]. The development of evidence-based recommendations alone is insufficient to produce a high-quality guideline as guidelines should be outcome focused, capable of adaptation to various global audiences, frequently updated and involve collaboration between all relevant stakeholders including consumer-led expert opinion [ 14 ]. Groups such as the Scottish Intercollegiate Guidelines Network and the Guidelines International Network have endorsed use of the tools produced by the Appraisal of Guidelines REsearch and Evaluation (AGREE) collaboration to evaluate the quality of clinical practice guidelines [ 15 , 16 ]. This review aimed to systematically identify and summarise existing guidelines pertaining to the provision of HETF in adults and assess the quality of guidelines and their recommendations using internationally recognised quality assessment tools.

A protocol for this systematic review of guidelines was developed a priori and registered with PROSPERO (identification CRD42023456223) in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement [ 17 ]. A protocol amendment was submitted (12 th December 2024) with changes to the grey literature sources searched and eligibility criteria after piloting the study selection process. Further detail for the data extraction plan was also provided. This review was also informed by the Cochrane Handbook for Systematic Reviews of Interventions and Johnston et al. methodological guide for systematic reviews of clinical practice guidelines [ 18 , 19 ].

Literature search

Five bibliographical databases (MEDLINE, EMBASE and PsycInfo (OVID interface), CINAHL, and Scopus) were searched for published eligible guidelines on HETF on September 26, 2023. A search strategy was developed for Medline and translated across the remaining four databases (Table S1 ).

Additionally a grey literature search including seven guideline repositories and 64 key government health agency and nutrition association websites was conducted on September 29, 2023. The choice of guideline repository was based on Cochrane recommendations and the websites included were informed by a preliminary Google search and content experts on the research team. A summary of the sources and search methods used is provided in Table S2 . The reference lists of included guidelines were also hand-searched to identify additional potentially eligible guidelines.

Eligibility criteria

Included guidelines contained a dedicated set of recommendations specific to the provision of HETF to people aged over 18 years old. Guidelines covering any aspect or stage of the patient journey associated with HETF, from initiation to management and discontinuation were included. These had to be explicitly identified as a guide, guideline, standard or recommendations. Guidelines had to be evidence-based and/or developed through consensus, although could be presented in any format and with any intended end-user. Records providing inadequate methodological detail to ascertain whether evidence-based and/or consensus methods were used were excluded. Guidelines pertaining exclusively to short term enteral feeding or where the duration of feeding could not be determined were excluded, as where guidelines for specific diseases or conditions unless they specifically addressed HETF. Narrative reviews and opinion pieces were excluded. Guidelines were included if they were available in English and were produced from 2000 onwards to ensure currency.

Study selection

All bibliographical records were imported into the reference management software EndNote (Version 20, Clarivate Philadelphia) where duplicates were removed as previously described [ 20 ]. The remaining records were imported into Covidence Systematic Review Software (Veritas Health Innovation, Australia 2023) for two-step screening conducted independently by two reviewers (AK, IT). Titles and abstracts were screened against eligibility criteria. Full-texts of records deemed eligible from this step were then obtained and screened. When consensus could not be reached between the two reviewers, conflicts were resolved through discussion with a third reviewer (SC). Where multiple editions existed, the most recent guideline was selected.

Data extraction and quality assessment of guidelines

A data extraction form was created in Excel (Microsoft Corporation Version 16.77.1, 2023) to collate pertinent information from eligible guidelines. Information extracted included: guideline title, authorship, publication and update year, applicable geographical region, any affiliated agencies or associations, the aspect(s) of HETF considered, the applicable population group, whether a systematic search was conducted, methods used to evaluate the body of evidence and what consensus method was used.

Quality appraisal was completed with the AGREE-II tool. This tool evaluates the methodological rigour of guideline development through 23 items organised into six domains, where each item is rated against specific criteria and considerations using a 7-point grading system (1 – strongly disagree to 7 – strongly agree). Guidelines are then assigned an overall assessment (1 – lowest possible quality to 7 – highest possible quality) accompanied by a statement on recommended use which considers the overall quality of the guideline and its appropriateness for use in practice [ 21 ].

Supporting documents including previous and abridged versions, quick reference guides, technical reports, methodological manuals, guideline development policy statements, standard operating procedures and supplementary materials were retrieved prior to quality appraisal. Where applicable, corresponding authors were contacted twice to request access to supporting documents cited in the guideline but not publicly available. If no response was received quality appraisal was conducted without the additional documents.

Data extraction and quality appraisal using AGREE-II was conducted concurrently by two independent reviewers (AK, IT). All appraisers were trained to apply the AGREE-II tool by studying the manual and relevant publications [ 21 , 22 ]. Application of the tool was also discussed prior to its use by the research team to promote consistency in how the tool was applied (MAF, AK, IT). For AGREE-II items which were not applicable to a guideline a rating of 1 (absence of information) was provided and this score was contexualised as recommended in the AGREE-II manual [ 21 ]. ‘Recommendations for use’ were informed by both the quality assessment and the availability of alternative guidelines. Differences in scores were resolved through discussion and final item scores and overall assessments reached through consensus. An experienced user of the tool (SC) then reviewed consensus scores from items where the two appraisers’ scores differed by >1. Consensus is an appropriate approach when less than four appraisers are available and has been previously employed [ 23 , 24 ]

Scaled domain scores were calculated using consensus scores and the formula: (obtained consensus score – minimum possible score)/(maximum possible score – minimum possible score) [ 21 ]. As the AGREE-II user manual does not define quality cut-off scores, high quality guidelines were considered those with domain 3 ‘rigour of development’ scaled scores ≥70% as a high score in this domain is indicative of high methodological quality and transparency in reporting [ 25 ]. The quality of recommendations from high quality guidelines were then assessed using the AGREE-Recommendation EXcellence (AGREE-REX) tool [ 26 ].

Data extraction and quality assessment of recommendations

The AGREE-REX tool assesses the quality of recommendations made by guidelines as determined by their clinical credibility, trustworthiness and implementability. The tool consists of nine items categorised into three domains. Each item consists of two evaluations, the first is informed by whether the recommendation(s) considered the criteria relevant to each item in their development, and the second optional evaluation rates the suitability of the recommendation(s) to a particular setting. Both evaluations use a 7-point grading system (1 – strongly disagree to 7 – strongly agree). For this quality appraisal only the first evaluation was completed as the results were not intended to guide adoption in a particular setting.

A second data extraction form was created in Excel (Microsoft Corporation Version 16.77.1, 2023) to collate all recommendations related to care of people receiving HETF from the included guidelines and their assigned grading. Relevant recommendations were extracted by one researcher (AK) and reviewed by a second (SC). The AGREE-REX tool was then applied to clusters of recommendations addressing a similar HETF topic within each included guideline. This approach was taken as it was believed that quality may vary between recommendations given the widely reported scarcity of high-quality research in this area and resource constraints made it unfeasible to assess each recommendation separately [ 26 ]. Six clusters were used, adapted from the categorisations used in the ESPEN Home Enteral Nutrition guideline [ 4 ], which was the sole high-quality guideline dedicated explicitly to HETF, and the nutrition care process [ 27 ]. Clusters included: commencement of HETF; care of feeding site and enteral access devices; recommendations for feeding; monitoring HETF; termination of HETF and requirements of HETF services. Additional detail for the clusters used is provided in Table S 3 . AGREE-REX assessment was independently completed by two reviewers (AK, IT) and final scores were agreed through consensus. Both assessors studied the AGREE-REX manual, and the tool was piloted on one cluster for a single guideline and results discussed prior to completing the remaining assessments. Scaled domain and overall scores were calculated using consensus scores and the formula: (obtained consensus score – minimum possible score)/(maximum possible score – minimum possible score) [ 26 ]. All data extraction forms and extracted data will be made available upon reasonable request.

Data synthesis

Guideline characteristics were summarised descriptively. Domain scores were presented as percentages (scaled scores) and overall assessments as a score of seven for AGREE-II and as a scaled percentage for AGREE-REX. Overall assessments were accompanied by a statement on the assessors’ recommendations for use. Item, domain and overall scores were summarised using descriptive statistics (median with interquartile range (IQR)) for both tools across all eligible guidelines. Median and range was used only when comparing AGREE-REX scaled domain scores across recommendation clusters as only two to three scores were being summarised. Domain results from both tools were also presented as colour-coded quartiles and recommendation gradings were presented as proportions. All analyses were carried out using Excel (Microsoft Corporation Version 16.77.1, 2023).

The database search identified 3650 records. A total of 970 duplicates were removed and 2680 records were screened based on their title and abstract. Following exclusion of 2635 records, 42 records were successfully retrieved for full-text screening and six guidelines were included. The grey literature search identified an additional 20 records from websites and guideline repositories, of which seven met the eligibility criteria. Seven additional records identified from citation chaining of included guidelines were screened of which two met eligibility criteria. A total of 15 guidelines were included in this review. The PRISMA flow diagram outlining the selection process is shown in Fig. 1 .

A total of 2707 unique records were identified from all sources, of which 15 were included.

Guideline characteristics

All guidelines were produced by professional associations or government agencies. The guidelines originated from the USA ( n  = 4), Europe ( n  = 3), the UK ( n  = 3), Australia ( n  = 2), France ( n  = 1), Italy ( n  = 1) and Korea ( n  = 1). The primary focus of most guidelines ( n  = 10) was clinical management of one or more methods of nutrition support. Of these, three were exclusive to HETF [ 4 , 28 , 29 ], two covered enteral nutrition more broadly [ 30 , 31 ], one addressed enteral and parenteral nutrition [ 32 ] and four encompassed all forms of nutrition support [ 12 , 33 , 34 , 35 ]. Four guidelines were dedicated to care of feeding sites and enteral access devices [ 36 , 37 , 38 , 39 , 40 ] and two studies focused on organisation of services providing care to people receiving HETF [ 29 , 41 ]. Seven of the guidelines included children in the target population, while exclusion of children was unclear in two guidelines. Eight of the guidelines employed a systematic literature search as part of their methodology and nine used standardised evidence grading systems. Four guidelines consistently used and clearly described a structured approach to reach consensus of recommendations. All guideline characteristics are outlined in Table 1 .

Assessment of guidelines using the AGREE-II tool

AGREE-II quality scores of the 15 guidelines included are presented in Table 2 . The median overall quality score out of 7 for all guidelines was 3 [3–5]. The NICE guideline on nutrition support for adults was the highest scoring guideline (6/7) both in terms of overall quality and across all six domains. The highest scoring domain across all guidelines was ‘clarity of presentation’ (83% [64–86%]) and the lowest scoring domain was ‘applicability’ (8% [2–15%]). Of all domain scores, 23% (21/90) had scaled domain scores ≥75% and 29% (26/90) had scaled domain scores <25%. The highest rated item across all guidelines was item 16 ‘the different options for management of the condition or health issue are clearly presented’ (domain 4) (7 [6–7]), while the lowest rated was item 20 ‘the potential resource implications of applying the recommendations have been considered’ (domain 5) (1 [1–1]). Raw consensus item scores are available in Table S 4 . Only three guidelines scored ≥70% for domain 3 ‘rigour of development’, proceeding to AGREE-REX appraisal.

Guideline recommendations and their assessment using the AGREE-REX tool

Of all recommendations 66% (72/109) were graded as Good Practice Points while 6% (6/109) were of grade A, 18% (20/109) of grade B and 10% (11/109) of grade O. All recommendations were grouped into six clusters which were each assessed using the AGREE-REX tool. A summary of recommendation grades stratified by cluster and guideline is presented in Table S 5 .

Clusters for all guidelines scored below 70% for all three domains of the AGREE-REX tool, with no overall score for any cluster >50% (Table 3 ). Across all guidelines, ‘Clinical Applicability’ (56% [39–61%]) was the highest scoring domain, with ‘care of feeding sites and enteral access devices’ (61% [33–61%]) and ‘recommendations for HETF feeds’ (61% [56–67%]) the highest scoring clusters in this domain. These clusters also consisted of the highest proportion of A-O graded recommendations with 45% (17/38) and 45% (9/20) respectively (Table S 5 ). ‘Values and Preferences’ (21% [17–25%]) was the lowest scoring domain with the corresponding item 6 ‘values and preferences of policy/decision-makers’ (1[1–2]) and item 7 ‘values and preferences of guideline developers’ (1 [1–2]) the lowest scoring items. Raw consensus item scores are available in Table S 6 . All recommendation clusters were recommended for use with modifications (Table S 6 ).

This review is the first to systematically identify, synthesise and evaluate the methodological quality of available guidelines and their recommendations for HETF. We identified and assessed 15 guidelines of which many were of poor methodological quality, either failing to employ systematic searches of the literature, utilising informal consensus methods, or simply lacking transparency and detail as to the methods employed. Only three of the identified guidelines were of high methodological quality however none of the recommendation clusters relevant to HETF from these guidelines achieved an overall AGREE-REX quality score > 50%. Numerous low-scoring items and domains from both the AGREE-II and AGREE-REX evaluations were attributed to the same methodological shortcomings of the appraised guidelines.

‘Rigour of development’ has been acknowledged as a critical domain in the appraisal of guideline quality [ 42 ]. While scores in this domain were low there was an improvement in the use of systematic search methods and structured consensus over time. A noticeable limitation of most guidelines was the absence of criteria for regular update with only four guidelines ever having been renewed. In the past six years, no updates had been made. ‘Evidence’ scores were generally low with a majority of recommendations being good practice points, based on low-level evidence or extrapolated from moderate-level evidence. Inconsistent alignment between the definitiveness of some of these good practice point recommendations and the rationale provided, or lack thereof, was the main reason for lower scoring on ‘applicability to target users’. Discordant recommendations, that is, when the strength of a recommendation is not reflective of the certainty of evidence, are warranted when there is low quality evidence suggesting benefit in life-threatening situations [ 43 , 44 , 45 , 46 ]. The absence of clinical equipoise in providing EN would constitute the conduct of certain randomised controlled trials in this population unethical [ 47 ]. When evidence is limited, guideline developers should be transparent as to the considerations made when formulating recommendations. This would include the perspective taken, the value assigned to relevant outcomes, acceptability of the recommendation to relevant stakeholders, resource requirements and the feasibility of implementation [ 48 , 49 ]. Scarcity of high-quality evidence should not deter guideline developers from creating or updating clinical guidance, rather the well documented limitations of the evidence base could support a redistribution of some resources to rigorous conduct in other aspects of guideline development such as stakeholder engagement and ensuring implementability. Benchmarking studies of local guideline uptake have demonstrated inconsistent adherence [ 7 ] and thus further engagement with HETF stakeholders including people receiving HETF, their carers, clinicians involved in service provision, service managers and guideline and policy-makers, would be warranted.

The practical utility of a guideline is only possible when developed with a plan of implementation. Most guidelines disregarded facilitators, barriers, and resource considerations to applying their recommendations. Qualitative studies with HETF service users and providers have highlighted the benefit of having access to providers with expertise in HETF including management of complications [ 50 ]. There are often financial barriers however in accessing services and challenges with co-ordinating care by a multidisciplinary team [ 10 ]. Oftentimes what may be clinically most suitable for a patient (e.g. feeding mode, formula choice or frequency of review) may not be feasible within the client and health service resources. Guidelines acknowledged implementation barriers and facilitators although tools and resources to address these were infrequently provided as were monitoring and auditing criteria. This may in part be secondary to the minimal involvement of key stakeholders in the development process and external review of these guidelines. Quality appraisals of guidelines for critical care nutrition and medical nutrition therapy in liver cirrhosis have also highlighted similar limitations in stakeholder consultation, applicability and consideration of values and preferences in formulating recommendations [ 51 , 52 , 53 , 54 ]. Economic analyses are also crucial in assuring the implementability of recommendations [ 55 ] although were noticeably absent in the guidelines assessed. Cost savings have been reported with the implementation of HETF-dedicated outpatient clinics [ 56 ] and advanced practice dietitian roles in gastrostomy management [ 57 ] – both practices which would have allowed for closer adherence to HETF guidelines. With ethical restrictions in the conduct of RCTs, economic modelling may serve as a more suitable approach to showcase the benefit of recommendations made for this population group.

All three high quality guidelines were recommended for use with modifications secondary to the prospect of improving quality with subsequent updates. NICE guidance was originally developed over two decades ago with an overall high methodological quality although with some informal consensus methods. New evidence has been considered in the need to update this guideline [ 58 ] and some supporting tools to facilitate implementation have been provided [ 59 , 60 ] although the healthcare space has changed drastically since its original inception. For instance, community-based replacement of gastrostomy tubes following traumatic displacement has become more commonplace following the COVID-19 pandemic [ 61 ] with the NHS also issuing a recovery plan for urgent and emergency services which involved expanded community services [ 62 ]. The guideline would now likely benefit from more current and meaningful consultation with stakeholders to ensure its relevance and usability [ 63 ]. Similarly, ESPEN guidelines’ quality could also be improved through wider or more clearly explicated consultation with consumers and policymakers. This has proven difficult secondary to unclear guidance [ 64 ] although some direction has been provided and the Cochrane Multi-Stakeholder Engagement (MuSE) Consortium seeks to provide guidance on the matter [ 65 ].

All guidelines were developed by professional associations and/or government agencies with suboptimal reporting of editorial independence. Funding body influence was not always applicable as many professional bodies are interested in generating guidelines to improve patient management, thus assigned scores of ‘1 (absence of information)’ reduced the overall domain 6 score. Conflict of interest was however poorly reported with most guidelines not describing the type of competing interests considered nor the methods employed in attaining them. While it is likely editorial independence existed for most guidelines, many did not indicate this correctly, similarly to other aspects of guideline development.

Strengths and limitations

Strengths of this review include using a systematic search of five databases and an extensive grey literature search where authors were contacted to source supporting materials. This study also used the AGREE-II and AGREE-REX tools which are reliable and valid tools dedicated to assessing the quality of guidelines and their recommendations. While the minimum number of appraisers assessed each guideline, a consensus method was used in both assessments to address this. Finally, predominantly publicly available guidelines were included, and it is possible that documents produced by associations only accessible via subscription were missed.

Conclusions

This review identified and analysed 15 guidelines regarding home enteral tube feeding from seven geographical regions, three of which were considered high quality. Despite their higher quality, even the NICE and ESPEN guidelines had methodological weaknesses which limit their usability and for this reason no guideline or recommendation cluster was recommended for use without modification. These findings highlight the importance of transparent and detailed reporting practices and the need to consider meaningful involvement of people receiving HETF and their carers, clinicians and service managers in guideline development to ensure recommendation applicability and implementability. Guideline developers should invest in economic analyses to accompany recommendations relating to service structure and provide targeted tools and resources such as competency criteria to support education and training of both clinicians and people receiving HETF.

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Acknowledgements

The authors thank academic librarians Ms Bernadette Carr and Ms Tess Aitken for their assistance in developing the search strategy.

This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors. AK is supported by a Research Training Program Stipend Scholarship from the Australian Government and the King and Amy O’Malley Trust Foundation Postgraduate Research Scholarship. MAF declares funding for other projects from National Health and Medical Research Council, Australian Research Council and NSW Health. SC declares funding for other projects from Sydney Local health District, Medical Research Future Fund and unrestricted research grants from Baxter Pharmaceuticals and Nutricia Australia. These funding sources had no involvement in, or restrictions on publication. Open Access funding enabled and organized by CAUL and its Member Institutions.

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Nutrition and Dietetics Group, Sydney Nursing School, Faculty of Medicine and Health, The University of Sydney, Camperdown, NSW, Australia

Andriana Korai, Isabella Thomson, Sharon Carey & Margaret Allman-Farinelli

Charles Perkins Centre, The University of Sydney, Camperdown, NSW, Australia

Andriana Korai, Isabella Thomson & Margaret Allman-Farinelli

Department of Nutrition and Dietetics, Royal Prince Alfred Hospital, Camperdown, NSW, Australia

Sharon Carey

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AK, SC, MAF contributed to conceptualisation, developed methodology and provided supervision. AK, IT conducted investigations (search strategy, screening, data extraction, quality appraisal), formal analysis and visualisation. SC also conducted quality appraisal. AK, IT drafted the original manuscript and SC, MAF were involved in review and editing. All authors read and approved the final manuscript.

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Korai, A., Thomson, I., Carey, S. et al. A systematic review and quality appraisal of guidelines and recommendations for home enteral tube feeding in adults. Eur J Clin Nutr (2024). https://doi.org/10.1038/s41430-024-01500-1

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Paré, G. and Kitsiou, S. (2017) 'Methods for Literature Reviews' , in: Lau, F. and Kuziemsky, C. (eds.)  Handbook of eHealth evaluation: an evidence-based approach . Victoria (BC): University of Victoria.

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Royal Literary Fund (2024)  The structure of a literature review.  Available at: https://www.rlf.org.uk/resources/the-structure-of-a-literature-review/ (Accessed: 23 July 2024).

Library Services for Undergraduate Research (2024) Literature review: a definition . Available at: https://libguides.wustl.edu/our?p=302677 (Accessed: 31 July 2024).

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Speaker 1: The first step of doing a systematic literature review is coming up with a review question, like what do you actually want to know about the world and how can you phrase that as a simple question. You can write down all of the questions you want and then choose from the best one or a combination but I like to go to ChatGPT and use them as like a sounding board and a research assistant so that they can help me really sort of refine what I actually want to do a systematic literature review on. So here we are, we head over and we say, help me define a systematic literature review research question about beards and their smell. Maybe that's what I was interested in. My beard smells lovely. It smells like Australian sandalwood at the moment. Beautiful. It says a systematic literature review research question should be specific blah blah blah. And then it comes up with one. How do microbial communities in beards influence blah blah blah. And it gives me kind of a first start. The one thing I found about any AI that you're asking, it makes a lot of assumptions about what you want to know. So I highly recommend that you go in and you sort of like re-prompt it and you say, I like this bit, but I don't like this bit, or this bit's good, but you're a little bit off on this area. That is how you kind of use this as a research assistant as like a sounding board for all of your ideas. Then once you've got a research question and you need to spend probably most of the time of the first bit of searching on this because it's so very important. Come up with a definitive but broad, and I know that is so contradictory, but you need to come up with something that is focused enough that it will give you sort of like a good outcome but not too broad that all of a sudden, you know, like you're dealing with thousands and thousands of papers. So that is the challenge, and use ChatGPT to get that balance. Now, you can also use frameworks. There's different frameworks that you can use which will help you with this first sort of like step. And I just asked ChatGPT. I'm familiar with some of these, but some of these were new to me as well. I said, what frameworks for a systematic literature review can be used for this question? And it says Prisma, it used Cochrane Handbook for systematic reviews, it's got the Joanna Briggs Institute Methodology, Spyder and Pico. One of the most famous ones arguably is Pico where you say, okay, I've got this P, population, I've got this I, intervention that I'm looking at, I've got this C, comparison of all of the things that I found and O, outcome. Then what happened when they did these things? And quite often the C stands for comparison because it's a quantitative measurement of comparing it to say like a placebo if you're doing a lot of health stuff or another sort of intervention. So that's how we use frameworks to start thinking about our research question. What population are we gonna look at? What intervention are we looking at? What comparison, if any, are we gonna look at? And we're gonna look for the outcomes within those systems and structures that we set in place. So that's step one. Step two, actually, is what defines a literature review from a systematic literature review? Let's get into that. This is so very important for a systematic literature review because we need to know what methods we are going to use to filter all of the different stuff that we're gonna come across. We wanna know stuff like what procedure are we gonna go through to find the literature. We wanna know what keywords we're gonna use, what semantic search terms we're gonna use in certain databases to find the literature. Now, I like to head over to something like Search Smart. This will give you sort of like the best databases to search for your systematic literature review. And so all you need to do is look for scholarly records or clinical trials if you want, put in the subjects or the keywords and then sort of like define whether or not you want systemic keyword searching, backwards citation, forwards, all of that sort of stuff and also non-paywall databases and you click Start Comparison and it will go off and give you all of the different databases that you can look at. Then, keywords. Keywords are so very important because we often find research based on how they're described like in the abstract or the title. So be very specific with your keywords. By the way, I have another video, go check it out here, where I talk about how to find all of the literature that you'll ever need using different approaches, AI, Boolean searches, old school keyword searches, and that video will allow you to find everything you need in your systematic review. But databases are very important. Where are you gonna search? what keywords are you gonna search for, what semantic search questions, and that's new for this sort of like era of AI because it allows us to actually just put our research question into a database and have it sort of understand that question and give us results back. So now we're on to the exciting part which is finding the research papers. The one thing I like to do first and foremost, and that's only possible now because of AI's semantic search. I love it so much. Let's head over to the three tools that I think you would wanna use. The first one is Elicit. Ask a research question. Beards and, ooh, not bears, and smells. Let's see, that's not really a research question, but let's see what it comes up with. But it's that sort of stuff that you need to sort of like thinking about. Like, is that a keyword combination that you want to put in all of the databases or not? Whatever you decide using your meat brain. So, here we go. Here's all of the different papers that I could talk about. Brilliant. The next one is consensus. Beards and smell. Then we can go off and find all of the papers here using that sort of semantic keyword search as well. And we've also got size space. I can go here, beards and smell. And this is where I like to find all of my stuff using keywords and semantic search. So making sense, oh, this hasn't really done too well with beards, beards and issues, blah, blah, blah. So overall, you can see that we've got a little bit of discrepancy between what these pick up. So it's very important, I think, that you try a few to see what works best for you. And then finally, we gotta head over to something like Google Scholar, and we wanna say, okay, what keywords are we gonna put in? This isn't semantic search, this is just putting in beards and smell. And we can use Boolean operators to make sure that we're actually gonna get the papers that are relevant for us. So we can go beards, and then and, because we want and, smell. There we are. So then we're gonna come up with all of the smell and beard articles that it's going to come up with. The smell report, shame and glory. Only the beards, even after beards became merely rather than daring, the rather radical, oh my God, I don't like this one. The British Journal of Sociology, come on now, you can do better than that. But that is where you can go and actually find all of this information. And so semantic, keywords, databases, and Boolean operators to have a look at what you're excluding and including in your search is very, very important. So that is the step three. Yeah, step three, that is searching for the paper. And now we need to filter and screen and read. Once we've ended up with a load of papers from our searching based on the criteria and the methods we set out in step two, we've now got like an exclusion and inclusion protocol where we need to say, okay, we've got all of these studies, Which ones are we going to include and which ones are we going to exclude? And it's a really sort of like simple process of just filtering. This is why you need a load of papers at the top. Put loads of papers at the top and then they have to filter down to the useful papers down the bottom. And it may only be a small fraction of all of the papers you found, but this is what a systematic review is all about. It's about making sure that we include the papers that are relevant for your research question and not just like general themes, which is like a normal literature review where we just sort of say, oh yeah, there's this theme and this theme and this theme. No, this one's much more focused, so we need to filter it. I like to use the Prisma flowchart to work out which ones I'm getting rid of and keep track of the ones I've got rid of and how much I've filtered it down. So a Prisma flowchart looks like this. We've got identification in the top here and then we've got records identified through database searching. In this case, they had 96. and then we've got other additional identified through other sources, and this was none in this bit. Then they removed duplicates, so there was two that were the same, so they removed one of them, and then they said, okay, we've got this many in screen, 95, and eligibility, full text articles assessed for eligibility, there was only five, and all of these were actually excluded because it didn't meet their criteria that they'd set out in part of their exclusion or inclusion criteria. So you can see we've got like examines treatment, not prevention. So this was like obviously like a health study where they were looking at treatment and not the prevention or something. So that was most of them, that was 52. Then one was pediatric, one was irrelevant. Oh no, loads were irrelevant, 37 were irrelevant. So you can see we've gone from 96 all the way down to five at this point. And then full text articles not included. Well, there was none there, which is great. but here we've got four which studies included in quantitative synthesis or a meta-analysis was only four, they got rid of 92 of them because they didn't meet the specific search and exclusion and inclusion criteria that they set. That is so important and that is very, very typical of a systematic review. So now it's about taking those special studies that you found and getting all of the important stuff out of them. you should read them, especially if there's only four. You should read them from end to beginning. No, don't read them like that. Read them however you want, normally with abstract, then to conclusions, then to introduction, then to method, anyway, you get the idea. Do you know what, actually, I've got another video on how to read like a PhD. Go check out that one there. It's much better than what I just said. But now you need to read them and you need to start thinking about how these studies are influencing your research question sort of response. Are they for it? Are they against it? Do they give you a new insight? Is there something sneaky in there when you look at them all together that is surprising? It's those sort of things that really should be sort of milling around in your head. We're not looking for any sort of definitive stuff just yet, but we just need to read, analyze, refine, understand, all of those stuff. Those words are very important, put them there. But now, we've got a couple of new ways that we can actually talk to all of our documents. So one place I really like is docanalyzer.ai and what you can do is upload your documents and tag them as, in this case I've got literature review, you can see I've got one, two, three, four, five, six here. So then we can go to labels and we can go chat with these six documents. And the one thing I love about docanalyzer is that it doesn't like try to make stuff up. If it doesn't understand what you're asking or it can't identify it in the documents that you've given it, it will just say, hey, I don't really know, can you give me a bit more information? It doesn't sort of like BS its way into chat, which I really like. So, for example here, it says to identify the important parts of the document, I would need more specific keywords or topics of interest. That's what I want from an AI, something that isn't just gonna make stuff up. Another thing you can do is head back over to size space, And in SciSpace, you can actually get results from my library. So if you put those very specific studies that you've filtered and found into your library, you can then ask it questions across that library, which I think is really, really fantastic. So not only do you read it all, if you can, if it's a sensible amount of papers, but then you can start chatting to all of the documents together in something like DocAnalyzer and SciSpace, and then you can get sort of further connections, further deeper inquiry into things that maybe you have missed. Or maybe there's just a question, you've read them all, and there's a question sort of in your mind. You're like, actually, does this apply to all of the papers or not? Put it into something like this and it will search across all of your documents. I absolutely love, I'm doing this today, Chef's Kiss, it's my new favorite thing. Chef's Kiss, yum, yum, yum, yum, yum. But doing that means that you're not gonna miss out on anything because you're going to use old school tactics by just reading, read, read, read, read, read, and new school tactics by using AI, AI, AI, AI. Together, they are the perfect combination, yes. And then it's all about writing it up, making sure that you actually talk about what your research question is, the methods you've used, the filtration criteria, and the exclusion and inclusion criteria, the keywords you search for, then what you've found, how they all sort of like relate together, and the outcome. What is the outcome of this literature review? Does it support your research questions? Does it give you a new insight? That is how you write this. That is the structure. It is so very sort of systematic. A systematic literature review has to be systematic, otherwise you'll just end up being completely lost in all of the papers. Oh, so many papers, so many papers. Filter them out, find the good ones, write it out. Brilliant. All right, if you like this video, Go check out this one where I talk about how to write an exceptional literature review with AI. It's going to be a great sort of addition to what you've learned in here. Go check it out.

Something old, new, and borrowed . Rise of the systematic reviews

• Published: 24 August 2024

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Systematic reviews and other types of literature reviews are more prevalent in clinical medicine than in other fields. The recurring need for improvement and updates in these disciplines has led to the Living Systematic Review (LSR) concept to enhance the effectiveness of scientific synthesis efforts. While LSR was introduced in 2014, its adoption outside clinical medicine has been limited, with one exception. However, it is anticipated that this will change in the future, prompting a detailed exploration of four key dimensions for LSR development, regardless of the scientific domain. These dimensions include (a) compliance with FAIR principles, (b) interactivity to facilitate easier access to scientific knowledge, (c) public participation for a more comprehensive review, and (d) extending the scope beyond mere updates to living systematic reviews. Each field needs to establish clear guidelines for drafting literature reviews as independent studies, with discussions centring around the central theme of the Living Systematic Review.

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The PRISMA 2020 statement: an updated guideline for reporting systematic reviews

• Matthew J. Page   ORCID: orcid.org/0000-0002-4242-7526 1 ,
• Joanne E. McKenzie 1 ,
• Patrick M. Bossuyt 2 ,
• Isabelle Boutron 3 ,
• Tammy C. Hoffmann 4 ,
• Cynthia D. Mulrow 5 ,
• Larissa Shamseer 6 ,
• Jennifer M. Tetzlaff 7 ,
• Elie A. Akl 8 ,
• Sue E. Brennan 1 ,
• Roger Chou 9 ,
• Julie Glanville 10 ,
• Jeremy M. Grimshaw 11 ,
• Asbjørn Hróbjartsson 12 ,
• Manoj M. Lalu 13 ,
• Tianjing Li 14 ,
• Elizabeth W. Loder 15 ,
• Evan Mayo-Wilson 16 ,
• Steve McDonald 1 ,
• Luke A. McGuinness 17 ,
• Lesley A. Stewart 18 ,
• James Thomas 19 ,
• Andrea C. Tricco 20 ,
• Vivian A. Welch 21 ,
• Penny Whiting 17 &
• David Moher 22  

Systematic Reviews volume  10 , Article number:  89 ( 2021 ) Cite this article

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An Editorial to this article was published on 19 April 2021

The Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) statement, published in 2009, was designed to help systematic reviewers transparently report why the review was done, what the authors did, and what they found. Over the past decade, advances in systematic review methodology and terminology have necessitated an update to the guideline. The PRISMA 2020 statement replaces the 2009 statement and includes new reporting guidance that reflects advances in methods to identify, select, appraise, and synthesise studies. The structure and presentation of the items have been modified to facilitate implementation. In this article, we present the PRISMA 2020 27-item checklist, an expanded checklist that details reporting recommendations for each item, the PRISMA 2020 abstract checklist, and the revised flow diagrams for original and updated reviews. In order to encourage its wide dissemination this article is freely accessible on BMJ, PLOS Medicine, Journal of Clinical Epidemiology and International Journal of Surgery journal websites.

Systematic reviews serve many critical roles. They can provide syntheses of the state of knowledge in a field, from which future research priorities can be identified; they can address questions that otherwise could not be answered by individual studies; they can identify problems in primary research that should be rectified in future studies; and they can generate or evaluate theories about how or why phenomena occur. Systematic reviews therefore generate various types of knowledge for different users of reviews (such as patients, healthcare providers, researchers, and policy makers) [ 1 , 2 ]. To ensure a systematic review is valuable to users, authors should prepare a transparent, complete, and accurate account of why the review was done, what they did (such as how studies were identified and selected) and what they found (such as characteristics of contributing studies and results of meta-analyses). Up-to-date reporting guidance facilitates authors achieving this [ 3 ].

The Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) statement published in 2009 (hereafter referred to as PRISMA 2009) [ 4 , 5 , 6 , 7 , 8 , 9 , 10 ] is a reporting guideline designed to address poor reporting of systematic reviews [ 11 ]. The PRISMA 2009 statement comprised a checklist of 27 items recommended for reporting in systematic reviews and an “explanation and elaboration” paper [ 12 , 13 , 14 , 15 , 16 ] providing additional reporting guidance for each item, along with exemplars of reporting. The recommendations have been widely endorsed and adopted, as evidenced by its co-publication in multiple journals, citation in over 60,000 reports (Scopus, August 2020), endorsement from almost 200 journals and systematic review organisations, and adoption in various disciplines. Evidence from observational studies suggests that use of the PRISMA 2009 statement is associated with more complete reporting of systematic reviews [ 17 , 18 , 19 , 20 ], although more could be done to improve adherence to the guideline [ 21 ].

Many innovations in the conduct of systematic reviews have occurred since publication of the PRISMA 2009 statement. For example, technological advances have enabled the use of natural language processing and machine learning to identify relevant evidence [ 22 , 23 , 24 ], methods have been proposed to synthesise and present findings when meta-analysis is not possible or appropriate [ 25 , 26 , 27 ], and new methods have been developed to assess the risk of bias in results of included studies [ 28 , 29 ]. Evidence on sources of bias in systematic reviews has accrued, culminating in the development of new tools to appraise the conduct of systematic reviews [ 30 , 31 ]. Terminology used to describe particular review processes has also evolved, as in the shift from assessing “quality” to assessing “certainty” in the body of evidence [ 32 ]. In addition, the publishing landscape has transformed, with multiple avenues now available for registering and disseminating systematic review protocols [ 33 , 34 ], disseminating reports of systematic reviews, and sharing data and materials, such as preprint servers and publicly accessible repositories. To capture these advances in the reporting of systematic reviews necessitated an update to the PRISMA 2009 statement.

Development of PRISMA 2020

A complete description of the methods used to develop PRISMA 2020 is available elsewhere [ 35 ]. We identified PRISMA 2009 items that were often reported incompletely by examining the results of studies investigating the transparency of reporting of published reviews [ 17 , 21 , 36 , 37 ]. We identified possible modifications to the PRISMA 2009 statement by reviewing 60 documents providing reporting guidance for systematic reviews (including reporting guidelines, handbooks, tools, and meta-research studies) [ 38 ]. These reviews of the literature were used to inform the content of a survey with suggested possible modifications to the 27 items in PRISMA 2009 and possible additional items. Respondents were asked whether they believed we should keep each PRISMA 2009 item as is, modify it, or remove it, and whether we should add each additional item. Systematic review methodologists and journal editors were invited to complete the online survey (110 of 220 invited responded). We discussed proposed content and wording of the PRISMA 2020 statement, as informed by the review and survey results, at a 21-member, two-day, in-person meeting in September 2018 in Edinburgh, Scotland. Throughout 2019 and 2020, we circulated an initial draft and five revisions of the checklist and explanation and elaboration paper to co-authors for feedback. In April 2020, we invited 22 systematic reviewers who had expressed interest in providing feedback on the PRISMA 2020 checklist to share their views (via an online survey) on the layout and terminology used in a preliminary version of the checklist. Feedback was received from 15 individuals and considered by the first author, and any revisions deemed necessary were incorporated before the final version was approved and endorsed by all co-authors.

The PRISMA 2020 statement

Scope of the guideline.

The PRISMA 2020 statement has been designed primarily for systematic reviews of studies that evaluate the effects of health interventions, irrespective of the design of the included studies. However, the checklist items are applicable to reports of systematic reviews evaluating other interventions (such as social or educational interventions), and many items are applicable to systematic reviews with objectives other than evaluating interventions (such as evaluating aetiology, prevalence, or prognosis). PRISMA 2020 is intended for use in systematic reviews that include synthesis (such as pairwise meta-analysis or other statistical synthesis methods) or do not include synthesis (for example, because only one eligible study is identified). The PRISMA 2020 items are relevant for mixed-methods systematic reviews (which include quantitative and qualitative studies), but reporting guidelines addressing the presentation and synthesis of qualitative data should also be consulted [ 39 , 40 ]. PRISMA 2020 can be used for original systematic reviews, updated systematic reviews, or continually updated (“living”) systematic reviews. However, for updated and living systematic reviews, there may be some additional considerations that need to be addressed. Where there is relevant content from other reporting guidelines, we reference these guidelines within the items in the explanation and elaboration paper [ 41 ] (such as PRISMA-Search [ 42 ] in items 6 and 7, Synthesis without meta-analysis (SWiM) reporting guideline [ 27 ] in item 13d). Box 1 includes a glossary of terms used throughout the PRISMA 2020 statement.

PRISMA 2020 is not intended to guide systematic review conduct, for which comprehensive resources are available [ 43 , 44 , 45 , 46 ]. However, familiarity with PRISMA 2020 is useful when planning and conducting systematic reviews to ensure that all recommended information is captured. PRISMA 2020 should not be used to assess the conduct or methodological quality of systematic reviews; other tools exist for this purpose [ 30 , 31 ]. Furthermore, PRISMA 2020 is not intended to inform the reporting of systematic review protocols, for which a separate statement is available (PRISMA for Protocols (PRISMA-P) 2015 statement [ 47 , 48 ]). Finally, extensions to the PRISMA 2009 statement have been developed to guide reporting of network meta-analyses [ 49 ], meta-analyses of individual participant data [ 50 ], systematic reviews of harms [ 51 ], systematic reviews of diagnostic test accuracy studies [ 52 ], and scoping reviews [ 53 ]; for these types of reviews we recommend authors report their review in accordance with the recommendations in PRISMA 2020 along with the guidance specific to the extension.

How to use PRISMA 2020

The PRISMA 2020 statement (including the checklists, explanation and elaboration, and flow diagram) replaces the PRISMA 2009 statement, which should no longer be used. Box  2 summarises noteworthy changes from the PRISMA 2009 statement. The PRISMA 2020 checklist includes seven sections with 27 items, some of which include sub-items (Table  1 ). A checklist for journal and conference abstracts for systematic reviews is included in PRISMA 2020. This abstract checklist is an update of the 2013 PRISMA for Abstracts statement [ 54 ], reflecting new and modified content in PRISMA 2020 (Table  2 ). A template PRISMA flow diagram is provided, which can be modified depending on whether the systematic review is original or updated (Fig.  1 ).

 PRISMA 2020 flow diagram template for systematic reviews. The new design is adapted from flow diagrams proposed by Boers [ 55 ], Mayo-Wilson et al. [ 56 ] and Stovold et al. [ 57 ] The boxes in grey should only be completed if applicable; otherwise they should be removed from the flow diagram. Note that a “report” could be a journal article, preprint, conference abstract, study register entry, clinical study report, dissertation, unpublished manuscript, government report or any other document providing relevant information

We recommend authors refer to PRISMA 2020 early in the writing process, because prospective consideration of the items may help to ensure that all the items are addressed. To help keep track of which items have been reported, the PRISMA statement website ( http://www.prisma-statement.org/ ) includes fillable templates of the checklists to download and complete (also available in Additional file 1 ). We have also created a web application that allows users to complete the checklist via a user-friendly interface [ 58 ] (available at https://prisma.shinyapps.io/checklist/ and adapted from the Transparency Checklist app [ 59 ]). The completed checklist can be exported to Word or PDF. Editable templates of the flow diagram can also be downloaded from the PRISMA statement website.

We have prepared an updated explanation and elaboration paper, in which we explain why reporting of each item is recommended and present bullet points that detail the reporting recommendations (which we refer to as elements) [ 41 ]. The bullet-point structure is new to PRISMA 2020 and has been adopted to facilitate implementation of the guidance [ 60 , 61 ]. An expanded checklist, which comprises an abridged version of the elements presented in the explanation and elaboration paper, with references and some examples removed, is available in Additional file 2 . Consulting the explanation and elaboration paper is recommended if further clarity or information is required.

Journals and publishers might impose word and section limits, and limits on the number of tables and figures allowed in the main report. In such cases, if the relevant information for some items already appears in a publicly accessible review protocol, referring to the protocol may suffice. Alternatively, placing detailed descriptions of the methods used or additional results (such as for less critical outcomes) in supplementary files is recommended. Ideally, supplementary files should be deposited to a general-purpose or institutional open-access repository that provides free and permanent access to the material (such as Open Science Framework, Dryad, figshare). A reference or link to the additional information should be included in the main report. Finally, although PRISMA 2020 provides a template for where information might be located, the suggested location should not be seen as prescriptive; the guiding principle is to ensure the information is reported.

Use of PRISMA 2020 has the potential to benefit many stakeholders. Complete reporting allows readers to assess the appropriateness of the methods, and therefore the trustworthiness of the findings. Presenting and summarising characteristics of studies contributing to a synthesis allows healthcare providers and policy makers to evaluate the applicability of the findings to their setting. Describing the certainty in the body of evidence for an outcome and the implications of findings should help policy makers, managers, and other decision makers formulate appropriate recommendations for practice or policy. Complete reporting of all PRISMA 2020 items also facilitates replication and review updates, as well as inclusion of systematic reviews in overviews (of systematic reviews) and guidelines, so teams can leverage work that is already done and decrease research waste [ 36 , 62 , 63 ].

We updated the PRISMA 2009 statement by adapting the EQUATOR Network’s guidance for developing health research reporting guidelines [ 64 ]. We evaluated the reporting completeness of published systematic reviews [ 17 , 21 , 36 , 37 ], reviewed the items included in other documents providing guidance for systematic reviews [ 38 ], surveyed systematic review methodologists and journal editors for their views on how to revise the original PRISMA statement [ 35 ], discussed the findings at an in-person meeting, and prepared this document through an iterative process. Our recommendations are informed by the reviews and survey conducted before the in-person meeting, theoretical considerations about which items facilitate replication and help users assess the risk of bias and applicability of systematic reviews, and co-authors’ experience with authoring and using systematic reviews.

Various strategies to increase the use of reporting guidelines and improve reporting have been proposed. They include educators introducing reporting guidelines into graduate curricula to promote good reporting habits of early career scientists [ 65 ]; journal editors and regulators endorsing use of reporting guidelines [ 18 ]; peer reviewers evaluating adherence to reporting guidelines [ 61 , 66 ]; journals requiring authors to indicate where in their manuscript they have adhered to each reporting item [ 67 ]; and authors using online writing tools that prompt complete reporting at the writing stage [ 60 ]. Multi-pronged interventions, where more than one of these strategies are combined, may be more effective (such as completion of checklists coupled with editorial checks) [ 68 ]. However, of 31 interventions proposed to increase adherence to reporting guidelines, the effects of only 11 have been evaluated, mostly in observational studies at high risk of bias due to confounding [ 69 ]. It is therefore unclear which strategies should be used. Future research might explore barriers and facilitators to the use of PRISMA 2020 by authors, editors, and peer reviewers, designing interventions that address the identified barriers, and evaluating those interventions using randomised trials. To inform possible revisions to the guideline, it would also be valuable to conduct think-aloud studies [ 70 ] to understand how systematic reviewers interpret the items, and reliability studies to identify items where there is varied interpretation of the items.

We encourage readers to submit evidence that informs any of the recommendations in PRISMA 2020 (via the PRISMA statement website: http://www.prisma-statement.org/ ). To enhance accessibility of PRISMA 2020, several translations of the guideline are under way (see available translations at the PRISMA statement website). We encourage journal editors and publishers to raise awareness of PRISMA 2020 (for example, by referring to it in journal “Instructions to authors”), endorsing its use, advising editors and peer reviewers to evaluate submitted systematic reviews against the PRISMA 2020 checklists, and making changes to journal policies to accommodate the new reporting recommendations. We recommend existing PRISMA extensions [ 47 , 49 , 50 , 51 , 52 , 53 , 71 , 72 ] be updated to reflect PRISMA 2020 and advise developers of new PRISMA extensions to use PRISMA 2020 as the foundation document.

We anticipate that the PRISMA 2020 statement will benefit authors, editors, and peer reviewers of systematic reviews, and different users of reviews, including guideline developers, policy makers, healthcare providers, patients, and other stakeholders. Ultimately, we hope that uptake of the guideline will lead to more transparent, complete, and accurate reporting of systematic reviews, thus facilitating evidence based decision making.

Box 1 Glossary of terms

Systematic review —A review that uses explicit, systematic methods to collate and synthesise findings of studies that address a clearly formulated question [ 43 ]

Statistical synthesis —The combination of quantitative results of two or more studies. This encompasses meta-analysis of effect estimates (described below) and other methods, such as combining P values, calculating the range and distribution of observed effects, and vote counting based on the direction of effect (see McKenzie and Brennan [ 25 ] for a description of each method)

Meta-analysis of effect estimates —A statistical technique used to synthesise results when study effect estimates and their variances are available, yielding a quantitative summary of results [ 25 ]

Outcome —An event or measurement collected for participants in a study (such as quality of life, mortality)

Result —The combination of a point estimate (such as a mean difference, risk ratio, or proportion) and a measure of its precision (such as a confidence/credible interval) for a particular outcome

Report —A document (paper or electronic) supplying information about a particular study. It could be a journal article, preprint, conference abstract, study register entry, clinical study report, dissertation, unpublished manuscript, government report, or any other document providing relevant information

Record —The title or abstract (or both) of a report indexed in a database or website (such as a title or abstract for an article indexed in Medline). Records that refer to the same report (such as the same journal article) are “duplicates”; however, records that refer to reports that are merely similar (such as a similar abstract submitted to two different conferences) should be considered unique.

Study —An investigation, such as a clinical trial, that includes a defined group of participants and one or more interventions and outcomes. A “study” might have multiple reports. For example, reports could include the protocol, statistical analysis plan, baseline characteristics, results for the primary outcome, results for harms, results for secondary outcomes, and results for additional mediator and moderator analyses

Box 2 Noteworthy changes to the PRISMA 2009 statement

• Inclusion of the abstract reporting checklist within PRISMA 2020 (see item #2 and Box 2 ).

• Movement of the ‘Protocol and registration’ item from the start of the Methods section of the checklist to a new Other section, with addition of a sub-item recommending authors describe amendments to information provided at registration or in the protocol (see item #24a-24c).

• Modification of the ‘Search’ item to recommend authors present full search strategies for all databases, registers and websites searched, not just at least one database (see item #7).

• Modification of the ‘Study selection’ item in the Methods section to emphasise the reporting of how many reviewers screened each record and each report retrieved, whether they worked independently, and if applicable, details of automation tools used in the process (see item #8).

• Addition of a sub-item to the ‘Data items’ item recommending authors report how outcomes were defined, which results were sought, and methods for selecting a subset of results from included studies (see item #10a).

• Splitting of the ‘Synthesis of results’ item in the Methods section into six sub-items recommending authors describe: the processes used to decide which studies were eligible for each synthesis; any methods required to prepare the data for synthesis; any methods used to tabulate or visually display results of individual studies and syntheses; any methods used to synthesise results; any methods used to explore possible causes of heterogeneity among study results (such as subgroup analysis, meta-regression); and any sensitivity analyses used to assess robustness of the synthesised results (see item #13a-13f).

• Addition of a sub-item to the ‘Study selection’ item in the Results section recommending authors cite studies that might appear to meet the inclusion criteria, but which were excluded, and explain why they were excluded (see item #16b).

• Splitting of the ‘Synthesis of results’ item in the Results section into four sub-items recommending authors: briefly summarise the characteristics and risk of bias among studies contributing to the synthesis; present results of all statistical syntheses conducted; present results of any investigations of possible causes of heterogeneity among study results; and present results of any sensitivity analyses (see item #20a-20d).

• Addition of new items recommending authors report methods for and results of an assessment of certainty (or confidence) in the body of evidence for an outcome (see items #15 and #22).

• Addition of a new item recommending authors declare any competing interests (see item #26).

• Addition of a new item recommending authors indicate whether data, analytic code and other materials used in the review are publicly available and if so, where they can be found (see item #27).

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Acknowledgements

We dedicate this paper to the late Douglas G Altman and Alessandro Liberati, whose contributions were fundamental to the development and implementation of the original PRISMA statement.

We thank the following contributors who completed the survey to inform discussions at the development meeting: Xavier Armoiry, Edoardo Aromataris, Ana Patricia Ayala, Ethan M Balk, Virginia Barbour, Elaine Beller, Jesse A Berlin, Lisa Bero, Zhao-Xiang Bian, Jean Joel Bigna, Ferrán Catalá-López, Anna Chaimani, Mike Clarke, Tammy Clifford, Ioana A Cristea, Miranda Cumpston, Sofia Dias, Corinna Dressler, Ivan D Florez, Joel J Gagnier, Chantelle Garritty, Long Ge, Davina Ghersi, Sean Grant, Gordon Guyatt, Neal R Haddaway, Julian PT Higgins, Sally Hopewell, Brian Hutton, Jamie J Kirkham, Jos Kleijnen, Julia Koricheva, Joey SW Kwong, Toby J Lasserson, Julia H Littell, Yoon K Loke, Malcolm R Macleod, Chris G Maher, Ana Marušic, Dimitris Mavridis, Jessie McGowan, Matthew DF McInnes, Philippa Middleton, Karel G Moons, Zachary Munn, Jane Noyes, Barbara Nußbaumer-Streit, Donald L Patrick, Tatiana Pereira-Cenci, Ba′ Pham, Bob Phillips, Dawid Pieper, Michelle Pollock, Daniel S Quintana, Drummond Rennie, Melissa L Rethlefsen, Hannah R Rothstein, Maroeska M Rovers, Rebecca Ryan, Georgia Salanti, Ian J Saldanha, Margaret Sampson, Nancy Santesso, Rafael Sarkis-Onofre, Jelena Savović, Christopher H Schmid, Kenneth F Schulz, Guido Schwarzer, Beverley J Shea, Paul G Shekelle, Farhad Shokraneh, Mark Simmonds, Nicole Skoetz, Sharon E Straus, Anneliese Synnot, Emily E Tanner-Smith, Brett D Thombs, Hilary Thomson, Alexander Tsertsvadze, Peter Tugwell, Tari Turner, Lesley Uttley, Jeffrey C Valentine, Matt Vassar, Areti Angeliki Veroniki, Meera Viswanathan, Cole Wayant, Paul Whaley, and Kehu Yang. We thank the following contributors who provided feedback on a preliminary version of the PRISMA 2020 checklist: Jo Abbott, Fionn Büttner, Patricia Correia-Santos, Victoria Freeman, Emily A Hennessy, Rakibul Islam, Amalia (Emily) Karahalios, Kasper Krommes, Andreas Lundh, Dafne Port Nascimento, Davina Robson, Catherine Schenck-Yglesias, Mary M Scott, Sarah Tanveer and Pavel Zhelnov. We thank Abigail H Goben, Melissa L Rethlefsen, Tanja Rombey, Anna Scott, and Farhad Shokraneh for their helpful comments on the preprints of the PRISMA 2020 papers. We thank Edoardo Aromataris, Stephanie Chang, Toby Lasserson and David Schriger for their helpful peer review comments on the PRISMA 2020 papers.

Provenance and peer review

Not commissioned; externally peer reviewed.

Patient and public involvement

Patients and the public were not involved in this methodological research. We plan to disseminate the research widely, including to community participants in evidence synthesis organisations.

There was no direct funding for this research. MJP is supported by an Australian Research Council Discovery Early Career Researcher Award (DE200101618) and was previously supported by an Australian National Health and Medical Research Council (NHMRC) Early Career Fellowship (1088535) during the conduct of this research. JEM is supported by an Australian NHMRC Career Development Fellowship (1143429). TCH is supported by an Australian NHMRC Senior Research Fellowship (1154607). JMT is supported by Evidence Partners Inc. JMG is supported by a Tier 1 Canada Research Chair in Health Knowledge Transfer and Uptake. MML is supported by The Ottawa Hospital Anaesthesia Alternate Funds Association and a Faculty of Medicine Junior Research Chair. TL is supported by funding from the National Eye Institute (UG1EY020522), National Institutes of Health, United States. LAM is supported by a National Institute for Health Research Doctoral Research Fellowship (DRF-2018-11-ST2–048). ACT is supported by a Tier 2 Canada Research Chair in Knowledge Synthesis. DM is supported in part by a University Research Chair, University of Ottawa. The funders had no role in considering the study design or in the collection, analysis, interpretation of data, writing of the report, or decision to submit the article for publication.

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Authors and affiliations.

School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia

Matthew J. Page, Joanne E. McKenzie, Sue E. Brennan & Steve McDonald

Department of Clinical Epidemiology, Biostatistics and Bioinformatics, Amsterdam University Medical Centres, University of Amsterdam, Amsterdam, Netherlands

Patrick M. Bossuyt

Université de Paris, Centre of Epidemiology and Statistics (CRESS), Inserm, F 75004, Paris, France

Isabelle Boutron

Institute for Evidence-Based Healthcare, Faculty of Health Sciences and Medicine, Bond University, Gold Coast, Australia

Tammy C. Hoffmann

Annals of Internal Medicine, University of Texas Health Science Center at San Antonio, San Antonio, Texas, USA

Cynthia D. Mulrow

Knowledge Translation Program, Li Ka Shing Knowledge Institute, Toronto, Canada; School of Epidemiology and Public Health, Faculty of Medicine, University of Ottawa, Ottawa, Canada

Larissa Shamseer

Evidence Partners, Ottawa, Canada

Jennifer M. Tetzlaff

Clinical Research Institute, American University of Beirut, Beirut, Lebanon; Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada

Elie A. Akl

Department of Medical Informatics and Clinical Epidemiology, Oregon Health & Science University, Portland, OR, USA

York Health Economics Consortium (YHEC Ltd), University of York, York, UK

Julie Glanville

Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Canada; School of Epidemiology and Public Health, University of Ottawa, Ottawa, Canada; Department of Medicine, University of Ottawa, Ottawa, Canada

Jeremy M. Grimshaw

Centre for Evidence-Based Medicine Odense (CEBMO) and Cochrane Denmark, Department of Clinical Research, University of Southern Denmark, JB Winsløwsvej 9b, 3rd Floor, 5000 Odense, Denmark; Open Patient data Exploratory Network (OPEN), Odense University Hospital, Odense, Denmark

Asbjørn Hróbjartsson

Department of Anesthesiology and Pain Medicine, The Ottawa Hospital, Ottawa, Canada; Clinical Epidemiology Program, Blueprint Translational Research Group, Ottawa Hospital Research Institute, Ottawa, Canada; Regenerative Medicine Program, Ottawa Hospital Research Institute, Ottawa, Canada

Manoj M. Lalu

Department of Ophthalmology, School of Medicine, University of Colorado Denver, Denver, Colorado, United States; Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA

Tianjing Li

Division of Headache, Department of Neurology, Brigham and Women’s Hospital, Harvard Medical School, Boston, Massachusetts, USA; Head of Research, The BMJ, London, UK

Elizabeth W. Loder

Department of Epidemiology and Biostatistics, Indiana University School of Public Health-Bloomington, Bloomington, Indiana, USA

Evan Mayo-Wilson

Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK

Luke A. McGuinness & Penny Whiting

Centre for Reviews and Dissemination, University of York, York, UK

Lesley A. Stewart

EPPI-Centre, UCL Social Research Institute, University College London, London, UK

James Thomas

Li Ka Shing Knowledge Institute of St. Michael’s Hospital, Unity Health Toronto, Toronto, Canada; Epidemiology Division of the Dalla Lana School of Public Health and the Institute of Health Management, Policy, and Evaluation, University of Toronto, Toronto, Canada; Queen’s Collaboration for Health Care Quality Joanna Briggs Institute Centre of Excellence, Queen’s University, Kingston, Canada

Andrea C. Tricco

Methods Centre, Bruyère Research Institute, Ottawa, Ontario, Canada; School of Epidemiology and Public Health, Faculty of Medicine, University of Ottawa, Ottawa, Canada

Vivian A. Welch

Centre for Journalology, Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Canada; School of Epidemiology and Public Health, Faculty of Medicine, University of Ottawa, Ottawa, Canada

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Contributions

JEM and DM are joint senior authors. MJP, JEM, PMB, IB, TCH, CDM, LS, and DM conceived this paper and designed the literature review and survey conducted to inform the guideline content. MJP conducted the literature review, administered the survey and analysed the data for both. MJP prepared all materials for the development meeting. MJP and JEM presented proposals at the development meeting. All authors except for TCH, JMT, EAA, SEB, and LAM attended the development meeting. MJP and JEM took and consolidated notes from the development meeting. MJP and JEM led the drafting and editing of the article. JEM, PMB, IB, TCH, LS, JMT, EAA, SEB, RC, JG, AH, TL, EMW, SM, LAM, LAS, JT, ACT, PW, and DM drafted particular sections of the article. All authors were involved in revising the article critically for important intellectual content. All authors approved the final version of the article. MJP is the guarantor of this work. The corresponding author attests that all listed authors meet authorship criteria and that no others meeting the criteria have been omitted.

Corresponding author

Correspondence to Matthew J. Page .

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Systematic Reviews

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Organisational factors associated with healthcare workforce development, recruitment, and retention in the United Kingdom: a systematic review

• Erkan Alkan 1 ,
• Noreen Cushen-Brewster 2 &
• Philip Anyanwu 1 , 3  

BMC Nursing volume  23 , Article number:  604 ( 2024 ) Cite this article

Metrics details

To synthesise evidence regarding organisational practice environment factors affecting healthcare workforce development, recruitment, and retention in the UK.

Methods/data sources

A systematic search of PubMed, Web of Science, EMBASE, and PsycINFO yielded ten relevant studies published between 2018 and 2023 and conducted in the UK (the last search was conducted in March 2023). Adhering to The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, two independent reviewers conducted screening, sifting, and data extraction, applying the quality assessment tool for risk of bias.

Results highlight key factors associated with staff intention to leave/turnover/retention: workplace challenges, aggression, moral distress, on-the-job embeddedness, leadership involvement, organisational support, and flexible shift patterns. Notably, aggression from colleagues, including clinical staff but not interdisciplinary personnel, has a more detrimental impact on staff intention to leave than aggression from patients.

The complex and context-dependent impacts of these organisational factors on the UK healthcare workforce underscore the need for tailored interventions. The review acknowledges limitations, including bias from excluding qualitative studies, a small pool of included studies, and nurse overrepresentation.

Summary statement

Securement and retainment issues affect different aspects of health and care services. Moreover, healthcare workforce shortages persist in the UK.

Our findings on the importance of workplace challenges and aggression, moral distress, on-the-job-embeddedness, leadership, flexible shift pattern, and organisational support in staff retention are important to addressing the current UK healthcare workforce crisis.

The findings of this review are important to healthcare commissioners, policymakers, and stakeholders, offering valuable insights for dealing with factors contributing to shortages in the healthcare workforce and enhancing staff satisfaction and retention.

Peer Review reports

What does this paper contribute to the wider global clinical community?

Contributes to the evidence on the role of organisational practice environment factors in healthcare workforce development and retention.

Introduction

Healthcare workforce development, recruitment, and retention are critical for providing quality services and achieving and sustaining global strategies, such as Universal Health Coverage (UHC), by ensuring a sufficient, well-trained, and stable workforce [ 1 , 2 , 3 ]. Effective healthcare workforce development involves continuous training and skill diversification, enhancing service quality. Recruitment strategies that address geographic disparities and offer incentives can improve accessibility and equity in healthcare. Retention efforts focused on job satisfaction, work-life balance, and ongoing professional development reduce turnover and ensure a motivated and capable workforce. Together, these elements can ensure that healthcare services are comprehensive, accessible, and of high quality, supporting the goals of UHC.

Countries at all income levels face challenges in the education, deployment, retention and performance of their healthcare workforce [ 4 ]. By 2030, a global shortage of 10 million health workers is estimated [ 4 , 5 ]. Recent events have impacted the healthcare workforce challenges. For example, around 100,000 nursing personnel in the United Kingdom (UK) initiated a two-day strike on December 15th 2022, protesting the government’s firm position on wage requests [ 6 ]. In addition to this industrial action, the health workforce has been influenced by the challenges posed by the COVID-19 pandemic. A recent review highlighted that nurses caring for COVID-19 patients, or those who had experienced COVID-19 infection themselves or within their team, exhibited an increased tendency to consider leaving their positions [ 7 ]. By the end of the first quarter of 2024, there were 31,294 vacancies within the Registered Nursing staff group in NHS England [ 8 ]. A similar staffing issue is seen among other healthcare professionals, including allied health professionals (AHPs) (paramedics, physiotherapists, occupational therapists, and dieticians, among others) [ 9 , 10 ]. During the pandemic, not only nurses but also other healthcare workers experienced detrimental effects related to the pandemic. A recent scoping review found that doctors, dentists, radiologic technologists, and other healthcare workers face heightened workload pressures, including more intensive patient care, additional non-routine tasks, increased documentation, greater demands and skill requirements, more overtime and extended work hours, and higher patient-to-nurse ratios [ 11 ].

Securement and retainment issues affect different aspects of health and care services. A high turnover and shortage of doctors, nurses and Allied Health Professionals (AHPs) indicate retention issues and impact care quality, patient outcomes, and the cost of healthcare delivery [ 12 , 13 , 14 , 15 ]. Addressing these issues requires an extensive understanding of their drivers.

Studies have identified several factors influencing healthcare workforce recruitment and retention, including organisational culture, professional development opportunities, staff level and mix, compensation and benefits, work-life balance, geographical location, support, transformational leadership, leadership, well-being, job satisfaction, technology and equipment [ 16 , 17 , 18 , 19 ]. A recent systematic review identified professional development opportunities and pay as important factors in NHS workers’ job satisfaction and retention [ 16 ]. Healthcare workers are often attracted to NHS organisations that offer competitive salaries and comprehensive benefits packages.

The relationship between recruitment/retention/turnover intention and contextual/organisational factors extends beyond the UK. In Europe, the economic climate and cost-of-living crisis in mid-2022 impacted pay, attrition rates and the attractiveness of working in healthcare [ 20 ]. A systematic review of the prevalence of intention to leave and determinants of retention among nurses and physicians in European and non-European countries reported job satisfaction, career development and work-life balance as the main determinants of job retention [ 21 ]. A recent qualitative study adopting co-creation workshops and Delphi sessions with healthcare professionals from Belgium, the Netherlands, Italy, and Poland reported professional and personal support, education, financial incentives, and regulatory measures as key to addressing staff retention in healthcare [ 22 ]. A study in China reported a reduction in turnover intention with an increase in staff salary level and job satisfaction, with factors such as conflicts with colleagues increasing turnover intention among nurses [ 23 ]. A global perspective, as presented in a systematic review, emphasises that turnover intention in nurses is influenced by organisational factors such as nursing home and staffing characteristics, resident characteristics, and job satisfaction [ 24 ].

Within the United Kingdom (UK) healthcare economy, there is inconsistency in reports on the impact of the organisational practice environment on healthcare workforce securement and retainment. As the evidence in this area keeps evolving with changes and events such as increased cost of living [ 25 ], there is a need to integrate information on what is known on this subject to support policies and practices toward healthcare workforce improvement.

This systematic review aims to advance an understanding of organisational practice environment factors affecting healthcare workforce development, recruitment, and retention in the UK by synthesising existing evidence in this area.

Methods/methodology

Guidelines and study registration.

This systematic review (without a meta-analysis) followed Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines [ 26 ]. The protocol was registered with PROSPERO, the International Prospective Register of Systematic Reviews (registration number: CRD42023412559).

Inclusion and/or exclusion criteria

Inclusion criteria were studies conducted in the UK, published in the English language in the last five years (2018 to 2023), peer-reviewed research articles, employed quantitative research designs (e.g., cross-sectional and longitudinal), and recruited nurses and/or various allied health professionals working in all healthcare settings as the study sample. To include nurses and allied health professionals working on a diverse range of roles, there was no restriction based on their roles. Papers published in English in the last five years (2018 to 2023), adopted a quantitative design (including mixed methods paper with the intention to extract only the quantitative results), and were conducted in the UK were selected. The primary predictor or independent variable of interest was indicators related to the organisational practice environment, and the primary outcomes were recruitment, retention, intention to leave/stay, and turnover. The eligibility criteria are further presented in Table  1 .

Exclusion criteria were studies conducted outside the UK, non-English-language publications, published before 2018, non-peer-reviewed sources (e.g., theses, literature reviews, editorials), non-quantitative research designs (e.g., qualitative and case studies), and other groups not falling under the specified allied health professions (such as pharmacists, clinicians, students and patients). Additionally, outcomes related to the quality of care and mental well-being were outside the scope of this review.

Search methods

We used the Population Intervention, Comparison and Outcome (PICO) framework (without the optional ‘comparison’ element as this was not relevant to our research question) to guide the search [ 27 , 28 ].

Population (P): Healthcare workforce (nurses and allied health professionals) in the United Kingdom.

Intervention (I): Organisational practice environment factors.

Outcome (O): Workforce development, recruitment, and retention.

Information sources

PubMed, Web of Science, EMBASE, and PsycINFO were searched for relevant articles; the last search was conducted in March 2023. An example of a database search strategy is provided in Appendix 1 (see Appendix 1, Additional File 1). The reference lists of the selected publications were also searched for eligible papers.

Study selection

All potential records generated from the search of databases were collated and uploaded into Endnote© Version X8. Duplicates were identified and removed using the Endnote functions. Two reviewers (PA and EA) screened titles and abstracts to assess each record according to the inclusion criteria. Screening of titles and abstracts resulted in the exclusion of papers ineligible based on population (e.g., first-year students, patients), design (review papers), and relevance of title and abstract. Studies retained after title and abstract screening were reviewed in full-text sifting by three researchers (NC, PA, and EA). Any disagreements that occurred among reviewers were resolved through discussion.

Data extraction

Two reviewers (EA and PA) independently performed data extraction. They used a data extraction form to extract information on the study design, participants’ characteristics, indicators of organisational practice environment factors reported, and study outcomes (Table  2 ).

Quality appraisal

The National Heart, Lung and Blood Institute (NHLBI) Study Quality Assessment Tool [ 39 ] for observational cohort and cross-sectional studies was used to assess the quality of the included studies for risk of bias (Table  3 ). The tool comprises 15 questions that thoroughly examine various aspects of the studies, such as their aims, sample size, design, outcome and independent measures, confounding variables, and inclusion/exclusion criteria. Two reviewers (EA and PA) independently assessed each question by assigning a rating of ‘yes’ for a low risk of bias, ‘no’ for a high risk of bias, ‘Not Reported’ when no supporting information was available, and ‘NA’ if the criteria were not applicable. Any discrepancies in the quality ratings between reviewers were resolved through discussions and consensus with the third reviewer. To ensure the validity and reliability of the review’s conclusions, studies rated as ‘poor’ will be removed as their results may be unreliable.

Data synthesis

Given the methods of analyses and outcomes reported in the included studies, a narrative synthesis, compared to a meta-analysis, was a better fit for synthesising the results. The narrative synthesis followed the methodologies proposed by the Cochrane Consumers and Communication Review Group’s Data Synthesis and Analysis document [ 40 ] and the Guidance on the Conduct of Narrative Synthesis in Systematic Reviews by the UK Economic and Social Research Council Methods Programme [ 41 ]. The results were integrated based on the reported organisational practice environment factors.

Results/findings

All potential records ( n =4216) generated from the search of databases were collated and uploaded into Endnote© Version X8. Duplicates ( n =1043) were identified and removed using the Endnote functions, leaving 3173 records. Screening of titles and abstracts resulted in the exclusion of 3001 papers. The full texts of the remaining 111 papers were screened, resulting in the exclusion of 101 papers due to inclusion criteria, study design and location. The remaining 10 papers (32–41) were included in the review (see Fig.  1 for the PRISMA flowchart showing the selection process). No additional papers were identified through the reference lists of the included studies.

Prisma diagram showing the selection of articles for review

Characteristics of the included studies

A summary table of the characteristics of the included studies is provided in Table  2 . Most of the studies recruited participants working in hospital settings, with two studies conducted in a care home/community nursing setting [ 33 , 37 ]. While our primary focus was on nursing and allied health professionals with no restriction based on role, it is important to highlight that the studies included in our review featured a range of distinct roles within these staff groups. These encompassed clinical and non-clinical roles, frontline clinical staff, and managerial positions. To further elucidate the composition of the study samples, we have detailed the specific staff groups investigated in each study within Table  2 . All the studies incorporated a quantitative component, with two adopting a mixed methods approach [ 31 , 35 ]. Nearly all the studies were cross-sectional; only one had a longitudinal design [ 33 ]. The sample sizes varied across the studies, ranging from 116 to 36,850 participants, with most studies reporting nurses as their participants. The analyses employed in the included studies were varied, with correlation and regression analyses commonly reported. Multiple tools were used to assess outcomes (see Appendix 2, Additional File 1 for a description of the indicators reported and how they were measured in each study). Authors employed various measurements in their studies to capture specific dimensions of interest. For example, when investigating intention to leave, some studies used single-item questions such as “Are you considering leaving your job?” [ 29 , 37 ] or multi-item Likert scale-based questions to gauge the degree of intention to leave [ 30 , 34 ]. Actual turnover was assessed through self-report measures, where care home managers, for example, reported the number of staff left over a given period [ 33 ]. Retention was measured using questionnaires that examined factors influencing retirement age and timing [ 31 ] or was calculated using organisational workforce data [ 36 ].

Quality assessment

Overall, the quality ratings varied across studies, with most studies rated as fair or good. The specific quality ratings for each study are provided in Table  3 . Six of the ten papers were rated as good, while four were rated as fair. All studies clearly stated their research aim/question. The study population was also clearly specified and defined in all studies. The participation rate of eligible persons was below 50% in most studies, except for two studies where this information was not reported. All study subjects were selected or recruited from the same or similar populations, and the timeframe was considered sufficient to observe associations between exposure and outcome. Most studies did not provide sample size justification or power calculation; only four studies reported this information [ 29 , 31 , 35 , 37 ]. Potential confounding variables were measured and adjusted for in most studies except for four [ 29 , 36 , 37 , 38 ].

Organisational practice environment factors

The associations between organisational environmental factors and healthcare staff intention to leave/actual turnover/retention is summarised in Table  4 .

Working conditions (workload, burnout, and job stress)

Four of the included studies [ 29 , 33 , 34 , 37 ] investigated associations between workplace challenges (job stress, burnout and working conditions) and staff turnover or intention to leave. The study reporting burnout (defined by the WHO as “ a syndrome conceptualised as resulting from chronic workplace stress that has not been successfully managed ” [ 42 ]) found no association with staff turnover [ 33 ]. One study reported a positive association between job stress (that is, the mental situation individuals may experience when they are confronted with job demands and pressures that do not align with their skills and capabilities [ 43 ]), and nurses’ intention to leave [ 34 ]. Two studies reported the effect of working conditions on intention to leave [ 29 , 37 ], with one focusing on staff experience working in COVID-19 high-risk areas [ 29 ]. The COVID-19-focused study found no difference in turnover intention between those working in higher- or lower-risk areas. Another study found that staff intention to leave significantly decreased with improvements in working conditions (0.49 (0.34–0.70), p  < 0.001) [ 37 ].

Workplace aggression

Workplace aggression, in this context, refers to encountering actions that pose potential harm, are actively avoided by the target, and take place during the target’s work duties [ 44 ]. Only one study investigated the impact of workplace aggression on staff intention to leave. The study by Cheng et al. found that experiencing aggression from either patients or colleagues had a damaging effect on staff intention to leave, with the impact of aggression from colleagues twice that from patients [ 30 ].

Moral distress

The results of the two studies that reported on moral distress were consistent. Colville et al. found that moral distress (resulting from situations when someone is aware of the correct course of action but institutional constraints create significant obstacles to following through with the right decision) predicts staff intention to leave and turnover [ 32 ]. Similarly, Witton et al. reported that moral distress was negatively correlated with intent to stay; nurses who stated they had high rates of moral distress were more likely to consider leaving their current employer [ 38 ].

On-the-job embeddedness

One of the included studies considered job embeddedness (the degree of connection employees have to their jobs through a network of social relationships and factors [ 45 ]), with a negative association between this organisational practice environment factor and nurses’ intention to leave reported [ 34 ].

Involvement in leadership and management

Two studies reported the effect of staff involvement in leadership and management. Quek et al. found that higher levels of distributed leadership significantly predicted lower turnover intention [ 35 ]. Robinson et al. investigated the association between involvement in improvement (measured using three indicators: the ability to make suggestions to improve their work, involvement in decisions on changes that affect their work area, and ability to make improvements in their area of work) and the retention of nurses working across different types of NHS Trusts (Community, Specialist, Mental Health and Acute). Only two indicators of improvement (ability to make suggestions to improve their work and ability to make improvements in their area of work) were significantly correlated with RN retention, and this was seen in those working in mental health and acute NHS trusts [ 36 ]. For RNs in Mental Health NHS Trusts, retention was positively correlated with their ability to make suggestions to improve their work and their ability to make improvements in their area of work. However, in Acute NHS Trusts, a negative correlation was seen between RNs’ ability to make improvements in their area of work and their retention.

Support (wellbeing and management support)

Two studies reported on aspects of organisational support. The COVID-19-focused study by Blake et al. found no significant differences in turnover intentions between staff who accessed a supported wellness centre set up in UK hospitals to mitigate the psychological impact of the pandemic and those who did not [ 29 ]. The other study reported that support from managers reduced the odds of staff indicating an intention to leave [ 37 ].

Flexible shift patterns

With a focus on older nurses (over 55 years of age), Cleaver et al. examined the relationship between shift patterns and the odds of working beyond retirement. The odds of working beyond retirement are significantly higher if staff can reduce their working hours and choose when to work or have a fixed working pattern. However, other factors, such as cessing to work shifts, nights and weekends, were not significantly associated with the intention to work beyond retirement [ 31 ].

Our review synthesised quantitative evidence on the impact of organisational practice environment factors on healthcare workforce development and retention. The included studies reported the impact of working conditions, workplace aggression, moral distress, on-the-job embeddedness, leadership and management involvement opportunities, well-being and management support and flexible shift patterns on the intention to leave, actual staff turnover and retention among nurses and AHPs in the UK. Intention to leave was the most reported outcome (with studies investigating its association with all reported organisation practice environment factors, except flexible shift pattern), demonstrating its importance in workforce planning and strategies for targeted retention, continuity of care, and employee engagement.

Our findings suggest that the influence of organisational factors on securement and retention is complex and context-dependent. For instance, findings on the impact of workplace challenges on intention to leave and staff turnover were mixed; while some studies indicate that workplace challenges, such as job stress and working conditions, are associated with higher intention to leave, other studies showed no significant relationship. These mixed findings could be attributed to various factors, including differences in study methodologies, sample characteristics, organisational contexts, events and the specific nature of the workplace challenges examined. A recent systematic review reported increased intention to leave among nurses driven by disruptive events such as the COVID-19 pandemic, with approximately one-third of nurses having thoughts about leaving their job [ 46 ].

Our review finding that workplace aggression from colleagues has a more detrimental impact on staff retention than workplace aggression from patients suggests that the source of aggression plays a significant role in its effect on staff intention to leave. A similar finding on the impact of aggression and its source on retention and securement has been reported in other UK [ 47 ] and non-UK studies [ 48 , 49 , 50 ]. Workplace aggression from colleagues has been attributed to factors such as misunderstanding of job roles and responsibilities, emotional exhaustion and job stress [ 49 , 50 ]. When aggression originates from colleagues, who are expected to provide support and collaboration, it can have a more profound negative impact on individuals’ job satisfaction and overall well-being. Additionally, aggression from colleagues may erode social support networks, trust, teamwork, and on-the-job-embeddedness (the extent to which employees feel rooted in their work, have strong social connections, and perceive a good fit between themselves and their colleagues/job) [ 34 , 51 ]. Our finding on on-the-job embeddedness emphasises the significance of fostering among colleagues a sense of belonging, positive relationships, and alignment to enhance staff retention.

The impact of moral distress on staff intention to leave resonates with the persistent workforce issues worsened by recent industrial actions and the cost-of-living challenges. Organisational factors such as working in an understaffed environment and inadequate financial remuneration can constrain healthcare professionals from acting in accordance with their ethical principles [ 52 ]. For instance, the recent cost-of-living crisis in the UK might partly explain the increasing reports of moral distress among healthcare professionals as they struggle with financial challenges while providing care, impacting job satisfaction and intentions to leave.

The perspective of our review is limited by the inclusion of only quantitative studies. Excluding qualitative studies could limit our ability to capture the process, complexity, and context of organisational practice environment factors’ influence on healthcare workforce securement and retention. Compared to observational studies, randomised controlled trials could have provided stronger evidence for causal inference. The review has other limitations stemming from the strict inclusion criteria, focusing solely on the UK population, resulting in a small number of studies with an overrepresentation of nurses compared to allied health professionals. The observational nature of the included studies introduces potential bias from uncontrolled confounders. While emphasising nursing and allied health professionals, it is acknowledged that diverse staff groups have unique needs. Balancing evidence from general population studies with role-specific investigations is crucial for a comprehensive understanding of healthcare workforce issues and devising solutions. The variation in outcome measures in the included studies (see Appendix 2) poses a challenge, hindering direct comparisons and preventing a meaningful meta-analysis due to the lack of standardised measurement approaches. Our focus on peer-reviewed publications, excluding grey literature, could lead to overlooking relevant studies; however, this restriction was important in ensuring the inclusion of high-quality, rigorously peer-reviewed research papers, thereby enhancing the reliability and validity of our findings. Acknowledging these limitations is essential for interpreting the nuanced landscape of healthcare workforce development and retention issues.

Conclusions

Our findings have practical, policy and research implications. This review contributes to the evidence needed by healthcare commissioners and policymakers to address persistent workforce securement and retention issues in the UK. Our results underscore the need for tailored strategies focusing on key aspects, such as reducing workplace aggression from colleagues. The review evidence can inform policies and practices aimed at promoting work-life balance, offering career development opportunities, fostering a positive workplace culture, providing competitive compensation, and implementing flexible work arrangements to enhance healthcare workforce retention. Additionally, our findings highlight the need for further research to understand how different organisational practice environment factors interact with individual and external factors to influence the intention to leave specific healthcare settings. Nevertheless, it is crucial to highlight that the healthcare workforce in the UK is dynamic and continues to be influenced by ongoing events, such as industrial actions and cost-of-living challenges [ 6 , 25 ]. Future research should address these dynamics, with an emphasis on developing strategies to meet the evolving challenges faced by the healthcare workforce.

Based on our findings, to improve healthcare staff development, recruitment, and retention, we recommend prioritising proactive organisational policies and interventions co-developed with healthcare workers that aim to create supportive and empowering work environments.

Data availability

The dataset used and/or analysed during the current study are available from the corresponding author on reasonable request.

Abbreviations

Sustainable Development Goals

Universal health coverage

United Kingdom

• Allied health professionals

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Acknowledgements

We would like to acknowledge Health Education England and the steering committee members (Dr Paul Driscoll-Evans, Mr Graham Seward, and Professor Lynne Wigens).

This study was funded by Health Education England (RD22061).

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Alkan, E., Cushen-Brewster, N. & Anyanwu, P. Organisational factors associated with healthcare workforce development, recruitment, and retention in the United Kingdom: a systematic review. BMC Nurs 23 , 604 (2024). https://doi.org/10.1186/s12912-024-02216-0

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Received : 19 March 2024

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DOI : https://doi.org/10.1186/s12912-024-02216-0

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