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Study Protocol

A scoping review protocol to identify strategies to implement evidence-based diabetic foot disease guidelines for healthcare professionals in primary care

[version 1; peer review: 3 approved with reservations]
PUBLISHED 21 Mar 2023
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Abstract

Background: Diabetes mellitus has been identified as a serious global public health concern. Diabetic foot disease is one of four major complications that impacts on people with the disease and health systems. The majority of diabetic foot care, including screening and treatment, occurs in the primary care sector. To provide optimal care, evidence-based guidance is essential for all healthcare professionals. There is little known about the implementation of these guidelines in primary care settings. The aim of this scoping review will be to identify strategic components used to support the implementation of diabetic foot disease evidence-based practice guidelines by healthcare professionals in primary care.
Methods: A scoping review drawing on methods and guidance from the Joanna Briggs Institute will be conducted and will be reported according to the PRISMA-ScR Checklist. This study will retrieve literature on strategic components used to implement diabetic foot disease evidence-based practice guidelines by health professionals in primary care, through a comprehensive search strategy in the following databases: CINAHL; Medline (Ovid); Embase; the Cochrane Library; and PsycINFO. Grey literature will be searched within the references of identified articles and in Lenus, BASE and LILACS. A data charting form will be developed with categories including: article details, population demographics, implementation strategies, strategy details, and evaluation methods such as feasibility and effectiveness, duration of intervention and duration of follow up.
Conclusions: Promoting foot care for people with diabetes in the primary care setting can make a significant impact on overall outcomes for the person and the health service. However, without the transition of evidence-based guidelines to practice, the impact can be difficult to assess. This study will map the evidence that can assist the transfer of evidence-based practice guidelines for diabetic foot care to healthcare professionals in primary care.

Keywords

diabetic foot disease, primary care, implementation, evidence-based guidelines

Introduction

The prevalence of diabetes mellitus and its’ associated complications is increasing globally1,2. All people with diabetes mellitus are at risk of developing diabetic foot disease (DFD), with a lifetime incidence of between 19 and 34%3. The presence of one or more risk factors of DFD can put the person at risk of ulceration and possible amputation4. The key risk factors are loss of protective sensation, peripheral arterial disease, foot deformity, a history of foot ulceration and previous lower extremity amputation5. Diabetic foot ulcers (DFU) have a significant impact on morbidity, mortality and quality of life610. The five year mortality rates following major amputation have been found to be comparable to cancer mortality rates, being as high as 56%11. It has also been established that there is a significant impact on the quality of life of people living with diabetes mellitus who suffer from DFD, with increased risk of foot ulceration and amputation9. DFD has been recognized as a significant financial burden to health care systems10,12. It is the treatment associated with the complication of DFD that constitutes the majority of the spending9. An Australian study examined the proportion of funding spent in the health system on the four major complications of diabetes mellitus including; cardiovascular disease, renal disease, ocular disease and DFD13. They found that DFD had the second highest burden on health services, but had the least funding associated with this complication13.

Research has highlighted that when resources are invested into the prevention and treatment of DFD it can have significant benefits for people at risk1420. The International Working Group on the Diabetic Foot (IWGDF), has identified screening and early identification of the “at risk” foot as being an important part of any health service strategy to prevent complications3. To successfully manage DFD, a multi-disciplinary approach is advocated internationally2125. The provision of screening and care for the “at risk” foot and treatment of active DFD is more efficient when provided in primary care with an integrated pathway for referral to tertiary services21,26,27. In a study examining the priorities of primary care professionals when assessing people with diabetes mellitus, it was reported that foot care was a low priority28. They found that unless the person presented with either a break in the skin of their foot or complained of tingling in the foot there was a low chance of foot care being a priority28. Some of the barriers identified to providing foot care for people with diabetes mellitus by health professionals include lack of education and training for health professionals, lack of guidelines and referral pathways, lack of access to appropriate professionals and lack of time in the clinical areas2933. While there is a dearth of information on enablers to implementing evidence-based practice for DFD, education and training, foot specialist teams and standardized assessment tools being available to health professionals were identified to improve diabetic foot care29,34.

The Joanna Briggs Institute (JBI) suggest that evidence implementation is a purposeful and enabling set of activities designed to engage key stakeholders with research evidence to inform decision-making and generate sustained improvement in the quality of healthcare delivery35. Implementation of evidence-based practice can enhance healthcare safety and improve patient outcomes. However, implementing evidence-based practice can be challenging, particularly in the primary healthcare setting, with very little consensus in the literature as to the best way to proceed3638. This scoping review aims to map the evidence on strategies that have been used to support primary care health professionals in the implementation of evidence-based guidelines as it relates to DFD39,40.

Protocol

Methods

This scoping review will be conducted in accordance with the guidelines from the Joanna Briggs Institute41 and reported according to the Preferred Reporting Items for Systematic Review and Meta-Analyses extension for Scoping Reviews (PRISMA-ScR) Checklist42.

Stage 1: Identifying the research question

The “Population, Context, Concept” (“PCC”) framework was used to determine the research question, while accounting for the methods from the JBI43 and Arksey and O’Malley’s (2005) scoping review framework44. The PCC helps construct a title without the need for outcomes, interventions or phenomena of interest43.

In this scoping review the population is health professionals working in primary care (Table 1). As terms for these health professionals can differ between health care systems this list is not exhaustive and may be added to, as different terms are identified in the literature. Concept refers to strategies used to implement DFD evidence-based guidelines. Strategy refers to studies with details of a multifaceted or single component strategy45. These components may be part of a wider strategy to improve diabetes care. The context is a healthcare environment providing care to people at risk of DFD outside the hospital environment. The term used will initially be primary care, but as the literature is searched, any other terms that have the same meaning will be used in the search strategy.

Table 1. PCC Framework.

PCC, Population, Context, Concept; DFD, diabetic foot disease.

CriteriaDeterminants
PopulationHealth professionals: practice nurses, public health nurses, community nurses, general practitioners, diabetic
clinical nurse specialist, podiatrists and other health professionals identified in the literature as being involved
diabetic foot care.
ConceptStrategies used to implement DFD evidence-based guidelines.
ContextPrimary care.

Primary research question

The primary research question is as follows: What strategies are used to implement diabetic foot care evidence-based practice guidelines in primary care by health professionals?

Secondary research questions

The secondary research questions are as follows:

  • What components are integrated into the strategies?

  • What implementation barriers and facilitators were identified in the studies?

  • What methods were used to evaluate the strategy?

  • What outcome measures were reported within each paper?

  • How and when were the outcomes assessed?

Stage 2: Identifying relevant studies

This study will retrieve relevant literature through a comprehensive search strategy (Table 2) in the MEDLINE (RRID:SCR_002185) database and then adopted for use in EBSCO CINAHL (RRID:SCR_022707); EMBASE (RRID:SCR_001650); the Cochrane Library (RRID:SCR_013000) and PsycINFO (RRID:SCR_014799). Grey literature will be searched within the references of identified articles and using; Lenus (Irish Health Research Repository); The Bielefeld Academic Search Engine (BASE) and Latin American and Caribbean Health Science Literature (LILACS). The search strategy was populated from a combination of free text search terms, text words, Medical Subject Headings (MeSH) terms and keywords with Boolean operators. Search terms will be used in combination with search filters to tailor for each database. The search strategy was developed with advice from a research librarian with expertise in the area of strategy development. The selected keywords and search string, relevant to Medline via Ovid, can be found in Table 2. Results from the search will be imported into Rayyan QCRI (RRID:SCR_017584), a review manager software, whereby citations will be collated and duplicates will be removed46.

Table 2. Search strategy for Medline (Ovid).

LineSearch term
1.Diabetic angiopathies/
2.Exp Diabetes complications/
3.Diabetic neuropathies/
4.Exp Diabetic foot/
5.(“Diabetic foot” adj3 ulcer*).tw.
6.(“Diabetic foot” adj3 wound*).tw.
7.“diabetic foot”.tw.
8.(Diabetes adj3 “type 2”).tw.
9.1 or 2 or 3 or 4 or 5 or 6 or 7or 8
10.Implementation science/
11.Health plan implementation/
12.Implement*.tw.
13.10 or 11 or 12
14.Primary Health Care/
15.(Primary adj2 care).tw.
16.Community care/
17.14 or 15
18.Exp Evidence-based practice/
19.(evidence adj2 based-practice).tw.
20.(evidence adj2 based practice).tw.
21.Guideline*.tw.
22.17 or 18 or 19 or 20
23.Health personnel/
24.((Healthcare or “health care”) adj2 professional*).tw.
25.((Healthcare or “health care”) adj2 provi*).tw.
26.((Healthcare or “health care”) adj2 personnel).tw.
27.((Healthcare or “health care”) adj2 worker*).tw.
28.22 or 23 or 24 or 25 or 26

Stage 3: Study selection

To ensure all relevant literature is captured, any intervention for healthcare professionals to implement diabetic foot care will be considered. Study selection will be based on the inclusion criteria provided in Table 3.

Table 3. Inclusion/exclusion criteria.

Inclusion criteriaExclusion criteria
Qualified health professionals to include practice nurses, public health nurses,
community nurses, general practitioners, diabetic clinical nurse specialists,
podiatrists, and other health professionals identified in the literature as being
involved in diabetic foot care.
Studies that look at interventions carried out by
non-qualified personnel, for example self-care
by the person with diabetes.
Settings: Primary care.Any setting that is not a primary care setting.
Strategies: Any strategy containing one or more components aimed at healthcare
professionals to implement diabetic foot care.
Strategies that are not aimed at health
professionals.
Study designs to include but not limited to randomized controlled trials, controlled
clinical trials, cohort studies, case series, case cohorts, systematic reviews.
Opinion pieces will not be included.
Articles must report on implementation of evidence-based guidelines for diabetic
foot disease.
All articles from inception of journal.

Similar to previous research, the selection of sources and evidence will take place over four steps47:

  • Step 1: Initial retrieval of sources, which will be performed by one author.

  • Step 2: Title screening. Titles will be screened against the inclusion criteria and will be retained accordingly. This step will be performed by two authors working independently, with any unresolved disagreements reviewed by a third author.

  • Step 3: Abstract screening. Abstracts will be screened against the inclusion criteria and retained accordingly. This step will be performed by two authors working independently. Unresolved disagreements between authors will be reviewed by a third author.

  • Step 4: Full text review. Articles will be retained if compliant with inclusion criteria. This will be performed by two authors and any disagreement will be reviewed by a third author. Numbers of articles included and excluded will be documented using the PRISMA-ScR standardised template42.

Stage 4: Charting the data

The extraction form will be collated based on the JBI template source of evidence details, characteristics and results extraction instrument41, evaluation methods and insight from previous work48. A data charting form will be developed drawing on categories, as agreed by the research team. The form will capture:

  • Study data such as authorship, publication year, article type, study design, country of origin, setting, sample size and study objectives.

  • Population demographics including gender and age.

  • Implementation strategies components.

  • What was the duration of the intervention and the duration of follow up?

  • Barriers and facilitators to implementing the strategy that were identified.

  • Evaluation methods used and what the evaluation method measured such as feasibility, efficacy, effectiveness.

  • What outcomes measures were reported?

  • How and when were the outcomes assessed?

Stage 5: Collating, summarizing, and reporting of results

Descriptive statistical analysis will be completed across categories and data reported for each selected study in tables and graphs. All entries will be checked by two authors.

Dissemination

The findings will be published in an open access peer-reviewed journal and made available on ARAN, University of Galway open access repository, subject to the open-access policies of the original publishers. The findings will be presented at a relevant international conference. Social media platforms will be used to promote the final paper once published.

Study status

This study has not yet been initiated.

Discussion

This scoping review will provide an overview of the evidence available to healthcare professionals in primary care to allow strategies to be devised for the implementation of the evidence-based guidance in relation to DFD. Any barriers or facilitators identified will also be presented to allow practitioners and organizations learn from these. The ability of practitioners and organizations to be able to anticipate barriers and facilitators prior to implementation of a strategy can lead to a greater uptake in the intervention by the population it is aimed at. This scoping review will provide the research base to allow all health care services in primary care diabetic foot care to be aware of the barriers and facilitators that they may encounter while devising an implementation strategy for diabetic foot care.

Promoting the foot care of people with diabetes in the primary care setting can make a significant impact on overall outcomes for the patient and their carers. There is also significant benefit to the health service in terms of cost and efficient use of resources. Improving the service for prevention and treatment of DFD in primary care will have a positive effect on the tertiary services, in terms of decreasing bed days and amputations. Evaluating the different elements of the implementation of a strategy is important. This paper will provide an overview of how different strategies are used to implement evidence-based guidelines. It will also identify how these strategies are evaluated in primary care and the outcome measure used internationally. The transition of evidence-based guidelines into practice can be difficult to assess, the evidence from this scoping review will provide a synthesis of outcomes that can be used by health service providers to assess their implementation strategies for diabetic foot care. This will be valuable for health service providers to ensure that resources put into diabetic foot care can be assessed in terms of outcomes for people with diabetes. This study will gather evidence that can assist health systems to transfer evidence-based practice for patients with diabetes at risk of DFD to primary health care professionals.

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how to cite this article
Naughten E, Giltenane M, O'Brien T et al. A scoping review protocol to identify strategies to implement evidence-based diabetic foot disease guidelines for healthcare professionals in primary care [version 1; peer review: 3 approved with reservations]. HRB Open Res 2023, 6:20 (https://doi.org/10.12688/hrbopenres.13665.1)
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
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 21 Mar 2023
Views
11
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Reviewer Report 06 Dec 2024
Mullan Leanne, Health Sciences, Australian Catholic University (Ringgold ID: 95359), Banyo, Brisbane, Australia 
Approved with Reservations
VIEWS 11
Thank you for the opportunity to review this study protocol, detailing a literature review focusing on the strategies to implement diabetes-related foot care guidelines into primary care. 

Please see my comments/feedback below.

- Just ... Continue reading
CITE
CITE
HOW TO CITE THIS REPORT
Leanne M. Reviewer Report For: A scoping review protocol to identify strategies to implement evidence-based diabetic foot disease guidelines for healthcare professionals in primary care [version 1; peer review: 3 approved with reservations]. HRB Open Res 2023, 6:20 (https://doi.org/10.21956/hrbopenres.14944.r35205)
NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article.
Views
28
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Reviewer Report 30 Nov 2023
Vikrant Rai, Western University of Health Sciences, 309 E. Second Street, Pomona, CA, USA 
Approved with Reservations
VIEWS 28
The article proposes to conduct a comprehensive study to outline the evidence-based guidelines for DFU and care for the diabetic foot during diabetic patients' visits to primary care. 

The protocol, inclusion, and exclusion criteria have been mentioned ... Continue reading
CITE
CITE
HOW TO CITE THIS REPORT
Rai V. Reviewer Report For: A scoping review protocol to identify strategies to implement evidence-based diabetic foot disease guidelines for healthcare professionals in primary care [version 1; peer review: 3 approved with reservations]. HRB Open Res 2023, 6:20 (https://doi.org/10.21956/hrbopenres.14944.r35556)
NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article.
Views
27
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Reviewer Report 30 Nov 2023
Virginie Blanchette, Department of Human Kinetics and Podiatric Medicine, Université du Québec à Trois-Rivières, Trois-Rivières, QC, Canada 
Approved with Reservations
VIEWS 27
Thank you for the opportunity to review this project, which I find very relevant. This is a scoping-type knowledge synthesis aimed at identifying studies reporting data following the implementation of good practices in the prevention and management of diabetic plantar ulcers. ... Continue reading
CITE
CITE
HOW TO CITE THIS REPORT
Blanchette V. Reviewer Report For: A scoping review protocol to identify strategies to implement evidence-based diabetic foot disease guidelines for healthcare professionals in primary care [version 1; peer review: 3 approved with reservations]. HRB Open Res 2023, 6:20 (https://doi.org/10.21956/hrbopenres.14944.r33575)
NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article.

Comments on this article Comments (0)

Version 1
VERSION 1 PUBLISHED 21 Mar 2023
Comment
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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