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Journal of Research in Nursing

Journal of Research in Nursing

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  • Description
  • Aims and Scope
  • Editorial Board
  • Abstracting / Indexing
  • Submission Guidelines

Journal of Research in Nursing publishes research on nursing topics and themes. Original research is published with the aim of encouraging evidence-based practice and improving the quality of patient care.

It publishes quality research papers on healthcare issues that inform nurses and other healthcare professionals globally. Through linking policy, research and development initiatives to clinical and academic excellence Journal of Research in Nursing aims to support nursing and healthcare professionals in their development, for the overall benefit of quality healthcare services.

"I have used Journal of Research in Nursing extensively in the course of a recent research project and think that it provides an invaluable reference point for nurse researchers particularly for up-to-date policy related information" Professor Donna Fitzmasons, Ulster University and Belfast Health and Social Care Trust, UK

" Journal of Research in Nursing is an important journal in UK Nursing and has made a significant contribution to the transfer of knowledge with direct relevance to the whole of the nursing community. Researchers have no hesitation in contributing papers to the journal highlighting the respect Journal of Research in Nursing has as a vehicle for the dissemination of research findings. The partnership with SAGE Publications will enable this success to be taken to the world stage. I wish the journal, its editor and editorial team every success in its 're-birth' and ongoing development" Professor Brendan McCormack, Head of Division of Nursing, Queen Margaret University, Edinburgh, UK

"A rip-roaring, highly policy and practice relevant research read" Dr Ann-Marie Rafferty, King's College London, UK This journal is a member of the Committee on Publication Ethics (COPE)

The Journal of Research in Nursing is a leading peer reviewed journal that blends good research with contemporary debates about policy and practice. The Journal of Research in Nursing contributes knowledge to nursing practice, research and local, national and international health and social care policy. Each issue contains a variety of papers and review commentaries within a specific theme. The editors are advised and supported by a board of key academics, practitioners and policy makers of international standing.

The Journal of Research in Nursing will:

• Ensure an evidence base to your practice and policy development

• Inform your research work at an advanced level

• Challenge you to critically reflect on the interface between practice, policy and research

Emeritus Professor of Nursing, University of Southampton, UK
Honorary Senior Teaching Fellow, University of Glasgow and Honorary Professor, Plymouth University
Visiting Professor of Nursing, City University, UK
Clinical Lead Research and Innovation, Institute of Nursing and Midwifery Care Excellence at Nottingham University Hospitals NHS Trust, UK
Emeritus Professor of Social Science and Health, De Montfort University, UK
Senior Lecturer, International, Glasgow Caledonian University, UK
Emerita Professor of Primary Care, University of South Wales, UK
Chief Nurse Research and Development, NHS Lothian, UK
Research Associate, University of Warwick, UK
Professor of Nursing Sociology, Head of Department of Social Sciences and Social Work, Bournemouth University, UK
Professor of Nursing, University of Birmingham/United Hospitals Birmingham NHS Foundation Trust, UK
Vice President of Research, Innovation and Graduate Studies, Waterford Institute of Technology, Ireland
Professor of Nursing and Associate Dean, University of Calgary, Canada
Professor of Nursing, Director and Head of Graduate Division, Nethersole School of Nursing, The Chinese University of Hong Kong, China
Professor and Executive Vice Dean, Rory Meyers College of Nursing, New York University, USA
Executive Chair for Research at UKRI, UK
Vice-Chancellor, University of Auckland, New Zealand
Matthew Flinders Fellow and Professor of Health Services and Implementation Research in the College of Nursing and Health Sciences, Flinders University, Australia
Assistant Professor of Nursing, University of Calgary, Canada
Professor of Nursing, University of Texas Health Science Center at San Antonio, USA
Professor of Nursing, Ulster University, Northern Ireland, UK
Head of the Research Unit in Health Care, Instituto de Salud Carlos III, Madrid, Spain
Professor Emerita, University of North Carolina at Chapel Hill, USA
Adjunct Associate Professor, School of Health Sciences, Massey University, New Zealand
Adjunct Professor of Nursing, College of Health and Medicine, University of Tasmania, Australia
  • Applied Social Sciences Index & Abstracts (ASSIA)
  • British Nursing Index
  • Clarivate Analytics: Emerging Sources Citation Index (ESCI)
  • Corporate ResourceNET
  • Cumulative Index to Nursing and Allied Health Literature CINAHL
  • MasterFILE Premier
  • Periodical Abstracts
  • Psychological Abstracts
  • Standard Periodical Directory
  • TOPIC Search

Manuscript Submission Guidelines: Journal of Research in Nursing

This Journal is a member of the Committee on Publication Ethics

This Journal recommends that authors follow the Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals formulated by the International Committee of Medical Journal Editors (ICMJE).

Please read the guidelines below then visit the Journal’s submission site http://mc.manuscriptcentral.com/jrn to upload your manuscript. Please note that manuscripts not conforming to these guidelines may be returned.

Only manuscripts of sufficient quality that meet the aims and scope of Journal of Research in Nursing will be reviewed.

There are no fees payable to submit or publish in this Journal. Open Access options are available - see section 3.3 below.

As part of the submission process you will be required to warrant that you are submitting your original work, that you have the rights in the work, that you are submitting the work for first publication in the Journal and that it is not being considered for publication elsewhere and has not already been published elsewhere, and that you have obtained and can supply all necessary permissions for the reproduction of any copyright works not owned by you.

  • What do we publish? 1.1 Aims & Scope 1.2 Article types 1.3 Writing your paper
  • Editorial policies 2.1 Peer review policy 2.2 Authorship 2.3 Acknowledgements 2.4 Funding 2.5 Declaration of conflicting interests 2.6 Research ethics and patient consent 2.8  Data
  • Publishing policies 3.1 Publication ethics 3.2 Contributor's publishing agreement 3.3 Open access and author archiving
  • Preparing your manuscript 4.1 Formatting 4.2 Artwork, figures and other graphics 4.3 Supplementary material 4.4 Reference style 4.5 English language editing services
  • Submitting your manuscript 5.1 ORCID 5.2 Information required for completing your submission 5.3 Permissions
  • On acceptance and publication 6.1 Sage Production 6.2 Online First publication 6.3 Access to your published article 6.4 Promoting your article
  • Further information

1. What do we publish?

1.1 Aims & Scope

Before submitting your manuscript to Journal of Research in Nursing , please ensure you have read the Aims & Scope .

1.2 Article Types

The  Journal of Research in Nursing  welcomes research papers and reviews on nursing, whether clinical, research, education or management topics. The contribution of the paper to, or implications for, both nursing practice and health and social care policy must be made explicit. Papers are normally restricted to a maximum of 5,000 words, excluding all elements (title page, abstract, notes, references, tables, biographical statement, etc.).

The Journal considers the following kinds of article for publication:

1.2.1 Research papers  should be presented under the following section headings:

Title Page File

JRN operates double anonymize peer review which means that all author information should be contained within a title page file (not shown to reviewers) and an author anonymised manuscript file. The title page file should include:

  • Manuscript Title
  • Running head (a short title)
  • This is required for each author: author name followed by job title and affiliation - first name in full, followed by family name, job title, department, institution and country. - <b>no other information</b>  (no  roles, academic credentials, positions of authority or emails). 
  • Correspondence information should be listed after the affiliations list in full. Write the name of one author for correspondence, their full postal address including postcode and country, tel and fax with international dialling codes, and email.
  • Declaration of interest section must appear here in the title page file to preserve anonymity.
  • All declarations of interest and funding must be outlined under the subheading “Declaration of interest” If authors have no declarations of interest to report, this must be explicitly stated. The suggested, but not mandatory, wording in such an instance is: The authors report no declarations of interest.
  • Ethical Permissions. Please include a statement regarding ethical permissions (or the reason why these were not needed).
  • Trial registration information (for interventions and observational studies) - must include the date the trial was registered in a public database, the trial start date, the registration number and the URL of the trial record.
  • Author biographies. Please include a 30-word biography for each author.

Main document file (the anonymized manuscript).

Your manuscript should not contain identifying information (note, self-citation is permitted). Please include the following elements:

Abstract - Please provide a structured abstract of no more than 200 words. The structured abstract should include the sub-headings of Background, Aims, Methods, Results and Conclusions.  Within the conclusions section please clearly state the paper’s contribution to nursing.

Keywords - six MeSH compliant keywords.

Introduction - this should set the scene, including the policy context, for the research study and state the research question/ hypothesis. This should be followed by a literature review, which should quote key articles directly relevant to the study

Methodology - this should be sufficiently detailed for subsequent researchers to follow; it should reiterate the aims and hypotheses of the study and why the methodology was chosen. Copies of research tools, such as questionnaires, should be included with the manuscript

Results - full results should be submitted, including relevant tables, figures and diagrams and details of statistical analysis

Discussion - this should be as full as possible and attempt to explain the results achieved and their significance to both nursing practice and health and social care policy. Limitations to the study should be highlighted in this section

Conclusion - this section should draw together the findings of the study, how they relate to the original aims and make recommendations as to how the work can be carried forward.  The paper’s contribution to nursing must be clearly stated.

Key points - a list of four or five key points drawing out the main findings and their implications for nursing practice, health and social care policy and future research.

References - JRN follows Harvard (author, date) style referencing. References should be complete - even when citing your own previous work. Authors should write objectively and not attach ownership to their sources, so anonymizing references is not required. View the Sage Harvard guidelines to ensure your manuscript conforms to this reference style.

Please do not include unpublished data or ‘in press’ sources since we are unable to verify the appropriateness of these.

Tables - as tabulated text/ data (if any)

Figure captions - listed after the tables (if any). Figures must be supplied as separate image format files.

S tatistical analysis should meet the minimum standards of reporting statistics in clinical research (see SAMPL http://www.equator-network.org/2013/02/11/sampl-guidelines-for-statistical-reporting/ ). You may also find the editorial by Amrhein V, Greenland S, McShane B. Retire statistical significance. Nature 2019; 567: 305-7 useful.

Figures - For guidance on the preparation of illustrations, pictures and graphs in electronic format, please visit Sage’s Manuscript Submission Guidelines

Supporting documents

Interventions must be accompanied by a completed CONSORT and TiDier flowchart and checklist.

Observations must be accompanied by a completed STROBE checklist.

The contribution of the paper to, or implications for, nursing practice and health and social care policy should be made explicit .

1.2.2 Review Articles

The contribution of the paper to, or implications for, nursing practice and health and social care policy must be made explicit.

1.3 Writing your paper

The Sage Author Gateway has some general advice and on  how to get published , plus links to further resources. Sage Author Services also offers authors a variety of ways to improve and enhance their article including English language editing, plagiarism detection, and video abstract and infographic preparation.

1.3.1 Make your article discoverable

When writing up your paper, think about how you can make it discoverable. The title, keywords and abstract are key to ensuring readers find your article through search engines such as Google. For information and guidance on how best to title your article, write your abstract and select your keywords, have a look at this page on the Gateway: How to Help Readers Find Your Article Online .

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2. Editorial policies

2.1 Peer review policy

Sage does not permit the use of author-suggested (recommended) reviewers at any stage of the submission process, be that through the web-based submission system or other communication. Reviewers should be experts in their fields and should be able to provide an objective assessment of the manuscript. Our policy is that reviewers should not be assigned to a paper if:

•  The reviewer is based at the same institution as any of the co-authors

•  The reviewer is based at the funding body of the paper

•  The author has recommended the reviewer

•  The reviewer has provided a personal (e.g. Gmail/Yahoo/Hotmail) email account and an institutional email account cannot be found after performing a basic Google search (name, department and institution). 

2.2 Authorship

All parties who have made a substantive contribution to the article should be listed as authors. Principal authorship, authorship order, and other publication credits should be based on the relative scientific or professional contributions of the individuals involved, regardless of their status. A student is usually listed as principal author on any multiple-authored publication that substantially derives from the student’s dissertation or thesis.

Please note that AI chatbots, for example ChatGPT, should not be listed as authors. For more information see the policy on Use of ChatGPT and generative AI tools .

2.3 Acknowledgements

All contributors who do not meet the criteria for authorship should be listed in an Acknowledgements section. Examples of those who might be acknowledged include a person who provided purely technical help, or a department chair who provided only general support.

2.3.1 Third party submissions

Where an individual who is not listed as an author submits a manuscript on behalf of the author(s), a statement must be included in the Acknowledgements section of the manuscript and in the accompanying cover letter. The statements must:

  • Disclose this type of editorial assistance – including the individual’s name, company and level of input
  • Identify any entities that paid for this assistance
  • Confirm that the listed authors have authorized the submission of their manuscript via third party and approved any statements or declarations, e.g. conflicting interests, funding, etc.

Where appropriate, Sage reserves the right to deny consideration to manuscripts submitted by a third party rather than by the authors themselves .

2.3.2 Writing assistance

Individuals who provided writing assistance, e.g. from a specialist communications company, do not qualify as authors and so should be included in the Acknowledgements section. Authors must disclose any writing assistance – including the individual’s name, company and level of input – and identify the entity that paid for this assistance”).

It is not necessary to disclose use of language polishing services.

Please supply any personal acknowledgements separately to the main text to facilitate anonymous peer review.

2.4 Funding

Journal of Research in Nursing requires all authors to acknowledge their funding in a consistent fashion under a separate heading.  Please visit the Funding Acknowledgements page on the Sage Journal Author Gateway to confirm the format of the acknowledgment text in the event of funding, or state that: This research received no specific grant from any funding agency in the public, commercial, or not-for-profit sectors. 

2.5 Declaration of conflicting interests

Journal of Research in Nursing encourages authors to include a declaration of any conflicting interests and recommends you review the good practice guidelines on the Sage Journal Author Gateway

2.6 Research ethics and patient consent

Medical research involving human subjects must be conducted according to the World Medical Association Declaration of Helsinki

Submitted manuscripts should conform to the ICMJE Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals , and all papers reporting animal and/or human studies must state in the methods section that the relevant Ethics Committee or Institutional Review Board provided (or waived) approval. Please ensure that you have provided the full name and institution of the review committee, in addition to the approval number.

For research articles, authors must state in the methods section whether participants provided informed consent and whether the consent was written or verbal. Authors must also state whether ethical approval was required or not for the research, please also include any relevant additional ethical considerations.

Information on informed consent to report individual cases or case series should be included in the manuscript text. A statement is required regarding whether written informed consent for patient information and images to be published was provided by the patient(s) or a legally authorized representative.

Please also refer to the ICMJE Recommendations for the Protection of Research Participants

Sage acknowledges the importance of research data availability as an integral part of the research and verification process for academic journal articles.

Journal of Research in Nursing requests all authors submitting any primary data used in their research articles [“alongside their article submissions” or “if the articles are accepted”] to be published in the online version of the journal, or provide detailed information in their articles on how the data can be obtained. This information should include links to third-party data repositories or detailed contact information for third-party data sources. Data available only on an author-maintained website will need to be loaded onto either the journal’s platform or a third-party platform to ensure continuing accessibility. Examples of data types include but are not limited to statistical data files, replication code, text files, audio files, images, videos, appendices, and additional charts and graphs necessary to understand the original research. [The editor(s) may consider limited embargoes on proprietary data.] The editor(s) can also grant exceptions for data that cannot legally or ethically be released. All data submitted should comply with Institutional or Ethical Review Board requirements and applicable government regulations. For further information, please contact the editorial office at [email address].

3. Publishing Policies

3.1 Publication ethics

Sage is committed to upholding the integrity of the academic record. We encourage authors to refer to the Committee on Publication Ethics’ International Standards for Authors and view the Publication Ethics page on the Sage Author Gateway .

3.1.1 Plagiarism

Journal of Research in Nursing and Sage take issues of copyright infringement, plagiarism or other breaches of best practice in publication very seriously. We seek to protect the rights of our authors and we always investigate claims of plagiarism or misuse of published articles. Equally, we seek to protect the reputation of the journal against malpractice. Submitted articles may be checked with duplication-checking software. Where an article, for example, is found to have plagiarised other work or included third-party copyright material without permission or with insufficient acknowledgement, or where the authorship of the article is contested, we reserve the right to take action including, but not limited to: publishing an erratum or corrigendum (correction); retracting the article; taking up the matter with the head of department or dean of the author's institution and/or relevant academic bodies or societies; or taking appropriate legal action.

3.1.2 Prior publication

If material has been previously published it is not generally acceptable for publication in a Sage journal. However, there are certain circumstances where previously published material can be considered for publication. Please refer to the guidance on the Sage Author Gateway or if in doubt, contact the Editor at the address given below.

3.2 Contributor's publishing agreement

Before publication, Sage requires the author as the rights holder to sign a Journal Contributor’s Publishing Agreement. Sage’s Journal Contributor’s Publishing Agreement is an exclusive licence agreement which means that the author retains copyright in the work but grants Sage the sole and exclusive right and licence to publish for the full legal term of copyright. Exceptions may exist where an assignment of copyright is required or preferred by a proprietor other than Sage. In this case copyright in the work will be assigned from the author to the society. For more information please visit the Sage Author Gateway .

3.3 Open access and author archiving

Journal of Research in Nursing  offers optional open access publishing via the Sage Choice programme and Open Access agreements, where authors can publish open access either discounted or free of charge depending on the agreement with Sage. Find out if your institution is participating by visiting Open Access Agreements at Sage . For more information on Open Access publishing options at Sage please visit Sage Open Access . For information on funding body compliance, and depositing your article in repositories, please visit Sage’s Author Archiving and Re-Use Guidelines and Publishing Policies .

Please check whether you are entitled to publish open access via a deal between your institution and Sage by checking this page of Open Access Agreements.

4. Preparing your manuscript for submission

4.1 Formatting

The preferred format for your manuscript is Word. LaTeX files are also accepted. Word and (La)Tex templates are available on the Manuscript Submission Guidelines page of our Author Gateway.

4.2 Artwork, figures and other graphics

For guidance on the preparation of illustrations, pictures and graphs in electronic format, please visit Sage’s Manuscript Submission Guidelines .

Figures supplied in colour will appear in colour online regardless of whether or not these illustrations are reproduced in colour in the printed version. For specifically requested colour reproduction in print, you will receive information regarding the costs from Sage after receipt of your accepted article.

4.3 Supplementary material

This journal is able to host additional materials online (e.g. datasets, podcasts, videos, images etc) alongside the full-text of the article. For more information please refer to our guidelines on submitting supplementary files .

4.4 Reference style

Journal of Research in Nursing adheres to the Sage Harvard reference style. View the Sage Harvard guidelines to ensure your manuscript conforms to this reference style.

If you use EndNote to manage references, you can download the Sage Harvard EndNote output file .

4.5 English language editing services

Authors seeking assistance with English language editing, translation, or figure and manuscript formatting to fit the journal’s specifications should consider using Sage Language Services. Visit Sage Language Services on our Journal Author Gateway for further information.

5. Submitting your manuscript

Journal of Research in Nursing is hosted on Sage Track, a web based online submission and peer review system powered by ScholarOne™ Manuscripts. Visit http://mc.manuscriptcentral.com/jrn to login and submit your article online.

IMPORTANT: Please check whether you already have an account in the system before trying to create a new one. If you have reviewed or authored for the journal in the past year it is likely that you will have had an account created.  For further guidance on submitting your manuscript online please visit ScholarOne Online Help.

As part of our commitment to ensuring an ethical, transparent and fair peer review process Sage is a supporting member of ORCID, the Open Researcher and Contributor ID . ORCID provides a unique and persistent digital identifier that distinguishes researchers from every other researcher, even those who share the same name, and, through integration in key research workflows such as manuscript and grant submission, supports automated linkages between researchers and their professional activities, ensuring that their work is recognized.

The collection of ORCID iDs from corresponding authors is now part of the submission process of this journal. If you already have an ORCID iD you will be asked to associate that to your submission during the online submission process. We also strongly encourage all co-authors to link their ORCID ID to their accounts in our online peer review platforms. It takes seconds to do: click the link when prompted, sign into your ORCID account and our systems are automatically updated. Your ORCID iD will become part of your accepted publication’s metadata, making your work attributable to you and only you. Your ORCID iD is published with your article so that fellow researchers reading your work can link to your ORCID profile and from there link to your other publications.

If you do not already have an ORCID iD please follow this link to create one or visit our ORCID homepage to learn more.

5.2 Information required for completing your submission

You will be asked to provide contact details and academic affiliations for all co-authors via the submission system and identify who is to be the corresponding author. These details must match what appears on your manuscript. At this stage please ensure you have included all the required statements and declarations and uploaded any additional supplementary files (including reporting guidelines where relevant).

5.3 Permissions

Please also ensure that you have obtained any necessary permission from copyright holders for reproducing any illustrations, tables, figures or lengthy quotations previously published elsewhere. For further information including guidance on fair dealing for criticism and review, please see the Copyright and Permissions page on the Sage Author Gateway .

6. On acceptance and publication

6.1 Sage Production

Your Sage Production Editor will keep you informed as to your article’s progress throughout the production process. Proofs will be sent by PDF to the corresponding author and should be returned promptly.  Authors are reminded to check their proofs carefully to confirm that all author information, including names, affiliations, sequence and contact details are correct, and that Funding and Conflict of Interest statements, if any, are accurate.

6.2 Online First publication

Online First allows final articles (completed and approved articles awaiting assignment to a future issue) to be published online prior to their inclusion in a journal issue, which significantly reduces the lead time between submission and publication. Visit the Sage Journals help page for more details, including how to cite Online First articles.

6.3 Access to your published article

Sage provides authors with online access to their final article.

6.4 Promoting your article

Publication is not the end of the process! You can help disseminate your paper and ensure it is as widely read and cited as possible. The Sage Author Gateway has numerous resources to help you promote your work. Visit the Promote Your Article page on the Gateway for tips and advice.

7. Further information

Any correspondence, queries or additional requests for information on the manuscript submission process should be sent to the Journal of Research in Nursing editorial office as follows:

[email protected]

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  • Open access
  • Published: 22 July 2024

Characteristics and quality of reporting qualitative nursing research related to the COVID-19 pandemic: a systematic search and critical review

  • Ian-In Vong 1 ,
  • Monique Rothan-Tondeur 1 , 2 &
  • Rita Georges Nohra 1  

BMC Nursing volume  23 , Article number:  498 ( 2024 ) Cite this article

153 Accesses

Metrics details

The COVID-19 (Coronavirus disease of 2019) pandemic caused major disruption to nursing research, especially qualitative research. Researchers had to overcome numerous challenges that potentially impacted the quality of the studies carried out.

The aim of this study is to assess the characteristics and quality of reporting qualitative nursing articles on the COVID-19 pandemic.

A systematic search and critical review using content analysis was conducted on published nurse-led articles using a qualitative approach related to the COVID-19 pandemic. A combination of the Consolidated Criteria for Reporting Qualitative Research (COREQ) and Standards for Reporting Qualitative Research (SRQR) checklists and additional items identified from the literature were used to assess the characteristics and overall quality of reporting of qualitative research.

Out of 63,494 articles screened, 444 met the inclusion criteria. Most studies were published in high-impact, Quartile 1 journals, with the majority originating from the USA. Common themes included workforce experiences and the impact of pandemic restrictions. Methodological quality varied, with a notable underuse of standardized reporting checklists. Despite pandemic-induced challenges in data collection, interviews remained the predominant method. However, the adoption of remote research methods and analysis software was limited.

The findings underscore the resilience and adaptability of nursing researchers during the pandemic. High-quality publications in top-tier journals indicate rigorous academic standards. However, the low utilization of reporting checklists suggests a need for greater emphasis on methodological transparency and adherence to established quality guidelines. This review highlights the importance of enhancing qualitative research practices to improve the rigor and reliability of studies, particularly in crisis contexts.

Peer Review reports

Introduction

The COVID-19 pandemic has threatened the health and well-being of global citizens which has led to a significant change in the attitude, lifestyle, and behavior of people from diverse professions [ 1 ]. Nurses have been and remain central to the pandemic––nurses are central to preventative, curative and palliative activities associated with COVID-19, and have taken these roles on in addition to their usual roles [ 2 ]. Nurses reported low job satisfaction, high levels of burnout, stress, and anxiety [ 3 ]. Researchers have experienced a decline in research motivation [ 4 ]. Scientific productivity, particularly among female academics, has suffered due to increased childcare responsibilities and psychological distress [ 5 ]. And parent researchers struggled to balance work and family responsibilities during the pandemic [ 6 ].

On the other hand, the travel restrictions and lockdown during the pandemic have undoubtedly affected all aspects of research, including qualitative research [ 7 , 8 ]. Qualitative nursing research is essential and important for understanding patient experiences, exploring complex healthcare phenomena, and guiding patient-centered care [ 9 ]. It provides insights into the subjective experiences, perceptions, and emotions of patients, families, and providers [ 10 ], bringing a holistic perspective to understanding the phenomena under study [ 11 ]. With qualitative methodologies, insight can be gained regarding the social responses to this pandemic, they are also the best methods to help explain, address, and plan for emergencies and pandemics, such as COVID-19 [ 7 , 12 , 13 ]. Restrictions during the pandemics made traditional data collection methods challenging [ 1 , 14 ]. Nurse researchers had to adapt to perform data collection in a virtual environment, shifting from face-to-face interviews to telephone or online meetings [ 1 ]; research participants were unwilling to show their faces at virtual meetings, and face-to-face interviews were only allowed with masks on [ 7 , 8 ]. These changes affected the quality and richness of data collection, missing important non-verbal elements such as attitude, gesture, and context [ 15 , 16 ].

Given the disruptive impact of the COVID-19 pandemic on nursing qualitative research activities, and deleterious effects on nurses, like emotional exhaustion [ 17 ], psychological distress [ 18 ], and burnout [ 3 , 19 ], but nurse researchers have also been very responsive to the pandemic, the Journal of Advanced Nursing has received hundreds of manuscripts focused on the pandemic, and more than 200 papers published on the COVID-19 pandemic in 2 years [ 2 ]. We doubted the quality of the publication. Scholarly journals are the most important media source for the dissemination of such research findings and information related to connecting this new evidence to practice [ 20 ] and nursing publication plays an essential role in improving nurses’ knowledge of new information and interesting this knowledge into nursing practice [ 21 ]. Together these phenomena might run the risk of producing poor quality qualitative research. Current literature provides two bibliometric analyses of COVID-19 research published in nursing journal, these provide the readers with only objective information on nursing publication related to COVID-19. The existing literature lacks comprehensive reviews that specifically focus on the characteristics and reporting quality of qualitative nursing research related to COVID-19. This study addresses this gap by providing a thorough analysis, which is crucial for guiding future research efforts and improving the overall quality of qualitative studies in nursing. By emphasizing the importance of maintaining high research quality, this study aims to contribute valuable insights that can inform future research, policymaking, and practice in nursing.

Providing a critical review of COVID-19 qualitative nursing research is an unmet need. To achieve this goal, we designed a systematic literature search including all available COVID-19 nursing qualitative articles using a large task force dedicated to the analysis of high-volume articles. We aimed at investigating the characteristics and the methodological quality assessment of reporting COVID-19 qualitative nursing publications.

We conducted a systematic literature search and a critical review using content analysis. This type of content analysis was to enable the production of measurements, occurrences, or comparisons through statistical or quantitative methods [ 22 ]. This review builds upon the methods utilized in two similar reviews [ 23 , 24 ], which assessed the characteristics of articles and described the methodological quality of the articles by presenting the percentage of compliance with each item of a standardized methodological reporting quality checklist. Our study adopted a pre-established checklist which was designed based on the Consolidated Criteria for Reporting Qualitative Research (COREQ) [ 25 ] and the Standards for Reporting Qualitative Research (SRQR) [ 26 ], along with other items identified in the literature to examine the quality of reporting in qualitative research.

This study is an ancillary study that extracted articles related to COVID-19 from the database of a large study aims to assess the characteristics and reporting quality using a qualitative approach in the field of nursing from 2012 to January 2023.

Search strategy

Several databases were consulted to ensure the inclusion of relevant studies in the field of nursing. The main databases are academic and medical databases, such as PubMed, CINAHL (Cumulative Index to Nursing and Allied Health Literature), Cairn, Embase, Web of science and Scopus. Document search strategies are developed using the MeSH thesaurus (Medical subject headings) and related keywords. The MEDLINE strategy has been developed and tested by the research team: “nursing research“[MH] OR “nursing research“[TW] OR (“nursing research“[Title/Abstract:~2]) OR nurs*[affiliation]) AND (“qualitative research“[MH] OR “qualitative research“[TIAB] OR “qualitative study“[TIAB] OR “qualitative studies“[TIAB] OR “grounded theory“[TIAB] OR “phenomenology“[TIAB] OR “ethnography“[TIAB] OR (“qualitative study“[Title/Abstract:~2] OR “qualitative studies“[Title/Abstract:~2] OR “qualitative research“[Title/Abstract:~2] OR “qualitative theory“[Title/Abstract:~2] OR “qualitative theories“[Title/Abstract:~2] OR “grounded study“[Title/Abstract:~2] OR “grounded studies“[Title/Abstract:~2] OR “grounded theory“[Title/Abstract:~2] OR “grounded theories“[Title/Abstract:~2] OR “grounded research“[Title/Abstract:~2] OR “ethnological study“[Title/Abstract:~2] OR “ethnological studies“[Title/Abstract:~2] OR “ethnological theory“[Title/Abstract:~2] OR “ethnological theories“[Title/Abstract:~2] OR “ethnological research“[Title/Abstract:~2] OR “phenomenological study“[Title/Abstract:~2] OR “phenomenological studies“[Title/Abstract:~2] OR “phenomenological theory“[Title/Abstract:~2] OR “phenomenological theories“[Title/Abstract:~2] OR “phenomenological research“[Title/Abstract:~2]. Then, a hand search was conducted to identified articles related to COVID-19. The literature search was performed between June 2023 to August 2023.

Inclusion and exclusion criteria

Any qualitative nursing research related to COVID-19 was included. The first authors must be nurses. The language was limited to English and French. Both peer-reviewed and pre-prints articles were included.

Articles related to non-human samples and full-text unavailable were excluded.

Article screening

We followed the PRISMA 2020 (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) for article selection. All articles yielded through an initial search from the databases were exported into Rayyan Software, a web-based tool designed to conduct and coordinate systematic literature reviews. Hand search was performed to identify articles related to COVID-19, and duplicates were removed. Next, affiliations were examined to determine if the first author was a nurse, and then titles and abstracts were reviewed to determine if the publication met inclusion and exclusion criteria. Two researchers finished the screening independently. Any discrepant result was discussed by the two reviewers and resolved by consensus, or where necessary, a third researcher was involved. Finally, the articles that met the inclusion and exclusion criteria were selected for full-text reading.

Data extraction and data analysis

We used the pre-established checklist combining items from the SRQR and COREQ checklists and adding other items identified in the literature to answer the objective of this study. The checklist included 33 items seen in Tables  1 and 9 items regarding characteristics of the articles, and 24 items regarding methodological quality assessment. The checklist was pilot-tested and revised. Revisions were made after discussion among the researchers and included clarification of checklist items and the response of researchers to each item. For items of the characteristics of the articles, data were extracted to Excel (Excel 2020, Microsoft Excel, Redmond, WA, USA) for categorization. For items of methodological quality assessment, ATLAS.ti software (version 23.2.1) was used. All identified articles were imported into the software for content analysis with the use of a coding function, codes were created according to the items on the data extraction checklist, researcher read the content of the full-text articles one by one, then identified and coded the phrases according to the codes. For example, the code “field note” was created, and the researcher identified and coded the content if it is mentioned in the article. The frequency of each code was calculated to identify the methodological quality of the included articles.

Ethical considerations

This study is a review based on published articles; ethical approval was not required.

A total of 63,494 articles were registered in Rayyan software. Of these, 918 articles (1.44%) were related to COVID-19. After the exclusion of 56 articles due to duplication, the titles, and abstracts of all the articles were examined and 393 articles were excluded due to affiliations in which the first author was not a nurse. The remaining studies were reviewed in full-text. There were 20 articles excluded due to articles with a non-qualitative approach, 4 articles written in a foreign language were excluded, and 1 article was excluded because of full-texted unavailable. A total of 444 full-text articles related to COVID-19 were analyzed. The flowchart is presented in Fig.  1 .

figure 1

Flowchart of articles screening

Characteristics of the COVID-19 qualitative nursing research

The 444 included articles were published in 196 different journals, one of which was published on MedRxiv, an online pre-print platform for non-peer-reviewed research, with the most articles being published in the International Journal of Environmental Research and Public Health ( n  = 28, 14.3%).

Table  2 shows the most productive journals in terms of COVID-19 nursing qualitative publications. With regard to the quartile of the journals, the studies were published most frequently in Q1 journals ( n  = 260, 58.6%), followed by Q2 ( n  = 118, 26.6%), Q3 ( n  = 49, 11.0%), Q4 ( n  = 12, 2.7%). The impact factors for each journal are grouped into 6 categories: Of the 444 articles, impact factor below 1 ( n  = 54, 12.2%), impact factor between 1 and 1.999 ( n  = 72, 16.2%). In addition, impact factor between 2 and 2.999 ( n  = 107, 24.1%), impact factor between 3 and 3.999 ( n  = 92, 20.7%), impact factor between 4 and 4.999 ( n  = 87, 19.6%), and impact factor of 5 or higher ( n  = 29, 6.5%). And 3 articles published in journals with an impact factor which is not applicable.

We then assessed the distribution of countries among all the included publications. The top 10 publishing countries were the United States ( n  = 64, 14.4%), Iran ( n  = 57, 12.8%), China ( n  = 35, 7.9%), Turkey ( n  = 33, 7.4%), Spain ( n  = 32, 7.2%), Canada ( n  = 22, 5.0%), Indonesia ( n  = 19, 4.3%), Italy ( n  = 16, 3.6%) and the United Kingdom ( n  = 16, 3.6%) respectively, and South Korea ( n  = 14, 3.2%), see Fig.  2 . Regarding the year of publication, 27 articles (6.1%) were published in 2020, 170 articles (38.3%) in 2021, and 240 articles (54.1%) in 2022.

figure 2

Distribution of countries of COVID-19 related qualitative nursing research published

The academic qualifications of the first authors were reported in 150 (33.8%) of the 444 articles. Of these, 113 (75.3%) first authors have a Ph.D degree ( n  = 113, 75.3%), Ph.D. candidates ( n  = 3, 2.0%), Ph.D. students ( n  = 7, 4.7%), Master degree ( n  = 23, 15.3%), Master students ( n  = 2, 1.3%), and Bachelor degree ( n  = 2, 1.3%). The affiliations of the first author were the universities ( n  = 395, 89.7%), the hospitals ( n  = 34, 7.7%), research centers ( n  = 12, 2.7%), and independent researchers ( n  = 1, 0.2%).

The focuses on COVID-19 qualitative nursing publications were categorized into 7 groups: workforce experience ( n  = 213, 48.0%), pandemic restrictions experience ( n  = 100, 22.5%), learning experience ( n  = 44, 9.9%), infected COVID-19 experience ( n  = 32, 7.2%), hospitalized experience ( n  = 30, 6.8%), psychological perception ( n  = 24, 5.4%), and guideline analysis ( n  = 1, 0.2%) during the COVID-19 pandemic, see Fig.  3 . The population was mainly clinical nurses ( n  = 197, 44.4%), nursing managers ( n  = 15, 3.4%), nurse educators ( n  = 5, 1.1%), nursing students ( n  = 50, 11.3%), other healthcare professionals ( n  = 18, 4.1%), COVID-19 patients ( n  = 31, 7.0%), other patients ( n  = 36, 8.1%), family members / caregivers ( n  = 24, 5.4%), and public ( n  = 68, 15.3%). Figures  4 and 5 shows the population distribution of the included articles.

figure 3

Focuses of COVID-19 qualitative nursing research

figure 4

Target population of COVID-19 qualitative nursing research

figure 5

Distribution of clinical nurses

Methodological quality assessment of COVID-19 qualitative nursing research

Table  3 shows the prevalence of the items for reporting the methodological quality assessment of the included articles.

Methodological orientation

Of the 444 articles, the most adopted approach was the descriptive approach ( n  = 165, 37.1%), Fig.  6 shows the types of approach adopted. Additionally, 84 (18.9%) of the articles only mentioned “qualitative study” without specifying which approach was being adopted.

figure 6

Types of approach adopted

Only one-third of the analyzed articles ( n  = 135, 30.4%) mentioned employing standardized reporting quality checklists. Among these, the COREQ checklist was the most utilized ( n  = 119, 26.8%), followed by the SRQR checklist ( n  = 16, 3.6%).

Data collection

Among the articles included, 382 (86%) used interviews/discussions as a data collection method, 20 articles (4.5%) used mixed methods for data collection, and 42 articles (9.5%) that used methods other than interviews/discussions, 2.7% used surveys with open questions, 2.03% carried out document analysis, 1.8% examined diaries, 1.6% analyzed comments on social media, 0.5% used the photovoice method, and finally 0.2% carried out an analysis of audio-newspapers, an analysis of video diaries, an analysis of media interviews, only 1 article used observation as data collection method.

With the articles using interview/discussion methods, 261 articles (64.9%) specified who conducted the interviews. And 78 of them (19.4%) provided detailed information on their professional profiles. Most articles ( n  = 327, 81.3%) mentioned the setting of data collection, with 65.4% ( n  = 214) conducted remotely, 28.4% ( n  = 93) conducted face-to-face, and 6.1% ( n  = 20) indicated that the interviews were conducted whether remotely or face-to-face depending on participants’ wishes. The remoted interviews were conducted by teleconference ( n  = 134, 57.3%), by telephone ( n  = 66, 28.2%), and by teleconference or telephone ( n  = 34, 14.5%), depending on the choice of participants. The software commonly used for teleconferencing was Zoom (44.5%), WhatsApp (11%), and Microsoft Teams (9.2%), while 35% did not mention which software was used, Fig.  7 shows the characteristics of data collection. Most articles ( n  = 340, 84.8%) specified the duration of the interviews, they were described in two ways: mean duration ( n  = 87, 25.6) or minimum and maximum duration ( n  = 253, 74.4%). Audio recording was most used (86.7%), followed by visual recording (13.0%), and a few (0.3%) mentioned whether audio/visual recording was used. Most articles ( n  = 351, 87.3%) provided interview guidelines, while only 16.9% ( n  = 68) pre-tested them.

figure 7

Characteristics of data collection

Participants

Most articles ( n  = 434, 97.7%) mentioned the number of samples. Almost all the articles ( n  = 443, 99.9%) provided a detailed description of the samples. The most common sampling method was purposive sampling ( n  = 244, 66.8%), followed by convenience sampling ( n  = 34, 9.3%) and snowball sampling ( n  = 33, 9.0%). Some articles ( n  = 54, 14.8%) used mixed sampling methods.

Data analysis

The commonly used methods of analysis were content analysis ( n  = 149, 36.0%) and thematic analysis ( n  = 143, 34.4%) (Fig.  8 ). And some articles did not specify which method was used ( n  = 14, 3.4%). And the most common software chosen by the authors were NVivo (46.9%), MAXQDA (26.7%), and ATLAS.ti (16.0%).

figure 8

Methods of data analysis

Presentation of results

All the articles (100%) presented their results in narrative form. The majority (90.3%) presented quotations in their results. Only 4.7% presented code recurrence. 18.7% used graphics to present their results, and 9.2% mentioned participants checking reports.

This study focused on the identification of the characteristics and reporting quality of qualitative nursing published research related to COVID-19 pandemic. We used a systematic search approach to identify qualitative nursing studies published related to the COVID-19 and then carried out a critical review with the use of content analysis of the identified articles, relying on a checklist created based on two standardized checklists (SRQR and COREQ). A total of 444 published studies were included and critically reviewed. The most productive country was the USA, which corresponds with a bibliometric analysis of COVID-19 research published in a nursing journal. This can be explained by the fact that the USA is one of the most impacted countries by COVID-19 [ 27 ] and is one of the most prolific countries regarding nursing research [ 28 ]. A significant finding of our study is that the majority of articles were published in journals ranked within Quartile 1. This suggests that the research produced during this period not only addressed urgent topics but also met high academic standards.

In addition, the findings revealed that the most represented topics and target population were related to the workforce experience and clinical nurses respectively, this is consistent with an article that focused on the reflections on nursing research during the pandemic COVID-19 [ 2 ]. Interestingly, clinical nurses were the predominant target population of the articles reviewed, this is possibly attributable to the challenge of conducting research with patients and the public due to pandemic-related restrictions. This thematic focus is likely driven by the critical challenge and changes by clinical nurses during the pandemic, highlighting their significant role in the frontline response and the need to understand and support them.

It was surprising to see that the use of standardized checklists to guide research studies by the researchers was notably low, with only 30.4% mentioning the use of standardized checklists. This finding is particularly noteworthy in the context of qualitative nursing research during the COVID-19 pandemic, a period that demanded high-quality evidence to inform rapidly changing clinical practices. The low adoption rate of standardized checklists may reflect gaps in researchers’ awareness or accessibility to these tools, or perhaps a broader issue in the research culture that undervalues structured guidance in study design and reporting, as these checklists aim to improve the quality of reporting these study types and allow readers to better understand the design, conduct, analysis and findings of published studies [ 25 ].

Traditional qualitative research data collection methods like interviews and discussions were supposed to be most impacted by the pandemic. Surprisingly, 86% ( n  = 382) of the included articles used interviews or discussions as the data collection methods, and 28% of the researchers remained choosing the face-to-face interview method. We questioned how communication and facial expression were observed if facemasks were worn during the interview. Among the included studies that used the interview method in data collection, a significant proportion with 66% of these interviews were conducted remotely, either by telephone or online. These findings align with the literature reviewed, where nursing researchers in the USA reported an increase in the use of online platforms, as well as sending emails and phone calls for data collection, a trend which has seen a significant increase [ 8 ]. Researchers in Japan also reported having to adapt their research methods according to changes in the research environment, moving from in-person interviews to remote telephone interviews, collecting data while maintaining the social distancing, and online data collection [ 8 ]. A randomized research study comparing online interviews to in-person interviews person to assess health conditions was conducted in Australia. The results of this study showed that online interviews were preferred by a greater proportion of participants than in-person interviews, and then those assigned to the online group had a lower dropout rate. Additionally, the use of online interviews did not result in a loss of data quality [ 29 ]. Another study also indicated that online modalities for conducting qualitative research did not lead to substantially different thematic findings than in-person data collection [ 30 ]. These suggest that remote data collection methods would be a good choice for researchers, especially in situations where face-to-face interactions are challenging or not possible. The success of remote interviews in maintaining data quality, participant engagement, and lower dropout rates indicates their viability as a robust alternative to traditional methods. This shift not only ensures the continuity of research during crises like the COVID-19 pandemic but also offers a flexible and efficient approach for future qualitative studies. Embracing remote data collection can enhance the adaptability of research designs and potentially broaden the reach and inclusivity of participant recruitment, making it a valuable methodological option for qualitative nursing researchers.

The adoption of software tools in data analysis was surprisingly low, with only 37% of studies utilizing such resources. This finding suggests a potential area for further development in qualitative research practices, particularly to enhance efficiency and collaboration, especially in scenarios necessitating remote work and data sharing, especially during the pandemic when social contact was limited. In addition, there are other benefits of using qualitative data analysis software, including freedom from manual and administrative tasks, saving time, greater flexibility, and improved validity and reliability, and traceability of qualitative research [ 31 ].

In summary, this study carried out an in-depth analysis of data relating to the journals, articles, researchers, and methods used, identifying both strengths and areas requiring improvement. It highlighted the editorial quality of the publications and the methodological diversity observed in qualitative nursing studies linked to the COVID-19 pandemic. We found that many articles demonstrated commendable transparency in explicitly detailing their research approach, data collection processes, sampling methods, and data analysis techniques. However, some areas need improvement. A key aspect is the insufficient representation of strategies to ensure study rigor, such as triangulation and validation by respondents. It is essential to include critical reflection on the role of researchers, potential biases and their influence during the analysis and selection of data for presentation. Additionally, discussions about data saturation and sequential analysis can significantly strengthen the quality of qualitative research reporting. It is important that authors not only explain the methods or techniques they used but also provide clear and detailed justifications for their choices.

The effective translation of nursing research into clinical practice is critical, especially as healthcare professionals heavily depend on the latest research to guide their practices and decisions. The variability in the quality and reliability of research articles can lead to the adoption of clinical practices that may not be supported by strong evidence, potentially affecting patient care and hindering the advancement of nursing practice [ 32 ]. Therefore, improving the transparency and rigor of research methodology reporting is essential to ensure that clinical practices are based on reliable and robust evidence. Our study highlights the importance of methodological clarity and the use of standardized checklists in guiding research, This is increasingly relevant as nursing research evolves to meet global health challenges. By ensuring the high quality of reporting qualitative research, we can better bridge the gap between research and clinical practice, leading to improved patient outcomes and more effective healthcare delivery.

Limitations

It is also essential to recognize that our research method may have some limitations. The diversity of qualitative research methods restricted our assessment to an overview of overall research reporting quality. Additionally, our inclusion criterion based on the first author as a nurse may have excluded studies conducted by nurse-led teams, but where academic conventions led to a different first author. The time limit of the database prevented us from including articles published after January 2023. Finally, we excluded articles not published in English or French, meaning that relevant articles in other languages may have been omitted.

Conclusions

In conclusion, we urge researchers to provide detailed information in their articles, thereby allowing audiences to carefully evaluate the effectiveness and adequacy of the methods and materials used to produce credible and useful results. We also recommend researchers to adopt validated critical appraisal checklists when conducting their studies. This study highlights the importance of continued reflection on qualitative research practices with a view to improving the reporting quality of future studies in the field of nursing, especially during the special period of a pandemic. Additionally, we plan to compare these results with ancillary studies to assess the characteristics and reporting quality of qualitative nursing research before the COVID-19 pandemic. In the future, we wish to open the way for future studies aimed at exploring the relationships between the different criteria identified and each qualitative approach.

Data availability

The data as well as detailed descriptions of the literature search and search outcome (including excluded articles) are available from the corresponding author upon request.

Abbreviations

Coronavirus disease of 2019

Consolidated Criteria for Reporting Qualitative Research

Standards for Reporting Qualitative Research

Medical Subject Heading

Cumulative Index to Nursing and Allied Health Literature

Preferred Reporting Items for Systematic Reviews and Meta-Analyses

United States of America

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Ian-In Vong (I.I.V.) and Rita Georges Nohra (R.G.N.) independently conducted the article screening. Monique Rothan-Tondeur (M.R.T.) was consulted to resolve any discrepancies that arose during the screening process. I.I.V. and R.G.N. were primarily responsible for writing the main manuscript text. M.R.T. provided critical revisions and contributed intellectual content to the manuscript draft. All authors have read and approved the final manuscript.

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Vong, II., Rothan-Tondeur, M. & Nohra, R.G. Characteristics and quality of reporting qualitative nursing research related to the COVID-19 pandemic: a systematic search and critical review. BMC Nurs 23 , 498 (2024). https://doi.org/10.1186/s12912-024-02138-x

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  • 3 Department of Vascular Surgery, The Second Affiliated Hospital of Mudanjiang Medical University, Mudanjiang, China
  • 4 Department of Cardiology, The Second Affiliated Hospital of Mudanjiang Medical University, Mudanjiang, China

This review examines recent advancements in interventional treatments and nursing care for lower extremity deep vein thrombosis (DVT), highlighting significant innovations and their clinical applications. It discusses the transition to novel anticoagulants such as Direct Oral Anticoagulants, which offer a safer profile and simplified management compared to traditional therapies. Mechanical interventions, including balloon angioplasty and venous stenting, are detailed for their roles in improving immediate and long-term vascular function in acute DVT cases. Furthermore, the use of image-guided techniques is presented as essential for enhancing the accuracy and safety of DVT interventions. Additionally, this study outlines advances in nursing care strategies, emphasizing comprehensive preoperative and postoperative evaluations to optimize patient outcomes. These evaluations facilitate tailored treatment plans, crucial for managing the complex needs of DVT patients. Long-term care strategies are also discussed, with a focus on patient education to ensure adherence to treatment protocols and to prevent recurrence. The synthesis aims to inform healthcare professionals about cutting-edge practices in DVT management, promoting a deeper understanding of how these advancements can be integrated into clinical practice. It also underscores the necessity for ongoing research to address challenges such as cost-effectiveness and patient compliance, ensuring that future treatments are both accessible and effective.

1 Introduction

Deep vein thrombosis (DVT) represents a significant medical condition characterized by the formation of blood clots within the major veins of the lower extremities ( 1 , 2 ). This condition not only induces pain, swelling, and limited mobility in the affected limb but also poses a severe risk of life-threatening pulmonary embolisms should a clot dislodge and migrate to the lungs ( 1 , 2 ). Given its prevalence and the severe complications associated with it, DVT is a critical public health issue demanding effective strategies for its prevention, diagnosis, and management ( 3 ).

Traditionally, the management of DVT has centered around anticoagulant therapy, the use of compression stockings, and occasionally, surgical interventions ( 4 ). While these treatments have proven beneficial, they come with notable limitations ( 5 ). Anticoagulants, for example, while effective in preventing clot progression and new clot formation, require rigorous monitoring to mitigate the risk of severe bleeding complications. Compression stockings are beneficial for reducing thrombus formation and edema but often face challenges with patient compliance ( 6 ). Furthermore, these conventional approaches do not fully address the recurrence of the condition or the long-term complications associated with DVT ( 6 ).

In response to these challenges, there has been a marked shift towards more innovative interventional treatments and care protocols in recent years ( 7 ). Advanced treatment modalities, including novel anticoagulants, mechanical thrombectomy, and image-guided minimally invasive procedures, have been developed ( 8 , 9 ). These innovations offer enhanced efficacy and safety, showing particular promise in the management of severe or complex DVT cases.

The objective of this mini review is to conduct a thorough evaluation and synthesis of the current scientific and clinical advancements in the interventional treatment and management of DVT. This mini review will scrutinize the latest research findings and clinical trials, aiming to elucidate how these innovative approaches have refined patient outcomes. Moreover, it explores prospective research avenues and potential advancements in technology that could further revolutionize the treatment landscape of DVT.

This review is crucial for healthcare professionals as it not only highlights contemporary treatment methodologies but also lays down a comprehensive framework for future investigations. Such rigorous examination is essential for advancing clinical practice and enhancing patient care in the realm of DVT.

2 Recent advances in interventional therapy of DVT in lower extremities

2.1 pharmacological interventions.

Pharmacological interventions play a pivotal role in the management of DVT, with significant advancements in both drug types and therapeutic strategies in recent years. Modern pharmacotherapy primarily involves anticoagulants and thrombolytics, which have substantially evolved to improve both efficacy and safety for patients ( 10 – 18 ) ( Table 1 ).

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Table 1 . Interventional therapy in patients with DVT in the lower extremities.

2.1.1 Anticoagulation therapy

The advent of direct oral anticoagulants (DOACs), including rivaroxaban, apixaban, and dabigatran, marks a significant shift from traditional warfarin therapy ( 10 – 18 ) ( Table 1 ). DOACs offer advantages such as reduced need for monitoring, fewer dietary and drug interactions, and a more stable therapeutic profile. Not requiring frequent INR monitoring, these anticoagulants simplify outpatient management and enhance patient adherence.

Clinical trials such as EINSTEIN, RE-COVER, and AMPLIFY have demonstrated the efficacy of DOACs in treating DVT with a notably lower risk of bleeding compared to traditional anticoagulants. These studies underline the role of DOACs in setting new standards for anticoagulation therapy ( 10 – 18 ).

Alongside established therapies, the development of anti-XI anticoagulants marks an innovative frontier in thromboprophylaxis ( 28 ). These agents specifically inhibit Factor XI, offering a targeted approach to reducing thrombosis risk while potentially minimizing bleeding complications—a common limitation of traditional anticoagulants ( 28 , 29 ). Emerging clinical trials have begun to explore the efficacy and safety profiles of these anticoagulants, indicating their promise for safer therapeutic regimens in populations at high risk of bleeding ( 30 ). The introduction of anti-XI agents underscores the dynamic evolution of anticoagulant therapy, aiming to balance efficacy and safety more effectively ( 31 ).

2.1.2 Thrombolytic therapy

Tissue plasminogen activator, such as alteplase, continues to be extensively utilized for acute DVT management, effectively dissolving clots and restoring venous flow ( 14 , 15 ) ( Table 1 ). Its application is crucial in managing severe thrombotic events where rapid resolution is necessary.

The ATTRACT trial, among others, has explored the role of thrombolytics in the early intervention of DVT to prevent post-thrombotic syndrome and chronic venous insufficiency. While highlighting the benefits in symptom reduction, these studies also stress the importance of careful patient selection to mitigate bleeding risks.

2.2 Mechanical interventional treatments

The development of mechanical interventional techniques has introduced novel therapeutic possibilities for DVT, especially beneficial for patients who are not ideal candidates for conventional anticoagulation ( 19 , 20 ) ( Table 1 ).

2.2.1 Balloon angioplasty

This technique involves the insertion of a catheter with an attached balloon into the thrombosed vein ( 21 ). Upon inflation, the balloon physically expands the vein, displacing the clot and restoring blood flow. This approach is particularly effective in acute cases where rapid amelioration of symptoms is critical ( 21 ) ( Table 1 ). Balloon angioplasty is typically reserved for critical cases requiring rapid restoration of venous flow due to significant obstruction ( 21 ). This intervention is particularly crucial in severe phlegmasia dolens, where there is an immediate risk of limb ischemia.

2.2.2 Venous stenting

Stenting involves the placement of a metallic mesh within the vein to maintain vascular patency and prevent future occlusions. It is particularly applicable in scenarios where venous stenosis persists post-thrombosis or when angioplasty alone does not suffice to restore normal blood flow ( 19 , 22 ). The stent acts as a scaffold, ensuring long-term patency and improving overall venous return, which is crucial for reducing recurrence rates and improving long-term outcomes ( 19 , 22 ). Stenting is primarily recommended for managing chronic venous insufficiency, particularly when compressive symptoms continue to persist despite the application of less invasive treatments ( 32 ).

Recent clinical data affirm that mechanical interventions like balloon angioplasty and stenting significantly enhance symptom management and quality of life ( 19 , 22 ) ( Table 1 ). However, the sustainability of treatment effects and the potential for long-term complications necessitate further research and careful patient follow-up.

2.3 Image-guided interventional strategies

Image-guided techniques have revolutionized the precision and safety of interventions for managing DVT, proving essential in both diagnosis and therapeutic application.

2.3.1 Ultrasound guidance

Color Doppler ultrasound is the frontline modality for diagnosing DVT, providing real-time, dynamic blood flow information. It is indispensable for guiding minimally invasive procedures such as catheter-directed thrombolysis, allowing for direct visualization of the thrombus and treatment effects ( 23 – 25 ) ( Table 1 ).

Advancements in Ultrasound Technology: The field of ultrasound technology has seen significant advancements, notably in the development of portable, high-resolution devices ( 33 ). These improvements have expanded the reach of ultrasound beyond traditional clinical settings, facilitating its use in remote locations and potentially increasing patient access to timely diagnosis and management.

Future Directions in Ultrasound and Digital Health Integration: Looking forward, the integration of ultrasound technology with digital health applications holds promising potential for enhancing patient management ( 34 ). Innovations on the horizon include wearable devices capable of continuous monitoring of vital parameters such as heart rate, oxygen saturation, and electrocardiographic signals ( 34 ). These devices could play a crucial role in early detection of complications, such as pulmonary embolism, and enhance preventive care. Furthermore, advancements are expected in the development of smart medication adherence tools that remind patients of dosage schedules, thereby improving compliance with treatment protocols ( 35 ).

These technological advancements are poised to transform the management of DVT, enhancing both the efficacy and safety of treatments and supporting proactive patient care through continuous monitoring and timely intervention.

2.3.2 Advanced imaging techniques

Computed tomography (CT) or magnetic resonance imaging (MRI) offers comprehensive imaging capabilities that extend beyond the limitations of ultrasound, especially useful in complex cases where clots are located in anatomically challenging positions ( 26 , 27 ). These modalities enable detailed visualization of the vascular anatomy, facilitating precise interventions such as stenting and targeted thrombolysis, ensuring interventions are performed with the highest accuracy ( 26 , 27 ) ( Table 1 ).

Specifically, the use of CT and MRI is highly restricted and generally recommended in specialized cases such as left iliac DVT in pregnant patients ( 26 , 27 ). In these patients, MRI is preferred over CT due to the absence of ionizing radiation, which poses a risk to the developing fetus ( 27 ). This ensures that both mother and fetus are safeguarded while obtaining essential diagnostic information to guide further treatment.

The integration of image-guided technology not only enhances the effectiveness of therapeutic interventions but also minimizes procedural risks, thereby improving patient safety and treatment outcomes. As imaging technology advances, future interventions are expected to become even more refined, further elevating the standard of care for patients with DVT.

3 Recent advances in nursing strategies of DVT in lower extremities

3.1 preoperative and postoperative care.

Effective preoperative and postoperative care is crucial in optimizing outcomes and minimizing complications in the interventional treatment of lower extremity DVT. Advancements in medical technology have greatly enhanced the precision of nursing assessments, which now play a pivotal role in the planning and execution of treatment ( Table 2 ).

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Table 2 . Nursing strategies in patients with DVT in the lower extremities.

Nursing Assessments: Modern nursing practices involve comprehensive evaluations using standardized tools that assess hemorheology, limb measurements, and a patient’s overall physiological and psychological state. These evaluations help clinicians identify patient-specific risk factors and predict potential complications, allowing for the creation of tailored interventional treatment plans ( 6 , 36 ). Furthermore, assessments extend to evaluating a patient’s understanding and preparedness for upcoming treatments, ensuring they are fully informed and ready both mentally and physically.

Preoperative Preparations: Key aspects of preoperative care include thorough health examinations to ascertain the patient’s baseline health status and detailed discussions to gauge their understanding and acceptance of the proposed interventions ( 37 – 39 ). Educating patients about what to expect during and after the procedure is critical. This education covers potential postoperative scenarios and adherence to prescribed self-care protocols.

Postoperative Management: Focuses on managing pain and overseeing wound care, essential for facilitating a swift recovery and optimizing the treatment’s success. Pain management strategies often encompass both pharmacological and non-pharmacological approaches, including physical therapy ( 40 ). Wound care involves regular monitoring and timely intervention if signs of infection arise, preventing further complications. Postoperative care also includes functional rehabilitation and ongoing psychological support, fostering a holistic recovery approach.

Implementing these refined care strategies can significantly enhance patient outcomes, reducing the risks and complications associated with the treatment of DVT ( Table 2 ).

3.2 Long-term care and patient education

Managing lower extremity DVT extends beyond immediate medical intervention and encompasses long-term care and patient education, which are essential for the sustained well-being of patients ( Table 2 ).

Home Care: After hospital discharge, home care becomes a critical aspect of a DVT patient’s routine, particularly during the recovery and maintenance phases. Patients need comprehensive instructions and continuous support for activities such as adhering to anticoagulation regimens and monitoring for adverse effects ( 41 , 42 ). The ongoing anticoagulation is crucial for preventing thrombus reformation but carries an inherent risk of bleeding, necessitating patient education on managing these risks effectively ( 41 , 42 ).

Lifestyle Modifications: Adjustments in daily living, such as maintaining an active lifestyle, achieving and sustaining an appropriate weight, and following a heart-healthy diet, are crucial ( 43 ). These modifications help mitigate the risk of recurrent DVT and enhance overall health.

Patient Education: This is an integral component of long-term management, empowering patients with knowledge about their condition, the importance of their treatment regimen, and the ability to recognize symptoms of potential complications ( 44 ). Education should not only provide disease and treatment-related information but also include practical advice on when and how to seek further medical assistance ( 44 ). Effective education transforms patients from passive recipients of healthcare into active participants in their health management, aiming to prevent recurrence and elevate their quality of life.

By enhancing these aspects of care, healthcare providers can ensure better management of DVT, promoting patient independence and improving outcomes in long-term disease management.

4 Nursing strategies for special populations in the treatment of DVT in lower extremities

Elderly Patients: Elderly individuals undergoing DVT intervention often present with multiple comorbidities, such as cardiovascular diseases and renal insufficiency, which can affect their response to anticoagulant therapy ( 45 ). The diminished drug metabolism typical in older age further elevates the risk of adverse reactions during treatment. Hence, nursing care for elderly patients should include meticulous monitoring of drug dosages and therapeutic responses. Care plans must also consider potential cognitive impairments and the availability of family support, tailoring education and support programs to meet their specific needs. This ensures that elderly patients receive care that is both effective and sensitive to their particular health status.

Pregnant Women: DVT treatment in pregnant women requires careful consideration of both maternal and fetal health due to the teratogenic risks associated with many standard anticoagulants ( 46 – 48 ). The selection and timing of therapeutic interventions must prioritize safety, avoiding any potential harm to the developing fetus. Physiological changes during pregnancy can alter the risk profile for thrombus formation and modify responses to treatment, necessitating vigilant monitoring and management ( 46 – 48 ). Collaborative efforts with obstetric specialists are essential to tailor interventions that safeguard the health of both mother and child, ensuring that treatment protocols are precisely followed.

Patients with Chronic Diseases: Individuals with chronic conditions such as cancer, diabetes, or cardiovascular disease may face additional challenges when undergoing DVT interventions ( 3 , 49 ). These conditions can influence both the choice of treatment and the overall prognosis. For instance, cancer patients are particularly susceptible to increased thrombotic risk due to the malignancy and associated treatments like chemotherapy. Nursing care strategies must be adaptive to these risks, adjusting therapeutic approaches to effectively manage and minimize the likelihood of recurrence. It is also crucial for the care team to address the comprehensive needs of these patients, including nutritional support, effective pain management, and psychological care, to enhance their overall quality of life and treatment outcomes.

In summary, effective nursing care for special populations undergoing treatment for lower extremity DVT requires a detailed understanding of each individual’s unique medical and personal circumstances. By implementing personalized and meticulously planned care strategies, healthcare providers can ensure that interventions are not only safe and effective but also aligned with the specific needs and conditions of elderly patients, pregnant women, and those with chronic diseases. This approach promotes optimal health outcomes and patient satisfaction.

5 Challenges and future directions in the interventional treatment of DVT in lower extremities

Despite notable advancements in the management of lower extremity DVT through interventional treatments, several challenges persist that affect the adoption and efficacy of these approaches.

5.1 Technological limitations

Current interventional techniques such as thrombectomy and catheter-directed thrombolysis are effective but involve complex procedures that require a high degree of technical skill ( 3 , 50 , 51 ). The reliance on sophisticated medical equipment also limits the application of these treatments in resource-constrained settings ( 3 , 50 , 51 ). Addressing these technological constraints involves simplifying procedures and developing equipment that is both cost-effective and suitable for use in a broader range of healthcare environments.

5.2 Cost-effectiveness

The high costs associated with interventional treatments for DVT pose significant barriers to their widespread use ( 41 , 49 – 53 ). These costs can be prohibitive for patients and healthcare systems, especially in lower-income areas. Future research must focus on conducting thorough cost-effectiveness analyses to identify economic strategies that can reduce expenses while maintaining or enhancing clinical outcomes. Exploring generic medication options, streamlined procedural techniques, and cost-sharing models could be viable approaches.

5.3 Patient acceptance

The acceptance of new or complex interventional treatments by patients is crucial for successful outcomes ( 41 , 54 ). Challenges in patient education and the communication of treatment benefits and risks are significant ( 41 , 54 ). Improving educational strategies to better inform patients about their options, the procedures involved, potential risks, and expected outcomes is essential. Enhanced communication efforts should aim to build trust and understanding, facilitating informed consent and engagement in treatment decisions.

5.4 Future research and innovations

Research in the coming years may concentrate on creating simpler, more affordable interventional techniques. There is a need to innovate in patient education and care coordination to adapt to the evolving landscape of healthcare delivery. Future developments could include ( 55 – 57 ):

Technology Advancements: Redesigning devices and simplifying interventional procedures to make them more accessible and easier to perform.

Digital Tools: Leveraging technology to enhance patient education, treatment transparency, and engagement through digital platforms that provide accessible information and support.

Interdisciplinary Approaches: Developing collaborative care models that integrate various healthcare professionals, including doctors, nurses, physical therapists, and social workers, to deliver holistic and coordinated care.

Such innovations are expected to optimize the management of DVT, significantly improve clinical outcomes, and broaden the application of interventional treatments, making them more accessible and effective across diverse patient populations and geographic locations.

A thorough evaluation of the recent developments in interventional treatments and nursing strategies for lower extremity DVT reveals several critical insights. Firstly, technological advancements in interventional methods have notably increased the efficiency and safety of treatments for DVT. The adoption of advanced anticoagulants, mechanical thrombectomy techniques, and image-guided minimally invasive surgeries has shown exceptional effectiveness in clinical settings, particularly in managing complex or high-risk DVT cases. Furthermore, enhancements in nursing strategies, including detailed assessments before and after surgery, effective pain management, and comprehensive long-term care coupled with patient education, have substantially improved both the rehabilitation outcomes and the overall quality of life for patients.

Despite these advancements, the need for continuous research is imperative. Future investigations should delve deeper into the capabilities of emerging technologies, especially focusing on their role in minimizing complications and fostering long-term wellness for patients. Moreover, there is a critical need to focus on increasing patient compliance with treatment regimens and improving the effectiveness of interdisciplinary collaborations to streamline and execute treatment protocols more efficiently. By addressing these areas, we can further refine DVT treatment processes and enhance the quality of care provided to patients, ultimately leading to significant improvements in their quality of life.

Author contributions

C-yJ: Conceptualization, Data curation, Methodology, Resources, Validation, Visualization, Writing – original draft, Writing – review & editing. D-dD: Data curation, Methodology, Resources, Validation, Visualization, Writing – original draft, Writing – review & editing. X-yB: Conceptualization, Methodology, Resources, Validation, Visualization, Writing – original draft, Writing – review & editing. XZ: Resources, Validation, Visualization, Writing – original draft, Writing – review & editing. Y-nW: Conceptualization, Data curation, Investigation, Project administration, Resources, Supervision, Validation, Visualization, Writing – original draft, Writing – review & editing.

The author(s) declare financial support was received for the research, authorship, and/or publication of this article. This study was partly supported by Research Project of the Heilongjiang Health Commission (20231414050484).

Conflict of interest

The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Publisher’s note

All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article, or claim that may be made by its manufacturer, is not guaranteed or endorsed by the publisher.

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Keywords: deep vein thrombosis, lower extremity, interventional therapy, anticoagulants, nursing care

Citation: Jia C-y, Dai D-d, Bi X-y, Zhang X and Wang Y-n (2024) Advancements in the interventional therapy and nursing care on deep vein thrombosis in the lower extremities. Front. Med . 11:1420012. doi: 10.3389/fmed.2024.1420012

Received: 19 April 2024; Accepted: 15 July 2024; Published: 26 July 2024.

Reviewed by:

Copyright © 2024 Jia, Dai, Bi, Zhang and Wang. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY) . The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

*Correspondence: Yi-ning Wang, [email protected]

Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.

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Sexual life experiences after myocardial infarction: A systematic review and synthesis of qualitative studies

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Emine Arikan, Gamze Yavaş, Sexual life experiences after myocardial infarction: A systematic review and synthesis of qualitative studies, European Journal of Cardiovascular Nursing , 2024;, zvae101, https://doi.org/10.1093/eurjcn/zvae101

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This study aims to systematically interpret and synthesize the data obtained from qualitative research about the sexual lives of individuals who have experienced myocardial infarction.

A thorough literature review was conducted between November and December 2023 across five electronic databases: PubMed, Web of Science, CINAHL, EBSCO, and Science Direct Embase. This article includes 12 studies published in English since 2000 that have examined the sexual experiences of individuals who have experienced myocardial infarction. This research adhered to the Enhancing Transparency in Reporting the Synthesis of Qualitative Research (ENTREQ) guidelines. We utilized the Critical Appraisal Skills Programme tool for qualitative research to evaluate the quality of all the papers included. To synthesize the data, the deductive and interpretation technique according to Sandelowski and Barroso's approach has been used. The sexual experiences of individuals who have experienced myocardial infarction were summarized under four main themes: changes in sexual life, barriers to engaging in sexual ıntercourse, an unmet need: ınformation, and sexuality as a part of routine care.

Patients’ expectations from counseling services regarding sexuality after MI are oriented towards these services providing more comprehensive information and incorporating multidisciplinary approaches. This demand clearly indicates the complex and multidimensional changes in sexual life after MI and underscores the necessity for healthcare professionals to play a more active role in this area

PROSPERO CRD42023483112

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Park H-Y, Jung M, Park G-Y Investigating the link between antipsychotic use and post-stroke infections in older people: multi-centre propensity score analysis. Age Ageing. 2024; 53:(6) https://doi.org/10.1093/ageing/afae117

Zhao X, Zhang H, Yu J, Liu N Independent and combined associations of handgrip strength and walking speed with cognitive function in older adults: evidence from a national cross-sectional study. Aging Ment Health. 2024; 1-8 https://doi.org/10.1080/13607863.2024.2360018

Storer B, Holden M, Kershaw K The prevalence of anxiety in respiratory and sleep diseases: a systematic review and meta-analysis. Respir Med. 2024; 230 https://doi.org/10.1016/j.rmed.2024.107677

Lewis SR, McGarrigle L, Pritchard MW Population-based interventions for preventing falls and fall-related injuries in older people. Cochrane Database Syst Rev. 2024; 1:(1) https://doi.org/10.1002/14651858.CD013789.pub2

Review of recently published articles

Aysha Mendes

Freelance journalist specialising in healthcare, psychology and nursing

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journal articles on research in nursing

Aysha Mendes provides a synopsis and brief review of a selection of recently published research articles that are of interest to community nurses, highlighting key points to keep you up to date; a full reference is provided for those who wish to read the research in more detail

Antipsychotic medications and post-stroke infection

New research exploring antipsychotic use in older people and examining their risk of infection following a stroke has been published in Age and Ageing. Studies conducted following stroke into post-stroke infection and antipsychotic use are scarce, explained Park et al. However, it is already known that stroke risk increases with age, and that infection risk appears to increase in people taking antipsychotic medication.

The aim of this study was to establish whether or not any link exists between antipsychotic use and the risk of infection after stroke. The researchers analysed data from adults across five university hospitals who experienced stroke between 2011 and 2020. The records from participants' inpatient stays were examined to establish whether antipsychotics had been administered. The primary outcome was infection following stroke after the first 2 days in hospital. The secondary outcome was the presence of pneumonia, bactaeremia or bacteriuria.

The sample was large: 23 885 patients who had experienced stroke for the first time. There were 2773 patients taking antipsychotic medication, and the researchers matched a cohort of non-users of the same number for comparison.

The results did not show an association between post-stroke risk and antipsychotic use. However, the authors advised that this does not necessarily confirm no association at all, and that practitioners must still exercise caution when prescribing these medications. Further research is needed on the same topic to gain further insight, the authors emphasised, because previous evidence did suggest antipsychotic use may be linked to increased infection risk.

Handgrip strength, walking speed and cognitive function

Existing research has examined possible associations between handgrip strength, walking speed and cognitive function in older adults, but has not delved into the independent and combined associations between these factors. A study by Zhao et al (2024) that examines this has been published in Aging and Mental Health. The authors explored these factors among Chinese older adults and ensured the sample was representative of the population on a national level.

The researchers recruited 4577 adults who were more than 60 years of age, and measured their handgrip strength with a dynamometer. They assessed walking speed with a 2.5-meter walking test. These measurements were classified into groups including low, normal and high categories. Cognitive function was assessed using the Telephone Interview for Cognitive Status tool.

Interestingly, the two physical measurements (for walking speed and handgrip) were significantly associated with cognitive function. Low strength and low speed were linked with a higher incidence among participants of reduced cognitive function. Where the two were co-occurring, the rate of low cognitive function was even higher among the participants.

The authors concluded that low handgrip and low walking speed in older people are linked independently to low cognitive function, and the rate of low cognitive function increases further where the two factors occur together. This may warrant further research in order to ascertain the best approach in care, treatment and rehabilitation within the population of older people showing signs of having these traits.

Anxiety in respiratory and sleep disorders

Respiratory Medicine has published a study exploring the mental health impact of respiratory and sleep disorders. Storer et al (2024) examined anxiety in particular, which has been associated with chronic physical health conditions in previous research. The authors also noted that anxiety can have a detrimental effect on quality of life and physical health outcomes.

Although there is a lot of research about the mental health impact of chronic illnesses, the authors noticed a sparsity of research with specific reference to sleep disorders and respiratory disease, and their association with anxiety. They conducted a systematic review and meta-analysis to gain insight into the global prevalence of anxiety among patients with these disorders.

The databases PubMed, Embase, Cochrane, PsycINFO and Google Scholar were used to carry out a search, from inception of each database to January 2023. The researchers searched for anxiety prevalence in people more than 16 years of age, who were respiratory and sleep medicine outpatients. The occurrence of anxiety symptoms was examined using self-report questionnaires, interviews and patient records. Overall, 116 studies were included, consisting of 36 340 participants, spanning 40 countries.

The pooled prevalence of anxiety was 30.3%. Storer et al also looked at specific conditions within these categories, to determine whether anxiety was higher for one disease compared with others. They found that the highest rate of anxiety was 43.1% in patients with pulmonary tuberculosis. The lowest occurrence of anxiety was interestingly in outpatients with COVID-19, at 23.4%. However, further research could delve into specifically when patients experienced their anxiety, because there may have been a surge of anxiety for various reasons during the height of the pandemic, occurring with the presentation of COVID-19. Anxiety was found to be higher in women with sleep and respiratory disorders.

The authors concluded that anxiety is a common mental health presentation, particularly among patients with respiratory and sleep disorders. This study highlights the importance of clinicians in these fields noticing and nurturing the mental health of patients, with thorough assessment, care and treatment in a timely fashion, as there may be many community patients experiencing anxiety but not receiving appropriate support. The study's findings also serve as a reminder to consider the holistic nature of care, addressing both patients' physical and mental health.

Population-based interventions to prevent falls and related injuries

Falls currently occur in about one-third of older people aged over 65 years. While individualised care and interventions are important, there is a place for and value in population-level interventions. The authors note that such initiatives can be used to target the whole community, with the aim of addressing the underlying societal, cultural or environmental conditions that are increasing the risk of falls in the first place.

In an effort to review and synthesise current evidence on the effects of population-based interventions for the prevention of falls and fall-related injuries in older people, a study by Lewis et al (2024) published in Cochrane Database Systematic Review carried out a search of six databases. These included CENTRAL, MEDLINE and Embase, as well as two trial registers in December 2020, along with a follow-up/top-up search of only the three databases mentioned in January 2023.

journal articles on research in nursing

A total of nine studies were included, consisting of two cluster randomised controlled trials (RCTs) and seven non-randomised trials. Of these, five were controlled before- and-after studies (CBAs), and two were controlled interrupted time series (CITS). In seven of the included studies, the number of older adults ranged from 1200 to 137 000 people. The other two studies included only numbers for the total population (67 300 and 172 500 people). The length of these studies ranged from 14 months–8 years.

Lewis et al used the Prevention of Falls Network European (ProFaNE) taxonomy to classify the types of interventions in the included studies. All studies evaluated multicomponent falls prevention interventions and one study also included a medication and nutrition intervention. All studies included some or all components of exercise, modification of environments (eg home, community and public spaces), staff training, and knowledge and education.

In the medication and nutr ition intervention study, older people in the intervention area were offered free calcium and vitamin D3 supplementation daily and women had fewer fall-related hospital admissions. However, the study was of very low certainty. Of the multicomponent studies, one cluster RCT reported lower rates of falls in the intervention area and the other studies noted no difference in either the rate of falls between intervention and control areas, rate of falls inside or outside the home, number of fallers or fall-related injuries. However, once again, findings were inconsistent and unclear. The two cluster RCTs included either high or uncertain risk of bias and the non-randomised trials were classified as low-certainty evidence. There were very inconsistent findings between all studies and the authors noted possible imprecision in some effect estimates.

The study concluded that due to the low-certainty evidence, it is unclear whether population-based multicomponent or nutrition and medication interventions are effective at reducing falls or fall-related injuries in older adults. The authors pointed out the need for cluster RCTs that are both methodologically robust and which have sufficiently large communities and numbers of clusters representative of the larger population within the country. The authors suggested the rate of sampling needs to be established in order to identify the appropriate size of communities to include. They went on to say that future studies would need to describe interventions in sufficient detail so that the effectiveness of individual components in multicomponent interventions can be shown.

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The Importance of Nursing Research

Nursing research has a tremendous influence on current and future professional nursing practice, thus rendering it an essential component of the educational process. This article chronicles the learning experiences of two undergraduate nursing students who were provided with the opportunity to become team members in a study funded by the National Institute of Nursing Research. The application process, the various learning opportunities and responsibilities performed by the students, and the benefits and outcomes of the experience are described. The authors hope that by sharing their learning experiences, more students will be given similar opportunities using the strategies presented in this article. Nursing research is critical to the nursing profession and is necessary for continuing advancements that promote optimal nursing care.

Throughout the 21st century, the role of nurse has evolved significantly. Nurses work in a variety of settings, including the hospital, the classroom, the community health department, the business sector, home health care, and the laboratory. Although each role carries different responsibilities, the primary goal of a professional nurse remains the same: to be the client's advocate and provide optimal care on the basis of evidence obtained through research.

Baccalaureate programs in the United States prepare students for entry-level nursing positions. The focus is to care for individuals throughout the human life span. Knowledge is acquired from textbooks, classroom and Web-based instruction, simulation, and clinical experiences. The goal of all programs is for students to graduate as safe, entry-level professionals, having received a well-rounded exposure to the nursing field. Students are exposed to evidence-based nursing practice throughout their curriculum; however, the allocated time for nursing research is often limited. Many programs require only one 3-credit hour course for nursing research. This amount of time is limited, despite the broad spectrum of nursing research and its influence on current and future nursing care.

Research is typically not among the traditional responsibilities of an entry-level nurse. Many nurses are involved in either direct patient care or administrative aspects of health care. Nursing research is a growing field in which individuals within the profession can contribute a variety of skills and experiences to the science of nursing care. There are frequent misconceptions as to what nursing research is. Some individuals do not even know how to begin to define nursing research. According to Polit and Beck (2006) , nursing research is:

systematic inquiry designed to develop knowledge about issues of importance to nurses, including nursing practice, nursing education, and nursing administration. (p. 4)

Nursing research is vital to the practice of professional nursing, and the importance of its inclusion during undergraduate instruction cannot be overemphasized. Only with exposure and experience can students begin to understand the concept and importance of nursing research.

The purpose of this article is to describe undergraduate students’ experiences of becoming aware of and participating in a federally funded research study from the National Institute of Nursing Research. As a part of funding for the study, which was an AREA award ( A cademic R esearch E nhancement A ward, R15 mechanism), there were designated opportunities for student involvement. The primary aim of the research study was to investigate the effects of gene-environment interactions on risk factors of preclinical cardiovascular disease in a cohort of 585 young adults who all had a positive family history of cardiovascular disease (i.e., essential hypertension or premature myocardial infarction at age 55 or younger in one or both biological parents or in one or more grandparents), verified in the medical record. Specific genes examined included cytochrome P-450, family 1, subfamily A, polypeptide 1; cytochrome P-450 2A; glutathione S-transferase mu 1; and glutathione S-transferase theta 1. Cardiovascular-dependent measures were diastolic blood pressure, endothelium-dependent arterial vasodilation, left ventricular mass indexed for body size, systolic blood pressure, and total peripheral resistance. The effects of ethnicity and gender were also explored.

Learning Opportunity

The learning process began with the principal investigator (M.S.T.) of the study visiting the junior class (class of 2007) of baccalaureate students at the Medical College of Georgia. This particular student group was chosen due to their academic standing because they would have the chance to take full advantage of learning directly from a nurse researcher for one full year before graduation. The principal investigator briefly presented and discussed the growing field of nursing research, the advancements made by nursing research, and the critical role of nursing research to nursing practice. The principal investigator also presented an overview of the funded research study and extended an invitation to students to apply for two part-time positions on the grant that were designed specifically for nursing student involvement. Students recognized the excellent opportunity and were intrigued with the future possibilities. They understood this option was unique and appeared to be a great pathway for becoming an active participant in learning the nursing research process through involvement in an official nursing research study.

The principal investigator established objective criteria for the application process. The criteria included writing a maximum 1-page essay sharing the reasons why the students wanted to join the research project as a team member and also sharing their personal and professional goals for involvement in the study. Many students were interested; thus, it was a very competitive process. The principal investigator reviewed the essays and selected approximately 10 prospective individuals for an interview. The interview was an extension of the essay. At the interview, the principal investigator further described the positions, provided a detailed overview of the grant, and had the opportunity to gain a better understanding of the student candidates. The students were encouraged to ask questions to further understand the expectations of the prospective opportunity. The interview also provided the students with increased exposure to the study's goal and more familiarization with the expectations of the funded positions.

After the interview process was completed, two individuals were selected, per the grant specifications. The selected individuals described the interview process as a positive experience that helped solidify their desire to become involved in the research study. The principal investigator emphasized that this job opportunity was designed to be a learning experience in which the students would be guided through the entire research study process and become members of a multidisciplinary team. Time responsibilities for each student included approximately 6 hours per week. The principal investigator communicated clearly that the nursing baccalaureate program was the first priority for the students, and thus provided a flexible work schedule.

Research Study Experience

The students began working in early april 2006. The first step in the work experience included 6 weeks of funded orientation. This was their first exposure to the research process; thus, it was important for the students to be provided with a strong foundation. Orientation included attending a team meeting and being introduced to the members of the multidisciplinary team (i.e., biostatistician, cardiologist, geneticists, nurse researcher, and psychologist, all of whom served as co-investigators, and the genetic laboratory personnel); reviewing the grant application; completing the Collaborative Institutional Training Initiative (CITI) (2000) ; completing the Roche educational program on genetics; and touring the worksite facilities. Reviewing the grant gave the students a better understanding of the specific aims and objectives of the study and the intended procedures of the genetic laboratory work in which the students would be involved. The complexity of the grant required the principal investigator to further explain and clarify specific details. The CITI training, which is required by the institution's Office of Human Research Protection, was completed online and took approximately 5.5 hours. The CITI program was presented in a tutorial format, and satisfactory completion of numerous quizzes was required. The task was tedious and time consuming, but valuable and essential, as it increased the awareness of the established codes of conduct for research. At the conclusion of the CITI training, the students understood the necessary policies and procedures for maintaining security and confidentiality of human subjects, the legal and ethical issues regarding the research process, and the essential procedures for research conduct.

Although the students had a basic understanding of genetics, they completed the Roche Genetics Education Program (2004) to gain a deeper understanding. The program was direct and easy to navigate and was excellent for all learning styles, as it contained both visual and auditory explanations. The explanations covered both basic and complex genetic concepts. Through the use of the genetics program, the students were able to comprehend abstract genetic details and to further understand the importance and influence of genetics on personal health. To conclude the orientation process, students were taught basic laboratory procedures, such as polymerase chain reaction and restrictive enzyme digestion, which were used to perform genotyping for the study. After these procedures had been observed several times, the students were given the opportunity to acquire hands-on experience with these laboratory techniques. Each of these components of the orientation process provided the students with the needed foundation for becoming involved in the research study.

After approximately 2 months of orientation, the students were ready to begin working in the genetics laboratory. One of the primary responsibilities of the students would be to further learn and become confident with genotyping techniques. The laboratory was shared among research personnel of several funded studies, with various research experiments being conducted concurrently. The students, under the supervision of the principal investigator and geneticist (H.Z.), also worked with experienced research assistants to perform the genotyping. The students maintained a daily log describing the laboratory genotyping procedures and experiments, and these logs were reviewed at team meetings. Although the actual procedure for polymerase chain reaction seemed straightforward, the students quickly learned that quality control must be used. Sometimes during genotyping, the DNA samples did not produce results. The students discovered that there are numerous contributing factors to successful polymerase chain reaction, such as quality of DNA templates, primer specifications, temperature settings, gel conditions, pipette measuring accuracy, and general laboratory techniques. Even the slightest error could result in permanent DNA sample loss, major experiment failure, or DNA sample contamination.

The students met with the research team members frequently to discuss and troubleshoot potential solutions and problem solve techniques that would foster improving the success rate and productivity of the genotyping. From the laboratory experience, the students learned that every detail must be considered and addressed precisely and meticulously when conducting experiments. Sometimes the process became frustrating, but the students soon discovered that patience and persistence were the most important attributes for a laboratory researcher to possess. The laboratory experience was an excellent hands-on learning opportunity. The students no longer viewed research as strictly information gathered from a journal or textbook, but rather as a physical act that required extreme concentration, dedication, and determination.

After spending numerous months in the laboratory performing the required genotyping, the students had the opportunity to be exposed to another role of a nurse researcher. They performed literature reviews regarding the study. Although the students had written papers in their nursing school program that required literature citations, they were not familiar with all of the library resources available to them. In no time, the students learned which library and online resources had the most validity and what would be the most relevant to their study. The literature search results provided the students and principal investigator with information on new studies that had been conducted on gene-environment interactions regarding tobacco smoke exposure and cardiovascular disease. From the literature review experience, the students learned the importance of being selective and time efficient. Often when a search was first begun, thousands of articles were listed, but the students learned the importance of narrowing the searches to the specific areas of focus. After the students completed their searches, they met with the principal investigator, who provided direction on the articles identified as the most relevant to the study.

The students continued working with the principal investigator during data review, analysis, and preparation of dissemination of the results (i.e., the publishing process). They helped to prepare an abstract submission of the study presented at an international meeting ( Tingen et al., 2007 ). They also helped with the preparation of manuscripts of the study results. By the conclusion of their work experience, the students will have been exposed to and participated in the entire research process.

Benefits and Outcomes

From the students’ perspectives, this opportunity was extremely beneficial. Prior to this experience, the students were not familiar with nursing research. Their original perception of research was that it was conducted by people with chemistry, biology, biochemistry, and genetic degrees in laboratories at major universities. They now realize that nursing and research can be combined and that optimal nursing care is dependent on the latest research findings. In addition, the students believe this opportunity has been beneficial in learning that nurse researchers are valuable to nurses in other settings. For example, one of the long-term goals of this research study is to develop appropriate interventions for children who are more susceptible to and at risk for the harmful effects of tobacco smoke due to their genetic heritage. The information obtained by a nurse researcher can be disseminated to nurses who work directly with the individuals to whom the research applies. Practice that has shown to be effective through research allows nurses to better advocate for patients and provide the best possible care. Although the majority of nurses who provide patient care will be consumers of nursing research, implementing evidence-based nursing practice is crucial to provide optimal nursing care. Information from nursing research has the potential to directly impact the care provided to patients in all health care settings.

Now that the students have had the opportunity to become more familiar with nursing research through involvement as team members, they recognize that their future professional possibilities are endless. Nursing research is an emerging and growing field in which individuals can apply their nursing education to discover new advancements that promote evidence-based care. They learned the research process and the important roles that each team member plays during the study phases of conception, design, implementation, analysis, and dissemination. Each aspect of the research process is important and contributes to the overall success of the study.

The students also discovered the benefit of trying new things. Prior to this experience, they had little exposure to the research process and nursing research. Consequently, they had to be receptive to learning and recognize that acquiring new knowledge was a gradual process. At times, the students felt anxious because all aspects were new, but they realized that without trying, they would never advance and feel comfortable with the research process. As the students reflected, they thought this was an excellent growing experience professionally, scholastically, and personally. In addition, this opportunity benefited the students’ peers through discussions and their sharing of work responsibilities, the research process, and the importance of evidence-based practice. As future nurses, the students are strong proponents of nursing research, and this experience has also broadened their horizons regarding future professional growth and opportunities. In addition, they have a better understanding of the importance of scientific evidence to support their clinical practice. As a result, the students thought that a stronger emphasis should be placed on nursing research in undergraduate baccalaureate education and that more students should have the opportunity to participate as team members in nursing research studies.

The students were almost one full year into nursing school and thought they had learned about all of the possibilities for their futures when they were first presented with this learning opportunity. They knew their future options were numerous and included working in acute care and community settings. They also realized they could further their education and pursue graduate degrees to include a master's degree and become an administrator, educator, clinical nurse specialist, nurse anesthetist, or nurse practitioner, or potentially pursue a doctorate. They did not know there was an emerging and growing field in which their nursing education could be applied and furthered—the area of research and the role of becoming a nurse researcher. Prior to this experience, students perceived their possibilities for a professional career in nursing were tremendous. Now by being involved in the entire process of conducting a federally funded research study, they realized their future professional possibilities are limitless.

The authors of this paper hope that by sharing their experience, they will encourage both nursing faculty and nursing students to not only introduce the research process into the nursing curriculum, but also to consider making nursing research a tangible and more integrated process. They think that a more beneficial approach to the introduction of research may be achieved through incorporating research-related content into each nursing course throughout the educational process. This could be conducted in addition to the current curriculum plan of many schools of nursing that require a single and concentrated 3-hour research course with a goal of research becoming a positive experience for students that is enthusiastically received as a new learning opportunity. In addition, students who are involved as team members in a funded research study may be provided with scheduled classroom opportunities for making progress reports to their peers. Also, the students could field questions regarding the research project and their experiences. These activities may foster increased learning and interest about research among the students’ classmates.

As nursing students are the future members of the nursing profession, and for the profession to continue to advance, nursing research must be the foundation of comprehensive, evidence-based clinical practice. This may only occur with increased exposure to nursing research. Therefore, it is critical that the future members of the nursing profession be exposed to, develop an appreciation for, and become more involved in nursing research, and thus incorporate its outcomes into the delivery of optimal professional nursing practice.

Acknowledgments

The lead author was awarded a grant (NR008871) from the National Institutes of Health, National Institute of Nursing Research.

  • Collaborative Institutional Training Initiative [April 14, 2006]; Office of Human Research Protection. The Medical College of Georgia. 2000 from http://www.mcg.edu/Research/ohrp/training/citi.html .
  • Polit DF, Beck CT. Essentials of nursing research: Methods, appraisal, and utilization. 6th ed. Lippincott Williams & Wilkins; Philadelphia: 2006. [ Google Scholar ]
  • Roche Genetics Education Program [May 10, 2006]; Education. 2004 from http://www.roche.com/research_and_development_r_d_overview/education.htm .
  • Tingen MS, Ludwig DA, Dong Y, Zhu H, Andrews JO, Burnett AH, et al. Tobacco smoke exposure and genetics: Youth at risk for cardiovascular disease.. Proceedings of the 13th Annual Meeting of the Society for Research on Nicotine and Tobacco.2007. p. 39. [ Google Scholar ]
  • Introduction
  • Conclusions
  • Article Information

5:2 MR indicates an intermittent fasting plan consisting of 2 nonconsecutive fasting days and 5 days of habitual intake per week and meal replacement diet.

A, Changes in hemoglobin A 1c (HbA 1c ) concentration from baseline to 16 weeks. The adjusted least-squares mean (LSM) changes were intermittent fasting plan consisting of 2 nonconsecutive fasting days and 5 days of habitual intake per week and meal replacement diet (5:2 MR), −1.9% (SE, 0.2%); metformin, −1.6% (SE, 0.2%); and empagliflozin, −1.5% (SE, 0.2%) (to convert to proportion of total hemoglobin, multiply by 0.01). The adjusted LSM difference between 5:2 MR and metformin was −0.3% (95% CI, −0.5% to 0.1%), and the adjusted LSM difference between 5:2 MR and empagliflozin was −0.4% (95% CI, −0.6% to 0.2%). B, Changes in HbA 1c concentration from baseline to 16 weeks in patients with overweight or obesity. C, Percentage of patients with HbA 1c concentrations of less than 7.0% or of less than 6.5% at week 16. D, Changes in fasting plasma glucose (FPG) concentrations from baseline to 16 weeks (to convert glucose to millimoles per liter, multiply by 0.0555). Error bars display SEs.

Patients were randomized to receive intermittent fasting plan consisting of 2 nonconsecutive fasting days and 5 days of habitual intake per week and meal replacement diet (5:2 MR) (n = 135), metformin (n = 134), or empagliflozin (n = 136). BMI indicates body mass index (calculated as weight in kilograms divided by height in meters squared); and LSM, least-squares mean.

Trial Protocol

eMethods. Multiple Imputation

eTable 1. Study Centers, Location, Ethics Committee Approvals

eTable 2. The Contents of Dietary and Exercise Guidance, and General Diabetes Education for All Participants

eTable 3. Nutrition Facts of Kang Zhijun™

eTable 4. Changes in Primary and Secondary Outcomes From Baseline to Week 16 (Intention-to-Treat Analysis)

eTable 5. Unadjusted Analyses of Outcomes From Baseline to Week 16 in the Three Groups

eTable 6. Primary and Secondary Outcomes From Baseline to Week 16 in Three Groups (Completers Analysis)

eTable 7. Primary and Secondary Outcomes From Baseline to Week 24 in Three Groups (Completers Analysis)

eFigure 1. Study Design

eFigure 2. The 5:2 MR Approach

eFigure 3. Changes in Body Weight

eFigure 4. Post-Hoc Subgroup Analysis of Weight Loss at Week 16 by Intention-to-Treat Analysis

eReference.

Data Sharing Statement

  • Fasting, Meal Substitute Improved Blood Sugar More Than Diabetes Drugs JAMA Medical News in Brief July 12, 2024 Emily Harris

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Guo L , Xi Y , Jin W, et al. A 5:2 Intermittent Fasting Meal Replacement Diet and Glycemic Control for Adults With Diabetes : The EARLY Randomized Clinical Trial . JAMA Netw Open. 2024;7(6):e2416786. doi:10.1001/jamanetworkopen.2024.16786

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A 5:2 Intermittent Fasting Meal Replacement Diet and Glycemic Control for Adults With Diabetes : The EARLY Randomized Clinical Trial

  • 1 Department of Endocrinology, Beijing Hospital, National Center of Gerontology, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing, China
  • 2 Department of Endocrinology, The Third Affiliated Hospital of Jinzhou Medical University, Jinzhou, Liaoning, China
  • 3 Department of Endocrinology, Nanyang Central Hospital, Nanyang, Henan, China
  • 4 Department of Endocrinology, Henan Provincial People’s Hospital, Zhengzhou, Henan, China
  • 5 Department of Endocrinology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, China
  • 6 Department of Endocrinology, Hebei Provincial People’s Hospital, Shijiazhuang, Hebei, China
  • 7 Department of Endocrinology, The Second Hospital of Hebei Medical University, Shijiazhuang, Hebei, China
  • 8 Department of Endocrinology, Sir Run Run Hospital, Nanjing Medical University, Nanjing, China
  • 9 Department of Endocrinology, The First Affiliated Hospital of Soochow University, Soochow, Jiangsu, China
  • 10 Department of Clinical Nutrition, Beijing Tongren Hospital, Capital Medical University, Beijing, China
  • Medical News in Brief Fasting, Meal Substitute Improved Blood Sugar More Than Diabetes Drugs Emily Harris JAMA

Question   What is the effect of a 16-week intermittent fasting plan consisting of 2 nonconsecutive fasting days and 5 days of habitual intake per week and meal replacement diet (5:2 MR) on the changes in hemoglobin A 1c level in Chinese adults with early type 2 diabetes?

Findings   In this randomized clinical trial of 405 adults, the 5:2 MR approach achieved better glycemic control at 16 weeks compared with metformin and empagliflozin.

Meaning   The 5:2 MR approach may serve as an effective initial lifestyle intervention instead of antidiabetic drugs for patients with type 2 diabetes.

Importance   An intermittent fasting plan consisting of 2 nonconsecutive fasting days and 5 days of habitual intake per week and meal replacement diet (5:2 MR) could provide additional benefits to patients with type 2 diabetes.

Objective   To evaluate the effect of the 5:2 MR on glycemic control among patients with early type 2 diabetes compared with metformin and empagliflozin.

Design, Setting, and Participants   The EARLY (Exploration of Treatment of Newly Diagnosed Overweight/Obese Type 2 Diabetes Mellitus) study is a randomized, open-label, active parallel-controlled clinical trial conducted between November 13, 2020, and December 29, 2022, in 9 centers across China. A total of 509 eligible patients underwent screening, out of which 405 were randomly assigned to 3 groups and included in the intention-to-treat analysis.

Interventions   Patients were randomly allocated in a 1:1:1 ratio to receive either metformin, empagliflozin, or 5:2 MR. The treatment was 16 weeks, with an 8-week follow-up.

Main Outcomes and Measures   The primary end point was the change in hemoglobin A 1c (HbA 1c ) level from baseline to 16 weeks. Secondary end points included changes in body weight, anthropometric measurements, and biochemical parameters.

Results   Of the 405 randomized participants (265 men [65.4%]; mean [SD] age, 45.5 [11.0] years; mean [SD] body mass index, 29.5 [4.1]; and mean [SD] HbA 1c level, 7.9% [0.6%]), 332 completed the 16-week treatment. From baseline to week 16, participants in the 5:2 MR group showed the greatest reduction in HbA 1c (least-squares mean [LSM], −1.9% [SE, 0.2%]), significantly greater than patients receiving metformin (LSM, −1.6% [SE, 0.2%]; adjusted LSM difference, −0.3% [95% CI, −0.4% to −0.1%]) and empagliflozin (LSM, −1.5% [SE, 0.2%]; adjusted LSM difference, −0.4% [95% CI, −0.6% to −0.2%]). At week 16, the mean weight loss in the 5:2 MR group (LSM, −9.7 kg [SE, 2.2 kg]) was greater than that in the metformin group (LSM, −5.5 kg [SE, 2.3 kg]) and empagliflozin group (LSM, −5.8 kg [SE, 2.3 kg]).

Conclusions and Relevance   This randomized clinical trial of Chinese adults with overweight or obesity and with early type 2 diabetes found that 5:2 MR could improve glycemic outcomes and weight loss in the short term compared with metformin or empagliflozin, making it a promising initial intervention and early management for type 2 diabetes.

Trial Registration   Chinese Clinical Trial Registry Identifier: ChiCTR2000040656

The latest data from the International Diabetes Federation in 2021 reveal that there are 537 million adults with diabetes globally, affecting approximately 1 in 10 adults. 1 China has the highest number of adults with diabetes in the world; from 2011 to 2021, the number increased from 90 million to 140.9 million, a 56.6% increase. 1 The prevalence of diabetes among Chinese adults is 12.4%. 2 According to China standards, 3 about half the population is either overweight (body mass index [BMI; calculated as weight in kilograms divided by height in meters squared] 24-27.9) or obese (BMI ≥28). 4

Overweight and obesity are significant risk factors for the development of type 2 diabetes. 5 - 7 Appropriate weight loss can improve glycemic control and reduce the dosage of antidiabetic drugs among patients with type 2 diabetes. 8 However, achieving weight loss is often challenging, necessitating the implementation of strategies such as meal replacement (MR) or dietary restriction.

Meal replacement is a prepackaged food or beverage that is substituted for 1 or more meals and provides energy. 9 The Look AHEAD study has demonstrated that, as part of a comprehensive lifestyle intervention, at 1 year MR effectively reduced hemoglobin A 1c (HbA 1c ) levels by 0.7% (to convert to proportion of total hemoglobin, multiply by 0.01) and achieved initial weight loss of 8.6% to 9.0% among patients with overweight or obesity and type 2 diabetes. 10 , 11 A systematic review including 23 studies and 7884 adults found that MR was associated with more weight loss (mean, −1.4 kg [95% CI −2.5 to −0.4 kg]) compared with other diets. 12 Important randomized clinical trials in White European indviduals (DiRECT), 13 Middle Eastern indviduals (DIADEM-I) 14 and South Asian individuals (STANDby) 15 have proved that MR can alleviate diabetes by lowering body weight.

As a dietary therapy, the 5:2 intermittent fasting diet involves 2 nonconsecutive fasting days (one-fourth the energy intake of habitual diet) and 5 days of habitual intake per week. 16 Individuals with obesity have successfully lost weight with this diet through both short-term and long-term interventions. 17 - 19 A single-center randomized clinical trial with a small sample size of 137 participants found that a 12-month 5:2 intermittent fasting diet significantly decreased HbA 1c levels among patients with overweight or obesity and type 2 diabetes, compared with a continuous energy restriction diet. 20

Combining the 5:2 intermittent fasting diet with MR (5:2 MR) could provide additional benefits to patients and is worthy of investigation. We aimed to investigate the efficacy of 16 weeks of 5:2 MR on HbA 1c changes among Chinese adults with overweight or obesity and early-stage type 2 diabetes.

The EARLY (Exploration of Treatment of Newly Diagnosed Overweight/Obese Type 2 Diabetes Mellitus) study is a randomized, open-label, active parallel-controlled clinical trial. The study protocol ( Supplement 1 ) was approved by the ethics committees of all participating centers (Beijing Hospital; the Third Affiliated Hospital of Jinzhou Medical University; Nanyang Central Hospital; Henan Provincial People’s Hospital; the First Affiliated Hospital of Zhengzhou University; Hebei Provincial People’s Hospital; the Second Hospital of Hebei Medical University; Sir Run Run Hospital, Nanjing Medical University; and the First Affiliated Hospital of Soochow University). The trial followed the International Conference on Harmonization Guidelines for Good Clinical Practice and the Declaration of Helsinki. 21 All patients provided written informed consent. This report adhered to the Consolidated Standards of Reporting Trials ( CONSORT ) reporting guideline.

We recruited adults with newly diagnosed (within 1 year) type 2 diabetes who had not used antidiabetic agents in the past 3 months, aged 18 to 65 years, with a BMI of 24 or more and an HbA 1c level of 7% to 9%. The recruitment was conducted concurrently at 9 hospitals across China (eTable 1 in Supplement 2 ) from November 13, 2020, to December 29, 2022. We excluded participants who had used weight-loss drugs or products within the past 3 months before enrollment, as well as pregnant or breastfeeding women ( Supplement 1 ).

Randomization was conducted using an interactive web response system. The randomization list of participants was generated by the stratified blocked randomization method using SAS software, version 9.4 (SAS Institute Inc), in which stratification was based on the center (block size of 9). Within each stratum, participants were randomized using a block randomization method, with a block size of 9, in a ratio of 1:1:1 to receive either metformin, empagliflozin, or 5:2 MR. Both the lists for participant and treatment allocation were inputted into the interactive web response system. At the study site, participants were administered treatment based on the randomization code and the corresponding treatment group obtained from the interactive web response system. Due to the nature of the intervention, blinding of participants and investigators was not feasible in this study. However, during the data analysis, the statisticians remained blinded to the study groupings.

The treatment period lasted for 16 weeks, followed by an 8-week follow-up (eFigure 1 in Supplement 2 ). All participants received dietary and exercise guidance as well as general diabetes education from nutritionists and research physicians in accordance with China Guideline 22 (eTable 2 in Supplement 2 ) every 4 weeks.

Patients in the 5:2 MR group consumed low-energy MR product A (Kang zhijun, Beijing MetabolicControl Technology Co Ltd; eTable 3 in Supplement 2 ). The 5:2 MR approach (eFigure 2 in Supplement 2 ) means that, within 1 week, there were 2 nonconsecutive days on which meals are replaced. On these 2 days, participants were required to consume 1 serving of Kang zhijun A instead of all 3 regular meals, with a daily energy intake of 500 kcal for women and 600 kcal for men. On the remaining 5 days, participants chose their own breakfast and lunch but had 1 serving of Kang zhijun B for dinner and were encouraged to monitor their calorie intake. Throughout the 16 weeks, dietary intake was recorded in a diary.

Patients took metformin (Shanghai Bristol-Myers Squibb), 0.5 g, twice a day. If the initial drug dosage was well tolerated, it was escalated to 2 g per day. Empagliflozin (Shanghai Boehringer Ingelheim), 10 mg, was administered once a day. During the study, patients were instructed to promptly contact the research center’s physician in case of severe hypoglycemia.

The primary outcome was the change in HbA 1c level from baseline to 16 weeks. Secondary outcomes included changes in weight (measured by InBody 770 [InBody]), BMI, waist circumference, hip circumference, waist to hip ratio, systolic and diastolic blood pressure, fasting plasma glucose (FPG) level, fasting insulin level, fasting C-peptide level, homeostasis model assessment of insulin resistance (HOMA-IR = FPG [mmol/L] × fasting insulin [μU/mL]/22.5), lipid profiles (total cholesterol, triglycerides, high-density lipoprotein cholesterol [HDL-C], and low-density lipoprotein cholesterollevels), and uric acid levels. The primary and secondary outcomes were reevaluated at the end of 8-week follow-up (week 24).

Adverse events were assessed throughout the study. Adverse events of particular interest included gastrointestinal reactions, urinary tract and reproductive system infections, hypoglycemia, and hyperglycemia. Laboratory testing was conducted at a central laboratory.

The sample size calculation was based on the SD of the change in HbA 1c level from a previous study, 23 with a 2-sided α of .05, β of 0.2, a minimum detectable between-group difference of 0.1%, and an anticipated SD of 0.2% based on pilot data analysis and a multiple pairwise comparison test using the Tukey-Kramer test. It was computed that each group required 108 participants using PASS 15 software (NCSS). Accounting for an expected 20% dropout rate, each group required 135 patients.

The primary outcome was analyzed following the intention-to-treat principle in the full analysis set, which included all randomized participants who received at least 1 dose of drugs or 5:2 MR. The safety outcome was analyzed in the safety analysis set, defined as participants randomized who received at least 1 dose of drugs or 5:2 MR and had safety assessment data collected at least once after the baseline.

The primary outcome was analyzed using the analysis of covariance model, which calculated the least-squares mean (LSM) and 95% CI to compare changes in HbA 1c level and key secondary outcomes among the 3 groups. The model adjusted for sex, age, height, weight, family history of diabetes and hypertension, physical activity, smoking, alcohol consumption, and baseline HbA 1c . Multiple imputation was used for missing values in the primary and key secondary outcomes (eMethods in Supplement 2 ). Post hoc subgroup analyses were conducted to explore the potential effect of baseline differences on HbA 1c and weight loss. Statistical analyses were performed using SPSS, version 24.0 software (SPSS Inc). All P values were from 2-sided tests and results were deemed statistically significant at P  < .05.

Of the 509 participants screened, 405 adults with type 2 diabetes (265 men [65.4%] and 140 women [34.6%]; mean [SD] age, 45.5 [11.0] years; mean [SD] BMI, 29.5 [4.1]; mean [SD] HbA 1c level, 7.9% [0.6%]) were randomly allocated. The patients’ baseline characteristics are presented in Table 1 . Of these 405 participants, 134 were randomized to the metformin group, 136 to the empagliflozin group, and 135 to the 5:2 MR group, all included in the intention-to-treat analysis ( Figure 1 ). Finally, 332 patients completed the 16-week treatment, for a completion rate of 82.0%.

At weeks 8 and 12, no patients in the 5:2 MR group required additional metformin for FPG level of 180.2 mg/dL or more and 2-hour plasma glucose of 250.5 mg/dL or more (to convert glucose to millimoles per liter, multiply by 0.0555). Only 1 patient in the metformin group had a FPG level of 218.0 mg/dL and consequently received additional empagliflozin.

At week 16, patients in the 5:2 MR group showed the greatest reduction in HbA 1c level (LSM, −1.9% [SE, 0.2%]), significantly greater than patients receiving metformin (−1.6% [SE, 0.2%]; adjusted LSM difference, −0.3% [95% CI, −0.5% to −0.1%]) and empagliflozin (−1.5% [SE, 0.2%]; adjusted LSM difference, −0.4% [95% CI, −0.6% to −0.2%]) ( Figure 2 A; eTable 4 in Supplement 2 ). However, there was no difference between the 2 drug groups (adjusted LSM difference, –0.2% [95% CI, –0.4% to 0.01%]; P  = .06). Post hoc subgroup analysis revealed that, apart from individuals aged 60 years or older, 5:2 MR mirrored the trend of HbA 1c reduction seen in the primary analysis ( Figure 3 ). The unadjusted baseline characteristics of patients supported these findings (eTable 5 in Supplement 2 ). Similarly, analyses of patients who completed the 16-week treatment also yielded consistent results (eTable 6 in Supplement 2 ). Among individuals with obesity, 5:2 MR significantly reduced HbA 1c compared with metformin (LSM difference, −0.4% [95% CI, –0.6% to –0.1%]) and empagliflozin (LSM difference, −0.4% [95% CI, –0.7% to –0.1%]) ( Figure 2 B). More patients in the 5:2 MR group (88.9% [120 of 135]) achieved an HbA 1c level less than 7% compared with the metformin (73.9% [99 of 34]; P  = .002) and empagliflozin (70.6% [96 of 136]; P  < .001) groups ( Figure 2 C). Similarly, in the 5:2 MR group, 80.0% of patients (108 of 135) achieved an HbA 1c level of less than 6.5%, surpassing metformin (60.4% [81 of 134]; P  < .001) and empagliflozin (55.1% [75 of 136]; P  < .001). Fasting plasma glucose levels in the 5:2 MR group decreased by −30.3 mg/dL (95% CI, −46.7 to −13.7 mg/dL) ( Figure 2 D). At the end of 8-week follow-up, 72 of 94 participants (76.6%) in the 5:2 MR group maintained an HbA 1c less than 6.5% (eTable 7 in Supplement 2 ).

At week 16, patients in the 5:2 MR group showed greater weight loss (LSM, −9.7 kg [SE, 2.2 kg]) than those in the metformin group (−5.5 kg [SE, 2.3 kg]; adjusted LSM difference, −4.2 kg [95% CI, −6.2 to −2.2 kg]) and empagliflozin group (−5.8 kg [SE, 2.3 kg]; adjusted LSM difference, −3.9 kg [95% CI, −5.9 to −1.9 kg]; eFigure 3A and eTable 4 in Supplement 2 ), with a greater proportion of those in the 5:2 MR group achieving weight loss (eFigure 3B in Supplement 2 ). Subgroup analyses confirmed this trend (eFigure 4 in Supplement 2 ). In addition, patients in the 5:2 MR group had significant reduction in waist and hip circumference and systolic and diastolic blood pressure, but showed no notable differences in most metabolic markers, except for triglyceride and HDL-C, compared with patients receiving antidiabetic drugs (eTable 4 in Supplement 2 ).

In the 5:2 MR group (n = 135), 1 patient experienced constipation, and 8 individuals (5.9%) had hypoglycemic symptoms, likely related to the low-energy diet ( Table 2 ). In the metformin group (n = 134), 26 individuals (19.4%) had mild gastrointestinal symptoms, and 8 individuals (6.0%) had hypoglycemia. In the empagliflozin group (n = 136), 3 patients (2.2%) experienced urinary symptoms, 5 patients (3.7%) experienced hypoglycemia, and 1 patient reported thirst. Two patients in the empagliflozin group experienced serious adverse events, including severe rash and hospitalization due to increased blood ketones, which resolved with treatment.

We found that among Chinese adults with overweight or obesity and newly diagnosed type 2 diabetes, the 5:2 MR approach achieved significant improvements in glycemic control and weight loss within a 16-week period, while also improving blood pressure and triglyceride and HDL-C levels. Therefore, 5:2 MR may potentially serve as an effective initial lifestyle intervention instead of antidiabetic drugs for early-stage type 2 diabetes.

Effective lifestyle interventions for patients with overweight and obesity and type 2 diabetes are crucial for achieving glycemic control and weight loss. Two single-center, small sample randomized clinical trials have confirmed that intermittent fasting can effectively reduce HbA 1c levels in these patients. 20 , 24 The 5:2 intermittent fasting diet for 12 months resulted in a reduction of 0.5% in HbA 1c level compared with a continuous energy restriction diet, with no difference in weight loss. 20 For patients with type 2 diabetes treated with insulin therapy, a 12-week 3:4 intermittent fasting intervention (3 days consuming 25% of recommended calories and 4 days without calorie restriction) led to a mean (SD) decrease of HbA 1c by 7.3 (12.0) mmol/mol (0.6% [1.1%]) and a mean (SD) weight loss of 4.8 (5.0) kg, with a daily total mean (SD) insulin dose reduction of 9 (10) IU. 24 A recent systematic review reported that the changes in HbA 1c after intermittent fasting intervention ranged from −1.5% to −0.3%. 25 Moreover, a meta-analysis of 2112 studies showed that partial or complete MR significantly reduced HbA 1c levels compared with conventional diabetes diets (−0.7% to −0.3%). 26 Our results found that after a 16-week intervention with the 5:2 MR, the mean HbA 1c reduction was 1.9%, greater than those achieved with metformin (0.3%) and empagliflozin (0.4%). According to American Diabetes Association recommendations, individuals with an HbA 1c of less than 6.5% for at least 6 months after the initiation of lifestyle interventions are considered to achieve diabetes remission. 27 In this study, 80.0% of patients reached this target with a 16-week 5:2 MR intervention. We acknowledge that the duration of our intervention was less than the recommended minimum of 6 months. Furthermore, at the end of the 8-week follow-up, 72 of 94 participants in the 5:2 MR group (76.6%) maintained an HbA 1c level of less than 6.5%, indicating that the 5:2 MR approach significantly and sustainably improves HbA 1c levels in patients with early type 2 diabetes.

In addition, our findings demonstrated that 5:2 MR reduced FPG levels, fasting insulin levels, C-peptide levels, and HOMA-IR. However, when compared with metformin and empagliflozin, the differences in fasting insulin levels, C-peptide levels, and HOMA-IR were not statistically significant. Animal studies have shown that fasting in diabetic mice can downregulate the expression of inflammatory factors, thereby alleviating inflammation. 28 A 5:2 MR plan may reshape the gut microbiota, promote white adipose tissue browning, and consequently reduce insulin resistance and the occurrence of obesity. 29 , 30 The MR used in this study contained omega-3 fatty acids and medium-chain fatty acids. Omega-3 fatty acids regulate leptin, inhibit fat synthesis, and promote fat breakdown. 31 Medium-chain fatty acids reduce heterotopic fat, enhance brown fat thermogenesis, and increase insulin sensitivity. 32

Compared with 2 antidiabetic drugs, 5:2 MR showed more significant and sustained benefits in weight loss and waist circumference reduction. Metformin exerts its effects by suppressing appetite, reducing insulin secretion, and improving gut microbiota. 33 Sodium-glucose cotransporter-2 inhibitors directly reduce body weight by increasing glucose excretion in the kidneys. 34 The DiRECT study confirmed that diabetes can be partially reversed through weight loss and proposed the “double cycle hypothesis,” suggesting that type 2 diabetes results from fat infiltration into the liver, pancreas, and muscle tissue, leading to the destruction of pancreatic β cells and tissue insulin resistance. Weight loss educes liver fat and significantly improves insulin resistance, and maintaining ideal body weight assists in β-cell function recovery, thus slowing down or even reversing the development of diabetes. 13 , 35 Our study cannot conclusively determine whether the glycemic improvement in patients with type 2 diabetes is due to weight loss or the 5:2 MR approach itself, requiring further investigation. The 5:2 MR reduced blood pressure and total cholesterol and increased HDL-C levels, consistent with previous studies indicating improved metabolic parameters with intermittent fasting and MR, 26 , 32 , 36 , 37 suggesting a potential cardiovascular protective effect.

The incidence of hypoglycemia was comparable across all 3 groups. When implementing a 5:2 MR intervention, it is essential to prevent hypoglycemia associated with low-energy diet. However, compared with medications, the 5:2 MR demonstrates favorable safety.

The 2020 China Guidelines emphasize lifestyle intervention as the foundational treatment for type 2 diabetes, with medication initiated only if lifestyle intervention fails to achieve glycemic control. 38 The EARLY study, for the first time to our knowledge, directly compared 5:2 MR with 2 widely used antidiabetic medications, providing evidence for the 5:2 MR approach as an effective initial lifestyle intervention for Chinese patients with early-stage type 2 diabetes.

This study has some limitations. First, it enrolled only patients not taking antidiabetic medication with a baseline HbA 1c level of less than 9%, so the efficacy of 5:2 MR for those taking medication or with a greater baseline HbA 1c needs further validation. Second, the 3-month washout period for eligibility regarding antidiabetic agents, including insulin, was short. A longer period without medication use (6 or 12 months) could offer more insights into prior medications’ effects. Third, the 5:2 MR intervention’s short duration means its long-term efficacy, especially for newly diagnosed patients with type 2 diabetes and overweight or obesity remains to be confirmed. Long-term follow-up studies are under way to assess the durability of 5:2 MR.

This randomized clinical study found that, for patients with newly diagnosed type 2 diabetes, a 16-week intervention with 5:2 MR could improve glycemic control and weight loss while also improving blood pressure, triglyceride levels, and HDL-C levels. Therefore, 5:2 MR may serve as an initial lifestyle intervention for patients with type 2 diabetes, providing an alternative to the use of metformin and empagliflozin medications.

Accepted for Publication: April 11, 2024.

Published: June 21, 2024. doi:10.1001/jamanetworkopen.2024.16786

Open Access: This is an open access article distributed under the terms of the CC-BY License . © 2024 Guo L et al. JAMA Network Open .

Corresponding Author: Lixin Guo, MD, Department of Endocrinology, Beijing Hospital, National Center of Gerontology, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, No. 1 Da Hua Rd, DongDan, Beijing 100730, China ( [email protected] ).

Author Contributions: Dr Guo had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. Drs Guo, Xi, and Jin are co–first authors.

Concept and design: Guo, Yu.

Acquisition, analysis, or interpretation of data: Guo, Xi, Jin, Yuan, Qin, Chen, Zhang, Y. Liu, Cheng, W. Liu.

Drafting of the manuscript: Guo, Xi, Jin, Yuan, Qin, Chen, Zhang, Y. Liu, Cheng, W. Liu.

Critical review of the manuscript for important intellectual content: Guo, W. Liu, Yu.

Statistical analysis: Guo, W. Liu.

Obtained funding: Guo, Qin.

Administrative, technical, or material support: Guo, Xi, Jin, Yuan, Chen, Zhang, Y. Liu, Cheng, Yu.

Supervision: Guo.

Conflict of Interest Disclosures: None reported.

Funding/Support: This trial was funded by Beijing MetabolicControl Technology Co Ltd.

Role of the Funder/Sponsor: The funding source had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.

Data Sharing Statement: See Supplement 3 .

Additional Contributions: We would like to thank the participants for their contributions to this trial. We also thank Bin Qiao, PhD, for providing medical writing support for the manuscript; he was not compensated for his contribution.

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Sharing research data

As a researcher, you are increasingly encouraged, or even mandated, to make your research data available, accessible, discoverable and usable.

Sharing research data is something we are passionate about too, so we’ve created this short video and written guide to help you get started.

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Research Data

What is research data.

While the definition often differs per field, generally, research data refers to the results of observations or experiments that validate your research findings. These span a range of useful materials associated with your research project, including:

Raw or processed data files

Research data  does not  include text in manuscript or final published article form, or data or other materials submitted and published as part of a journal article.

Why should I share my research data?

There are so many good reasons. We’ve listed just a few:

How you benefit

You get credit for the work you've done

Leads to more citations! 1

Can boost your number of publications

Increases your exposure and may lead to new collaborations

What it means for the research community

It's easy to reuse and reinterpret your data

Duplication of experiments can be avoided

New insights can be gained, sparking new lines of inquiry

Empowers replication

And society at large…

Greater transparency boosts public faith in research

Can play a role in guiding government policy

Improves access to research for those outside health and academia

Benefits the public purse as funding of repeat work is reduced

How do I share my research data?

The good news is it’s easy.

Yet to submit your research article?  There are a number of options available. These may vary depending on the journal you have chosen, so be sure to read the  Research Data  section in its  Guide for Authors  before you begin.

Already published your research article?  No problem – it’s never too late to share the research data associated with it.

Two of the most popular data sharing routes are:

Publishing a research elements article

These brief, peer-reviewed articles complement full research papers and are an easy way to receive proper credit and recognition for the work you have done. Research elements are research outputs that have come about as a result of following the research cycle – this includes things like data, methods and protocols, software, hardware and more.

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You can publish research elements articles in several different Elsevier journals, including  our suite of dedicated Research Elements journals . They are easy to submit, are subject to a peer review process, receive a DOI and are fully citable. They also make your work more sharable, discoverable, comprehensible, reusable and reproducible.

The accompanying raw data can still be placed in a repository of your choice (see below).

Uploading your data to a repository like Mendeley Data

Mendeley Data is a certified, free-to-use repository that hosts open data from all disciplines, whatever its format (e.g. raw and processed data, tables, codes and software). With many Elsevier journals, it’s possible to upload and store your data to Mendeley Data during the manuscript submission process. You can also upload your data directly to the repository. In each case, your data will receive a DOI, making it independently citable and it can be linked to any associated article on ScienceDirect, making it easy for readers to find and reuse.

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View an article featuring Mendeley data opens in new tab/window  (just select the  Research Data  link in the left-hand bar or scroll down the page).

What if I can’t submit my research data?

Data statements offer transparency.

We understand that there are times when the data is simply not available to post or there are good reasons why it shouldn’t be shared.  A number of Elsevier journals encourage authors to submit a data statement alongside their manuscript. This statement allows you to clearly explain the data you’ve used in the article and the reasons why it might not be available.  The statement will appear with the article on ScienceDirect. 

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Showcasing your research data on ScienceDirect

We have 3 top tips to help you maximize the impact of your data in your article on ScienceDirect.

Link with data repositories

You can create bidirectional links between any data repositories you’ve used to store your data and your online article. If you’ve published a data article, you can link to that too.

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Enrich with interactive data visualizations

The days of being confined to static visuals are over. Our in-article interactive viewers let readers delve into the data with helpful functions such as zoom, configurable display options and full screen mode.

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Cite your research data

Get credit for your work by citing your research data in your article and adding a data reference to the reference list. This ensures you are recognized for the data you shared and/or used in your research. Read the  References  section in your chosen journal’s  Guide for Authors  for more information.

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Ready to get started?

If you have yet to publish your research paper, the first step is to find the right journal for your submission and read the  Guide for Authors .

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Already published? Just view the options for sharing your research data above.

1 Several studies have now shown that making data available for an article increases article citations.

Nursing home staffing mandate would save thousands of lives, researchers say

Researchers say new rules would save lives. the nursing home industry sued to block them, saying they're unrealistic and would lead to closures..

A new federal rule could save nearly 13,000 lives a year, researchers say, despite pushback from nursing home officials who argue the updated staffing standards could lead to home closures.

At the request of Sen. Elizabeth Warren, D-Massachusetts, University of Pennsylvania researchers estimated the number of lives that would be saved under the Biden administration's finalized minimum staffing rule for nursing homes. The researchers said fully implementing the Center for Medicare & Medicaid Services' staffing rule would result in 12,945 fewer deaths yearly.

The number of lives saved by implementing the staffing rule would be "staggering," Warren said.

"It’s shameful that the nursing home industry would rather line its own pockets than follow these standards, provide better care, and save lives," Warren told USA TODAY.

Industry groups representing nursing homes said the federal staffing minimum would place an undue burden on homes that already struggle to fill shifts during a nationwide nursing shortage.

The Penn estimates do not address whether nursing homes might be forced to close as a result of the new regulation. Such a disruption could force residents to find another home.

Administration sets minimum staffing levels; industry sues

In April, the Biden administration  announced a new rule requiring nursing homes that get federal payments to meet minimum staffing requirements for registered nurses and nurse aides. Under the rule, nursing homes must provide each resident a daily minimum of 0.55 hours of care from a registered nurse and 2.45 hours from a certified nursing assistant. Each resident would get at least 3.48 hours of nurse care daily, and a registered nurse would staff homes at all times.

The rule will be phased in beginning next month; homes will have until May 2026 to meet the staffing ratios.

In May, nursing home groups sued the U.S. Department of Health and Human Services and CMS in an attempt to block the rule, arguing the pricy staffing requirements would prompt nursing homes to close.

The American Health Care Association and the Texas Health Care Association stated in a federal lawsuit in the Northern District of Texas that it makes no sense" to mandate a 24/7 registered nurse requirement and "rigid staffing ratios on thousands and thousands of nursing homes across the country."

"If CMS’s new standards are permitted to take effect, hundreds of nursing homes will likely be forced to downsize or close their doors entirely," the lawsuit says. "That threatens to displace tens of thousands of nursing home residents from their current facilities, while forcing countless other seniors and family members to wait longer, search farther, and pay more for the care they need."

Nursing homes currently fall short

AHCA estimates nursing homes would need to hire more than 100,000 registered nurses and nurse aides at an annual cost of $6.5 billion to comply with the federal requirements.

The University of Pennsylvania researchers noted that 83% of U.S. nursing homes had overall staffing levels in the first half of 2023 that were below the minimum requirement.

Dr. Rachel Werner, a professor of health care management and economics at the University of Pennsylvania, said the analysis relied on earlier research that estimated how total nurse staffing hours can affect mortality rates. Her team examined how death rates would change under the more robust staffing required by the new rule. Based on that review, she and a colleague concluded enforcing the CMS rule would save 12,945 lives per year.

Werner said patient safety hazards at inadequately staffed homes are well documented. She cited incidents such as medication errors, patient falls going undetected and dangerous pressure sores that developed on patients who remained in their beds for hours without being turned.

"There's a number of ways in which understaffed nursing homes increase the number of mistakes and decrease individual attention to nursing home residents that ultimately affect mortality," Werner said.

Werner said nursing homes can be exempt from the staffing rule if they are located in a designated workforce shortage area.

Questions about nursing home safety surfaced when more than 200,000 nursing home residents and staff died from COVID-19 in 2020 and 2021, the first two years of the pandemic.

In May, Warren,  Bernie Sanders and Richard Blumenthal along with Reps. Jan Schakowsky and Lloyd Doggett sent letters to executives of three large chains , questioning the nursing homes' spending on executive compensation, stock buybacks and dividends after the industry protested the staffing rule.

Ken Alltucker is on X at @kalltucker, contact him by email at [email protected] .

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The Limitations of Journal-Based Metrics

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  • Journal lists that rate the quality of academic publications were created to help libraries prioritize their journal purchasing decisions, not to measure the value of individual intellectual contributions.
  • Even so, research-focused business schools increasingly rely on journal lists to evaluate faculty intellectual contributions, compelling faculty to focus more on where they publish than on what they publish.
  • To produce research with true societal impact, business schools must abandon one-size-fits-all journal list metrics in favor of diverse, personalized, mission-driven research objectives for each faculty member.

  Research-oriented business schools face a major challenge: How can they measure faculty research performance in ways that are fair, transparent, mission-aligned, and representative of the impact of each faculty member’s contributions?  

Many institutions, especially those where research is an important part of their missions, address this challenge by rewarding only a narrow set of intellectual contributions, leaving faculty to pursue scholarship outside these parameters at their own professional risk. This reality affects deans, tenured professors, tenure-track faculty, doctoral students, and any other students or staff who conduct research as part of their jobs or degree programs. 

In many ways, business schools are stuck in a trap that they have made for themselves. In exchange for a straightforward way to measure faculty intellectual contributions, they willingly choose to evaluate faculty based on a journal’s average citations across all articles, not on an individual article’s quality and impact. As a result, our collective discourse about the value of research has shifted to focus more on journal list rankings than on the quality, value, and impact of research.

But this system is not sustainable. For business schools to secure their long-term future and demonstrate their value outside a narrow academic world, it is essential that they break out of this self-perpetuating trap. But doing so will require courage, nonconformity, and systematic effort. 

A Faulty Methodology 

Over the past few decades, business education and other disciplines have shifted to relying on journal lists, sometimes exclusively, to evaluate the scholarly performance of their faculty members and departments. The practice has become so deeply embedded in higher education that it has become costly for schools and faculty members to end, or even reduce, their reliance on journal lists. 

The lists most commonly used for this purpose are wide-ranging. Some categorize journals into quartiles, grades, or similar measures, such as the  Academic Journal Guide  compiled by the Chartered Association of Business Schools (CABS) in the U.K. or the lists that are part of the  Social Sciences Citation Index  from Clarivate Analytics.  

Other resources offer a single list of acceptable journals, such as the Financial Times   Top 50 Journals  list. There also is ShanghaiRanking’s  Global Ranking of Academic Subjects , which selects 50 journals each in the disciplines of business administration, management, and finance, as well as 25 each in public administration and hospitality and tourism management.   

In exchange for a straightforward way to measure faculty intellectual contributions, business schools willingly choose to evaluate faculty based on a journal’s average citations across all articles. But this system is not sustainable.

Most lists measure journal quality by the average number of citations their articles receive—a metric originally intended to help libraries prioritize their journal purchasing decisions. However, many educational institutions have converted journal lists into a way to measure the value of individual intellectual contributions. Variation in citations among articles is very high, making journal lists an extremely unreliable way to judge the quality of a single individual or a scholarly paper.

In other words, using journal-level analytics to judge individual-level performance breaks the rules of good methodology. 

AACSB accreditation standards recognize a wide range of intellectual contributions that qualify faculty members as Scholarly Academics. Even so, business schools with research-oriented missions use journal lists to govern their faculty appointments, faculty classification, promotion and tenure decisions, and contract renewals. Hence, adherence to journal lists has become a matter of personal survival for many tenure-track faculty.  

I saw this in my own institution, Nottingham University Business School China at the University of Nottingham Ningbo China (UNNC). This focus has been driven partly by university-level policies that have increasingly emphasized publication in highly rated journals on a few lists, such as the CABS list, as well as more science- and technology-oriented lists.   

These policies have permeated not only promotion decisions, but also contract renewals (most academics at UNNC are employed on five-year renewable contracts). In practice, the career progression of faculty is based more on the rigid application of the “hard” criteria of journal list metrics and less on “soft” criteria such as teaching quality or the impact and originality of research. As a result, when I served as the dean at the business school, I was forced to let go of some excellent teachers whose publications did not meet these narrow scholarly criteria. 

The Dangers of a ‘Journal Metric’ Mindset 

Of course, the use of journal lists as a performance metric makes some sense, because they can serve as a leading indicator of research quality. After all, a poorly researched article is unlikely to be accepted by a quality journal.

However, many highly ranked journals evaluate articles based not only on the objective quality of research, but also on several self-perpetuating metrics. For instance, the publication criteria of these journals tend to prioritize sophisticated research methods and conventional conceptual approaches.

This encourages scholars to focus on  incremental development of existing theories  through quantitative research using rigorous statistics. Unfortunately, these statistics can be based on variables that are questionable proxies for what they are supposedly measuring.  

Moreover, highly ranked journals can have lengthy publication cycles. This means that research on current developments in a fast-changing business world will likely be out of date by the time it is published.   

Perhaps the most troubling consequence of using journal metrics to evaluate individual performance is that the discourse of research has become based more on a journal’s ranking than on the published research itself. Even the authors of so-called systematic literature reviews tend to use journal rankings rather than paper originality to select which research results to include, which can  bring into question the comprehensive nature of these reviews . 

The research culture of a business school has become more like that of a sales department looking to hit its targets than of an academic community looking to advance knowledge.

This mindset is being socialized into current and future generations of faculty members, affecting them at all levels of their careers. It starts in doctoral programs, where PhD students are told to focus on journal rankings when selecting what to read. As they look to publish their dissertation results, doctoral candidates are encouraged to submit their work to journals on the lists used by the universities where they want to apply for jobs, whether or not those outlets are appropriate for their research topics.   

So, research-oriented academics must play an optimization game in which they balance quantity and quality. They must publish enough articles to get jobs, have their contracts renewed, gain tenure, and avoid performance pressure. Not surprisingly, if they work at institutions that give equal credit for joint authorship of articles, the number of authors per paper inevitably rises.   

Overall, the research culture of a business school has become more like that of a sales department looking to hit its targets than of an academic community looking to advance knowledge. 

The Disconnect Between Research and Impact 

The implications extend into the real world, where few managers read business research because it is hidden behind paywalls and written in language that is inaccessible to nonacademics. As a result, very few studies in business and management have practical significance, either to businesses or to business classrooms.  

Within business education, many schools differentiate between faculty who focus on research and those who focus on teaching. In principle, this approach should recognize the different strengths required to produce high-quality research and to deliver excellent education to students at all levels.  

In reality, research-oriented faculty often view teaching-oriented faculty as second-class. Similarly, it can be difficult for excellent teachers to be promoted, let alone to have their contributions recognized.   

Even research-focused faculty can be negatively affected if their work does not fit with the dominant pattern of academic journal publication. They might not receive the same recognition and workload allowances as their more conventional colleagues. So, while it’s common for business schools to say they value teaching-oriented staff, it’s disappointingly rare for schools to have sound, consistent strategies to reward these individuals.  

What Can Be Done 

I strongly believe that reliance on journal lists to measure the quality of faculty research is inappropriate. Moreover, given that AACSB and other associations now require schools to demonstrate the impact of their research, the use of journal lists is of little value in this regard—and is even counterproductive.  

Unfortunately, there is no simple solution to this systemic problem. But the first step is to recognize the limited validity and pervasive negative impact of current research metrics. As the 2012  Declaration on Research Assessment  (DORA) states, academic institutions should “not use journal-based metrics, such as Journal Impact Factors, as a surrogate measure of the quality of individual research articles, to assess an individual scientist’s contributions, or in hiring, promotion, or funding decisions.”  

The second step is to apply this recommendation, not just sign the declaration. It’s a step that a  growing number of academic institutions  are starting to take. 

As part of this process, business schools can take the following measures: 

  • Set targets for research diversity that recognize different research styles, as well as intellectual contributions that go beyond academic journal publications. 
  • Abandon one-size-fits-all journal list metrics in favor of more diverse and personalized research objectives for each faculty member.  
  • Emphasize research with multidimensional impact, rather than taking a unidimensional “box ticking” approach with journal lists. 
  • Change faculty classification methods to incorporate a wider range of scholarly outputs. 
  • Change explicit and implicit recognition systems, so that Scholarly Academics are no longer viewed as the most valued contributors to the school’s mission. For example, give the highest prestige to those who effectively combine academic and professional engagement and set minimum target levels for professionally engaged staff, not just Scholarly Academics.  

Bodies like AACSB are already taking the lead in emphasizing research impact, responsible research, and diverse intellectual contributions. But, ultimately, business schools must choose to take courageous action to develop better systems of research measurement. Otherwise, they will find themselves in a funding crisis as their target audiences turn to institutions whose research has greater relevance beyond academic circles. 

This article represents my personal views and not those of any academic institution.

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OUWB’s Afonso, Wasserman named Dean’s Distinguished Professors

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Afonso and Wasserman

Two professors from Oakland University William Beaumont School of Medicine have each achieved the faculty rank of Dean’s Distinguished Professor. 

The Oakland University Board of Trustees approved the title changes recommended by Oakland University President Ora Hirsch Pescovitz, M.D., at its regular meeting on June 28, 2024.

Nelia Afonso, M.D., professor, and Jason Wasserman, Ph.D., professor — both from OUWB’s Department of Foundational Medical Studies — each received the title.

“This prestigious recognition is not merely a personal achievement but a testament to the collaborative efforts of our academic community,” said Afonso.

Wasserman shared similar thoughts.

“The thing that means the most to me is that it was the result of a nomination of at least 10 of my colleagues,” he said. “It’s a really nice honor.”

The rank of Dean’s Distinguished Professor was established in 2021 upon approval from the OU Provost and the OU Assistant Vice President of Academic Human Resources. It’s a permanent, honorific title that acknowledges contributions of employed, full-time, tenured faculty at the rank of professor.

According to the recommendations from Pescovitz, the designation “shall be afforded to awardees who have superior teaching skills that encompass the breadth and depth of their discipline, a distinguished record of public service, and scholarly, creative, and artistic achievements.”

‘Truly been a privilege’

Sarah Lerchenfeldt, Pharm.D., associate professor and interim co-chair, Department of Foundational Medical Studies, nominated Afonso.

In her nomination, Lerchenfeldt said Afonso “exemplifies the criteria” for the title.

“Since joining OUWB as a founding faculty member, she has demonstrated unparalleled dedication to medical education, significantly enhancing both the academic and practical aspects of these fields,” wrote Lerchenfeldt.

The nomination noted Afonso’s scholarly excellence, particularly in the domains of education, clinical skills, women’s health, and vaccine hesitancy. Lerchenfeldt said that Afonso was principal investigator for the Merck Investigator Studies program project called “Promoting Vaccine Confidence in Medical and Dental Students.” The project secured about $179,000 in funding.

The nomination also pointed to Afonso’s efforts to develop and refine the curriculum for OUWB’s Art and Practice of Medicine (APM) course, previous awards she received, commitment to service, and leadership roles with organizations like the Southeast Michigan Center for Medical Education.

“Dr. Afonso’s tenure at OUWB has been marked by a commitment to advancing medical education, research, and community health,” wrote Lerchenfeldt. “Her work not only reflects the values and mission of our institution, but also sets a benchmark for academic and professional excellence.”

Afonso said it has “truly been a privilege” to receive the title.

“I have been fortunate to be part of this medical school since its inception and I am grateful for the numerous opportunities provided that have fostered my growth as a physician, educator, and researcher,” she said. “I appreciate the dedication and commitment of our faculty and staff, whose support has been instrumental in implementing various curricular innovations.”

‘Invaluable member of OUWB faculty’  

Wasserman , who joined OUWB in 2013, was nominated by a group of 10 other faculty from the Department of Foundational Medical Studies.

They called him a “prolific and influential scholar” on several topics: homelessness, clinical bioethics, and Holocaust medicine.

“His scholarship and research range from core bioethics topics, such as autonomy and informed consent, to empirical research and qualitative inquiry into homelessness and medical ethics,” they wrote, and noted that he has published three books, 12 book chapters and supplements, 64 peer-reviewed journal articles, 22 editor-reviewed articles, and seven invited articles.

“Dr. Wasserman’s extensively cited research has contributed to important debates surrounding ethics in medical education, care for homeless individuals, pediatric ethical concerns, euthanasia, the rights of patients without decision-making capacity, and immunization policy,” wrote the nominators.

They also noted Wasserman’s roles in shaping the Medical Humanities and Clinical Bioethics (MHCB) curriculum, replacing traditional essay assignments with extemporaneous self-reflection videos, development of interactive iBooks, serving as a mentor to more than 50 OUWB students for their  Embark  projects, and developing a national training course in bioethics for the Arnold P. Gold Foundation.

The nominators also mentioned Wasserman’s history of service. In 2020, he was appointed as one of only two Provost Fellows for Faculty Diversity at Oakland University. In 2022, he was honored with the OU Founder’s Day Award for Faculty Excellence in Diversity, Equity, and Inclusion. He also chaired the admissions committee for five years, served as director of student professionalism for nine years, co-founded  Street Medicine Oakland , launched the Center for Moral Values in Health Medicine, and more.

And he has plans to do even more, including launching a new student-led journal on ethics, humanities, and social justice, and a health care ethics debate tournament that will be open to all OU students.  

“One of the reasons I came to OUWB was because it was a new school and there was a lot of opportunity to be entrepreneurial,” he said. “I didn’t want to go to some well-established place where the expectation is you teach your courses, you write papers, and otherwise just let things run.”

For more information, contact Andrew Dietderich, senior marketing specialist, OUWB, at [email protected] .

To request an interview, visit the OUWB Communications & Marketing  webpage .

This work is licensed under a  Creative Commons Attribution-NonCommercial 4.0 International License .

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