Keywords
COVID-19, Diabetic Foot Ulcer, Disruption to Care, Pandemic, Telemedicine
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Flynn S, Kirwan E, MacGilchrist C and McIntosh C. The impact of COVID-19 on the care of diabetic foot ulcers: a scoping review protocol [version 1; peer review: 1 approved, 1 approved with reservations]. HRB Open Res 2023, 6:55 (https://doi.org/10.12688/hrbopenres.13745.1)
NOTE: If applicable, it is important to ensure the information in square brackets after the title is included in all citations of this article.
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Study Protocol
The impact of COVID-19 on the care of diabetic foot ulcers: a scoping review protocol
[version 1; peer review: 1 approved, 1 approved with reservations]
PUBLISHED 14 Sep 2023
OPEN PEER REVIEW
REVIEWER STATUS
Abstract
Corresponding author:
Sinead Flynn
Competing interests:
No competing interests were disclosed.
Grant information:
The first author (SF) is in receipt of the Hardiman Research Scholarship from the University of Galway, Galway, Ireland. This research will be completed in part fulfilment of a structured PhD in podiatric medicine.
The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
Copyright:
© 2023 Flynn S et al.
This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
How to cite: Flynn S, Kirwan E, MacGilchrist C and McIntosh C. The impact of COVID-19 on the care of diabetic foot ulcers: a scoping review protocol [version 1; peer review: 1 approved, 1 approved with reservations]. HRB Open Res 2023, 6:55 (https://doi.org/10.12688/hrbopenres.13745.1)
First published: 14 Sep 2023, 6:55 (https://doi.org/10.12688/hrbopenres.13745.1)
Latest published: 14 Sep 2023, 6:55 (https://doi.org/10.12688/hrbopenres.13745.1)
The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
Introduction
The prevalence of diabetes mellitus (DM) is rising across the globe; in Europe, it is estimated that 61 million adults are currently diagnosed with DM, representing 1 in every 11 adults1. Concerningly, this figure is projected to rise to 69 million by 2045, an increase of 13%1. While 1 in 3 (36%) adults who are living with DM remain undiagnosed1. DMs is a global epidemic that causes significant mortality; in Europe there were 1.1 million deaths due to diabetes in 20211, comparable to the total cumulative COVID-19 deaths in Europe during the entire pandemic which was reported by the World Health Organisation to be 1.45 million as of November 20212. The COVID-19 pandemic continues to impact on the health of the population and health care provision across the globe. Whilst the priority of health services was to treat those with severe COVID-19 infection this has led to the neglect of many conditions, particularly non-communicable diseases including DM3. The traditional model of care for the treatment of diabetic foot ulcers was face-to-face, usually in a hospital setting, providing wound debridement, offloading and wound healing treatment modalities for those with DFU. With the advent of the COVID-19 pandemic, this traditional approach was not always feasible, and a paradigm shift was required towards the delivery of care for those with diabetic foot ulcers3. Whilst this has produced many challenges, this forced shift may change how healthcare services are delivered permanently as people build on positive changes made to delivering care in this very challenging time4. This new paradigm of care shifts treatment away from hospital care to community-based care with more in-home visits, greater self-monitoring and self-management of foot ulcers, higher acuity community clinic visits, telemedicine, and remote patient monitoring5. Thus, it is timely to conduct research on diabetic foot disease that that will focus on the prevention of diabetes-related foot complications, through education, improved communication and screening utilising advanced technologies for remote monitoring, as well as focus on new treatment paradigms to improve patient outcomes and better facilitate wound healing in those with acute foot ulcers. The time is right to embrace these positive changes and to conduct research that will innovate, transform and improve diabetic foot care service provision and the lives of people living with DFU.
A systematic scoping review design represents a methodology that allows assessment of emerging evidence, as well as a first step in research development6. A scoping review was chosen to survey the current evidence base on the impact of COVID-19 on the care of DFU. At a news briefing in March 2020 the Director General of the World Health Organisation, Dr. Tedros Adhanom Ghebreyesus, declared the outbreak of COVID-19 a pandemic in March 20207, and therefore published data on this topic/its greater impacts and influence on the wider society is limited and restricted to the last three years. This scoping review process will enable the research team to identify gaps in the literature and systematically map the existing research on the topic. A preliminary search, using the search string detailed in the methods section under the subheading ‘Search strategy’ was undertaken of MEDLINE (RRID:SCR_002185), the Cochrane Database of Systematic Reviews (RRID:SCR_013000) and Joanna Briggs Institute (JBI) Evidence Synthesis this was completed prior to commencing the scoping review and no current or underway systematic reviews or scoping reviews on the topic were identified.
The aims of this review are to 1) identify the nature and extent of the research evidence regarding the COVID-19 pandemic and how this impacted and disrupted the care of DFU during the pandemic and the subsequent impact on patient outcomes 2) investigate transformation in models of care and service delivery, adoption of new technologies and new models of service innovations, including modalities such as of telehealth, that were adopted during the pandemic.
Methods
This review will be conducted in accordance with the Joanna Briggs Institute methodology for scoping reviews7 and the Preferred Reporting Items for Systematic reviews and Meta-Analysis extension for Scoping Reviews (PRISMA-ScR) will guide the reporting of results8.
Protocol
This protocol was developed in accordance with the steps developed by Arksey and O’Malley (2005)9 and the HRB open author guidelines. The protocol was registered with the Open Science Framework on the 27th of May 2022, and the Digital Object Identifier (DOI) is https://doi.org/10.17605/OSF.IO/VHYQF.
Research question
According to the Joanna Briggs Institute (2015), the “PCC” framework will be utilised in this scoping review to develop the research questions, with PCC standing for population, concept and context. The PCC provides structure when developing the inclusion and exclusion criteria which will help guide the screening process.
Participants
Published literature that consisted of primary research involving individuals with diabetic foot disease including active ulceration and, in receipt of care for said disease during the COVID-19 pandemic.
Concept
The concept of this review is to establish how the COVID-19 pandemic impacted upon the care of DFU and the subsequent impact on patient outcomes and investigate transformation in models of care and service delivery that were adopted during the pandemic.
Context
The context in which this review refers to is the time in which the COVID-19 pandemic played a factor in the provision of care due to government imposed pandemic lockdowns.
The following research question was formulated “What impact had the COVID-19 pandemic on the care of diabetic foot ulcers?”
Types of sources
Specific inclusion and exclusion criteria will be applied to yield the most relevant studies to include in the review.
Inclusion criteria
All studies published in English.
Studies from the year 2020 to present.
Studies investigating the provision of care of active DFD during the COVID-19 pandemic.
Studies with participants over the age of 18.
Studies reporting on transformation in models of care and service delivery for the care of active diabetic foot disease during the COVID-19 pandemic
Exclusion criteria
Studies not published in English
Studies published before March 2020.
Systematic reviews, meta-analysis, reports, pilot studies, conference presentations or incomplete studies.
Studies with limited case studies.
Studies whereby participants were under 18/paediatric diabetes.
Studies that explored the impact of COVID-19 on diabetes as a whole and not diabetic foot ulceration specifically.
This scoping review will consider both quantitative and qualitative research papers and all research methodologies reporting primary data. Due to the limited research published in the area, certain opinion papers will also be considered for inclusion in this scoping review if written by a recognised global expert in the field. No ethical approval is required to complete the scoping review as no participant involvement takes place.
Search strategy
To identify potentially relevant documents, searches will be carried out using databases associated with the University of Galway James Hardiman Library including SCOPUS (RRID:SCR_022559), PubMed (RRID:SCR_004846), Elsevier (RRID:SCR_013811), MEDLINE (RRID:SCR_002185), and Science Direct. Google Scholar (RRID:SCR_008878) will also be utilised for further searching of references from included papers, the grey literature will also be searched where applicable. Keywords and Medical Subject Headings (MeSH) terms will be used to obtain papers and further inspection of reference lists will be used to identify suitable papers.
Various trial searches were independently carried out by members of the research team before the following search strategy was agreed upon through team discussion. The following search string will be used for the final search for all databases:
Diabetic Foot[MeSH] AND (foot OR feet OR "lower extremity" OR "lower extremities" OR "lower leg" OR "lower legs" OR "lower limb" OR "lower limbs") AND (ulcer OR amputation* OR disorder* OR complaint* OR deformity* OR disability* OR condition* OR complication* AND Covid 19* OR Coronavirus* OR SARS-CoV-2*)
Study/source of evidence selection
In order to process and screen the literature obtained from the extensive searches, the systematic review management system Covidence (RRID:SCR_016484) will be used for the study selection process. This process will be split into four stages: importing references, title and abstract screening, full-text screening and finally data extraction. To begin this process, all papers yielded from the search will be exported to EndNote (RRID:SCR_014001) and from there, downloaded in XML format to be uploaded to Covidence (RRID:SCR_016484). Once exported to Covidence, duplicate papers will be automatically removed by the software. In the initial phase of data extraction, all titles and abstracts will be independently screened by three authors (SF, CMcI, CMacG). Each paper will be voted on by two of the three authors (SF, CMcI, CMacG). Any disagreements/conflicts on papers that are present will be discussed at research meetings until a consensus is agreed upon. In phase three, potentially eligible citations will be reviewed in the full text against the inclusion criteria. Similarly, any disagreements will be, again, resolved between the reviewers (SF, CMcI, CMacG, EK) at group discussion. Papers deemed suitable at this stage will then be exported to a .CSV file. During data extraction, a more in-depth analysis of each paper will be carried out. Papers may still be excluded at this stage due to incomplete/lacking data sets, irrelevance etc. One author (SF) will work on extracting the data using a standardised data extraction form in Microsoft Excel (RRID:SCR_016137), and a second author, (CMcI, CMacG, EK) will then independently verify the extracted data.
Reasons for exclusion of sources of evidence at full text that do not meet the inclusion criteria will be recorded and reported in the scoping review.
Data extraction
Included papers will be presented in a Preferred Reporting Items for Systematic Reviews and Meta-analyses extension for scoping review (PRISMA-ScR) flow diagram7. Data will be extracted from papers included in the scoping review by two independent reviewers using a data extraction tool developed by the authors. The data extracted will include specific details about the participants, concept, context, study methods and key findings relevant to the review question/s
The draft data extraction tool (Excel) will be modified and revised as necessary during the process of extracting data from each included evidence source. Modifications will be detailed in the scoping review.
The draft data extraction form is based on JBI guidelines on data extraction for scoping reviews8.
The following study characteristics are to be extracted manually:
Author/year of publication
Country
Setting
Study design
Participant recruitment
Data tool
Data collectors
Inclusion/Exclusion criteria
Methodology
Sample size
Number of type 1 diabetic participants
Number of type 2 diabetic participants
Duration of diabetes
Gender
Management of diabetes
DFU outcomes
Transformations/Innovations in Care
Key findings
Strengths of the study
Limitations of the study
Any issues that arose in the studies
Data analysis and presentation
A PRISMA flow chart will be used to display the study selection and rationale for the exclusion of sources. A combined approach to include descriptive synthesis and narrative synthesis will be undertaken to summarise and present the findings of the scoping review. The results will be presented in a descriptive format that aligns with the aims of the review in combination with a narrative synthesis of the findings that will present an overview of the current evidence base regardless of the methodological quality of the studies or risk of bias.
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how to cite this article
Flynn S, Kirwan E, MacGilchrist C and McIntosh C. The impact of COVID-19 on the care of diabetic foot ulcers: a scoping review protocol [version 1; peer review: 1 approved, 1 approved with reservations]. HRB Open Res 2023, 6:55 (https://doi.org/10.12688/hrbopenres.13745.1)
NOTE: If applicable, it is important to ensure the information in square brackets after the title is included in all citations of this article.
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Open Peer Review
Current Reviewer Status:
Key to Reviewer Statuses
VIEW
HIDE
ApprovedThe paper is scientifically sound in its current form and only minor, if any, improvements are suggested
Approved with reservations
A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit.
Not approvedFundamental flaws in the paper seriously undermine the findings and conclusions
Version 1
VERSION 1
PUBLISHED 14 Sep 2023
Views
6
How to cite this report:
Subrata SA. Reviewer Report For: The impact of COVID-19 on the care of diabetic foot ulcers: a scoping review protocol [version 1; peer review: 1 approved, 1 approved with reservations]. HRB Open Res 2023, 6:55 (https://doi.org/10.21956/hrbopenres.15036.r38497)
The direct URL for this report is:
https://hrbopenresearch.org/articles/6-55/v1#referee-response-38497
https://hrbopenresearch.org/articles/6-55/v1#referee-response-38497
NOTE: it is important to ensure the information in square brackets after the title is included in this citation.
Reviewer Report 29 Oct 2024
Approved with Reservations
VIEWS 6
Thank you for thinking of this journal.
After a preliminary look, I wanted to share a few constructive points that may enhance your study’s focus and alignment with current research trends. Given that the pandemic has officially ... Continue reading
After a preliminary look, I wanted to share a few constructive points that may enhance your study’s focus and alignment with current research trends. Given that the pandemic has officially ... Continue reading
CITE
HOW TO CITE THIS REPORT
Subrata SA. Reviewer Report For: The impact of COVID-19 on the care of diabetic foot ulcers: a scoping review protocol [version 1; peer review: 1 approved, 1 approved with reservations]. HRB Open Res 2023, 6:55 (https://doi.org/10.21956/hrbopenres.15036.r38497)
The direct URL for this report is:
https://hrbopenresearch.org/articles/6-55/v1#referee-response-38497
https://hrbopenresearch.org/articles/6-55/v1#referee-response-38497
NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article.
Views
7
How to cite this report:
Moore Z. Reviewer Report For: The impact of COVID-19 on the care of diabetic foot ulcers: a scoping review protocol [version 1; peer review: 1 approved, 1 approved with reservations]. HRB Open Res 2023, 6:55 (https://doi.org/10.21956/hrbopenres.15036.r37246)
The direct URL for this report is:
https://hrbopenresearch.org/articles/6-55/v1#referee-response-37246
https://hrbopenresearch.org/articles/6-55/v1#referee-response-37246
NOTE: it is important to ensure the information in square brackets after the title is included in this citation.
Reviewer Report 30 Nov 2023
Approved
VIEWS 7
Many thanks for this well written, clearly justified protocol for a scoping review of the impact of COVID-19 on the care of diabetic foot ulcers. I would suggest the following:
- The title should reflect that the review
CITE
HOW TO CITE THIS REPORT
Moore Z. Reviewer Report For: The impact of COVID-19 on the care of diabetic foot ulcers: a scoping review protocol [version 1; peer review: 1 approved, 1 approved with reservations]. HRB Open Res 2023, 6:55 (https://doi.org/10.21956/hrbopenres.15036.r37246)
The direct URL for this report is:
https://hrbopenresearch.org/articles/6-55/v1#referee-response-37246
https://hrbopenresearch.org/articles/6-55/v1#referee-response-37246
NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article.
Alongside their report, reviewers assign a status to the article:
Approved - the paper is scientifically sound in its current form and only minor, if any, improvements are suggested
Approved with reservations -
A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit.
Not approved - fundamental flaws in the paper seriously undermine the findings and conclusions
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