Prevalence and incidence of peripheral neuropathy, peripheral artery disease, foot disease, and lower extremity amputation in people with diabetes in Ireland; a systematic review protocol.

Sinead Kavanagh; Jennifer A. Pallin; Ann Sinead Doherty; Peter Lazzarini; Linda O'Keeffe; Claire M Buckley

doi:10.12688/hrbopenres.13823.1

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Study Protocol

Prevalence and incidence of peripheral neuropathy, peripheral artery disease, foot disease, and lower extremity amputation in people with diabetes in Ireland; a systematic review protocol.

[version 1; peer review: 1 approved, 1 approved with reservations]

Sinead Kavanagh^1,2, Jennifer A. Pallin ¹, Ann Sinead Doherty³, Peter Lazzarini^4,5, Linda O'Keeffe¹, Claire M Buckley¹

Sinead Kavanagh^1,2, Jennifer A. Pallin ¹, [...] Ann Sinead Doherty³, Peter Lazzarini^4,5, Linda O'Keeffe¹, Claire M Buckley¹

PUBLISHED 03 Jan 2024

Author details Author details

¹ School of Public Health, University College Cork, Cork, County Cork, Ireland
² Department of Endocrinology, Bantry Hospital, Bantry, Cork, Ireland
³ Department of General Practice, University College Cork, Cork, County Cork, Ireland
⁴ School of Public Health and Social Work,, Queensland University of Technology, Brisbane, Queensland, Australia
⁵ Allied Health Research Collaborative, The Prince Charles Hospital, Brisbane, Queensland, Australia

Sinead Kavanagh
Roles: Conceptualization, Methodology, Writing – Original Draft Preparation, Writing – Review & Editing

Jennifer A. Pallin
Roles: Conceptualization, Methodology, Supervision, Writing – Original Draft Preparation, Writing – Review & Editing

Ann Sinead Doherty
Roles: Methodology, Supervision, Writing – Review & Editing

Peter Lazzarini
Roles: Methodology

Linda O'Keeffe
Roles: Methodology, Writing – Review & Editing

Claire M Buckley
Roles: Conceptualization, Methodology, Supervision, Writing – Review & Editing

OPEN PEER REVIEW

REVIEWER STATUS

Abstract

Introduction

Internationally, the prevalence of diabetes is increasing, and with this comes an increase in diabetes related complications. Diabetic foot disease is the most common lower extremity complication in people with diabetes, and is associated with major morbidity, mortality, and costs to health services. Despite this burden, the incidence and prevalence of diabetic foot disease is unknown in Ireland. This paper presents a protocol for a systematic review to examine the incidence and prevalence of diabetic foot disease in the Irish population.

Methods

A systematic review will be performed using the Preferred Reporting Items for Systematic Review and Meta-Analyses guidelines. Pubmed, EMBASE, and Lenus, the Irish Health Research repository, will be searched for publications in any language and without restrictions to date. Title, abstract, and full text screening will be carried out independently by two investigators. Publications reporting on the incidence or prevalence of peripheral neuropathy, peripheral artery disease, ulceration, or amputation in people with diabetes in Ireland, from a defined geographical catchment area of Ireland, will be included. Joanna Briggs Institute (JBI) Critical Appraisal tool will be used to assess included studies methodological quality. Results will be reported in line with the Preferred Reporting Items for Systematic Review and Meta-Analyses guidelines.

Conclusion

The results of this systematic review can be used to inform appropriate stakeholders on the incidence and prevalence of diabetic foot disease in Irish populations, enabling decision making around appropriate use of resources to help prevent, and improve management of this disease.

Systematic review registration

CRD42023472904

Keywords

Diabetic foot disease, foot ulceration, amputation, Irish health system, incidence, prevalence.

Corresponding author: Jennifer A. Pallin

Competing interests: No competing interests were disclosed.

Grant information: Health Research Board Ireland [CDA-2019-007].
The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

Copyright: © 2024 Kavanagh 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: Kavanagh S, Pallin JA, Doherty AS et al. Prevalence and incidence of peripheral neuropathy, peripheral artery disease, foot disease, and lower extremity amputation in people with diabetes in Ireland; a systematic review protocol. [version 1; peer review: 1 approved, 1 approved with reservations]. HRB Open Res 2024, 7:1 (https://doi.org/10.12688/hrbopenres.13823.1) First published: 03 Jan 2024, 7:1 (https://doi.org/10.12688/hrbopenres.13823.1) Latest published: 21 Aug 2024, 7:1 (https://doi.org/10.12688/hrbopenres.13823.2)

Introduction

Globally, the prevalence and incidence of type 1 and type 2 diabetes mellitus continues to increase¹. With an increase in diabetes prevalence, comes an increase in diabetes related macrovascular complications, including cardiovascular, cerebrovascular, and peripheral artery disease, and microvascular complications including retinopathy, peripheral neuropathy, and nephropathy. Peripheral neuropathy and peripheral artery disease are significant risk factors for diabetic foot ulcers and lower limb amputations, each of which place a significant negative burden on those affected and on health systems, resulting in increased risk of death, poorer quality of life and significant costs to health systems^2–8. In addition, the risk of a person undergoing a lower-extremity amputation is 22 times higher in a person with diabetes when compared to a person without and up to 80% of diabetes related amputations are preceded by a diabetic foot ulcer^9,10.

To reduce the morbidity and mortality associated with these complications, timely access to appropriate health services is necessary. In line with international recommendations, this involves identifying and referring those with risk factors for ulceration and amputation to appropriate diabetic foot prevention and management services¹¹. However, evidence suggests that many people are not being screened for risk factors and there is insufficient staff to deal with service demands on diabetic foot services^12,13. One way of overcoming this is by ensuring enough resources (e.g., healthcare professionals, infrastructures, and finances) are in place to provide screening for risk factors, and implementation of prevention and management strategies for the foot at-risk of ulceration and amputation. To ensure this, up-to-date population level estimates of the incidence and prevalence of these complications are required to identify public health priorities and allow for appropriate health service planning. Previously published systematic reviews and meta-analyses have estimated a global prevalence of 6.3% for diabetic foot ulcers, with higher prevalence in North America (13%) and Africa (7.2%), and lower prevalence in Europe (5.1%), Asia (5.5%), and Oceania (3%)¹⁴. Regarding diabetic foot disease, it is estimated that between 19–34% of people with diabetes will develop this throughout their lifetime, with further evidence suggesting that years lived with diabetic foot disease is increasing globally¹⁵.

In Ireland a national diabetes registry does not exist. Thus, prevalence of diabetes and associated complications are based on estimates¹⁶. Reports suggest that the incidence of diabetes related amputations is increasing¹⁷, however, little is known about the incidence or prevalence of other diabetes related lower extremity complications. This study describes a protocol for a systematic review aiming to identify and synthesise the incidence and prevalence of diabetes related lower extremity complications in Irish populations.

Methods

This protocol was developed using the Preferred Reporting Items for Systematic Reviews and Meta-Analysis Protocols Checklist (PRISMA-P), and the Joanna Briggs Institute Manual for systematic reviews^18–20. The protocol has been registered prospectively on PROSPERO database for systematic reviews (registration number CRD42023472904).

Study aim

To identify and synthesise the incidence and prevalence of diabetes related lower extremity complications in Irish populations.

Objectives

To identify the following incidences and prevalence in Ireland:

1. Diabetes related peripheral neuropathy.
2. Diabetes related peripheral artery disease.
3. Diabetes related foot ulceration.
4. Diabetes related lower extremity amputations (total, major and minor).

Eligibility criteria

Population: Studies including people residing in the Republic of Ireland with a diagnosis of diabetes, and at least one of the following complications: peripheral neuropathy, peripheral artery disease, foot ulceration, and minor or major lower extremity amputation²¹. Studies will be excluded if data relating to the Irish population cannot be separated from other population groups (e.g., those from the United Kingdom), and where we cannot not differentiate between those with and without a diagnosis of diabetes. The populations of interest for this review will need to be populations from a defined geographical catchment area of Ireland (e.g., national population, inpatient population etc) due to the requirement of a clearly defined denominator. Publication from a single centre(s) will be excluded, unless general or diabetes-population information for the selected centres is provided or if data is adjusted or compared to the overall Irish population demographics.
Settings: Studies carried out in community settings (including GP settings, primary care centre etc) and hospital settings (including inpatient and outpatient) will be included.
Study design: Prospective and retrospective cross-sectional, case-control or cohort studies will be included. Case reports, case series, and grey literature including reports published by public bodies and informal communications will be excluded. Also, studies that do not report original data will be excluded.

There will be no restrictions on year of publication and language.

Outcomes

The outcomes of interest will be prevalence or incidence of peripheral neuropathy, peripheral artery disease, ulceration, and amputation, as defined by the International Working Group for the Diabetic Foot (IWGDF)²¹.

Search strategy

The following databases will be searched: ‘PubMed’, ‘EMBASE’, and the Irish Health Research repository ‘Lenus’ will be used. The Condition Context Population (CoCoPop) framework¹⁹ was used to inform development of the search strategy, which was developed in Embase (See Box 1) and will be adapted for use in PubMed and the Irish Health Research repository ‘Lenus’. The search strategy will utilise keywords associated with the concepts of diabetic foot disease and incidence and prevalence. Boolean operators AND, OR and proximity operators will be utilised to combine search headings, where appropriate. Backward citation searching of articles selected for full text review will also be carried out.

Box 1. Embase Search

1. peripheral AND ('neuropathy'/exp OR neuropathy)
2. 'ischemia'/exp OR 'ischemia'
3. 'peripheral vascular disease'/exp OR 'peripheral vascular disease'
4. #2 OR #3
5. 'ulcer'/exp
6. 'foot'/exp
7. #5 AND #6
8. 'foot disease'/exp
9. 'diabetic foot'/exp
10. 'amputation'/exp
11. 'limb loss'/exp
12. #11 OR #11
13. #7 OR #8 OR #9
14. Incidence/exp
15. Prevalence/exp
16. #14 OR #15
17. 'ireland'/exp
18. 'irish (citizen)'/exp OR 'irish (citizen)'
19. #17 OR #18
20. 'diabetes mellitus'/exp

For peripheral neuropathy:

21. #1 AND #16 AND #20
22. #21 AND #19

For peripheral artery disease:

23. #4 AND #16 AND #20
24. #23 AND #19

For diabetic foot ulcers:

25. #13 AND #16 AND #19
26. #13 AND #19

For amputations:

27. #12 AND #19
28. #12 AND #16 AND #20
29. #27 AND #19

Data management and study selection

Software. Mendeley reference management system will be used as a bibliography manager, and Covidence (https://www.covidence.org/) will be used for screening. The statistical Package Rev Man 5.4 will be used for meta-analysis.

Study screening and selection. Results from each database will be imported into Mendeley, and at this stage any duplicates will be removed. Identified articles will then be exported to Covidence for title and abstract screening. This will be conducted independently by two reviewers. Any conflicts at this stage will be discussed, and where consensus cannot be reached, a third reviewer will be consulted. The same process will be employed for full text screening.

Data extraction

Data extraction will be conducted by one reviewer using a standardised data extraction drafted form in Microsoft Excel then rechecked by a second reviewer for accuracy. Reviewers will not extract data from any studies in which they were an author or co-author to prevent any conflict of interest or potential bias. It will include the following details:

Author and year
Study design
Study setting e.g., hospital or community setting.
Year(s) of data collection
Population characteristics including participant age, gender, diabetes type and diabetes duration.
Outcomes of interest
- ○ Peripheral neuropathy
- ○ Peripheral artery disease
- ○ Foot ulcer
- ○ Lower extremity amputation (total, minor or major)
How outcomes were measured e.g., was it from medical chart review, clinical assessment, self-reported.

Quality assessment

The most appropriate Joanna Briggs Institute (JBI) Critical Appraisal tool will be used to assess included studies methodological quality and establish the degree to which bias was addressed in the study’s design, conduct, and analysis^19,22. To assess these parameters, the JBI checklists offer a series of questions to which ‘Yes’, ‘No’, ‘Unclear’, and ‘Not applicable’ are the provided answers. Assessment will be carried out by two reviewers independently, and where disagreements occur, a third reviewer will be consulted.

Presenting and reporting of results

A PRISMA flow diagram will be included to illustrate the study selection process. Tables will be used to allow for presentation of study characteristics, quality assessment scores and reporting of incidence and prevalence. In addition, data will be synthesised using a narrative synthesis approach to allow for comparison of similarities and the disparities between the findings of identified studies. This includes comparisons of results (prevalence and incidence of outcome of interest) between study settings, participant characteristics, measurement of outcomes, and methodological quality of included studies. In addition, if possible, subgroup comparison between national and regional studies will also be conducted. A meta-analysis will be performed if at least three publications reporting on the same outcome of interest, using similar definitions to identify the outcome, in a similar population of interest, with data collected within 10 years of each other are found. Meta-analyses will be used to calculate pooled incidence or prevalence estimates using a random-effects model, with the I² test used to examine heterogeneity across publications.

Conclusion

The systematic review outlined in this protocol will synthesise the existing evidence on incidence and prevalence of peripheral neuropathy, peripheral artery disease, ulceration, and amputation in people with diabetes residing in the Republic of Ireland. It is believed this review will help inform stakeholders on the burden of diabetic foot disease and help inform them on the appropriate use of resources to reduce the burden associated with diabetic foot disease in Ireland.

Study status

The protocol was registered prospectively with Prospero (CRD42023472904).

Ethics

Ethical approval is not required for a systematic review.

Data availability

Underlying data

No data are associated with this article.

Reporting guidelines

OSF: PRISMA-P checklist for ‘Prevalence and incidence of peripheral neuropathy, peripheral artery disease, foot disease and lower extremity amputation in people with diabetes in Ireland; a systematic review protocol’. See: https://doi.org/10.17605/OSF.IO/THD78

Author contributions

Sinead K: Conceptualization, Methodology, writing – Original Draft Preparation, writing – Review & Editing.

Pallin JA: Methodology, writing – Final Draft Preparation, writing – Review & Editing.

Lazzerini P: Methodology, Review & Editing.

O’Keeffe L: Methodology, Review & Editing.

Doherty A: : Methodology, Review & Editing.

Buckley CM: Supervision, Writing – Review & Editing.

SK is the guarantor.

Faculty Opinions recommended

References

1. Sun H, Saeedi P, Karuranga S, et al.: IDF Diabetes Atlas: Global, regional and country-level diabetes prevalence estimates for 2021 and projections for 2045. Diabetes Res Clin Pract. 2022; 183: 109119. PubMed Abstract | Publisher Full Text
2. Saluja S, Anderson SG, Hambleton I, et al.: Foot ulceration and its association with mortality in diabetes mellitus: a meta-analysis. Diabet Med. 2020; 37(2): 211–218. PubMed Abstract | Publisher Full Text
3. Ribu L, Birkeland K, Hanestad BR, et al.: A longitudinal study of patients with diabetes and foot ulcers and their health-related quality of life: wound healing and quality-of-life changes. J Diabetes Complications. 2008; 22(6): 400–407. PubMed Abstract | Publisher Full Text
4. Sekhar MS, Thomas RR, Unnikrishnan MK, et al.: Impact of diabetic foot ulcer on health-related quality of life: A cross-sectional study. Semin Vasc Surg. 2015; 28(3–4): 165–171. PubMed Abstract | Publisher Full Text
5. Brownrigg JRW, Davey J, Holt PJ, et al.: The association of ulceration of the foot with cardiovascular and all-Cause mortality in patients with diabetes: A meta-analysis. Diabetologia. 2012; 55(11): 2906–2912. PubMed Abstract | Publisher Full Text
6. Kerr M, Barron E, Chadwick P, et al.: The cost of diabetic foot ulcers and amputations to the National Health Service in England. Diabet Med. 2019; 36(8): 995–1002. PubMed Abstract | Publisher Full Text
7. Gillespie P, Kelly L, Hurley L, et al.: The effect of foot ulcers on costs of care for people with diabetes in Ireland. The Diabetic Foot Journal. 2014; 17(3): 107–12. Reference Source
8. Gooday C, Hardeman W, Game F, et al.: A qualitative study to understand people’s experiences of living with Charcot neuroarthropathy. Diabet Med. 2022; 39(6): e14784. PubMed Abstract | Publisher Full Text | Free Full Text
9. Pecoraro RE, Reiber GE, Burgess EM: Pathways to Diabetic Limb Amputation Basis for Prevention. Diabetes Care. 1990; 13(5): 513–521. PubMed Abstract | Publisher Full Text
10. Buckley CM, O’Farrell A, Canavan RJ, et al.: Trends in the incidence of lower extremity amputations in people with and without diabetes over a five-year period in the republic of Ireland. PLoS One. 2012; 7(7): e41492. PubMed Abstract | Publisher Full Text | Free Full Text
11. Bus SA, Sacco ICN, Monteiro Soares M, et al.: Guidelines on the Prevention of Foot Ulcers in Persons with Diabetes IWGDF 2023 Update. Diabetes Metab Res Rev. 2023: e3651. PubMed Abstract | Publisher Full Text
12. Pankhurst CJW, Edmonds ME: Barriers to foot care in patients with diabetes as identified by healthcare professionals. Diabet Med. 2018; 35(8): 1072–1077. PubMed Abstract | Publisher Full Text
13. O’Neill K, Riordan F, Racine E, et al.: Adoption and Initial Implementation of a National Integrated Care Programme for Diabetes: A Realist Evaluation. Int J Integr Care. 2022; 22(3): 3. PubMed Abstract | Publisher Full Text | Free Full Text
14. Zhang P, Lu J, Jing Y, et al.: Global epidemiology of diabetic foot ulceration: a systematic review and meta-analysis †. Ann Med. 2017; 49(2): 106–116. PubMed Abstract | Publisher Full Text
15. Zhang Y, Lazzarini PA, McPhail SM, et al.: Global disability burdens of diabetes-related lower-extremity complications in 1990 and 2016. Diabetes Care. 2020; 43(5): 964–974. PubMed Abstract | Publisher Full Text
16. Diabetes Ireland: Diabetes Prevalence in Ireland. Published 2022. Accessed July 31, 2023.
17. Diabetes Ireland: Diabetes Footcare Statistics 2017-2021. 2022; Accessed July 31, 2023.
18. Page MJ, McKenzie JE, Bossuyt PM, et al.: The PRISMA 2020 statement: an updated guideline for reporting systematic reviews. BMJ. 2021; 372: n71. PubMed Abstract | Publisher Full Text | Free Full Text
19. Aromataris E, Munn Z: JBI Manual for Evidence Synthesis. Joanna Briggs Institute. Publisher Full Text
20. Shamseer L, Moher D, Clarke M, et al.: Preferred reporting items for systematic review and meta-analysis protocols (PRISMA-P) 2015: elaboration and explanation. BMJ. 2015; 349: g7647. PubMed Abstract | Publisher Full Text
21. Van Netten JJ, Bus SA, Apelqvist J, et al.: Definitions and criteria for diabetes-related foot disease (IWGDF 2023 update). Diabetes Metab Res Rev. 2023; 13: 16. PubMed Abstract | Publisher Full Text
22. Barker TH, Stone JC, Sears K, et al.: Revising the JBI quantitative critical appraisal tools to improve their applicability: an overview of methods and the development process. JBI Evid Synth. 2023; 21(3): 478–493. PubMed Abstract | Publisher Full Text

Comments on this article Comments (0)

Version 2

VERSION 2 PUBLISHED 03 Jan 2024

Author details Author details

Sinead Kavanagh
Roles: Conceptualization, Methodology, Writing – Original Draft Preparation, Writing – Review & Editing

Jennifer A. Pallin
Roles: Conceptualization, Methodology, Supervision, Writing – Original Draft Preparation, Writing – Review & Editing

Ann Sinead Doherty
Roles: Methodology, Supervision, Writing – Review & Editing

Peter Lazzarini
Roles: Methodology

Linda O'Keeffe
Roles: Methodology, Writing – Review & Editing

Claire M Buckley
Roles: Conceptualization, Methodology, Supervision, Writing – Review & Editing

Competing interests

No competing interests were disclosed.

Grant information

Health Research Board Ireland [CDA-2019-007].
The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

Article Versions (2)

version 2

Revised

Published: 21 Aug 2024, 7:1

https://doi.org/10.12688/hrbopenres.13823.2

version 1

Published: 03 Jan 2024, 7:1

https://doi.org/10.12688/hrbopenres.13823.1

© 2024 Kavanagh 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.

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how to cite this article

Kavanagh S, Pallin JA, Doherty AS et al. Prevalence and incidence of peripheral neuropathy, peripheral artery disease, foot disease, and lower extremity amputation in people with diabetes in Ireland; a systematic review protocol. [version 1; peer review: 1 approved, 1 approved with reservations]. HRB Open Res 2024, 7:1 (https://doi.org/10.12688/hrbopenres.13823.1)

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

Version 1

VERSION 1

PUBLISHED 03 Jan 2024

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Reviewer Report 03 Jun 2024

Adrian H Heald, Salford Royal Hospital, University of Manchester, Manchester, UK

Approved with Reservations

https://doi.org/10.21956/hrbopenres.15133.r39652

Thank you for giving me the opportunity to review this protocol. I support the proposal.

The authors are very modest about the implications for the findings of this excellent piece of work. Please can the abstract and ... Continue reading

Thank you for giving me the opportunity to review this protocol. I support the proposal.

The authors are very modest about the implications for the findings of this excellent piece of work. Please can the abstract and overall conclusion reflect the international i,e global relevance of this piece of work

In relation to potential small improvements, re search terms it is important that 3 things be considered:

Sociodemographic situation- [Ref-1,2]
Urban vs rural location- [Ref-3]
Mobility-[Ref-4]

The relevant papers (as above) to this that should be included in the Introduction
Otherwise I am happy with the paper
Dr Adrian Heald

Is the rationale for, and objectives of, the study clearly described?

Yes
Is the study design appropriate for the research question?

Yes
Are sufficient details of the methods provided to allow replication by others?

Yes
Are the datasets clearly presented in a useable and accessible format?

Yes

References

1. Saluja S, Anderson SG, Hambleton I, Shoo H, et al.: Foot ulceration and its association with mortality in diabetes mellitus: a meta-analysis.Diabet Med. 2020; 37 (2): 211-218 PubMed Abstract | Publisher Full Text
2. Anderson SG, Shoo H, Saluja S, Anderson CD, et al.: Social deprivation modifies the association between incident foot ulceration and mortality in type 1 and type 2 diabetes: a longitudinal study of a primary-care cohort.Diabetologia. 2018; 61 (4): 959-967 PubMed Abstract | Publisher Full Text
3. Stedman M, Lunt M, Davies M, Fulton-McAlister E, et al.: Controlling antibiotic usage-A national analysis of General Practitioner/Family Doctor practices links overall antibiotic levels to demography, geography, comorbidity factors with local discretionary prescribing choices.Int J Clin Pract. 2020; 74 (8): e13515 PubMed Abstract | Publisher Full Text
4. Orlando G, Reeves ND, Boulton AJM, Ireland A, et al.: Sedentary behaviour is an independent predictor of diabetic foot ulcer development: An 8-year prospective study.Diabetes Res Clin Pract. 2021; 177: 108877 PubMed Abstract | Publisher Full Text

Competing Interests: No competing interests were disclosed.

I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above.

CITE

Report a concern

Author Response 23 Aug 2024

Jennifer Pallin, School of Public Health, University College Cork, Cork, Ireland

23 Aug 2024

Author Response
Dear Dr Heald,
Thank you for taking the time for reviewing our protocol, and for your constructive feedback. As a result, revisions have been made, and points raised have been ... Continue reading
Dear Dr Heald,
Thank you for taking the time for reviewing our protocol, and for your constructive feedback. As a result, revisions have been made, and points raised have been addressed below.

Please can the abstract and overall conclusion reflect the international i,e global relevance of this piece of work
We have updated the abstract and introduction to emphasize the impact diabetic foot disease can have on individuals and health systems globally. Based on your recommendations we have included reference number 1 and 2 to support these points.

However, we have not included reference 3 and 4, as we do not agree they strengthen the quality of the introduction section. The aim of reference 3 was to quantify the impact of different factors on levels of antibiotic prescribing choices by GP/family doctors. While we acknowledge this is an important area, particularly for people experiencing diabetic foot ulcers and infections, we do not believe inclusion of this paper strengthens the quality of the introduction section.

The aim of reference 4 was to prospectively explore the association between sedentary time (SED-time) and the development of diabetic foot ulcer (DFU) in people with diabetic peripheral neuropathy (DPN). While we acknowledge risk factors for diabetic foot ulcer onset is an important area for consider, we do not believe inclusion of this paper strengthens the quality of the introduction section. However, we acknowledge your point that we should emphasize the global relevance of this piece of work, and so we have included other internationally relevant pieces of work. We will also take this advice on board when writing the results paper.

In relation to potential small improvements, re search terms it is important that 3 things be considered:
Sociodemographic situation- [Ref-1,2]

Urban vs rural location- [Ref-3]

Mobility-[Ref-4]

We thank the reviewer for the suggestion of additional factors to consider. As we have already completed the search using the terms indicated in version 1 of the protocol we have opted not to repeat the search with these as aspects as search terms. Instead, we have included additional points for data extraction, where information on these factors is available.
Dear Dr Heald,
Thank you for taking the time for reviewing our protocol, and for your constructive feedback. As a result, revisions have been made, and points raised have been addressed below.

Please can the abstract and overall conclusion reflect the international i,e global relevance of this piece of work
We have updated the abstract and introduction to emphasize the impact diabetic foot disease can have on individuals and health systems globally. Based on your recommendations we have included reference number 1 and 2 to support these points.

However, we have not included reference 3 and 4, as we do not agree they strengthen the quality of the introduction section. The aim of reference 3 was to quantify the impact of different factors on levels of antibiotic prescribing choices by GP/family doctors. While we acknowledge this is an important area, particularly for people experiencing diabetic foot ulcers and infections, we do not believe inclusion of this paper strengthens the quality of the introduction section.

The aim of reference 4 was to prospectively explore the association between sedentary time (SED-time) and the development of diabetic foot ulcer (DFU) in people with diabetic peripheral neuropathy (DPN). While we acknowledge risk factors for diabetic foot ulcer onset is an important area for consider, we do not believe inclusion of this paper strengthens the quality of the introduction section. However, we acknowledge your point that we should emphasize the global relevance of this piece of work, and so we have included other internationally relevant pieces of work. We will also take this advice on board when writing the results paper.

In relation to potential small improvements, re search terms it is important that 3 things be considered:
Sociodemographic situation- [Ref-1,2]

Urban vs rural location- [Ref-3]

Mobility-[Ref-4]

We thank the reviewer for the suggestion of additional factors to consider. As we have already completed the search using the terms indicated in version 1 of the protocol we have opted not to repeat the search with these as aspects as search terms. Instead, we have included additional points for data extraction, where information on these factors is available.
Competing Interests: No competing interests were disclosed. Close
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COMMENTS ON THIS REPORT

Author Response 23 Aug 2024

Jennifer Pallin, School of Public Health, University College Cork, Cork, Ireland

23 Aug 2024

Author Response
Dear Dr Heald,
Thank you for taking the time for reviewing our protocol, and for your constructive feedback. As a result, revisions have been made, and points raised have been ... Continue reading
Dear Dr Heald,
Thank you for taking the time for reviewing our protocol, and for your constructive feedback. As a result, revisions have been made, and points raised have been addressed below.

Please can the abstract and overall conclusion reflect the international i,e global relevance of this piece of work
We have updated the abstract and introduction to emphasize the impact diabetic foot disease can have on individuals and health systems globally. Based on your recommendations we have included reference number 1 and 2 to support these points.

However, we have not included reference 3 and 4, as we do not agree they strengthen the quality of the introduction section. The aim of reference 3 was to quantify the impact of different factors on levels of antibiotic prescribing choices by GP/family doctors. While we acknowledge this is an important area, particularly for people experiencing diabetic foot ulcers and infections, we do not believe inclusion of this paper strengthens the quality of the introduction section.

The aim of reference 4 was to prospectively explore the association between sedentary time (SED-time) and the development of diabetic foot ulcer (DFU) in people with diabetic peripheral neuropathy (DPN). While we acknowledge risk factors for diabetic foot ulcer onset is an important area for consider, we do not believe inclusion of this paper strengthens the quality of the introduction section. However, we acknowledge your point that we should emphasize the global relevance of this piece of work, and so we have included other internationally relevant pieces of work. We will also take this advice on board when writing the results paper.

In relation to potential small improvements, re search terms it is important that 3 things be considered:
Sociodemographic situation- [Ref-1,2]

Urban vs rural location- [Ref-3]

Mobility-[Ref-4]

We thank the reviewer for the suggestion of additional factors to consider. As we have already completed the search using the terms indicated in version 1 of the protocol we have opted not to repeat the search with these as aspects as search terms. Instead, we have included additional points for data extraction, where information on these factors is available.
Dear Dr Heald,
Thank you for taking the time for reviewing our protocol, and for your constructive feedback. As a result, revisions have been made, and points raised have been addressed below.

Please can the abstract and overall conclusion reflect the international i,e global relevance of this piece of work
We have updated the abstract and introduction to emphasize the impact diabetic foot disease can have on individuals and health systems globally. Based on your recommendations we have included reference number 1 and 2 to support these points.

However, we have not included reference 3 and 4, as we do not agree they strengthen the quality of the introduction section. The aim of reference 3 was to quantify the impact of different factors on levels of antibiotic prescribing choices by GP/family doctors. While we acknowledge this is an important area, particularly for people experiencing diabetic foot ulcers and infections, we do not believe inclusion of this paper strengthens the quality of the introduction section.

The aim of reference 4 was to prospectively explore the association between sedentary time (SED-time) and the development of diabetic foot ulcer (DFU) in people with diabetic peripheral neuropathy (DPN). While we acknowledge risk factors for diabetic foot ulcer onset is an important area for consider, we do not believe inclusion of this paper strengthens the quality of the introduction section. However, we acknowledge your point that we should emphasize the global relevance of this piece of work, and so we have included other internationally relevant pieces of work. We will also take this advice on board when writing the results paper.

In relation to potential small improvements, re search terms it is important that 3 things be considered:
Sociodemographic situation- [Ref-1,2]

Urban vs rural location- [Ref-3]

Mobility-[Ref-4]

We thank the reviewer for the suggestion of additional factors to consider. As we have already completed the search using the terms indicated in version 1 of the protocol we have opted not to repeat the search with these as aspects as search terms. Instead, we have included additional points for data extraction, where information on these factors is available.
Competing Interests: No competing interests were disclosed. Close
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Reviewer Report 22 Mar 2024

Zena Moore, RCSI University of Medicine and Health Sciences, Dublin, Ireland

Approved

https://doi.org/10.21956/hrbopenres.15133.r38450

Many thanks for this protocol for a very important systematic review. The methods are in general clearly described, however, there are 2 minor issues for clarification. 1. In terms of data extraction, given that you are interested in incidence as well as prevalence, length of patient follow up should be extracted, where this information is available. 2. In terms of quality appraisal, you are vague regarding which exact quality appraisal tool(s) will be employed, I think you could provide some concrete examples, given that you have said that the following study designs are eligible for inclusion: Prospective and retrospective cross-sectional, case-control or cohort studies.

Is the rationale for, and objectives of, the study clearly described?

Yes
Is the study design appropriate for the research question?

Yes
Are sufficient details of the methods provided to allow replication by others?

Yes
Are the datasets clearly presented in a useable and accessible format?

Yes

Competing Interests: No competing interests were disclosed.

Reviewer Expertise: Systematic review methods.

I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard.

CITE

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Author Response 23 Aug 2024

Jennifer Pallin, School of Public Health, University College Cork, Cork, Ireland

23 Aug 2024

Author Response

Dear Prof Moore,
Thank you for taking the time for reviewing our protocol, and for your constructive feedback. Also, thank you for approving our protocol. However, based on your ... Continue reading
Dear Prof Moore,
Thank you for taking the time for reviewing our protocol, and for your constructive feedback. Also, thank you for approving our protocol. However, based on your feedback, revisions have been made and points raised have been addressed below.

In terms of data extraction, given that you are interested in incidence as well as prevalence, length of patient follow up should be extracted, where this information is available
Based on your feedback, we have included length of follow-up in data extraction. We have ammended the protocol to reflect this.

In terms of quality appraisal, you are vague regarding which exact quality appraisal tool(s) will be employed, I think you could provide some concrete examples, given that you have said that the following study designs are eligible for inclusion: Prospective and retrospective cross-sectional, case-control or cohort studies.
Regarding quality appraisal, we acknowledge we were vague on exactly what JBI quality appraisal tool we would use. We have taken this feedback on board, and will make sure it is clearly stated in the final systematic review publication.

Dear Prof Moore,
Thank you for taking the time for reviewing our protocol, and for your constructive feedback. Also, thank you for approving our protocol. However, based on your feedback, revisions have been made and points raised have been addressed below.

In terms of data extraction, given that you are interested in incidence as well as prevalence, length of patient follow up should be extracted, where this information is available
Based on your feedback, we have included length of follow-up in data extraction. We have ammended the protocol to reflect this.

In terms of quality appraisal, you are vague regarding which exact quality appraisal tool(s) will be employed, I think you could provide some concrete examples, given that you have said that the following study designs are eligible for inclusion: Prospective and retrospective cross-sectional, case-control or cohort studies.
Regarding quality appraisal, we acknowledge we were vague on exactly what JBI quality appraisal tool we would use. We have taken this feedback on board, and will make sure it is clearly stated in the final systematic review publication.
Competing Interests: No competing interests were disclosed. Close
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COMMENTS ON THIS REPORT

Author Response 23 Aug 2024

Jennifer Pallin, School of Public Health, University College Cork, Cork, Ireland

23 Aug 2024

Author Response

Dear Prof Moore,
Thank you for taking the time for reviewing our protocol, and for your constructive feedback. Also, thank you for approving our protocol. However, based on your ... Continue reading
Dear Prof Moore,
Thank you for taking the time for reviewing our protocol, and for your constructive feedback. Also, thank you for approving our protocol. However, based on your feedback, revisions have been made and points raised have been addressed below.

In terms of data extraction, given that you are interested in incidence as well as prevalence, length of patient follow up should be extracted, where this information is available
Based on your feedback, we have included length of follow-up in data extraction. We have ammended the protocol to reflect this.

In terms of quality appraisal, you are vague regarding which exact quality appraisal tool(s) will be employed, I think you could provide some concrete examples, given that you have said that the following study designs are eligible for inclusion: Prospective and retrospective cross-sectional, case-control or cohort studies.
Regarding quality appraisal, we acknowledge we were vague on exactly what JBI quality appraisal tool we would use. We have taken this feedback on board, and will make sure it is clearly stated in the final systematic review publication.

Dear Prof Moore,
Thank you for taking the time for reviewing our protocol, and for your constructive feedback. Also, thank you for approving our protocol. However, based on your feedback, revisions have been made and points raised have been addressed below.

In terms of data extraction, given that you are interested in incidence as well as prevalence, length of patient follow up should be extracted, where this information is available
Based on your feedback, we have included length of follow-up in data extraction. We have ammended the protocol to reflect this.

In terms of quality appraisal, you are vague regarding which exact quality appraisal tool(s) will be employed, I think you could provide some concrete examples, given that you have said that the following study designs are eligible for inclusion: Prospective and retrospective cross-sectional, case-control or cohort studies.
Regarding quality appraisal, we acknowledge we were vague on exactly what JBI quality appraisal tool we would use. We have taken this feedback on board, and will make sure it is clearly stated in the final systematic review publication.
Competing Interests: No competing interests were disclosed. Close
Report a concern

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Version 2

VERSION 2 PUBLISHED 03 Jan 2024

Open Peer Review

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Reviewer Reports

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	1	2	3
Version 2 (revision) 21 Aug 24	read		read
Version 1 03 Jan 24	read	read

Zena Moore, RCSI University of Medicine and Health Sciences, Dublin, Ireland
Adrian H Heald, University of Manchester, Manchester, UK
Zulfiqarali G Abbas, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania

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Reviewer Report

15 Views

13 Nov 2024 | for Version 2

Zulfiqarali G Abbas, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania

15 Views Cite this report Responses(0)

Approved With Reservations

Your Report

Title: Prevalence and incidence of peripheral neuropathy, peripheral artery disease, foot disease, and lower extremity amputation in people with diabetes in Ireland
Strengths

Clear research aims and relevance: The protocol addresses a significant gap in diabetic foot disease epidemiology in Ireland, given the absence of a national diabetes registry. By providing prevalence and incidence estimates, this review could inform stakeholders about the need for targeted interventions.
Comprehensive Methodology: The protocol follows the PRISMA-P guidelines, with a structured approach to data collection, screening, and analysis.
Detailed inclusion and exclusion criteria: The well-defined criteria for population, settings, and study design ensure consistency and clarity in study selection, minimising bias.
Appropriate Data Extraction and Quality Assessment: The use of the Joanna Briggs Institute (JBI) tool for critical appraisal shows an attempt to ensure methodological rigor. The protocol also accounts for relevant factors like sociodemographic, urban versus rural location, and patient mobility.

Limitations and Areas for Improvement

Lack of Specific Quality Assessment Tools: While the protocol mentions the use of JBI tools, it doesn’t specify the exact tools for different study designs, which could limit clarity.
Limited Scope in Search Strategy: While the Coco Pop framework is used, the search strategy could be expanded to include more databases to ensure broader coverage. Limiting the search to PubMed, EMBASE, and Lenus might overlook grey literature that may not be present in mainstream databases.
Ambiguity in Meta-Analysis Plans: Although a meta-analysis is proposed if criteria are met, there is no indication of how data heterogeneity will be managed or the potential use of meta-regression to account for varying study characteristics.
Justification for Excluding Single-Centre Studies: Excluding single-centre studies may limit the review’s comprehensiveness. Including a rationale for this decision would strengthen the protocol.

Is the rationale for, and objectives of, the study clearly described?

Yes
Is the study design appropriate for the research question?

Yes
Are sufficient details of the methods provided to allow replication by others?

Yes
Are the datasets clearly presented in a useable and accessible format?

Yes

Competing Interests

No competing interests were disclosed.

Reviewer Expertise

Consultant Physician, Diabetologist and diabetic related foot complications

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Reviewer Report

16 Views

27 Aug 2024 | for Version 2

Zena Moore, RCSI University of Medicine and Health Sciences, Dublin, Ireland

16 Views Cite this report Responses(0)

Approved

I have no new comments to make

Competing Interests

No competing interests were disclosed.

Reviewer Expertise

Systematic review methods.

I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard.

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Reviewer Report

45 Views

03 Jun 2024 | for Version 1

Adrian H Heald, Salford Royal Hospital, University of Manchester, Manchester, UK

45 Views Cite this report Responses(1)

Approved With Reservations

Sociodemographic situation- [Ref-1,2]
Urban vs rural location- [Ref-3]
Mobility-[Ref-4]

The relevant papers (as above) to this that should be included in the Introduction
Otherwise I am happy with the paper
Dr Adrian Heald

Is the rationale for, and objectives of, the study clearly described?

Yes
Is the study design appropriate for the research question?

Yes
Are sufficient details of the methods provided to allow replication by others?

Yes
Are the datasets clearly presented in a useable and accessible format?

Yes

References

Competing Interests

No competing interests were disclosed.

Respond to this report

Responses (1)

Author Response

23 Aug 2024

Jennifer Pallin, School of Public Health, University College Cork, Cork, Ireland

Dear Dr Heald,
Thank you for taking the time for reviewing our protocol, and for your constructive feedback. As a result, revisions have been made, and points raised have been addressed below.

Please can the abstract and overall conclusion reflect the international i,e global relevance of this piece of work
We have updated the abstract and introduction to emphasize the impact diabetic foot disease can have on individuals and health systems globally. Based on your recommendations we have included reference number 1 and 2 to support these points.

However, we have not included reference 3 and 4, as we do not agree they strengthen the quality of the introduction section. The aim of reference 3 was to quantify the impact of different factors on levels of antibiotic prescribing choices by GP/family doctors. While we acknowledge this is an important area, particularly for people experiencing diabetic foot ulcers and infections, we do not believe inclusion of this paper strengthens the quality of the introduction section.

The aim of reference 4 was to prospectively explore the association between sedentary time (SED-time) and the development of diabetic foot ulcer (DFU) in people with diabetic peripheral neuropathy (DPN). While we acknowledge risk factors for diabetic foot ulcer onset is an important area for consider, we do not believe inclusion of this paper strengthens the quality of the introduction section. However, we acknowledge your point that we should emphasize the global relevance of this piece of work, and so we have included other internationally relevant pieces of work. We will also take this advice on board when writing the results paper.

In relation to potential small improvements, re search terms it is important that 3 things be considered:
Sociodemographic situation- [Ref-1,2]

Urban vs rural location- [Ref-3]
Mobility-[Ref-4]

We thank the reviewer for the suggestion of additional factors to consider. As we have already completed the search using the terms indicated in version 1 of the protocol we have opted not to repeat the search with these as aspects as search terms. Instead, we have included additional points for data extraction, where information on these factors is available.

View more View less

Competing Interests

No competing interests were disclosed.

Back to all reports

Reviewer Report

50 Views

22 Mar 2024 | for Version 1

Zena Moore, RCSI University of Medicine and Health Sciences, Dublin, Ireland

50 Views Cite this report Responses(1)

Approved

Is the rationale for, and objectives of, the study clearly described?

Yes
Is the study design appropriate for the research question?

Yes
Are sufficient details of the methods provided to allow replication by others?

Yes
Are the datasets clearly presented in a useable and accessible format?

Yes

Competing Interests

No competing interests were disclosed.

Reviewer Expertise

Systematic review methods.

I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard.

Respond to this report

Responses (1)

Author Response

23 Aug 2024

Jennifer Pallin, School of Public Health, University College Cork, Cork, Ireland

Dear Prof Moore,
Thank you for taking the time for reviewing our protocol, and for your constructive feedback. Also, thank you for approving our protocol. However, based on your feedback, revisions have been made and points raised have been addressed below.

In terms of data extraction, given that you are interested in incidence as well as prevalence, length of patient follow up should be extracted, where this information is available
Based on your feedback, we have included length of follow-up in data extraction. We have ammended the protocol to reflect this.

In terms of quality appraisal, you are vague regarding which exact quality appraisal tool(s) will be employed, I think you could provide some concrete examples, given that you have said that the following study designs are eligible for inclusion: Prospective and retrospective cross-sectional, case-control or cohort studies.
Regarding quality appraisal, we acknowledge we were vague on exactly what JBI quality appraisal tool we would use. We have taken this feedback on board, and will make sure it is clearly stated in the final systematic review publication.

View more View less

Competing Interests

No competing interests were disclosed.

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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Prevalence and incidence of peripheral neuropathy, peripheral artery disease, foot disease, and lower extremity amputation in people with diabetes in Ireland; a systematic review protocol.

Abstract

Introduction

Methods

Conclusion

Systematic review registration

Keywords

Introduction

Methods

Study aim

Objectives

Eligibility criteria

Outcomes

Search strategy

Box 1. Embase Search

Data management and study selection

Data extraction

Quality assessment

Presenting and reporting of results

Conclusion

Study status

Ethics

Data availability

Underlying data

Reporting guidelines

Author contributions

References

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Prevalence and incidence of peripheral neuropathy, peripheral artery disease, foot disease, and lower extremity amputation in people with diabetes in Ireland; a systematic review protocol.

Abstract

Introduction

Methods

Conclusion

Systematic review registration

Keywords

Introduction

Methods

Study aim

Objectives

Eligibility criteria

Outcomes

Search strategy

Box 1. Embase Search

Data management and study selection

Data extraction

Quality assessment

Presenting and reporting of results

Conclusion

Study status

Ethics

Data availability

Underlying data

Reporting guidelines

Author contributions

References

Comments on this article Comments (0)

Open Peer Review

Comments on this article Comments (0)

Open Peer Review

Reviewer Status

Reviewer Reports

Comments on this article

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Are you a HRB-funded researcher?

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