A Protocol for a Scoping Review to assess the influence of psychological factors on the development and progression of diabetes-related foot ulcers

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McGuire" }, { "@type": "Person", "name": "Claire MacGilchrist" }, { "@type": "Person", "name": "Rosie Dunne" }, { "@type": "Person", "name": "Ellen Kirwan" }, { "@type": "Person", "name": "Deirdre Ní Neachtain" }, { "@type": "Person", "name": "Ketan Dhatariya" }, { "@type": "Person", "name": "Virginie Blanchette" }, { "@type": "Person", "name": "Hannah Durand" }, { "@type": "Person", "name": "Anda Dragomir" }, { "@type": "Person", "name": "Caroline McIntosh" } ], "publisher": { "@type": "Organization", "name": "HRB Open Research", "logo": { "@type": "ImageObject", "url": "https://hrbopenresearch.org/img/AMP/HRB_image.png", "height": 566, "width": 60 } }, "image": { "@type": "ImageObject", "url": "https://hrbopenresearch.org/img/AMP/HRB_image.png", "height": 1200, "width": 127 }, "description": " Introduction Diabetes-related foot ulcers (DFUs) are a major complication of diabetes and are associated with high morbidity and mortality rates. Psychological factors have been found to play a role in wound healing (Frasier et al., 2024; Robinson et al., 2017; Walburn et al., 2009) but it remains uncertain if psychological interventions can help individuals with an active DFU, or a history of DFUs, to achieve complete or improved wound healing or prevent recurrence. Objective A recent Cochrane review by McGloin et al. (2021) examined existing psychological interventions for individuals with DFU and emphasized the need for more interventions and stronger study designs to evaluate their efficacy. Building on this, the proposed scoping review aims to: 1) Investigate the emotional consequences and burdens of living with DFU, and 2) Examine how psychosocial factors influence the progression and management of ulcerations. Methods This review will be conducted in accordance with the Joanna Briggs Institute methodology for scoping reviews and the Preferred Reporting Items for Systematic reviews and Meta-Analysis extension for Scoping Reviews (PRISMA-ScR) will guide the reporting of results. Discussion While factors such as stress, depression and social support have been identified as variables that may negatively affect DFU healing, there is a need for a greater understanding of how variables such as these may influence progression and recurrence. This review will comprise of a broad and systematically mapped synthesis of the identified data. Following this review, qualitative studies will be conducted, and their findings, along with those from the scoping review, will inform the development of a psychological intervention that will aim to improve psychosocial functioning and mitigate the progression and recurrence of DFUs. 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HRB Open Res 2025, 7 :18 ( https://doi.org/10.12688/hrbopenres.13755.3 ) NOTE: If applicable, it is important to ensure the information in square brackets after the title is included in all citations of this article. Close Copy Citation Details Export Export Citation Sciwheel EndNote Ref. Manager Bibtex ProCite Sente EXPORT Select a format first Track Share ▬ ✚ Study Protocol Revised A Protocol for a Scoping Review to assess the influence of psychological factors on the development and progression of diabetes-related foot ulcers [version 3; peer review: 6 approved with reservations, 2 not approved] Michelle Hanlon 1,2 , Brian E. McGuire 1,2 , Claire MacGilchrist https://orcid.org/0000-0003-3660-9072 2-4 , [...] Rosie Dunne https://orcid.org/0000-0003-2256-5590 5 , Ellen Kirwan https://orcid.org/0000-0003-1169-8232 3 , Deirdre Ní Neachtain 6 , Ketan Dhatariya https://orcid.org/0000-0003-3619-9579 7,8 , Virginie Blanchette https://orcid.org/0000-0002-5901-8964 9 , Hannah Durand https://orcid.org/0000-0002-8761-0519 10 , Anda Dragomir https://orcid.org/0000-0002-5083-018X 11 , Caroline McIntosh https://orcid.org/0000-0003-1801-9554 2-4 Michelle Hanlon 1,2 , Brian E. McGuire 1,2 , [...] Claire MacGilchrist https://orcid.org/0000-0003-3660-9072 2-4 , Rosie Dunne https://orcid.org/0000-0003-2256-5590 5 , Ellen Kirwan https://orcid.org/0000-0003-1169-8232 3 , Deirdre Ní Neachtain 6 , Ketan Dhatariya https://orcid.org/0000-0003-3619-9579 7,8 , Virginie Blanchette https://orcid.org/0000-0002-5901-8964 9 , Hannah Durand https://orcid.org/0000-0002-8761-0519 10 , Anda Dragomir https://orcid.org/0000-0002-5083-018X 11 , Caroline McIntosh https://orcid.org/0000-0003-1801-9554 2-4 PUBLISHED 03 Mar 2025 Author details Author details 1 School of Psychology & Centre for Pain Research, University of Galway, Galway, County Galway, H91 TK33, Ireland 2 CDA Diabetic Foot Disease: from PRevention to Improved Patient Outcomes (HRB CDA DFD PRIMO) programme, University of Galway, Galway, County Galway, H91 TK33, Ireland 3 Discipline of Podiatric Medicine, School of Health Sciences, University of Galway, Galway, County Galway, H91 TK33, Ireland 4 Alliance for Research and Innovation in Wounds, College of Medicine, Nursing & Health Sciences, University of Galway, Galway, County Galway, H91 TK33, Ireland 5 Research Services, James Hardiman Library, University of Galway, Galway, County Galway, H91 TK33, Ireland 6 Independent Patient Representative, Galway, Ireland 7 Elsie Bertram Diabetes Centre, Norfolk and Norwich University Hospitals NHS Foundation Trust, Norwich, NR4 7UY, UK 8 Norwich Medical School, University of East Anglia, Norwich, NR4 7TJ, UK 9 Department of Human Kinetics and Podiatric Medicine, Université du Québec à Trois-Rivières, Trois-Rivières, Québec,, G8Z 4M3, Canada 10 Division of Psychology, Faculty of Natural Sciences, University of Stirling, Scotland, FK9 4LA, UK 11 Montreal Behavioural Medicine Centre, Concordia University, Montréal, H4J 1C5, Canada Michelle Hanlon Roles: Conceptualization, Formal Analysis, Investigation, Methodology, Project Administration, Validation, Visualization, Writing – Original Draft Preparation, Writing – Review & Editing Brian E. McGuire Roles: Conceptualization, Funding Acquisition, Investigation, Methodology, Supervision, Validation, Visualization, Writing – Review & Editing Claire MacGilchrist Roles: Conceptualization, Investigation, Methodology, Supervision, Validation, Visualization, Writing – Review & Editing Rosie Dunne Roles: Methodology, Validation, Visualization, Writing – Review & Editing Ellen Kirwan Roles: Methodology, Validation, Writing – Review & Editing Deirdre Ní Neachtain Roles: Validation, Visualization, Writing – Review & Editing Ketan Dhatariya Roles: Methodology, Validation, Visualization, Writing – Review & Editing Virginie Blanchette Roles: Methodology, Validation, Visualization, Writing – Review & Editing Hannah Durand Roles: Methodology, Validation, Writing – Review & Editing Anda Dragomir Roles: Methodology, Validation, Writing – Review & Editing Caroline McIntosh Roles: Conceptualization, Funding Acquisition, Investigation, Methodology, Supervision, Validation, Visualization, Writing – Review & Editing OPEN PEER REVIEW DETAILS REVIEWER STATUS This article is included in the Public and Patient Involvement collection. Abstract Introduction Diabetes-related foot ulcers (DFUs) are a major complication of diabetes and are associated with high morbidity and mortality rates. Psychological factors have been found to play a role in wound healing (Frasier et al. , 2024; Robinson et al. , 2017; Walburn et al. , 2009) but it remains uncertain if psychological interventions can help individuals with an active DFU, or a history of DFUs, to achieve complete or improved wound healing or prevent recurrence. Objective A recent Cochrane review by McGloin et al. (2021) examined existing psychological interventions for individuals with DFU and emphasized the need for more interventions and stronger study designs to evaluate their efficacy. Building on this, the proposed scoping review aims to: 1) Investigate the emotional consequences and burdens of living with DFU, and 2) Examine how psychosocial factors influence the progression and management of ulcerations. Methods This review will be conducted in accordance with the Joanna Briggs Institute methodology for scoping reviews and the Preferred Reporting Items for Systematic reviews and Meta-Analysis extension for Scoping Reviews (PRISMA-ScR) will guide the reporting of results. Discussion While factors such as stress, depression and social support have been identified as variables that may negatively affect DFU healing, there is a need for a greater understanding of how variables such as these may influence progression and recurrence. This review will comprise of a broad and systematically mapped synthesis of the identified data. Following this review, qualitative studies will be conducted, and their findings, along with those from the scoping review, will inform the development of a psychological intervention that will aim to improve psychosocial functioning and mitigate the progression and recurrence of DFUs. READ ALL READ LESS Keywords Diabetic foot ulcer; wound healing; emotions; psychology; psychosocial impact; psychological intervention; scoping review Corresponding Author(s) Michelle Hanlon ( [email protected] ) Caroline McIntosh ( [email protected] ) Close Corresponding authors: Michelle Hanlon, Caroline McIntosh Competing interests: No competing interests were disclosed. Grant information: Health Research Board (HRB) Ireland CDA-PA-2019-011. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. Copyright: © 2025 Hanlon M 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: Hanlon M, McGuire BE, MacGilchrist C et al. A Protocol for a Scoping Review to assess the influence of psychological factors on the development and progression of diabetes-related foot ulcers [version 3; peer review: 6 approved with reservations, 2 not approved] . HRB Open Res 2025, 7 :18 ( https://doi.org/10.12688/hrbopenres.13755.3 ) First published: 18 Apr 2024, 7 :18 ( https://doi.org/10.12688/hrbopenres.13755.1 ) Latest published: 03 Mar 2025, 7 :18 ( https://doi.org/10.12688/hrbopenres.13755.3 ) Revised Amendments from Version 2 In response to the peer review comments, the authors have conducted a comprehensive revision of the manuscript to improve clarity. We have rephrased several sections to present our key concepts more effectively and have included explanatory notes, particularly regarding the rationale for selecting a scoping review methodology, to enhance reader understanding. In response to the peer review comments, the authors have conducted a comprehensive revision of the manuscript to improve clarity. We have rephrased several sections to present our key concepts more effectively and have included explanatory notes, particularly regarding the rationale for selecting a scoping review methodology, to enhance reader understanding. See the authors' detailed response to the review by Anas Ababneh See the authors' detailed response to the review by Raquel Marques See the authors' detailed response to the review by Rebecca M Crocker See the authors' detailed response to the review by Loretta Vileikyte See the authors' detailed response to the review by Gustav Jarl READ REVIEWER RESPONSES Introduction Living with a complex wound presents profound challenges that significantly impact an individual's physical, psychological, and socio-economic well-being. The prolonged healing process, susceptibility to infection, and need for specialized care create a relentless cycle of medical attention and self-management. When diabetes is present all of these challenges are further exacerbated as the individual is then also predisposed to prolonged wound healing due to a complex pathophysiology involving vascular, neuropathic, immune, and biochemical components ( Spampinato et al. , 2020 ). Diabetes-related Foot Ulcers (DFUs) are a type of complex wound that are notoriously difficult to heal and necessitate rigorous daily wound care that places a substantial burden on the medical system, patients and caregivers ( Frykberg & Banks, 2015 ; Greenhalgh, 2003 ). Defined as a full-thickness wound (a wound that penetrates dermal tissues) below the ankle in a person with currently or previously diagnosed diabetes mellitus, a DFU is usually accompanied by neuropathy and/or peripheral artery disease in the lower extremity ( IWGDF, 2023 ; van Netten et al. , 2016 . The progression and outcomes from DFU are worsened by a number of complications associated with living with diabetes and there is a high risk of reoccurrence. Chronic ulceration can lead to adverse patient outcomes and complications, including sepsis and amputation above or below the knee ( Armstrong et al. , 2017 ). Irish data has shown that the lifetime risk of an individual with diabetes mellitus undergoing an amputation was 22.3 times that of an individual without diabetes mellitus and it has been suggested that up to 85% of such amputations are preceded by a non-healing DFU ( Buckley et al. , 2012 ). There is also significant mortality associated with DFUs, with up to 50% of patients not surviving 5 years post amputation. In people with diabetes mellitus who have a ‘high risk’ foot or an active foot ulcer, the risk of premature death is up to nine times the risk of amputation due to the underlying co-morbid diabetes and the risk of premature cardiovascular disease ( Vadiveloo et al. , 2018 ). Rationale for this research Early intervention for DFU is listed as a key priority in both national and international guidelines and strategies ( HSE: Model of Care for the Diabetic Foot, 2021 ; International Working Group of the Diabetic Foot (IWGDF, 2023) ; NHS: National Diabetes Foot Care Audit, 2022 . However, despite this international consensus on care delivery based on risk, a systematic review of prevention strategies concluded that the evidence base for interventions to prevent first foot ulcers is ‘practically non-existent’ ( van Netten et al. , 2016 ). This same review of interventions to prevent recurrent ulcers found there is strong evidence for self-management and footwear interventions but weak evidence for other interventions. A recent Cochrane systematic review ( McGloin et al. , 2021 ) also highlighted the limited psychological interventions that currently exist for patients with DFU and the need for more robust studies in this area. Building on this research, the proposed scoping review is being conducted to: 1) Investigate the emotional consequences and burdens of living with DFUs, and; 2) Examine how psychosocial factors influence the progression and management of ulcerations. The review is being conducted as part of a PhD project. Findings from this review, and subsequent qualitative studies, will inform the development of a psychological intervention that will aim to enhance psychosocial functioning and reduce the progression and recurrence of foot ulcers. A scoping review methodology was selected for this study as this methodology will allow synthesis and appraisal of the wider evidence-base, including non-RCT designed studies. In addition, a scoping review was deemed to be the most suitable methodology for this review for the following reasons: 1. The exploratory nature of the topic The interplay between psychological factors and DFUs is a relatively underexplored area. A scoping review allows for the exploration of a wide range of psychological aspects, including depression, anxiety, stigma, and coping mechanisms, rather than focusing narrowly on a specific question. A scoping review is also considered the most appropriate methodology to broadly map the key sources and types of evidence available on the area of interest, and identify gaps for further research, when the extent and nature of the research is largely unknown ( Arksey & O'Malley, 2005 ; Pham et al. , 2014 ). 2. Identifying Research Gaps A scoping review can systematically identify gaps in the current literature regarding psychological factors affecting DFUs. This is critical for guiding future research directions, which is particularly beneficial for a PhD study, such as this, that is aiming to contribute original insights to the field. It can also reveal which psychological factors are well-researched and which are neglected, allowing the researcher to focus their PhD on the most pertinent and impactful areas. 3. Inclusion of Diverse Study Designs A scoping review allows for the inclusion of different types of studies (qualitative, quantitative, mixed-methods), which is essential in a complex area like psychological health. This flexibility can provide richer insights into how psychological factors impact DFUs. By synthesizing various research methodologies, the review can offer a comprehensive understanding of the psychological dimensions affecting patients with DFUs. 4. More flexible than Systematic Reviews Scoping reviews do not require the same level of stringent inclusion/exclusion criteria as systematic reviews, allowing for a more flexible approach to literature inclusion. This is particularly useful in a field where studies may vary significantly in focus and methodology. In summary, this research is being carried out with a scoping review methodology, rather than as a systematic review, due to the exploratory nature, capacity to identify research gaps, flexibility in study inclusion, and ability to synthesize diverse forms of evidence. This methodological approach will offer a comprehensive foundation for understanding the psychological dimensions of DFUs and will effectively guide future research initiatives. Methods This review is being conducted to (a) explore the emotional and psychosocial burden of living with DFU and (b) examine if psychological variables lead to poor outcomes in DFU. Prior to starting the review, a thorough review on existing literature was carried out. This preliminary search indicated that while several studies have explored related topics, there was a lack of comprehensive reviews specifically addressing the questions that the authors wanted to answer. This gap underscored the significance of our scoping review and its potential to contribute new insights to the field. The aim of this review will thus be to provide a synthesis of exsisting knowledge in the area and gain a greater understanding of how psychological factors may impact behaviour, progression of the disease, and management of the condition, in order to make sure that the psychological intervention that is developed will target the most important factors. The review will be conducted in accordance with the Joanna Briggs Institute methodology for scoping reviews ( Peters et al. , 2020 ) and the Preferred Reporting Items for Systematic reviews and Meta-Analysis extension for Scoping Reviews (PRISMA-ScR) will guide the reporting of results ( Tricco et al. , 2018 ). Principal terminology definitions Complex wound: In recent years, chronic wounds have been described as “complex wounds,” in order to represent the multifactorial dynamic tissue healing process that is involved ( Hall et al. , 2014 ; Labib & Winters, 2023 ). For a wound to be classified as a complex wound, it must show one of the following features ( Ferreira et al. , 2006 ): 1) Persistent for more than three months; 2) Compromised vascularity or necrosis; 3) Presence of infection; 4) Associated comorbidities impair healing potential. Diabetes-Related Foot Ulcer (DFU): A diabetes-related foot ulcer (DFU) has been defined as a break in the skin of the foot of a person with diabetes, which penetrates as a minimum to the epidermis and part of the dermis ( McDermott et al. , 2023 ). DFUs are classified as neuropathic, ischemic, or neuro-ischemic based on their underlying causes e.g. whether they are caused by systemic factors such as hyperglycemia or immune dysfunction or by local factors such as pressure or trauma ( Jeffcoate et al. 2024 ). Additionally, DFUs can be categorized by severity using classification systems such as SINBAD ( IWGDF, 2023 ). Systems such as this assist healthcare providers in predicting patient outcomes and determining the most appropriate treatment strategies. Wound healing: A healed wound or complete wound closure can be defined as 100% re-epithelialization of the wound without drainage ( Armstrong et al. , 2020 ). For an individual with diabetes, several biological elements can adversely affect ulcer healing including persistent and impaired inflammation, loss of protective sensation, motor neuropathy causing abnormal biomechanics, peripheral arterial disease, and infection ( Rayman et al. , 2020 ). Systemic factors such as age, sex, stress levels, medication (steroids, NSAIDs), alcohol use, and diet may also impact wound healing ( Chhabra et al. , 2017 ). The management of a DFU is thus particularly challenging and proper wound care (such as cleaning the wound, keeping it moist, and protecting it from further injury or infection) is critical to facilitate healing. The management of lifestyle factors, blood sugar levels, infection, and other underlying medical conditions is also essential for successful healing of DFUs ( Alexiadou & Doupis, 2012 ). This review will be looking at wound healing in relation to the impact that psychological factors have on management, progression and reoccurrence. DFU Reoccurrence: A new foot ulcer in a person who has a history of foot ulceration, irrespective of location and time, since previous foot ulcer ( IWGDF, 2023 ) This review will be looking at the role that emotional and psychosocial factors may play in the recurrence of a DFU. Emotional wellbeing. Emotional wellbeing refers to a person's overall mental and emotional state of being, characterized by the ability to manage and regulate emotions, cope with stress and adversity, and experience a sense of life satisfaction and overall psychological functioning ( Huppert & So, 2013 ). This review will be looking at the impact that living with a DFU has on emotional wellbeing. Psychosocial wellbeing. Psychosocial wellbeing refers to the combination of psychological and social factors that contribute to an individual's overall sense of well-being ( Eisenberg et al. , 2007 ). Encompassing an individual's mental, emotional, social, and spiritual well-being, psychosocial wellbeing can be impacted by a variety of internal and external factors such as cultural and societal norms, physical health, economic status, personal relationships, and life experiences. This review will be looking at the impact that living with a DFU has on psychosocial functioning, and its subsequent effects on overall well-being. Protocol This protocol is structured according to the steps suggested by Arksey and O’Malley (2005) . Any deviations from the protocol will be tracked on the review’s Open Science Framework project page. The protocol was registered with the Open Science Framework on 17 November 2022 (DOI: 10.17605/OSF.IO/U5JDW ). Stage 1: Identifying the research question As recommended by the Joanna Briggs Institute (2015) , the PCC (Population/ participants, Concept and Context) framework was used to cultivate the research questions for this scoping review. This framework acts as a guide to facilitate the construction of a clear and meaningful title and the development of subsequent question(s) for a scoping review. For the current review, the authors are interested in individuals with diabetes-related foot ulcers (P) and exploring how living with this condition impacts their emotional and social wellbeing (C) in order to investigate the influence of psychological factors on DFU healing/ reoccurrence outcomes (C). Research Questions 1. What are the psychological and emotional consequences of living with diabetes-related foot ulcers? 2. Do psychosocial factors influence progression or reoccurrence of ulceration in patients who have diabetes-related foot ulcers? Stage 2: Identifying relevant studies Eligibility criteria. The PCC framework used for developing the research questions will inform inclusion and exclusion criteria, and consequently the literature search strategy ( Peters et al. , 2020 ). A justification will be provided for all exclusion criteria and any given limitations that are required ( Pollock et al. , 2021 ; Tricco et al. , 2018 ). The review will consider both qualitative and quantitative primary research in the English language and between the years 2002 and 2022, to ensure currency of content. Unpublished (grey literature) will also be included. See Table 1 for full inclusion and exclusion criteria. Table 1. Inclusion and exclusion criteria. PCC Framework Inclusion Criteria Exclusion Criteria Justification Population (Individuals with DFU) • Publications that report on studies related to diabetes-related foot ulcers. • Any publication about diabetes that does not relate to the foot. • Any publication relating to other diabetes-related lower extremity complications (diabetes-related foot infections) or ulcers. • The objective of the study is to investigate diabetic foot ulcers specifically. Including publications that address general diabetes management or unrelated diabetic complications could dilute the focus and relevance of the findings, making it challenging to draw specific conclusions about DFUs. Concept (Emotional implications and Psychosocial impact) • Publications that report on emotional responses experienced as a result of living with DFU. • Publications that report on psychosocial impacts experienced as a result of living with DFU. • Any publication that explores the emotional implications of living with diabetes but does not explore diabetes-related foot specifically. • Any publication relating to emotional implications of other chronic conditions. • Any publication that explores the psychosocial impacts of living with diabetes as a condition but does not look at the diabetic foot. • Any publication relating to the psychosocial impact of living with other chronic conditions. • This inclusion criteria ensures a targeted exploration of the specific emotional challenges and psychosocial impact faced by individuals living with DFUs. • This exclusion criteria maintains the specificity of the research, preventing dilution of findings with broader diabetes-related emotional and psychosocial issues that may not apply to DFUs. Emotional and psychosocial experiences can vary widely among different complications of diabetes, and focusing solely on DFUs ensures relevant and actionable insights. • Understanding these impacts is essential for developing targeted interventions that address both the emotional and social dimensions of living with DFUs, Context (Management, wound healing and recurrence) • Publications that report on emotional and psychosocial factors and their impact on self-management and wound healing in DFU. • Any publication that looks at the role that emotional and psychosocial factors have on self-management and wound healing but does not explore this in relation to the diabetic foot specifically. • Any publications relating to self management and wound healing in other chronic conditions. • This inclusion criteria focuses on understanding how emotional and psychosocial factors specifically influence self-management and wound healing in those with DFUs. By examining these factors, the research can uncover insights that inform holistic treatment approaches, addressing both physical healing and the emotional well-being of patients. Search strategy An expert university librarian has been part of the research team from the start of this scoping review. They have assisted with designing and refining the search strategy and provided guidance on how best to adapt these terms for individual databases. This input is crucial to ensure the search strategy and results are transparent and auditable. A three-step search strategy will be utilised for the scoping review. First, an initial search of two databases, PubMed and PsycINFO, will be undertaken, followed by an analysis of the text words contained in the title and abstract of retrieved papers. Using the PCC framework, ideas will be expanded using search terms and appropriate thesaurus terms and synonyms. A second search using all identified keywords and index terms will then be undertaken across all included databases. Databases to be searched include the Cochrane Database of Systematic Reviews, OVID (Medline), EMBASE (Elsevier), CINAHL (EBSCO), PsycINFO (EBSCO), SCOPUS and Web of Science Core Collection. Thirdly, the reference lists of identified reports and articles will be searched for additional sources. A search for grey material will also be carried out within ProQuest E-Thesis Portal, and Lenus. See Table 2 for search strategy development. Table 2. Search strategy development. Concept 1 Concept 2 Concept 3 Concept 4 Key concepts The Condition (Diabetic Foot Ulcer) Emotional implications (Living with Diabetic Foot Ulcer) Psychosocial impact (Managing/living with Diabetic Foot Ulcer) Wound Healing (Effect emotional and psychosocial factors- & associated behaviours-have on wound healing in Diabetic Foot Ulcer) Free text terms / natural language terms Related Terms & Synonyms: Diabetic foot ulcer Diabetic foot disease Diabetic foot Diabetic foot syndrome Related Terms & Synonyms: Emotions Feelings Emotional Reactions Emotional Responses Emotional Status Emotional Factors Related Terms & Synonyms: Psychological factors Psychological behaviours Psychosocial stressors Social aspects Social Behaviours Psychosocial Related Terms & Synonyms: Ulcer healing Wound: Injury Healing: Recovery Rehabilitation Controlled vocabulary terms / Subject terms (MeSH terms, Emtree terms) Diabetic foot diabetic foot feet, diabetic foot, diabetic foot ulcer, diabetic diabetes-kw *Diabetes Mellitus *Diabetes Complications Foot ulcer* plantar ulcer* venous ulcer*.tw. neuropathic ulcer*. tw *Emotional adjustment emotional adaptation* psychological adjustment emotional intelligence* social intelligence* emotional regulation emotion self-regulation emotional-mp *Anxiety angst anxieties, social nervousness mood, depression distress, stress *Psychology psychological factor psychological side effect psychology* psychosocial factor* *Clinical psychology Positive psychology *Quality of life HRQL Health related quality of quality sleep quality Wound healing/ Wound infection/ Debridement/ exp "Wounds and Injuries"/ neuropathic ulcer*.tw. neuropathic wound.tw. foot wound.tw. diabetic wound.tw. chronic wound.tw. (nonhealing* adj3 ulcer*).tw. (“hard to heal” adj3 wound*).tw. Stage 3: Study selection Screening for this review will be conducted within Covidence, a systematic review data management system https://www.covidence.org/ ( Covidence, 2019 ). Covidence is a core component of the Cochrane review production toolkit and has also been endorsed by the Joanna Briggs Institute. An open access alternative such as Rayyan ( https://www.rayyan.ai/ ) could also be used. Pilot testing will be conducted prior to embarking on source selection. This will involve the research team selecting a sample of 25 titles and abstracts at random and two members (MH and EK) independently screening them using the pre-defined eligibility criteria and definitions. The team will then meet and if any discrepancies have been identified these will be discussed and modifications will be made to the eligibility criteria and definitions if required. Screening will start once an agreement rate of 75% (or greater) is achieved. Using the pre-specified inclusion and exclusion criteria, two reviewers will independently screen each title and abstract. A third independent reviewer will be consulted and make the final decision regarding inclusion if consensus is not reached between the two reviewers. The process of study selection will be reported using a PRISMA flow diagram ( Tricco et al. , 2018 ), which will then be updated once the review is completed. Stage 4: Charting the data The research team will design a data charting tool, as set out by the PRISMA-ScR Checklist ( Tricco et al. , 2018 ), to which the following information will be extracted by two members of the research team: Author(s) Year of publication Study title Origin/country of origin/origins (where the source was published or conducted) Aims/purpose Context Population Sample size Study design/intervention type Risk of bias Key findings that relate to the scoping review question/s. To ensure that the coding framework is consistently applied, two team members will pilot test the charting table by using a sample (10%) of the complete list of retrieved studies that are to be included. If necessary, modifications to the categories and revisions to the charting table may occur at this stage. Any discrepancies or queries that emerge from the pilot will be discussed by the full team before going ahead with the data extraction process. During this iterative process, the authors are aware that the charting tool may also need to be adjusted to ensure accurate representation of all data sources. Stage 5: Collating, summarising, and reporting of results A PRISMA flow diagram will be used to visually represent study selection and reasons for exclusion at full text review. Presentation of the results will be in a visual and aggregate form ( e.g., using charts and tables), as well as a descriptive format aligning to the objectives and scope of this review. Step 6: Consultation with stakeholders In order to identify any further references and studies that should be included and to gather feedback regarding the scoping review findings, the Arksey and O’Malley framework proposes an optional sixth step that involves consulting with key stakeholders. The authors of this paper believe this to be a very worthwhile and valuable exercise as it will ensure that the search strategy includes all relevant and appropriate terms and will enhance the relevance of the research overall by gathering feedback on the content. A stakeholder group that included multidisciplinary team members and external collaborators were thus consulted in advance of beginning this review. The group consisted of an independent patient representative (DNN), a clinical psychologist (AD), a podiatrist (VB), a health researcher (HD), and an endocrinologist (KD). Patient and Public Involvement Patient and public involvement (PPI) is an important and meaningful part of research. Accordingly, the authors have begun the process of recruiting a panel of patient representatives to this research project. Understanding the complexity of how emotional and psychosocial factors impact DFU development and reoccurrence is key to informing the content of interventions and the research team believe that any intervention that aims to improve outcomes should be designed with the voice of the user in mind. To ensure PPI practice is based on the best evidence, the GRIPP2-SF checklist tool ( Staniszewska et al. , 2017 ) will guide reporting of PPI involvement in this study. Discussion DFUs impose a major medical, psychological, social, and financial burden upon patients. In addition to the demands associated with the need to frequently attend healthcare services, effective management of a DFU requires affected individuals to engage in complex, continual, and demanding self-care behaviours. From previous research, we know that this can exert a heavy burden on patients and that psychological issues such as depression and anxiety are commonly experienced ( Ahmad et al. , 2018 ; Hurst et al. , 2020 ; Iversen et al. , 2015 ; Price et al. , 2014 ; Vileikyte et al. , 2020 ; Winkley et al. , 2012 ). Research also indicates that psychological factors can exacerbate the physical challenges associated with DFUs, negatively impacting overall quality of life and treatment adherence ( Hurst et al. , 2020 ; Vileikyte et al. , 2020 ). However, further research is needed to understand how psychosocial and emotional factors affect individuals with a history of ulceration. This research will thus investigate how emotional and psychosocial factors influence the management and progression of diabetic foot ulcers (DFUs). Gaining insights into these dynamics can clarify the impact of psychosocial (emotional and social) and behavioral factors (such as coping strategies and health-related behaviors) on health outcomes for individuals with DFUs. Understanding these relationships will enable researchers to develop more effective interventions tailored to enhance both psychological well-being and foot health, ultimately improving treatment success and the quality of life for patients ( Vileikyte et al. , 2020 ; Westby et al. , 2020 ). Data availability No data are associated with this article. Faculty Opinions recommended References Ahmad A, Abujbara M, Jaddou H, et al. : Anxiety and depression among adult patients with diabetic foot: prevalence and associated factors. J Clin Med Res. 2018; 10 (5): 411–418. PubMed Abstract | Publisher Full Text | Free Full Text Alexiadou K, Doupis J: Management of diabetic foot ulcers. Diabetes Ther. 2012; 3 (1): 4. 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PubMed Abstract | Publisher Full Text Comments on this article Comments (0) Version 3 VERSION 3 PUBLISHED 18 Apr 2024 ADD YOUR COMMENT Comment Author details Author details 1 School of Psychology & Centre for Pain Research, University of Galway, Galway, County Galway, H91 TK33, Ireland 2 CDA Diabetic Foot Disease: from PRevention to Improved Patient Outcomes (HRB CDA DFD PRIMO) programme, University of Galway, Galway, County Galway, H91 TK33, Ireland 3 Discipline of Podiatric Medicine, School of Health Sciences, University of Galway, Galway, County Galway, H91 TK33, Ireland 4 Alliance for Research and Innovation in Wounds, College of Medicine, Nursing & Health Sciences, University of Galway, Galway, County Galway, H91 TK33, Ireland 5 Research Services, James Hardiman Library, University of Galway, Galway, County Galway, H91 TK33, Ireland 6 Independent Patient Representative, Galway, Ireland 7 Elsie Bertram Diabetes Centre, Norfolk and Norwich University Hospitals NHS Foundation Trust, Norwich, NR4 7UY, UK 8 Norwich Medical School, University of East Anglia, Norwich, NR4 7TJ, UK 9 Department of Human Kinetics and Podiatric Medicine, Université du Québec à Trois-Rivières, Trois-Rivières, Québec,, G8Z 4M3, Canada 10 Division of Psychology, Faculty of Natural Sciences, University of Stirling, Scotland, FK9 4LA, UK 11 Montreal Behavioural Medicine Centre, Concordia University, Montréal, H4J 1C5, Canada Michelle Hanlon Roles: Conceptualization, Formal Analysis, Investigation, Methodology, Project Administration, Validation, Visualization, Writing – Original Draft Preparation, Writing – Review & Editing Brian E. McGuire Roles: Conceptualization, Funding Acquisition, Investigation, Methodology, Supervision, Validation, Visualization, Writing – Review & Editing Claire MacGilchrist Roles: Conceptualization, Investigation, Methodology, Supervision, Validation, Visualization, Writing – Review & Editing Rosie Dunne Roles: Methodology, Validation, Visualization, Writing – Review & Editing Ellen Kirwan Roles: Methodology, Validation, Writing – Review & Editing Deirdre Ní Neachtain Roles: Validation, Visualization, Writing – Review & Editing Ketan Dhatariya Roles: Methodology, Validation, Visualization, Writing – Review & Editing Virginie Blanchette Roles: Methodology, Validation, Visualization, Writing – Review & Editing Hannah Durand Roles: Methodology, Validation, Writing – Review & Editing Anda Dragomir Roles: Methodology, Validation, Writing – Review & Editing Caroline McIntosh Roles: Conceptualization, Funding Acquisition, Investigation, Methodology, Supervision, Validation, Visualization, Writing – Review & Editing Competing interests No competing interests were disclosed. Grant information Health Research Board (HRB) Ireland CDA-PA-2019-011. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. Article Versions (3) version 3 Revised Published: 03 Mar 2025, 7:18 https://doi.org/10.12688/hrbopenres.13755.3 version 2 Revised Published: 01 Oct 2024, 7:18 https://doi.org/10.12688/hrbopenres.13755.2 version 1 Published: 18 Apr 2024, 7:18 https://doi.org/10.12688/hrbopenres.13755.1 Copyright © 2025 Hanlon M 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. Download Export To Sciwheel Bibtex EndNote ProCite Ref. Manager (RIS) Sente metrics VIEWS $counts.viewCount downloads Citations open_in_new 0 open_in_new 0 open_in_new SEE MORE DETAILS CITE how to cite this article Hanlon M, McGuire BE, MacGilchrist C et al. A Protocol for a Scoping Review to assess the influence of psychological factors on the development and progression of diabetes-related foot ulcers [version 3; peer review: 6 approved with reservations, 2 not approved] . HRB Open Res 2025, 7 :18 ( https://doi.org/10.12688/hrbopenres.13755.3 ) NOTE: If applicable, it is important to ensure the information in square brackets after the title is included in all citations of this article. COPY CITATION DETAILS track receive updates on this article Track an article to receive email alerts on any updates to this article. TRACK THIS ARTICLE Share Open Peer Review Current Reviewer Status: ? Key to Reviewer Statuses VIEW HIDE 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 Version 3 VERSION 3 PUBLISHED 03 Mar 2025 Revised Views 0 Cite How to cite this report: Borbjerg MK and Røikjer J. Reviewer Report For: A Protocol for a Scoping Review to assess the influence of psychological factors on the development and progression of diabetes-related foot ulcers [version 3; peer review: 6 approved with reservations, 2 not approved] . HRB Open Res 2025, 7 :18 ( https://doi.org/10.21956/hrbopenres.15482.r50871 ) The direct URL for this report is: https://hrbopenresearch.org/articles/7-18/v3#referee-response-50871 NOTE: it is important to ensure the information in square brackets after the title is included in this citation. Close Copy Citation Details Reviewer Report 04 Nov 2025 Mette Krabsmark Borbjerg , Steno Diabetes Center North Denmark, Aalborg University Hospital, Aalborg, Denmark Johan Røikjer , Steno Diabetes Center North Denmark, Aalborg University Hospital, Aalborg, Denmark Approved with Reservations VIEWS 0 https://doi.org/10.21956/hrbopenres.15482.r50871 Dear Hanlon and colleagues, This is important work and an interesting foundation for the PhD project. Below you can find my comments on your published protocol. Regarding “Objective”: Your objective suggests that you will examine ... Continue reading READ ALL Dear Hanlon and colleagues, This is important work and an interesting foundation for the PhD project. Below you can find my comments on your published protocol. Regarding “Objective”: Your objective suggests that you will examine the impact of psychological factors; this phrasing could imply an interpretation of results, which is not the aim of scoping reviews. You could consider using phrasings such as “...map and summarize existing evidence on...”and “…how psychological factors have been explored in relation to …”. The phrase “…in order to make sure that the psychological intervention that is developed will target the most important factors” seems to refer to your future interventional study. This sentence is therefore not relevant in your scoping review protocol. Consider rephrasing to make it more generalizable, e.g., “will identify key knowledge gaps to inform the development of future psychological interventions.” Regarding “PCC”: The phrasing used for your concept implies causal relations; consider rephrasing. The context in your PCC does not correlate with the traditional understanding of context. To comply with the framework, the context could be “in primary care”, “in hospital settings”, or “in Europe”. If you have no specific context, state that there are no limitations or remove the context. Per JBI protocol, you could consider cultural/sub-cultural factors, geographic location, specific racial or gender-based interests, or details about the specific setting. Regarding “Research questions”: For research question 1, consider changing the wording to “What psychological and emotional consequences have been reported in the literature …”, as this would be more appropriate for a scoping review. For research question 2, the use of the term “influence” is problematic for a scoping review, as it implies a measure of effect. Consider the phrasing “What psychosocial factors have been studied in relation to progression or recurrence of ulceration…” Regarding “Eligibility criteria”: For your population, it could be relevant to specify your criteria further. This could be a clarification of how the DFU should be diagnosed, e.g., is it allowed to be self-reported? Specify all that apply or state that there are no limitations in how DFU is diagnosed. For the concept, a description of eligible measures of emotional/psychological data is missing. If you wish to include all forms of measures, state that there are no requirements as to how it is assessed (interview, survey etc.). As described under PCC, your context does not describe the true context. For your eligibility criteria on types of sources, a more in-depth description is needed, including which types of grey literature (thesis, opinion statements, conference abstracts) you are including. In addition, consider adding a statement on whether systematic reviews will be included. If excluded, will the reference list of the systematic reviews be evaluated for additional studies? You could add “Types of studies” to Table 1. Regarding “study selection”: You state both Covidence and Rayyan as possible software; it would be preferred that you only state the one applicable for the study. You do not address the full text screening process; this should be added. It should be described how you will handle unpublished studies and missing data, i.e., will authors be contacted for additional information. Regarding “data extraction”: The data extraction is not specific enough. What exact data will be extracted for this point, “ Key findings that relate to the scoping review question/s”? Per the JBI template, a draft of your data extraction tool should be available in the protocol appendix; alternatively, you could refer to your OSF project. Regarding “Results”: This part is not described in enough detail. Determine how to best present your data; it should relate to the specific research questions, meaning that your decisions should make it possible to answer your research question. Regarding “PPI”: How will PPI be part of this specific scoping review (not your intervention study, but this review)? Regarding “Discussion”: The discussion suggests an interpretation of the relationship between factors. I would recommend rephrasing this section to reflect a more descriptive and exploratory aim. Is the rationale for, and objectives of, the study clearly described? Yes Is the study design appropriate for the research question? Partly Are sufficient details of the methods provided to allow replication by others? No Are the datasets clearly presented in a useable and accessible format? Not applicable Competing Interests: No competing interests were disclosed. Reviewer Expertise: Diabetes and its complications, particularly diabetic neuropathy and diabetic foot ulcer (DFU), with a focus on their impact on mental health and quality of life. We confirm that we have read this submission and believe that we have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however we have significant reservations, as outlined above. Close READ LESS CITE CITE HOW TO CITE THIS REPORT Borbjerg MK and Røikjer J. Reviewer Report For: A Protocol for a Scoping Review to assess the influence of psychological factors on the development and progression of diabetes-related foot ulcers [version 3; peer review: 6 approved with reservations, 2 not approved] . HRB Open Res 2025, 7 :18 ( https://doi.org/10.21956/hrbopenres.15482.r50871 ) The direct URL for this report is: https://hrbopenresearch.org/articles/7-18/v3#referee-response-50871 NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article. COPY CITATION DETAILS Report a concern Respond or Comment COMMENT ON THIS REPORT Views 0 Cite How to cite this report: Sukarni S. Reviewer Report For: A Protocol for a Scoping Review to assess the influence of psychological factors on the development and progression of diabetes-related foot ulcers [version 3; peer review: 6 approved with reservations, 2 not approved] . HRB Open Res 2025, 7 :18 ( https://doi.org/10.21956/hrbopenres.15482.r48129 ) The direct URL for this report is: https://hrbopenresearch.org/articles/7-18/v3#referee-response-48129 NOTE: it is important to ensure the information in square brackets after the title is included in this citation. Close Copy Citation Details Reviewer Report 20 Aug 2025 Sukarni Sukarni , Chronic Care and Wound Management Nursing, Kanazawa University, Kanazawa, Japan; Nursing, Tanjungpura University, Pontianak, Kalimantan Barat, Indonesia Approved with Reservations VIEWS 0 https://doi.org/10.21956/hrbopenres.15482.r48129 Clarity and Coherence of the Rationale and Research Objectives While the rationale is supported by clinical context and previous reviews, the objectives remain somewhat ambiguous. Although the manuscript mentions gaps in psychological intervention research for DFUs, it does not ... Continue reading READ ALL Clarity and Coherence of the Rationale and Research Objectives While the rationale is supported by clinical context and previous reviews, the objectives remain somewhat ambiguous. Although the manuscript mentions gaps in psychological intervention research for DFUs, it does not clearly explain if the review will map psychological determinants, evaluate their associations with clinical outcomes, or examine patient-reported burdens. Detail and Transparency in the Data Charting and Synthesis Plan The search strategy and inclusion/exclusion criteria are clearly articulated, and the PCC framework is applied consistently. However, more detail is needed on the data charting process and synthesis plan, especially regarding how the extracted data will be categorized and analyzed. Recommendations Clarify whether the review aims to describe the range of psychological and psychosocial impacts, identify associations with wound outcomes, or map intervention strategies. Doing so will clarify the study's purpose and ensure that it aligns with the appropriate scope of a scoping review. Include a clearer explanation of the data charting tool and how it relates to the review questions. A table linking key data fields to specific objectives would enhance transparency and replicability. Additionally, describe how discrepancies between reviewers during data extraction will be handled. Is the rationale for, and objectives of, the study clearly described? Partly Is the study design appropriate for the research question? Yes Are sufficient details of the methods provided to allow replication by others? Partly Are the datasets clearly presented in a useable and accessible format? Not applicable Competing Interests: No competing interests were disclosed. Reviewer Expertise: Wound care, diabetic foot care, management DFU (Nurse specialist in Wound Care) 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. Close READ LESS CITE CITE HOW TO CITE THIS REPORT Sukarni S. Reviewer Report For: A Protocol for a Scoping Review to assess the influence of psychological factors on the development and progression of diabetes-related foot ulcers [version 3; peer review: 6 approved with reservations, 2 not approved] . HRB Open Res 2025, 7 :18 ( https://doi.org/10.21956/hrbopenres.15482.r48129 ) The direct URL for this report is: https://hrbopenresearch.org/articles/7-18/v3#referee-response-48129 NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article. COPY CITATION DETAILS Report a concern Respond or Comment COMMENT ON THIS REPORT Views 0 Cite How to cite this report: McGloin H. Reviewer Report For: A Protocol for a Scoping Review to assess the influence of psychological factors on the development and progression of diabetes-related foot ulcers [version 3; peer review: 6 approved with reservations, 2 not approved] . HRB Open Res 2025, 7 :18 ( https://doi.org/10.21956/hrbopenres.15482.r46689 ) The direct URL for this report is: https://hrbopenresearch.org/articles/7-18/v3#referee-response-46689 NOTE: it is important to ensure the information in square brackets after the title is included in this citation. Close Copy Citation Details Reviewer Report 05 May 2025 Helen McGloin , St Angela's College, Sligo, Ireland Approved with Reservations VIEWS 0 https://doi.org/10.21956/hrbopenres.15482.r46689 Research Purpose, Questions and Consistency with Methods This is an important topic for review, however, the purpose and research questions are not consistent throughout. The protocol needs a full and thorough edit to make sure that the components under ... Continue reading READ ALL Research Purpose, Questions and Consistency with Methods This is an important topic for review, however, the purpose and research questions are not consistent throughout. The protocol needs a full and thorough edit to make sure that the components under investigation are defined and consistent throughout. The purpose and questions for the review need to be tracked through the methods - for example the inclusion criteria table specifies understanding how emotional and psychosocial factors influence self-management, but self-management is not specified in the research aim or questions or the search criteria. Terms change between the research question, the inclusion criteria and the search criteria which will be very confusing when you search the literature and screen the results. The research purpose and questions lack the clarity needed to inform the review process therefore the search strategy and inclusion criteria do not match the purpose of the review. Once these have been clarified the title of the review may need to change. The second research question needs to be edited to reflect the remit of a scoping review which is to map out and describe the evidence rather than determine cause and effect. Search Strategy DFU recurrence is specified in the research question, but it isn’t listed in the search criteria. Self-management is specified in the inclusion criteria but has not been included in the search terms. Why is the search timeframe limited up to 2022? Collating Evidence A coding framework is mentioned on p 23 but no explanation of what this is to be used for. Very little detail of the plan for collating, summarising and reporting the results of the review. Suggested Action Points Clarify and define the components under review Clarify the purpose of the review in relation to the self-management of DFU Revise the search strategy and the inclusion criteria Give more detail for Stage 5 Review the title – should ‘psychosocial’ factors be used instead? Is the rationale for, and objectives of, the study clearly described? No Is the study design appropriate for the research question? Partly Are sufficient details of the methods provided to allow replication by others? No Are the datasets clearly presented in a useable and accessible format? Not applicable Competing Interests: No competing interests were disclosed. Reviewer Expertise: Diabetes, Systematic review, empowerment, Health Coaching 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. Close READ LESS CITE CITE HOW TO CITE THIS REPORT McGloin H. Reviewer Report For: A Protocol for a Scoping Review to assess the influence of psychological factors on the development and progression of diabetes-related foot ulcers [version 3; peer review: 6 approved with reservations, 2 not approved] . HRB Open Res 2025, 7 :18 ( https://doi.org/10.21956/hrbopenres.15482.r46689 ) The direct URL for this report is: https://hrbopenresearch.org/articles/7-18/v3#referee-response-46689 NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article. COPY CITATION DETAILS Report a concern Respond or Comment COMMENT ON THIS REPORT Views 0 Cite How to cite this report: Jarl G. Reviewer Report For: A Protocol for a Scoping Review to assess the influence of psychological factors on the development and progression of diabetes-related foot ulcers [version 3; peer review: 6 approved with reservations, 2 not approved] . HRB Open Res 2025, 7 :18 ( https://doi.org/10.21956/hrbopenres.15482.r46276 ) The direct URL for this report is: https://hrbopenresearch.org/articles/7-18/v3#referee-response-46276 NOTE: it is important to ensure the information in square brackets after the title is included in this citation. Close Copy Citation Details Reviewer Report 12 Mar 2025 Gustav Jarl , Örebro University, Örebro, Sweden Approved with Reservations VIEWS 0 https://doi.org/10.21956/hrbopenres.15482.r46276 I thank the Editor and Authors for the opportunity to review this manuscript again. I think the manuscript has been improved since the last time I read it and I have mainly minor comments. Title I ... Continue reading READ ALL I thank the Editor and Authors for the opportunity to review this manuscript again. I think the manuscript has been improved since the last time I read it and I have mainly minor comments. Title I think the title only reflects one part of the bi-directional relationship that the study aims to investigate. Abstract I suggest to delete citations from the abstract section. The abstract objective does not include prevention of DFU recurrence. Please revise for clarity. "Following this review, qualitative studies will be conducted, and their findings, along with those from the scoping review, will inform the development of a psychological intervention that will aim to improve psychosocial functioning and mitigate the progression and recurrence of DFUs." I suggest to rephrase this as general recommendations for future research, rather than the studies planned by the authors conducting this review. Introduction Does the first reference (Spampinato 2020) cover all the statements of the first three sentences in the introduction? If not, please add more references. Please update the reference (van Netten 2016), which is the IWGDF review of 2016, to the latest IWGDF review version. "The review is being conducted as part of a PhD project. Findings from this review, and subsequent qualitative studies, will inform the development of a psychological intervention that will aim to enhance psychosocial functioning and reduce the progression and recurrence of foot ulcers." I suggest to rephrase this as a recommendation for how this review can inform subsequent research in general instead of as a description of the author's PhD project. I also suggest to delete references to the author's PhD project in section "2. Identifying Research Gaps" Methods "This review is being conducted to (a) explore the emotional and psychosocial burden of living with DFU and (b) examine if psychological variables lead to poor outcomes in DFU." Please revise to also include ulcer recurrance. Principal terminology definitions In this section, different key terms are defined. Some terms are shortly defined (e.g., DFU reoccurance) while other terms are both defined and contextualized/discussed (e.g. diabetes-related foot ulcer, and wound healing). I suggest to try to keep it consistent, and focus on definitions, whithout going deeper into discussing the terms. I find it difficult to understand the difference between emotional wellbeing and psychosocial wellbeing, as the latter is stated to include "emotional" I find the last sentence, "This review will be looking at the impact that living with a DFU has on psychosocial functioning, and its subsequent effects on overall well-being", to make it more confusing. I do not think the aim is to look at psychosocial functioning. Also, this will result in three types of well-being: emotional, psychosocial, and overall wellbeing. I suggest to keep the number of key terms down, and define and use them consistenlty throughtout the text. Protocol I appreciate the clarity of the research questions, please check that the aim when mentioned in different parts of the manuscript are aligned with these research questions and use the same terms. Is there a reason for stopping the review with publications up to 2022? "Origin/country of origin/origins (where the source was published or conducted)" I find this difficult to read, please clarify, e.g. "country of origin" (or could it be something else than countries?) Terminology Please check that terms are used consistently. Both ulcer "reoccurance" and "recurrrance" are used. Also, diabetes-related foot ulcers are mainly used, but on few places, also diabetic foot ulcers (Discussion and key koncepts in table 2) Table 1 Emotional implications, excl criteria: "• Any publication that explores the emotional implications of living with diabetes but does not explore diabetes-related foot specifically." should it be "diabetes-related foot ulcer"? Managament, justification: "This inclusion criteria focuses on understanding how emotional and psychosocial factors specifically influence self-management and wound healing in those with DFUs." Should not prevention of recurrence be included here as well? Table 2 "diabetic foot ulcer" is mentioned under key concepts, should it be "diabetes-related foot ulcer"? Controlled vocabulary terms, concept 1: "diabetic foot" is mentioned twice Controlled vocabulary terms, concept 3: "Health related quality of quality". Should it be "...of life"? Competing Interests: No competing interests were disclosed. Reviewer Expertise: diabetes-related foot disease, especially offloading for preventing and healing DFUs, and patient adherence. 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. Close READ LESS CITE CITE HOW TO CITE THIS REPORT Jarl G. Reviewer Report For: A Protocol for a Scoping Review to assess the influence of psychological factors on the development and progression of diabetes-related foot ulcers [version 3; peer review: 6 approved with reservations, 2 not approved] . HRB Open Res 2025, 7 :18 ( https://doi.org/10.21956/hrbopenres.15482.r46276 ) The direct URL for this report is: https://hrbopenresearch.org/articles/7-18/v3#referee-response-46276 NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article. COPY CITATION DETAILS Report a concern Respond or Comment COMMENT ON THIS REPORT Version 2 VERSION 2 PUBLISHED 01 Oct 2024 Revised Views 0 Cite How to cite this report: Jarl G. Reviewer Report For: A Protocol for a Scoping Review to assess the influence of psychological factors on the development and progression of diabetes-related foot ulcers [version 3; peer review: 6 approved with reservations, 2 not approved] . HRB Open Res 2025, 7 :18 ( https://doi.org/10.21956/hrbopenres.15331.r43289 ) The direct URL for this report is: https://hrbopenresearch.org/articles/7-18/v2#referee-response-43289 NOTE: it is important to ensure the information in square brackets after the title is included in this citation. Close Copy Citation Details Reviewer Report 13 Dec 2024 Gustav Jarl , Örebro University, Örebro, Sweden Not Approved VIEWS 0 https://doi.org/10.21956/hrbopenres.15331.r43289 I thank the authors and Editors for the opportunity to read this protocol manuscript. I find the approach to investigate the bi-directional relationship between DFU and psychological factors intriguing, but also challenging at is will emcompass many aspects and relationships. ... Continue reading READ ALL I thank the authors and Editors for the opportunity to read this protocol manuscript. I find the approach to investigate the bi-directional relationship between DFU and psychological factors intriguing, but also challenging at is will emcompass many aspects and relationships. My main concern is the study aim which has implications for the rest of the study. The study aim is not entirely clear and varies across the manuscript, e.g., "interventions" and "prevention" are mentioned in some parts of the manuscript, but not in all. The main aim is to address the above-mentioned bi-directional relationship between psychological factors and DFU, which can be divided into A: Effects of psychological variables on a) DFU improvement or healing b) DFU prevention (including incidence of first-ever DFU or recurrance) This could include both observational and interventional studies, but I don't think the PCC framework is appropriate for interventional studies. B: Effects of living with active DFU on a) psychological variables I think the aims need to be clarified throughout the text, as they also have implications for other parts of the study (e.g., if choosing to use PICO in addition to PCC, how to structure the data extraction, etc.) Definition of DFU (p.15), please note that this is the definition of DF disease, not DFU. Paragraph on behavioural factors (p.15): I think some text in parantheses can be removed ("the individual may behave differently due to" and "an individual’s behaviour may be directly or indirectly influenced by the available") Table 1, Inclusion criteria, The condition: I suggest to simplify this to studies related to DFU, the risk of listing detailed aspects of study types is that certain relevant studies may be excluded. Reference: van Netten et al (2016). Please update to latest version (2023). Is the rationale for, and objectives of, the study clearly described? Partly Is the study design appropriate for the research question? Partly Are sufficient details of the methods provided to allow replication by others? Yes Are the datasets clearly presented in a useable and accessible format? Not applicable Competing Interests: No competing interests were disclosed. Reviewer Expertise: diabetes-related foot disease, especially offloading for preventing and healing DFUs, and patient adherence. I confirm that I have read this submission and believe that I have an appropriate level of expertise to state that I do not consider it to be of an acceptable scientific standard, for reasons outlined above. Close READ LESS CITE CITE HOW TO CITE THIS REPORT Jarl G. Reviewer Report For: A Protocol for a Scoping Review to assess the influence of psychological factors on the development and progression of diabetes-related foot ulcers [version 3; peer review: 6 approved with reservations, 2 not approved] . HRB Open Res 2025, 7 :18 ( https://doi.org/10.21956/hrbopenres.15331.r43289 ) The direct URL for this report is: https://hrbopenresearch.org/articles/7-18/v2#referee-response-43289 NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article. COPY CITATION DETAILS Report a concern Author Response 05 Mar 2025 Michelle Hanlon , $usrAffiliation 05 Mar 2025 Author Response Thank you very much for taking the time to review our article and for providing this valuable feedback. Please find our responses to your comments below: 1. We have ... Continue reading Thank you very much for taking the time to review our article and for providing this valuable feedback. Please find our responses to your comments below: 1. We have now amended the aims and hope this makes our intentions clearer. 2. Thank you for highlighting this. We have now amended the definition accordingly. 3. Thank you for this suggestion. This paragraph has now been amended. 4. Thank you for this input. The table has been updated accordingly. 5.Thank you for highlighting this. The reference has now been updated. Thank you very much for taking the time to review our article and for providing this valuable feedback. Please find our responses to your comments below: 1. We have now amended the aims and hope this makes our intentions clearer. 2. Thank you for highlighting this. We have now amended the definition accordingly. 3. Thank you for this suggestion. This paragraph has now been amended. 4. Thank you for this input. The table has been updated accordingly. 5.Thank you for highlighting this. The reference has now been updated. Competing Interests: No competing interests were disclosed. Close Report a concern Respond or Comment COMMENTS ON THIS REPORT Author Response 05 Mar 2025 Michelle Hanlon , $usrAffiliation 05 Mar 2025 Author Response Thank you very much for taking the time to review our article and for providing this valuable feedback. Please find our responses to your comments below: 1. We have ... Continue reading Thank you very much for taking the time to review our article and for providing this valuable feedback. Please find our responses to your comments below: 1. We have now amended the aims and hope this makes our intentions clearer. 2. Thank you for highlighting this. We have now amended the definition accordingly. 3. Thank you for this suggestion. This paragraph has now been amended. 4. Thank you for this input. The table has been updated accordingly. 5.Thank you for highlighting this. The reference has now been updated. Thank you very much for taking the time to review our article and for providing this valuable feedback. Please find our responses to your comments below: 1. We have now amended the aims and hope this makes our intentions clearer. 2. Thank you for highlighting this. We have now amended the definition accordingly. 3. Thank you for this suggestion. This paragraph has now been amended. 4. Thank you for this input. The table has been updated accordingly. 5.Thank you for highlighting this. The reference has now been updated. Competing Interests: No competing interests were disclosed. Close Report a concern COMMENT ON THIS REPORT Views 0 Cite How to cite this report: Ababneh A. Reviewer Report For: A Protocol for a Scoping Review to assess the influence of psychological factors on the development and progression of diabetes-related foot ulcers [version 3; peer review: 6 approved with reservations, 2 not approved] . HRB Open Res 2025, 7 :18 ( https://doi.org/10.21956/hrbopenres.15331.r43295 ) The direct URL for this report is: https://hrbopenresearch.org/articles/7-18/v2#referee-response-43295 NOTE: it is important to ensure the information in square brackets after the title is included in this citation. Close Copy Citation Details Reviewer Report 27 Nov 2024 Anas Ababneh , Yarmouk University, Irbid, Irbid Governorate, Jordan Approved with Reservations VIEWS 0 https://doi.org/10.21956/hrbopenres.15331.r43295 Please use diabetes-related foot ulcers (DFUs) instead of diabetic foot ulceration Is there a need to use “bi-directional”? It seems that this research aims to assess the association between mental health and the ... Continue reading READ ALL Please use diabetes-related foot ulcers (DFUs) instead of diabetic foot ulceration Is there a need to use “bi-directional”? It seems that this research aims to assess the association between mental health and the healing of DFUs. There is no need for “psychological factors and diabetic foot ulceration” in the title. It is weak evidence to report that there is a common belief about the association between psychology and healing. The objective of this review should be more focused. i.e, the association between psychological factors and DFU healing, or the authors might be more open-minded to be more focused on one psychological factor. i.e, depression and healing or anxiety and healing etc.. In the discussion section, there are some variables such as adherence to treatment and social support are technically not psychological variables. Also, I would focus on this review on one major outcome which is DFUs healing. Incidence and recurrence DFUs are different outcomes and assessing these outcomes might confuse this review. Many references in the introduction section are old. Why there is a definition of complex wounds while this study targets DFUs? Are other complex wounds will be included in addition of DFUs? Again, there are other variables in the methods section including emotional wellbeing and psychosocial and behavioural factors. These are a lot of variables while the study aim from the title seems to focus on psychological factors. I would narrow the scope of this review. I would describe the operational definition of wound healing in the methods section. For instance, wound size measurements or healing time. Is there a need to define DFU recurrence while this review assesses wound healing? The research questions are NOT in match with the research title. I am confused now. Is this review about the association between mental health factors and wound healing or reoccurrence of DFUs? Also, is this review about assessing the psychological and emotional impact on people who live with DFUs? I’ve though this study assess the association between psychological factor and DFU healing. Overall, this review needs to be much focused. Is the rationale for, and objectives of, the study clearly described? Partly 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? Partly Competing Interests: No competing interests were disclosed. Reviewer Expertise: Diabetic foot, diabetes, wound care, chronic disease, nursing 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. Close READ LESS CITE CITE HOW TO CITE THIS REPORT Ababneh A. Reviewer Report For: A Protocol for a Scoping Review to assess the influence of psychological factors on the development and progression of diabetes-related foot ulcers [version 3; peer review: 6 approved with reservations, 2 not approved] . HRB Open Res 2025, 7 :18 ( https://doi.org/10.21956/hrbopenres.15331.r43295 ) The direct URL for this report is: https://hrbopenresearch.org/articles/7-18/v2#referee-response-43295 NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article. COPY CITATION DETAILS Report a concern Author Response 05 Mar 2025 Michelle Hanlon , $usrAffiliation 05 Mar 2025 Author Response Thank you very much for taking the time to review our manuscript and for providing this insightful feedback. Please find our responses to your comments below: 1. Thank you ... Continue reading Thank you very much for taking the time to review our manuscript and for providing this insightful feedback. Please find our responses to your comments below: 1. Thank you for highlighting this. We have now updated this term throughout the manuscript. 2.Thank you for your question regarding the use of the term "bi-directional".We are using this term to emphasize the complex and reciprocal relationship that exsists between mental health factors and diabetes-related foot ulcers . We believe the term "bi-directional" reflects the understanding that psychological factors, such as anxiety and depression, can negatively impact the healing process of diabetes-related foot ulcers by influencing treatment adherence and self-care behaviors. Conversely, the presence of diabetes-related foot ulcers can lead to increased psychological distress, creating a feedback loop that complicates both mental and physical health outcomes. By using "bi-directional," we aimed to highlight this interplay. That said, we appreciate your feedback and have amended the title. 3.Thank you for your feedback regarding the title of our research. We appreciate your perspective on the focus of our study. We have amended our title and hope that our focus is now clearer 4.The authors have now changed the sentence in question “Psychological factors are believed to play a role in wound healing, but it remains uncertain if psychological interventions can help individuals with an active DFU, or a history of DFUs, to achieve complete or improved wound healing or prevent recurrence.” to “Psychological factors have been found to play a role in wound healing (Frasier at al., 2024; Robinson et al.,2017; Walburn et al.2009).but it remains uncertain if psychological interventions can help individuals with an active DFU, or a history of DFUs, to achieve complete or improved wound healing or prevent recurrence. 5.Thank you for your valuable feedback regarding the focus of our review. We understand the importance of having a clear and targeted objective, and we appreciate your suggestions. Our decision to adopt a broader scope for this scoping review stems from the complexity of the relationship between psychological factors and DFU healing. Psychological factors such as anxiety, depression, and stress often interact and co-occur, influencing healing in multifaceted ways. By examining these factors collectively, we aim to provide a comprehensive overview that captures the nuances of their interrelationships rather than isolating a single factor. Focusing solely on one psychological aspect, while valuable, may limit our understanding of how various factors contribute to DFU healing. Our intention is to highlight the overarching patterns and connections that exist among these psychological factors, thereby creating a foundation for future research that can explore specific relationships in greater detail. 6.Thank you for your insightful feedback regarding the discussion section of our review. We appreciate your observations about the inclusion of variables such as adherence to treatment and social support. While it is true that adherence to treatment and social support are not strictly psychological variables, we chose to include them because they play a significant role in the overall psychological context that affects DFU healing. Adherence to treatment is often influenced by mental health factors, such as motivation and perceived self-efficacy, while social support can provide emotional and practical resources that alleviate psychological stress. By considering these variables, we aim to present a more holistic view of the factors impacting DFU healing. Regarding your suggestion to focus exclusively on DFU healing as the primary outcome, we appreciate the importance of clarity in our objectives. However, we believe that including the incidence and recurrence of DFUs enriches the discussion by providing a broader understanding of how psychological factors might influence not just healing but also the likelihood of future complications. This comprehensive approach can help identify areas for targeted interventions and inform clinical practices. That said, we will take your feedback into account and have tried to work to clarify the distinction between the outcomes in our discussion. 7. We acknowledge the importance of incorporating recent studies to provide a current context for our research and have aimed to do so throughout this manuscript. The foundational studies we also included, while older, serve to establish the historical context and ongoing relevance of the psychological factors related to DFU healing. 8. Thank you for this feedback. No other complex wounds will be included. The original manuscript started by providing a comprehensive background on diabetes. A reviewer suggested that as DFUs are complex wounds that we should instead start the review by providing a background on complex wounds. The authors agreed and amended it accordingly. 9.Thank you for feedback. We have now hopefully addressed this in our previous response to your comments on the discussion section. 10.Thank you for your feedback regarding the placement of the operational definition of wound healing. We appreciate your suggestion to include this information in the methods section. Our rationale for including the operational definition of wound healing with other definitions in the introduction is to provide a comprehensive understanding of the terms that underpin our review. By defining wound healing alongside other relevant concepts, we aim to establish a clear framework for readers, ensuring they grasp the context and significance of our research from the outset. While specific details about wound size measurements and healing time are indeed important, we believe that the approach that we have taken helps to clarify the broader implications of wound healing as it relates to psychological factors and DFU healing. 11. Thank you for your insightful critique and we appreciate your perspective. We believe that it is important to define and address DFU recurrence as recurrence is often influenced by factors related to both healing and ongoing management, including psychological factors, adherence to treatment, and social support. We also believe that addressing the concept of recurrence highlights the importance of not only achieving healing but also preventing future complications. 12. Thank you for your thoughtful feedback regarding the clarity and alignment of our title with the research questions. We appreciate your concerns and the opportunity to clarify our intentions and have amended the title and manuscript accordingly. Thank you very much for taking the time to review our manuscript and for providing this insightful feedback. Please find our responses to your comments below: 1. Thank you for highlighting this. We have now updated this term throughout the manuscript. 2.Thank you for your question regarding the use of the term "bi-directional".We are using this term to emphasize the complex and reciprocal relationship that exsists between mental health factors and diabetes-related foot ulcers . We believe the term "bi-directional" reflects the understanding that psychological factors, such as anxiety and depression, can negatively impact the healing process of diabetes-related foot ulcers by influencing treatment adherence and self-care behaviors. Conversely, the presence of diabetes-related foot ulcers can lead to increased psychological distress, creating a feedback loop that complicates both mental and physical health outcomes. By using "bi-directional," we aimed to highlight this interplay. That said, we appreciate your feedback and have amended the title. 3.Thank you for your feedback regarding the title of our research. We appreciate your perspective on the focus of our study. We have amended our title and hope that our focus is now clearer 4.The authors have now changed the sentence in question “Psychological factors are believed to play a role in wound healing, but it remains uncertain if psychological interventions can help individuals with an active DFU, or a history of DFUs, to achieve complete or improved wound healing or prevent recurrence.” to “Psychological factors have been found to play a role in wound healing (Frasier at al., 2024; Robinson et al.,2017; Walburn et al.2009).but it remains uncertain if psychological interventions can help individuals with an active DFU, or a history of DFUs, to achieve complete or improved wound healing or prevent recurrence. 5.Thank you for your valuable feedback regarding the focus of our review. We understand the importance of having a clear and targeted objective, and we appreciate your suggestions. Our decision to adopt a broader scope for this scoping review stems from the complexity of the relationship between psychological factors and DFU healing. Psychological factors such as anxiety, depression, and stress often interact and co-occur, influencing healing in multifaceted ways. By examining these factors collectively, we aim to provide a comprehensive overview that captures the nuances of their interrelationships rather than isolating a single factor. Focusing solely on one psychological aspect, while valuable, may limit our understanding of how various factors contribute to DFU healing. Our intention is to highlight the overarching patterns and connections that exist among these psychological factors, thereby creating a foundation for future research that can explore specific relationships in greater detail. 6.Thank you for your insightful feedback regarding the discussion section of our review. We appreciate your observations about the inclusion of variables such as adherence to treatment and social support. While it is true that adherence to treatment and social support are not strictly psychological variables, we chose to include them because they play a significant role in the overall psychological context that affects DFU healing. Adherence to treatment is often influenced by mental health factors, such as motivation and perceived self-efficacy, while social support can provide emotional and practical resources that alleviate psychological stress. By considering these variables, we aim to present a more holistic view of the factors impacting DFU healing. Regarding your suggestion to focus exclusively on DFU healing as the primary outcome, we appreciate the importance of clarity in our objectives. However, we believe that including the incidence and recurrence of DFUs enriches the discussion by providing a broader understanding of how psychological factors might influence not just healing but also the likelihood of future complications. This comprehensive approach can help identify areas for targeted interventions and inform clinical practices. That said, we will take your feedback into account and have tried to work to clarify the distinction between the outcomes in our discussion. 7. We acknowledge the importance of incorporating recent studies to provide a current context for our research and have aimed to do so throughout this manuscript. The foundational studies we also included, while older, serve to establish the historical context and ongoing relevance of the psychological factors related to DFU healing. 8. Thank you for this feedback. No other complex wounds will be included. The original manuscript started by providing a comprehensive background on diabetes. A reviewer suggested that as DFUs are complex wounds that we should instead start the review by providing a background on complex wounds. The authors agreed and amended it accordingly. 9.Thank you for feedback. We have now hopefully addressed this in our previous response to your comments on the discussion section. 10.Thank you for your feedback regarding the placement of the operational definition of wound healing. We appreciate your suggestion to include this information in the methods section. Our rationale for including the operational definition of wound healing with other definitions in the introduction is to provide a comprehensive understanding of the terms that underpin our review. By defining wound healing alongside other relevant concepts, we aim to establish a clear framework for readers, ensuring they grasp the context and significance of our research from the outset. While specific details about wound size measurements and healing time are indeed important, we believe that the approach that we have taken helps to clarify the broader implications of wound healing as it relates to psychological factors and DFU healing. 11. Thank you for your insightful critique and we appreciate your perspective. We believe that it is important to define and address DFU recurrence as recurrence is often influenced by factors related to both healing and ongoing management, including psychological factors, adherence to treatment, and social support. We also believe that addressing the concept of recurrence highlights the importance of not only achieving healing but also preventing future complications. 12. Thank you for your thoughtful feedback regarding the clarity and alignment of our title with the research questions. We appreciate your concerns and the opportunity to clarify our intentions and have amended the title and manuscript accordingly. Competing Interests: No competing interests were disclosed. Close Report a concern Respond or Comment COMMENTS ON THIS REPORT Author Response 05 Mar 2025 Michelle Hanlon , $usrAffiliation 05 Mar 2025 Author Response Thank you very much for taking the time to review our manuscript and for providing this insightful feedback. Please find our responses to your comments below: 1. Thank you ... Continue reading Thank you very much for taking the time to review our manuscript and for providing this insightful feedback. Please find our responses to your comments below: 1. Thank you for highlighting this. We have now updated this term throughout the manuscript. 2.Thank you for your question regarding the use of the term "bi-directional".We are using this term to emphasize the complex and reciprocal relationship that exsists between mental health factors and diabetes-related foot ulcers . We believe the term "bi-directional" reflects the understanding that psychological factors, such as anxiety and depression, can negatively impact the healing process of diabetes-related foot ulcers by influencing treatment adherence and self-care behaviors. Conversely, the presence of diabetes-related foot ulcers can lead to increased psychological distress, creating a feedback loop that complicates both mental and physical health outcomes. By using "bi-directional," we aimed to highlight this interplay. That said, we appreciate your feedback and have amended the title. 3.Thank you for your feedback regarding the title of our research. We appreciate your perspective on the focus of our study. We have amended our title and hope that our focus is now clearer 4.The authors have now changed the sentence in question “Psychological factors are believed to play a role in wound healing, but it remains uncertain if psychological interventions can help individuals with an active DFU, or a history of DFUs, to achieve complete or improved wound healing or prevent recurrence.” to “Psychological factors have been found to play a role in wound healing (Frasier at al., 2024; Robinson et al.,2017; Walburn et al.2009).but it remains uncertain if psychological interventions can help individuals with an active DFU, or a history of DFUs, to achieve complete or improved wound healing or prevent recurrence. 5.Thank you for your valuable feedback regarding the focus of our review. We understand the importance of having a clear and targeted objective, and we appreciate your suggestions. Our decision to adopt a broader scope for this scoping review stems from the complexity of the relationship between psychological factors and DFU healing. Psychological factors such as anxiety, depression, and stress often interact and co-occur, influencing healing in multifaceted ways. By examining these factors collectively, we aim to provide a comprehensive overview that captures the nuances of their interrelationships rather than isolating a single factor. Focusing solely on one psychological aspect, while valuable, may limit our understanding of how various factors contribute to DFU healing. Our intention is to highlight the overarching patterns and connections that exist among these psychological factors, thereby creating a foundation for future research that can explore specific relationships in greater detail. 6.Thank you for your insightful feedback regarding the discussion section of our review. We appreciate your observations about the inclusion of variables such as adherence to treatment and social support. While it is true that adherence to treatment and social support are not strictly psychological variables, we chose to include them because they play a significant role in the overall psychological context that affects DFU healing. Adherence to treatment is often influenced by mental health factors, such as motivation and perceived self-efficacy, while social support can provide emotional and practical resources that alleviate psychological stress. By considering these variables, we aim to present a more holistic view of the factors impacting DFU healing. Regarding your suggestion to focus exclusively on DFU healing as the primary outcome, we appreciate the importance of clarity in our objectives. However, we believe that including the incidence and recurrence of DFUs enriches the discussion by providing a broader understanding of how psychological factors might influence not just healing but also the likelihood of future complications. This comprehensive approach can help identify areas for targeted interventions and inform clinical practices. That said, we will take your feedback into account and have tried to work to clarify the distinction between the outcomes in our discussion. 7. We acknowledge the importance of incorporating recent studies to provide a current context for our research and have aimed to do so throughout this manuscript. The foundational studies we also included, while older, serve to establish the historical context and ongoing relevance of the psychological factors related to DFU healing. 8. Thank you for this feedback. No other complex wounds will be included. The original manuscript started by providing a comprehensive background on diabetes. A reviewer suggested that as DFUs are complex wounds that we should instead start the review by providing a background on complex wounds. The authors agreed and amended it accordingly. 9.Thank you for feedback. We have now hopefully addressed this in our previous response to your comments on the discussion section. 10.Thank you for your feedback regarding the placement of the operational definition of wound healing. We appreciate your suggestion to include this information in the methods section. Our rationale for including the operational definition of wound healing with other definitions in the introduction is to provide a comprehensive understanding of the terms that underpin our review. By defining wound healing alongside other relevant concepts, we aim to establish a clear framework for readers, ensuring they grasp the context and significance of our research from the outset. While specific details about wound size measurements and healing time are indeed important, we believe that the approach that we have taken helps to clarify the broader implications of wound healing as it relates to psychological factors and DFU healing. 11. Thank you for your insightful critique and we appreciate your perspective. We believe that it is important to define and address DFU recurrence as recurrence is often influenced by factors related to both healing and ongoing management, including psychological factors, adherence to treatment, and social support. We also believe that addressing the concept of recurrence highlights the importance of not only achieving healing but also preventing future complications. 12. Thank you for your thoughtful feedback regarding the clarity and alignment of our title with the research questions. We appreciate your concerns and the opportunity to clarify our intentions and have amended the title and manuscript accordingly. Thank you very much for taking the time to review our manuscript and for providing this insightful feedback. Please find our responses to your comments below: 1. Thank you for highlighting this. We have now updated this term throughout the manuscript. 2.Thank you for your question regarding the use of the term "bi-directional".We are using this term to emphasize the complex and reciprocal relationship that exsists between mental health factors and diabetes-related foot ulcers . We believe the term "bi-directional" reflects the understanding that psychological factors, such as anxiety and depression, can negatively impact the healing process of diabetes-related foot ulcers by influencing treatment adherence and self-care behaviors. Conversely, the presence of diabetes-related foot ulcers can lead to increased psychological distress, creating a feedback loop that complicates both mental and physical health outcomes. By using "bi-directional," we aimed to highlight this interplay. That said, we appreciate your feedback and have amended the title. 3.Thank you for your feedback regarding the title of our research. We appreciate your perspective on the focus of our study. We have amended our title and hope that our focus is now clearer 4.The authors have now changed the sentence in question “Psychological factors are believed to play a role in wound healing, but it remains uncertain if psychological interventions can help individuals with an active DFU, or a history of DFUs, to achieve complete or improved wound healing or prevent recurrence.” to “Psychological factors have been found to play a role in wound healing (Frasier at al., 2024; Robinson et al.,2017; Walburn et al.2009).but it remains uncertain if psychological interventions can help individuals with an active DFU, or a history of DFUs, to achieve complete or improved wound healing or prevent recurrence. 5.Thank you for your valuable feedback regarding the focus of our review. We understand the importance of having a clear and targeted objective, and we appreciate your suggestions. Our decision to adopt a broader scope for this scoping review stems from the complexity of the relationship between psychological factors and DFU healing. Psychological factors such as anxiety, depression, and stress often interact and co-occur, influencing healing in multifaceted ways. By examining these factors collectively, we aim to provide a comprehensive overview that captures the nuances of their interrelationships rather than isolating a single factor. Focusing solely on one psychological aspect, while valuable, may limit our understanding of how various factors contribute to DFU healing. Our intention is to highlight the overarching patterns and connections that exist among these psychological factors, thereby creating a foundation for future research that can explore specific relationships in greater detail. 6.Thank you for your insightful feedback regarding the discussion section of our review. We appreciate your observations about the inclusion of variables such as adherence to treatment and social support. While it is true that adherence to treatment and social support are not strictly psychological variables, we chose to include them because they play a significant role in the overall psychological context that affects DFU healing. Adherence to treatment is often influenced by mental health factors, such as motivation and perceived self-efficacy, while social support can provide emotional and practical resources that alleviate psychological stress. By considering these variables, we aim to present a more holistic view of the factors impacting DFU healing. Regarding your suggestion to focus exclusively on DFU healing as the primary outcome, we appreciate the importance of clarity in our objectives. However, we believe that including the incidence and recurrence of DFUs enriches the discussion by providing a broader understanding of how psychological factors might influence not just healing but also the likelihood of future complications. This comprehensive approach can help identify areas for targeted interventions and inform clinical practices. That said, we will take your feedback into account and have tried to work to clarify the distinction between the outcomes in our discussion. 7. We acknowledge the importance of incorporating recent studies to provide a current context for our research and have aimed to do so throughout this manuscript. The foundational studies we also included, while older, serve to establish the historical context and ongoing relevance of the psychological factors related to DFU healing. 8. Thank you for this feedback. No other complex wounds will be included. The original manuscript started by providing a comprehensive background on diabetes. A reviewer suggested that as DFUs are complex wounds that we should instead start the review by providing a background on complex wounds. The authors agreed and amended it accordingly. 9.Thank you for feedback. We have now hopefully addressed this in our previous response to your comments on the discussion section. 10.Thank you for your feedback regarding the placement of the operational definition of wound healing. We appreciate your suggestion to include this information in the methods section. Our rationale for including the operational definition of wound healing with other definitions in the introduction is to provide a comprehensive understanding of the terms that underpin our review. By defining wound healing alongside other relevant concepts, we aim to establish a clear framework for readers, ensuring they grasp the context and significance of our research from the outset. While specific details about wound size measurements and healing time are indeed important, we believe that the approach that we have taken helps to clarify the broader implications of wound healing as it relates to psychological factors and DFU healing. 11. Thank you for your insightful critique and we appreciate your perspective. We believe that it is important to define and address DFU recurrence as recurrence is often influenced by factors related to both healing and ongoing management, including psychological factors, adherence to treatment, and social support. We also believe that addressing the concept of recurrence highlights the importance of not only achieving healing but also preventing future complications. 12. Thank you for your thoughtful feedback regarding the clarity and alignment of our title with the research questions. We appreciate your concerns and the opportunity to clarify our intentions and have amended the title and manuscript accordingly. Competing Interests: No competing interests were disclosed. Close Report a concern COMMENT ON THIS REPORT Views 0 Cite How to cite this report: Crocker RM. Reviewer Report For: A Protocol for a Scoping Review to assess the influence of psychological factors on the development and progression of diabetes-related foot ulcers [version 3; peer review: 6 approved with reservations, 2 not approved] . HRB Open Res 2025, 7 :18 ( https://doi.org/10.21956/hrbopenres.15331.r42925 ) The direct URL for this report is: https://hrbopenresearch.org/articles/7-18/v2#referee-response-42925 NOTE: it is important to ensure the information in square brackets after the title is included in this citation. Close Copy Citation Details Reviewer Report 21 Nov 2024 Rebecca M Crocker , The University of Arizona, Tucson, Arizona, USA Not Approved VIEWS 0 https://doi.org/10.21956/hrbopenres.15331.r42925 Overall comments: In describing the study objective, I would change the text such that rather than providing a better understanding of the issue, which is really beyond the scope of a review article, the authors can state instead that ... Continue reading READ ALL Overall comments: In describing the study objective, I would change the text such that rather than providing a better understanding of the issue, which is really beyond the scope of a review article, the authors can state instead that this review will analyze the state of our current knowledge on the topic of bi-directionality and suggest/identify critical areas of future research necessary to inform the development or adaptation of a tailored psychological intervention that will aim to optimise wellbeing and improve outcomes for individuals with DFU. Introduction: The Introduction has good, relevant information but it takes too long for you to introduce the topic of the review, so I would suggest further highlighting the psychological/mental health issues in the opening paragraph. "Rationale for Study" I am not sure if this is an appropriate sub-heading given that this is a review article rather than a study. I suggest rephrasing to reflect common language of review articles and also to move the part about bi-directional psychological impact higher up in the paragraph. Methods As a review this is not an investigation, it is a synthesis of the existing knowledge. The first paragraph and the research questions need to be re-worded to make this distinction clear. Discussion The discussion does not adequately address the existing evidence in the literature that you have included and therefore does not answer the research questions or advance our understanding of these issues. Is the rationale for, and objectives of, the study clearly described? Partly Is the study design appropriate for the research question? Partly Are sufficient details of the methods provided to allow replication by others? Yes Are the datasets clearly presented in a useable and accessible format? Partly Competing Interests: No competing interests were disclosed. Reviewer Expertise: patient experiences of DFUs; communication of genetic and behavioral risk factors for non-alcoholic fatty liver disease; sources of stress and resilience among Latino immigrants, self-administration of cancer screening among Latinos I confirm that I have read this submission and believe that I have an appropriate level of expertise to state that I do not consider it to be of an acceptable scientific standard, for reasons outlined above. Close READ LESS CITE CITE HOW TO CITE THIS REPORT Crocker RM. Reviewer Report For: A Protocol for a Scoping Review to assess the influence of psychological factors on the development and progression of diabetes-related foot ulcers [version 3; peer review: 6 approved with reservations, 2 not approved] . HRB Open Res 2025, 7 :18 ( https://doi.org/10.21956/hrbopenres.15331.r42925 ) The direct URL for this report is: https://hrbopenresearch.org/articles/7-18/v2#referee-response-42925 NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article. COPY CITATION DETAILS Report a concern Author Response 05 Mar 2025 Michelle Hanlon , $usrAffiliation 05 Mar 2025 Author Response Thank you very much for taking the time to review our manuscript and for providing valuable insight. Please see our responses to each of your comments below: 1. Thank ... Continue reading Thank you very much for taking the time to review our manuscript and for providing valuable insight. Please see our responses to each of your comments below: 1. Thank you for this feedback. We have now amended the objective accordingly. 2. Thank you for this feedback. We have now amended the introduction based on your input. 3. Thank you for your input. We have amended the sub-heading. 4. Thank you for your input. We have re-phrased this section to make this clearer. 5. Thank you for this insight. We have updated this section accordingly. Thank you very much for taking the time to review our manuscript and for providing valuable insight. Please see our responses to each of your comments below: 1. Thank you for this feedback. We have now amended the objective accordingly. 2. Thank you for this feedback. We have now amended the introduction based on your input. 3. Thank you for your input. We have amended the sub-heading. 4. Thank you for your input. We have re-phrased this section to make this clearer. 5. Thank you for this insight. We have updated this section accordingly. Competing Interests: No competing interests were disclosed. Close Report a concern Respond or Comment COMMENTS ON THIS REPORT Author Response 05 Mar 2025 Michelle Hanlon , $usrAffiliation 05 Mar 2025 Author Response Thank you very much for taking the time to review our manuscript and for providing valuable insight. Please see our responses to each of your comments below: 1. Thank ... Continue reading Thank you very much for taking the time to review our manuscript and for providing valuable insight. Please see our responses to each of your comments below: 1. Thank you for this feedback. We have now amended the objective accordingly. 2. Thank you for this feedback. We have now amended the introduction based on your input. 3. Thank you for your input. We have amended the sub-heading. 4. Thank you for your input. We have re-phrased this section to make this clearer. 5. Thank you for this insight. We have updated this section accordingly. Thank you very much for taking the time to review our manuscript and for providing valuable insight. Please see our responses to each of your comments below: 1. Thank you for this feedback. We have now amended the objective accordingly. 2. Thank you for this feedback. We have now amended the introduction based on your input. 3. Thank you for your input. We have amended the sub-heading. 4. Thank you for your input. We have re-phrased this section to make this clearer. 5. Thank you for this insight. We have updated this section accordingly. Competing Interests: No competing interests were disclosed. Close Report a concern COMMENT ON THIS REPORT Views 0 Cite How to cite this report: Marques R. Reviewer Report For: A Protocol for a Scoping Review to assess the influence of psychological factors on the development and progression of diabetes-related foot ulcers [version 3; peer review: 6 approved with reservations, 2 not approved] . HRB Open Res 2025, 7 :18 ( https://doi.org/10.21956/hrbopenres.15331.r42597 ) The direct URL for this report is: https://hrbopenresearch.org/articles/7-18/v2#referee-response-42597 NOTE: it is important to ensure the information in square brackets after the title is included in this citation. Close Copy Citation Details Reviewer Report 21 Nov 2024 Raquel Marques , Universidade Católica Portuguesa, Institute of Health Sciences, Porto, Portugal Approved with Reservations VIEWS 0 https://doi.org/10.21956/hrbopenres.15331.r42597 Thank you for reviewing the article. However, there are several aspects that require further clarification, including: According to JBI recommendations, preliminary research should be carried out to understand whether other reviews have been carried out in this ... Continue reading READ ALL Thank you for reviewing the article. However, there are several aspects that require further clarification, including: According to JBI recommendations, preliminary research should be carried out to understand whether other reviews have been carried out in this area, “As a result of the limited number of RCTs available, there is a high risk of bias so conclusions cannot be drawn”. However, this limitation alone does not constitute a valid justification for conducting a scoping review. It is crucial to recognize that systematic reviews of the literature, particularly those based on RCTs, represent the highest level of evidence in the hierarchy of scientific research. These reviews synthesize data from well-designed studies to provide robust and reliable conclusions. That said, it is also important to note that there are thematic areas or research contexts where conducting RCTs is either impractical or ethically unfeasible. In such cases, alternative approaches, including other types of primary research or evidence synthesis, may be necessary. Therefore, a scoping review should only be undertaken when its objectives are clearly defined and aligned with the need to explore or map a research field, not merely as a response to the absence of RCTs. Eligibility criteria must be defined by the PCC Competing Interests: No competing interests were disclosed. Reviewer Expertise: Wound care, complex wound, assessment wound. 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. Close READ LESS CITE CITE HOW TO CITE THIS REPORT Marques R. Reviewer Report For: A Protocol for a Scoping Review to assess the influence of psychological factors on the development and progression of diabetes-related foot ulcers [version 3; peer review: 6 approved with reservations, 2 not approved] . HRB Open Res 2025, 7 :18 ( https://doi.org/10.21956/hrbopenres.15331.r42597 ) The direct URL for this report is: https://hrbopenresearch.org/articles/7-18/v2#referee-response-42597 NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article. COPY CITATION DETAILS Report a concern Author Response 05 Mar 2025 Michelle Hanlon , $usrAffiliation 05 Mar 2025 Author Response Thank you very much for taking the time to review our article and for highlighting the need for preliminary research to be conducted before starting a review such as this. ... Continue reading Thank you very much for taking the time to review our article and for highlighting the need for preliminary research to be conducted before starting a review such as this. Apologies that we did not make this clear in our initial writeup. A thorough review of existing literature on the topic was indeed conducted prior to initiating our scoping review. We appreciate your guidance in emphasizing the importance of this preliminary research and have now updated our article to clarify this. We have also provided further justification on why a scoping review was conducted instead of a systematic review and have clarified the context of our study within the existing literature. Thank you for helping us enhance the rigor of our work. Thank you very much for taking the time to review our article and for highlighting the need for preliminary research to be conducted before starting a review such as this. Apologies that we did not make this clear in our initial writeup. A thorough review of existing literature on the topic was indeed conducted prior to initiating our scoping review. We appreciate your guidance in emphasizing the importance of this preliminary research and have now updated our article to clarify this. We have also provided further justification on why a scoping review was conducted instead of a systematic review and have clarified the context of our study within the existing literature. Thank you for helping us enhance the rigor of our work. Competing Interests: No competing interests were disclosed. Close Report a concern Respond or Comment COMMENTS ON THIS REPORT Author Response 05 Mar 2025 Michelle Hanlon , $usrAffiliation 05 Mar 2025 Author Response Thank you very much for taking the time to review our article and for highlighting the need for preliminary research to be conducted before starting a review such as this. ... Continue reading Thank you very much for taking the time to review our article and for highlighting the need for preliminary research to be conducted before starting a review such as this. Apologies that we did not make this clear in our initial writeup. A thorough review of existing literature on the topic was indeed conducted prior to initiating our scoping review. We appreciate your guidance in emphasizing the importance of this preliminary research and have now updated our article to clarify this. We have also provided further justification on why a scoping review was conducted instead of a systematic review and have clarified the context of our study within the existing literature. Thank you for helping us enhance the rigor of our work. Thank you very much for taking the time to review our article and for highlighting the need for preliminary research to be conducted before starting a review such as this. Apologies that we did not make this clear in our initial writeup. A thorough review of existing literature on the topic was indeed conducted prior to initiating our scoping review. We appreciate your guidance in emphasizing the importance of this preliminary research and have now updated our article to clarify this. We have also provided further justification on why a scoping review was conducted instead of a systematic review and have clarified the context of our study within the existing literature. Thank you for helping us enhance the rigor of our work. Competing Interests: No competing interests were disclosed. Close Report a concern COMMENT ON THIS REPORT Version 1 VERSION 1 PUBLISHED 18 Apr 2024 Views 0 Cite How to cite this report: Vileikyte L. Reviewer Report For: A Protocol for a Scoping Review to assess the influence of psychological factors on the development and progression of diabetes-related foot ulcers [version 3; peer review: 6 approved with reservations, 2 not approved] . HRB Open Res 2025, 7 :18 ( https://doi.org/10.21956/hrbopenres.15047.r40226 ) The direct URL for this report is: https://hrbopenresearch.org/articles/7-18/v1#referee-response-40226 NOTE: it is important to ensure the information in square brackets after the title is included in this citation. Close Copy Citation Details Reviewer Report 21 Jun 2024 Loretta Vileikyte , The University of Manchester, Manchester, England, UK Not Approved VIEWS 0 https://doi.org/10.21956/hrbopenres.15047.r40226 Hanlon and colleagues describe a protocol for a scoping review of the bi-directional relationship between diabetic foot ulcer healing and mental factors. Specifically, they aim to identify: 1) emotional and psychosocial burden of living with DFU and (b) psychological variables ... Continue reading READ ALL Hanlon and colleagues describe a protocol for a scoping review of the bi-directional relationship between diabetic foot ulcer healing and mental factors. Specifically, they aim to identify: 1) emotional and psychosocial burden of living with DFU and (b) psychological variables that may lead to poor outcomes in DFU. I do not believe that a scoping review is the way to answer the bi-directionality question. There are already more published reviews (systematic, scoping etc) than there are original, high-quality studies. An overview of systematic reviews in this area ( Crawford, F et al. Reliability of the evidence to guide decision-making in foot ulcer prevention in diabetes: an overview of systematic reviews. BMC Med Res Methodol 22 , 274 (2022) identified 30 reviews that collectively assessed 26 largely poor-quality RCTs with substantial overlap. Most of these systematic reviews are at high risk of bias and fail to provide reliable evidence for decision-making. To answer the research question regarding the bi-directional relationships between psychological/emotional factors and DFUs, the authors should conduct a longitudinal, adequately powered study of well-defined (DFU and psychological factors) population to determine: analysis 1: the incidence of DFUs and the associated risk with psychological factors (e.g., depression), and analysis 2: the incidence of e.g., depression and associated risk with DFUs. See [1] Is the rationale for, and objectives of, the study clearly described? Partly Is the study design appropriate for the research question? No Are sufficient details of the methods provided to allow replication by others? Partly Are the datasets clearly presented in a useable and accessible format? Not applicable References 1. Golden SH, Lazo M, Carnethon M, Bertoni AG, et al.: Examining a bidirectional association between depressive symptoms and diabetes. JAMA . 2008; 299 (23): 2751-9 PubMed Abstract | Publisher Full Text Competing Interests: No competing interests were disclosed. Reviewer Expertise: The role of psychological/behavioral factors in patient adaptation to diabetic neuropathy and foot ulceration I confirm that I have read this submission and believe that I have an appropriate level of expertise to state that I do not consider it to be of an acceptable scientific standard, for reasons outlined above. Close READ LESS CITE CITE HOW TO CITE THIS REPORT Vileikyte L. Reviewer Report For: A Protocol for a Scoping Review to assess the influence of psychological factors on the development and progression of diabetes-related foot ulcers [version 3; peer review: 6 approved with reservations, 2 not approved] . HRB Open Res 2025, 7 :18 ( https://doi.org/10.21956/hrbopenres.15047.r40226 ) The direct URL for this report is: https://hrbopenresearch.org/articles/7-18/v1#referee-response-40226 NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article. COPY CITATION DETAILS Report a concern Author Response 03 Oct 2024 Michelle Hanlon , $usrAffiliation 03 Oct 2024 Author Response Thank you very much for agreeing to review our paper. We really appreciate your feedback, and the time and consideration that you put in to your response and suggested amendments. This piece of ... Continue reading Thank you very much for agreeing to review our paper. We really appreciate your feedback, and the time and consideration that you put in to your response and suggested amendments. This piece of work is being conducted as part of a PhD study. Therefore, it would not be feasible due to time and cost restraints to conduct a longitudinal study. In terms of methodology, we believe that a scoping review is an appropriate means of laying the foundations for an empirical study, as it allows us to scope the full literature to inform the design of the next phase of the research. Thank you very much again for taking the time to offer the suggestion and perhaps we can revisit it for further postdoctoral research studies on the topic. Thank you very much for agreeing to review our paper. We really appreciate your feedback, and the time and consideration that you put in to your response and suggested amendments. This piece of work is being conducted as part of a PhD study. Therefore, it would not be feasible due to time and cost restraints to conduct a longitudinal study. In terms of methodology, we believe that a scoping review is an appropriate means of laying the foundations for an empirical study, as it allows us to scope the full literature to inform the design of the next phase of the research. Thank you very much again for taking the time to offer the suggestion and perhaps we can revisit it for further postdoctoral research studies on the topic. Competing Interests: No competing interests were disclosed. Close Report a concern Respond or Comment COMMENTS ON THIS REPORT Author Response 03 Oct 2024 Michelle Hanlon , $usrAffiliation 03 Oct 2024 Author Response Thank you very much for agreeing to review our paper. We really appreciate your feedback, and the time and consideration that you put in to your response and suggested amendments. This piece of ... Continue reading Thank you very much for agreeing to review our paper. We really appreciate your feedback, and the time and consideration that you put in to your response and suggested amendments. This piece of work is being conducted as part of a PhD study. Therefore, it would not be feasible due to time and cost restraints to conduct a longitudinal study. In terms of methodology, we believe that a scoping review is an appropriate means of laying the foundations for an empirical study, as it allows us to scope the full literature to inform the design of the next phase of the research. Thank you very much again for taking the time to offer the suggestion and perhaps we can revisit it for further postdoctoral research studies on the topic. Thank you very much for agreeing to review our paper. We really appreciate your feedback, and the time and consideration that you put in to your response and suggested amendments. This piece of work is being conducted as part of a PhD study. Therefore, it would not be feasible due to time and cost restraints to conduct a longitudinal study. In terms of methodology, we believe that a scoping review is an appropriate means of laying the foundations for an empirical study, as it allows us to scope the full literature to inform the design of the next phase of the research. Thank you very much again for taking the time to offer the suggestion and perhaps we can revisit it for further postdoctoral research studies on the topic. Competing Interests: No competing interests were disclosed. Close Report a concern COMMENT ON THIS REPORT Views 0 Cite How to cite this report: Marques R. Reviewer Report For: A Protocol for a Scoping Review to assess the influence of psychological factors on the development and progression of diabetes-related foot ulcers [version 3; peer review: 6 approved with reservations, 2 not approved] . HRB Open Res 2025, 7 :18 ( https://doi.org/10.21956/hrbopenres.15047.r39739 ) The direct URL for this report is: https://hrbopenresearch.org/articles/7-18/v1#referee-response-39739 NOTE: it is important to ensure the information in square brackets after the title is included in this citation. Close Copy Citation Details Reviewer Report 15 May 2024 Raquel Marques , Universidade Católica Portuguesa, Institute of Health Sciences, Porto, Portugal Approved with Reservations VIEWS 0 https://doi.org/10.21956/hrbopenres.15047.r39739 Thank you for submitting this work. These types of studies are needed to contribute to the improvement of care provided to patients with wounds. The protocol is well-written and easy to follow, with a logical structure. ... Continue reading READ ALL Thank you for submitting this work. These types of studies are needed to contribute to the improvement of care provided to patients with wounds. The protocol is well-written and easy to follow, with a logical structure. I have a few comments for the authors: In the title add the word protocol I suggest choosing different keywords from the title, so your study has more scope, for example: wounds and injuries; Review the literature. The introduction of the protocol could explore the challenges of living with a complex wound, the process of healing such wounds, and some risk factors for delayed healing, instead of explaining what diabetes is. In the methodology, clearly define the PCC. Review the exclusion criteria, it is not enough to deny the inclusion criteria. The discussion can be enriched with what already exists in the literature on the topic. References, to mention as 2023 IWGDF Guidelines instead of 2019. 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? Partly Are the datasets clearly presented in a useable and accessible format? Yes Competing Interests: No competing interests were disclosed. Reviewer Expertise: Wound care, complex wound, assessment wound. 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. Close READ LESS CITE CITE HOW TO CITE THIS REPORT Marques R. Reviewer Report For: A Protocol for a Scoping Review to assess the influence of psychological factors on the development and progression of diabetes-related foot ulcers [version 3; peer review: 6 approved with reservations, 2 not approved] . HRB Open Res 2025, 7 :18 ( https://doi.org/10.21956/hrbopenres.15047.r39739 ) The direct URL for this report is: https://hrbopenresearch.org/articles/7-18/v1#referee-response-39739 NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article. COPY CITATION DETAILS Report a concern Author Response 03 Oct 2024 Michelle Hanlon , $usrAffiliation 03 Oct 2024 Author Response Thank you very much for taking the time to review our paper. The authors have made significant revisions based on your suggestions and are very grateful for the constructive feedback ... Continue reading Thank you very much for taking the time to review our paper. The authors have made significant revisions based on your suggestions and are very grateful for the constructive feedback and valuable insights. Thank you very much for taking the time to review our paper. The authors have made significant revisions based on your suggestions and are very grateful for the constructive feedback and valuable insights. Competing Interests: No competing interests were disclosed. Close Report a concern Respond or Comment COMMENTS ON THIS REPORT Author Response 03 Oct 2024 Michelle Hanlon , $usrAffiliation 03 Oct 2024 Author Response Thank you very much for taking the time to review our paper. The authors have made significant revisions based on your suggestions and are very grateful for the constructive feedback ... Continue reading Thank you very much for taking the time to review our paper. The authors have made significant revisions based on your suggestions and are very grateful for the constructive feedback and valuable insights. Thank you very much for taking the time to review our paper. The authors have made significant revisions based on your suggestions and are very grateful for the constructive feedback and valuable insights. Competing Interests: No competing interests were disclosed. Close Report a concern COMMENT ON THIS REPORT Comments on this article Comments (0) Version 3 VERSION 3 PUBLISHED 18 Apr 2024 ADD YOUR COMMENT Comment keyboard_arrow_left keyboard_arrow_right Open Peer Review Reviewer Status info_outline 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 Reviewer Reports Invited Reviewers 1 2 3 4 5 6 7 8 Version 3 (revision) 03 Mar 25 read read read read Version 2 (revision) 01 Oct 24 read read read read Version 1 18 Apr 24 read read Raquel Marques , Universidade Católica Portuguesa, Institute of Health Sciences, Porto, Portugal Loretta Vileikyte , The University of Manchester, Manchester, UK Rebecca M Crocker , The University of Arizona, Tucson, USA Anas Ababneh , Yarmouk University, Irbid, Jordan Gustav Jarl , Örebro University, Örebro, Sweden Helen McGloin , St Angela's College, Sligo, Ireland Sukarni Sukarni , Kanazawa University, Kanazawa, Japan; Tanjungpura University, Pontianak, Indonesia Mette Krabsmark Borbjerg , Aalborg University Hospital, Aalborg, Denmark Johan Røikjer , Aalborg University Hospital, Aalborg, Denmark Comments on this article All Comments (0) Add a comment Sign up for content alerts Sign Up You are now signed up to receive this alert keyboard_arrow_left Back to all reports Reviewer Report 0 Views copyright © 2025 Borbjerg M et al. This is an open access peer review report 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. 04 Nov 2025 | for Version 3 Mette Krabsmark Borbjerg , Steno Diabetes Center North Denmark, Aalborg University Hospital, Aalborg, Denmark Johan Røikjer , Steno Diabetes Center North Denmark, Aalborg University Hospital, Aalborg, Denmark 0 Views copyright © 2025 Borbjerg M et al. This is an open access peer review report 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. format_quote Cite this report speaker_notes Responses (0) Approved With Reservations info_outline 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 Dear Hanlon and colleagues, This is important work and an interesting foundation for the PhD project. Below you can find my comments on your published protocol. Regarding “Objective”: Your objective suggests that you will examine the impact of psychological factors; this phrasing could imply an interpretation of results, which is not the aim of scoping reviews. You could consider using phrasings such as “...map and summarize existing evidence on...”and “…how psychological factors have been explored in relation to …”. The phrase “…in order to make sure that the psychological intervention that is developed will target the most important factors” seems to refer to your future interventional study. This sentence is therefore not relevant in your scoping review protocol. Consider rephrasing to make it more generalizable, e.g., “will identify key knowledge gaps to inform the development of future psychological interventions.” Regarding “PCC”: The phrasing used for your concept implies causal relations; consider rephrasing. The context in your PCC does not correlate with the traditional understanding of context. To comply with the framework, the context could be “in primary care”, “in hospital settings”, or “in Europe”. If you have no specific context, state that there are no limitations or remove the context. Per JBI protocol, you could consider cultural/sub-cultural factors, geographic location, specific racial or gender-based interests, or details about the specific setting. Regarding “Research questions”: For research question 1, consider changing the wording to “What psychological and emotional consequences have been reported in the literature …”, as this would be more appropriate for a scoping review. For research question 2, the use of the term “influence” is problematic for a scoping review, as it implies a measure of effect. Consider the phrasing “What psychosocial factors have been studied in relation to progression or recurrence of ulceration…” Regarding “Eligibility criteria”: For your population, it could be relevant to specify your criteria further. This could be a clarification of how the DFU should be diagnosed, e.g., is it allowed to be self-reported? Specify all that apply or state that there are no limitations in how DFU is diagnosed. For the concept, a description of eligible measures of emotional/psychological data is missing. If you wish to include all forms of measures, state that there are no requirements as to how it is assessed (interview, survey etc.). As described under PCC, your context does not describe the true context. For your eligibility criteria on types of sources, a more in-depth description is needed, including which types of grey literature (thesis, opinion statements, conference abstracts) you are including. In addition, consider adding a statement on whether systematic reviews will be included. If excluded, will the reference list of the systematic reviews be evaluated for additional studies? You could add “Types of studies” to Table 1. Regarding “study selection”: You state both Covidence and Rayyan as possible software; it would be preferred that you only state the one applicable for the study. You do not address the full text screening process; this should be added. It should be described how you will handle unpublished studies and missing data, i.e., will authors be contacted for additional information. Regarding “data extraction”: The data extraction is not specific enough. What exact data will be extracted for this point, “ Key findings that relate to the scoping review question/s”? Per the JBI template, a draft of your data extraction tool should be available in the protocol appendix; alternatively, you could refer to your OSF project. Regarding “Results”: This part is not described in enough detail. Determine how to best present your data; it should relate to the specific research questions, meaning that your decisions should make it possible to answer your research question. Regarding “PPI”: How will PPI be part of this specific scoping review (not your intervention study, but this review)? Regarding “Discussion”: The discussion suggests an interpretation of the relationship between factors. I would recommend rephrasing this section to reflect a more descriptive and exploratory aim. Is the rationale for, and objectives of, the study clearly described? Yes Is the study design appropriate for the research question? Partly Are sufficient details of the methods provided to allow replication by others? No Are the datasets clearly presented in a useable and accessible format? Not applicable Competing Interests No competing interests were disclosed. Reviewer Expertise Diabetes and its complications, particularly diabetic neuropathy and diabetic foot ulcer (DFU), with a focus on their impact on mental health and quality of life. We confirm that we have read this submission and believe that we have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however we have significant reservations, as outlined above. reply Respond to this report Responses (0) Borbjerg MK and Røikjer J. Peer Review Report For: A Protocol for a Scoping Review to assess the influence of psychological factors on the development and progression of diabetes-related foot ulcers [version 3; peer review: 6 approved with reservations, 2 not approved] . HRB Open Res 2025, 7 :18 ( https://doi.org/10.21956/hrbopenres.15482.r50871) NOTE: it is important to ensure the information in square brackets after the title is included in this citation. The direct URL for this report is: https://hrbopenresearch.org/articles/7-18/v3#referee-response-50871 keyboard_arrow_left Back to all reports Reviewer Report 0 Views copyright © 2025 Sukarni S. This is an open access peer review report 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. 20 Aug 2025 | for Version 3 Sukarni Sukarni , Chronic Care and Wound Management Nursing, Kanazawa University, Kanazawa, Japan; Nursing, Tanjungpura University, Pontianak, Kalimantan Barat, Indonesia 0 Views copyright © 2025 Sukarni S. This is an open access peer review report 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. format_quote Cite this report speaker_notes Responses (0) Approved With Reservations info_outline 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 Clarity and Coherence of the Rationale and Research Objectives While the rationale is supported by clinical context and previous reviews, the objectives remain somewhat ambiguous. Although the manuscript mentions gaps in psychological intervention research for DFUs, it does not clearly explain if the review will map psychological determinants, evaluate their associations with clinical outcomes, or examine patient-reported burdens. Detail and Transparency in the Data Charting and Synthesis Plan The search strategy and inclusion/exclusion criteria are clearly articulated, and the PCC framework is applied consistently. However, more detail is needed on the data charting process and synthesis plan, especially regarding how the extracted data will be categorized and analyzed. Recommendations Clarify whether the review aims to describe the range of psychological and psychosocial impacts, identify associations with wound outcomes, or map intervention strategies. Doing so will clarify the study's purpose and ensure that it aligns with the appropriate scope of a scoping review. Include a clearer explanation of the data charting tool and how it relates to the review questions. A table linking key data fields to specific objectives would enhance transparency and replicability. Additionally, describe how discrepancies between reviewers during data extraction will be handled. Is the rationale for, and objectives of, the study clearly described? Partly Is the study design appropriate for the research question? Yes Are sufficient details of the methods provided to allow replication by others? Partly Are the datasets clearly presented in a useable and accessible format? Not applicable Competing Interests No competing interests were disclosed. Reviewer Expertise Wound care, diabetic foot care, management DFU (Nurse specialist in Wound Care) 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. reply Respond to this report Responses (0) Sukarni S. Peer Review Report For: A Protocol for a Scoping Review to assess the influence of psychological factors on the development and progression of diabetes-related foot ulcers [version 3; peer review: 6 approved with reservations, 2 not approved] . HRB Open Res 2025, 7 :18 ( https://doi.org/10.21956/hrbopenres.15482.r48129) NOTE: it is important to ensure the information in square brackets after the title is included in this citation. The direct URL for this report is: https://hrbopenresearch.org/articles/7-18/v3#referee-response-48129 keyboard_arrow_left Back to all reports Reviewer Report 0 Views copyright © 2025 McGloin H. This is an open access peer review report 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. 05 May 2025 | for Version 3 Helen McGloin , St Angela's College, Sligo, Ireland 0 Views copyright © 2025 McGloin H. This is an open access peer review report 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. format_quote Cite this report speaker_notes Responses (0) Approved With Reservations info_outline 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 Research Purpose, Questions and Consistency with Methods This is an important topic for review, however, the purpose and research questions are not consistent throughout. The protocol needs a full and thorough edit to make sure that the components under investigation are defined and consistent throughout. The purpose and questions for the review need to be tracked through the methods - for example the inclusion criteria table specifies understanding how emotional and psychosocial factors influence self-management, but self-management is not specified in the research aim or questions or the search criteria. Terms change between the research question, the inclusion criteria and the search criteria which will be very confusing when you search the literature and screen the results. The research purpose and questions lack the clarity needed to inform the review process therefore the search strategy and inclusion criteria do not match the purpose of the review. Once these have been clarified the title of the review may need to change. The second research question needs to be edited to reflect the remit of a scoping review which is to map out and describe the evidence rather than determine cause and effect. Search Strategy DFU recurrence is specified in the research question, but it isn’t listed in the search criteria. Self-management is specified in the inclusion criteria but has not been included in the search terms. Why is the search timeframe limited up to 2022? Collating Evidence A coding framework is mentioned on p 23 but no explanation of what this is to be used for. Very little detail of the plan for collating, summarising and reporting the results of the review. Suggested Action Points Clarify and define the components under review Clarify the purpose of the review in relation to the self-management of DFU Revise the search strategy and the inclusion criteria Give more detail for Stage 5 Review the title – should ‘psychosocial’ factors be used instead? Is the rationale for, and objectives of, the study clearly described? No Is the study design appropriate for the research question? Partly Are sufficient details of the methods provided to allow replication by others? No Are the datasets clearly presented in a useable and accessible format? Not applicable Competing Interests No competing interests were disclosed. Reviewer Expertise Diabetes, Systematic review, empowerment, Health Coaching 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. reply Respond to this report Responses (0) McGloin H. Peer Review Report For: A Protocol for a Scoping Review to assess the influence of psychological factors on the development and progression of diabetes-related foot ulcers [version 3; peer review: 6 approved with reservations, 2 not approved] . HRB Open Res 2025, 7 :18 ( https://doi.org/10.21956/hrbopenres.15482.r46689) NOTE: it is important to ensure the information in square brackets after the title is included in this citation. The direct URL for this report is: https://hrbopenresearch.org/articles/7-18/v3#referee-response-46689 keyboard_arrow_left Back to all reports Reviewer Report 0 Views copyright © 2025 Jarl G. This is an open access peer review report 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. 12 Mar 2025 | for Version 3 Gustav Jarl , Örebro University, Örebro, Sweden 0 Views copyright © 2025 Jarl G. This is an open access peer review report 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. format_quote Cite this report speaker_notes Responses (0) Approved With Reservations info_outline 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 I thank the Editor and Authors for the opportunity to review this manuscript again. I think the manuscript has been improved since the last time I read it and I have mainly minor comments. Title I think the title only reflects one part of the bi-directional relationship that the study aims to investigate. Abstract I suggest to delete citations from the abstract section. The abstract objective does not include prevention of DFU recurrence. Please revise for clarity. "Following this review, qualitative studies will be conducted, and their findings, along with those from the scoping review, will inform the development of a psychological intervention that will aim to improve psychosocial functioning and mitigate the progression and recurrence of DFUs." I suggest to rephrase this as general recommendations for future research, rather than the studies planned by the authors conducting this review. Introduction Does the first reference (Spampinato 2020) cover all the statements of the first three sentences in the introduction? If not, please add more references. Please update the reference (van Netten 2016), which is the IWGDF review of 2016, to the latest IWGDF review version. "The review is being conducted as part of a PhD project. Findings from this review, and subsequent qualitative studies, will inform the development of a psychological intervention that will aim to enhance psychosocial functioning and reduce the progression and recurrence of foot ulcers." I suggest to rephrase this as a recommendation for how this review can inform subsequent research in general instead of as a description of the author's PhD project. I also suggest to delete references to the author's PhD project in section "2. Identifying Research Gaps" Methods "This review is being conducted to (a) explore the emotional and psychosocial burden of living with DFU and (b) examine if psychological variables lead to poor outcomes in DFU." Please revise to also include ulcer recurrance. Principal terminology definitions In this section, different key terms are defined. Some terms are shortly defined (e.g., DFU reoccurance) while other terms are both defined and contextualized/discussed (e.g. diabetes-related foot ulcer, and wound healing). I suggest to try to keep it consistent, and focus on definitions, whithout going deeper into discussing the terms. I find it difficult to understand the difference between emotional wellbeing and psychosocial wellbeing, as the latter is stated to include "emotional" I find the last sentence, "This review will be looking at the impact that living with a DFU has on psychosocial functioning, and its subsequent effects on overall well-being", to make it more confusing. I do not think the aim is to look at psychosocial functioning. Also, this will result in three types of well-being: emotional, psychosocial, and overall wellbeing. I suggest to keep the number of key terms down, and define and use them consistenlty throughtout the text. Protocol I appreciate the clarity of the research questions, please check that the aim when mentioned in different parts of the manuscript are aligned with these research questions and use the same terms. Is there a reason for stopping the review with publications up to 2022? "Origin/country of origin/origins (where the source was published or conducted)" I find this difficult to read, please clarify, e.g. "country of origin" (or could it be something else than countries?) Terminology Please check that terms are used consistently. Both ulcer "reoccurance" and "recurrrance" are used. Also, diabetes-related foot ulcers are mainly used, but on few places, also diabetic foot ulcers (Discussion and key koncepts in table 2) Table 1 Emotional implications, excl criteria: "• Any publication that explores the emotional implications of living with diabetes but does not explore diabetes-related foot specifically." should it be "diabetes-related foot ulcer"? Managament, justification: "This inclusion criteria focuses on understanding how emotional and psychosocial factors specifically influence self-management and wound healing in those with DFUs." Should not prevention of recurrence be included here as well? Table 2 "diabetic foot ulcer" is mentioned under key concepts, should it be "diabetes-related foot ulcer"? Controlled vocabulary terms, concept 1: "diabetic foot" is mentioned twice Controlled vocabulary terms, concept 3: "Health related quality of quality". Should it be "...of life"? Competing Interests No competing interests were disclosed. Reviewer Expertise diabetes-related foot disease, especially offloading for preventing and healing DFUs, and patient adherence. 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. reply Respond to this report Responses (0) Jarl G. Peer Review Report For: A Protocol for a Scoping Review to assess the influence of psychological factors on the development and progression of diabetes-related foot ulcers [version 3; peer review: 6 approved with reservations, 2 not approved] . HRB Open Res 2025, 7 :18 ( https://doi.org/10.21956/hrbopenres.15482.r46276) NOTE: it is important to ensure the information in square brackets after the title is included in this citation. The direct URL for this report is: https://hrbopenresearch.org/articles/7-18/v3#referee-response-46276 keyboard_arrow_left Back to all reports Reviewer Report 0 Views copyright © 2024 Jarl G. This is an open access peer review report 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. 13 Dec 2024 | for Version 2 Gustav Jarl , Örebro University, Örebro, Sweden 0 Views copyright © 2024 Jarl G. This is an open access peer review report 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. format_quote Cite this report speaker_notes Responses (1) Not Approved info_outline 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 I thank the authors and Editors for the opportunity to read this protocol manuscript. I find the approach to investigate the bi-directional relationship between DFU and psychological factors intriguing, but also challenging at is will emcompass many aspects and relationships. My main concern is the study aim which has implications for the rest of the study. The study aim is not entirely clear and varies across the manuscript, e.g., "interventions" and "prevention" are mentioned in some parts of the manuscript, but not in all. The main aim is to address the above-mentioned bi-directional relationship between psychological factors and DFU, which can be divided into A: Effects of psychological variables on a) DFU improvement or healing b) DFU prevention (including incidence of first-ever DFU or recurrance) This could include both observational and interventional studies, but I don't think the PCC framework is appropriate for interventional studies. B: Effects of living with active DFU on a) psychological variables I think the aims need to be clarified throughout the text, as they also have implications for other parts of the study (e.g., if choosing to use PICO in addition to PCC, how to structure the data extraction, etc.) Definition of DFU (p.15), please note that this is the definition of DF disease, not DFU. Paragraph on behavioural factors (p.15): I think some text in parantheses can be removed ("the individual may behave differently due to" and "an individual’s behaviour may be directly or indirectly influenced by the available") Table 1, Inclusion criteria, The condition: I suggest to simplify this to studies related to DFU, the risk of listing detailed aspects of study types is that certain relevant studies may be excluded. Reference: van Netten et al (2016). Please update to latest version (2023). Is the rationale for, and objectives of, the study clearly described? Partly Is the study design appropriate for the research question? Partly Are sufficient details of the methods provided to allow replication by others? Yes Are the datasets clearly presented in a useable and accessible format? Not applicable Competing Interests No competing interests were disclosed. Reviewer Expertise diabetes-related foot disease, especially offloading for preventing and healing DFUs, and patient adherence. I confirm that I have read this submission and believe that I have an appropriate level of expertise to state that I do not consider it to be of an acceptable scientific standard, for reasons outlined above. reply Respond to this report Responses (1) Author Response 05 Mar 2025 Michelle Hanlon, Thank you very much for taking the time to review our article and for providing this valuable feedback. Please find our responses to your comments below: 1. We have now amended the aims and hope this makes our intentions clearer. 2. Thank you for highlighting this. We have now amended the definition accordingly. 3. Thank you for this suggestion. This paragraph has now been amended. 4. Thank you for this input. The table has been updated accordingly. 5.Thank you for highlighting this. The reference has now been updated. View more View less Competing Interests No competing interests were disclosed. reply Respond Report a concern Jarl G. Peer Review Report For: A Protocol for a Scoping Review to assess the influence of psychological factors on the development and progression of diabetes-related foot ulcers [version 3; peer review: 6 approved with reservations, 2 not approved] . HRB Open Res 2025, 7 :18 ( https://doi.org/10.21956/hrbopenres.15331.r43289) NOTE: it is important to ensure the information in square brackets after the title is included in this citation. The direct URL for this report is: https://hrbopenresearch.org/articles/7-18/v2#referee-response-43289 keyboard_arrow_left Back to all reports Reviewer Report 0 Views copyright © 2024 Ababneh A. This is an open access peer review report 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. 27 Nov 2024 | for Version 2 Anas Ababneh , Yarmouk University, Irbid, Irbid Governorate, Jordan 0 Views copyright © 2024 Ababneh A. This is an open access peer review report 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. format_quote Cite this report speaker_notes Responses (1) Approved With Reservations info_outline 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 Please use diabetes-related foot ulcers (DFUs) instead of diabetic foot ulceration Is there a need to use “bi-directional”? It seems that this research aims to assess the association between mental health and the healing of DFUs. There is no need for “psychological factors and diabetic foot ulceration” in the title. It is weak evidence to report that there is a common belief about the association between psychology and healing. The objective of this review should be more focused. i.e, the association between psychological factors and DFU healing, or the authors might be more open-minded to be more focused on one psychological factor. i.e, depression and healing or anxiety and healing etc.. In the discussion section, there are some variables such as adherence to treatment and social support are technically not psychological variables. Also, I would focus on this review on one major outcome which is DFUs healing. Incidence and recurrence DFUs are different outcomes and assessing these outcomes might confuse this review. Many references in the introduction section are old. Why there is a definition of complex wounds while this study targets DFUs? Are other complex wounds will be included in addition of DFUs? Again, there are other variables in the methods section including emotional wellbeing and psychosocial and behavioural factors. These are a lot of variables while the study aim from the title seems to focus on psychological factors. I would narrow the scope of this review. I would describe the operational definition of wound healing in the methods section. For instance, wound size measurements or healing time. Is there a need to define DFU recurrence while this review assesses wound healing? The research questions are NOT in match with the research title. I am confused now. Is this review about the association between mental health factors and wound healing or reoccurrence of DFUs? Also, is this review about assessing the psychological and emotional impact on people who live with DFUs? I’ve though this study assess the association between psychological factor and DFU healing. Overall, this review needs to be much focused. Is the rationale for, and objectives of, the study clearly described? Partly 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? Partly Competing Interests No competing interests were disclosed. Reviewer Expertise Diabetic foot, diabetes, wound care, chronic disease, nursing 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. reply Respond to this report Responses (1) Author Response 05 Mar 2025 Michelle Hanlon, Thank you very much for taking the time to review our manuscript and for providing this insightful feedback. Please find our responses to your comments below: 1. Thank you for highlighting this. We have now updated this term throughout the manuscript. 2.Thank you for your question regarding the use of the term "bi-directional".We are using this term to emphasize the complex and reciprocal relationship that exsists between mental health factors and diabetes-related foot ulcers . We believe the term "bi-directional" reflects the understanding that psychological factors, such as anxiety and depression, can negatively impact the healing process of diabetes-related foot ulcers by influencing treatment adherence and self-care behaviors. Conversely, the presence of diabetes-related foot ulcers can lead to increased psychological distress, creating a feedback loop that complicates both mental and physical health outcomes. By using "bi-directional," we aimed to highlight this interplay. That said, we appreciate your feedback and have amended the title. 3.Thank you for your feedback regarding the title of our research. We appreciate your perspective on the focus of our study. We have amended our title and hope that our focus is now clearer 4.The authors have now changed the sentence in question “Psychological factors are believed to play a role in wound healing, but it remains uncertain if psychological interventions can help individuals with an active DFU, or a history of DFUs, to achieve complete or improved wound healing or prevent recurrence.” to “Psychological factors have been found to play a role in wound healing (Frasier at al., 2024; Robinson et al.,2017; Walburn et al.2009).but it remains uncertain if psychological interventions can help individuals with an active DFU, or a history of DFUs, to achieve complete or improved wound healing or prevent recurrence. 5.Thank you for your valuable feedback regarding the focus of our review. We understand the importance of having a clear and targeted objective, and we appreciate your suggestions. Our decision to adopt a broader scope for this scoping review stems from the complexity of the relationship between psychological factors and DFU healing. Psychological factors such as anxiety, depression, and stress often interact and co-occur, influencing healing in multifaceted ways. By examining these factors collectively, we aim to provide a comprehensive overview that captures the nuances of their interrelationships rather than isolating a single factor. Focusing solely on one psychological aspect, while valuable, may limit our understanding of how various factors contribute to DFU healing. Our intention is to highlight the overarching patterns and connections that exist among these psychological factors, thereby creating a foundation for future research that can explore specific relationships in greater detail. 6.Thank you for your insightful feedback regarding the discussion section of our review. We appreciate your observations about the inclusion of variables such as adherence to treatment and social support. While it is true that adherence to treatment and social support are not strictly psychological variables, we chose to include them because they play a significant role in the overall psychological context that affects DFU healing. Adherence to treatment is often influenced by mental health factors, such as motivation and perceived self-efficacy, while social support can provide emotional and practical resources that alleviate psychological stress. By considering these variables, we aim to present a more holistic view of the factors impacting DFU healing. Regarding your suggestion to focus exclusively on DFU healing as the primary outcome, we appreciate the importance of clarity in our objectives. However, we believe that including the incidence and recurrence of DFUs enriches the discussion by providing a broader understanding of how psychological factors might influence not just healing but also the likelihood of future complications. This comprehensive approach can help identify areas for targeted interventions and inform clinical practices. That said, we will take your feedback into account and have tried to work to clarify the distinction between the outcomes in our discussion. 7. We acknowledge the importance of incorporating recent studies to provide a current context for our research and have aimed to do so throughout this manuscript. The foundational studies we also included, while older, serve to establish the historical context and ongoing relevance of the psychological factors related to DFU healing. 8. Thank you for this feedback. No other complex wounds will be included. The original manuscript started by providing a comprehensive background on diabetes. A reviewer suggested that as DFUs are complex wounds that we should instead start the review by providing a background on complex wounds. The authors agreed and amended it accordingly. 9.Thank you for feedback. We have now hopefully addressed this in our previous response to your comments on the discussion section. 10.Thank you for your feedback regarding the placement of the operational definition of wound healing. We appreciate your suggestion to include this information in the methods section. Our rationale for including the operational definition of wound healing with other definitions in the introduction is to provide a comprehensive understanding of the terms that underpin our review. By defining wound healing alongside other relevant concepts, we aim to establish a clear framework for readers, ensuring they grasp the context and significance of our research from the outset. While specific details about wound size measurements and healing time are indeed important, we believe that the approach that we have taken helps to clarify the broader implications of wound healing as it relates to psychological factors and DFU healing. 11. Thank you for your insightful critique and we appreciate your perspective. We believe that it is important to define and address DFU recurrence as recurrence is often influenced by factors related to both healing and ongoing management, including psychological factors, adherence to treatment, and social support. We also believe that addressing the concept of recurrence highlights the importance of not only achieving healing but also preventing future complications. 12. Thank you for your thoughtful feedback regarding the clarity and alignment of our title with the research questions. We appreciate your concerns and the opportunity to clarify our intentions and have amended the title and manuscript accordingly. View more View less Competing Interests No competing interests were disclosed. reply Respond Report a concern Ababneh A. Peer Review Report For: A Protocol for a Scoping Review to assess the influence of psychological factors on the development and progression of diabetes-related foot ulcers [version 3; peer review: 6 approved with reservations, 2 not approved] . HRB Open Res 2025, 7 :18 ( https://doi.org/10.21956/hrbopenres.15331.r43295) NOTE: it is important to ensure the information in square brackets after the title is included in this citation. The direct URL for this report is: https://hrbopenresearch.org/articles/7-18/v2#referee-response-43295 keyboard_arrow_left Back to all reports Reviewer Report 0 Views copyright © 2024 Crocker R. This is an open access peer review report 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. 21 Nov 2024 | for Version 2 Rebecca M Crocker , The University of Arizona, Tucson, Arizona, USA 0 Views copyright © 2024 Crocker R. This is an open access peer review report 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. format_quote Cite this report speaker_notes Responses (1) Not Approved info_outline 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 Overall comments: In describing the study objective, I would change the text such that rather than providing a better understanding of the issue, which is really beyond the scope of a review article, the authors can state instead that this review will analyze the state of our current knowledge on the topic of bi-directionality and suggest/identify critical areas of future research necessary to inform the development or adaptation of a tailored psychological intervention that will aim to optimise wellbeing and improve outcomes for individuals with DFU. Introduction: The Introduction has good, relevant information but it takes too long for you to introduce the topic of the review, so I would suggest further highlighting the psychological/mental health issues in the opening paragraph. "Rationale for Study" I am not sure if this is an appropriate sub-heading given that this is a review article rather than a study. I suggest rephrasing to reflect common language of review articles and also to move the part about bi-directional psychological impact higher up in the paragraph. Methods As a review this is not an investigation, it is a synthesis of the existing knowledge. The first paragraph and the research questions need to be re-worded to make this distinction clear. Discussion The discussion does not adequately address the existing evidence in the literature that you have included and therefore does not answer the research questions or advance our understanding of these issues. Is the rationale for, and objectives of, the study clearly described? Partly Is the study design appropriate for the research question? Partly Are sufficient details of the methods provided to allow replication by others? Yes Are the datasets clearly presented in a useable and accessible format? Partly Competing Interests No competing interests were disclosed. Reviewer Expertise patient experiences of DFUs; communication of genetic and behavioral risk factors for non-alcoholic fatty liver disease; sources of stress and resilience among Latino immigrants, self-administration of cancer screening among Latinos I confirm that I have read this submission and believe that I have an appropriate level of expertise to state that I do not consider it to be of an acceptable scientific standard, for reasons outlined above. reply Respond to this report Responses (1) Author Response 05 Mar 2025 Michelle Hanlon, Thank you very much for taking the time to review our manuscript and for providing valuable insight. Please see our responses to each of your comments below: 1. Thank you for this feedback. We have now amended the objective accordingly. 2. Thank you for this feedback. We have now amended the introduction based on your input. 3. Thank you for your input. We have amended the sub-heading. 4. Thank you for your input. We have re-phrased this section to make this clearer. 5. Thank you for this insight. We have updated this section accordingly. View more View less Competing Interests No competing interests were disclosed. reply Respond Report a concern Crocker RM. Peer Review Report For: A Protocol for a Scoping Review to assess the influence of psychological factors on the development and progression of diabetes-related foot ulcers [version 3; peer review: 6 approved with reservations, 2 not approved] . HRB Open Res 2025, 7 :18 ( https://doi.org/10.21956/hrbopenres.15331.r42925) NOTE: it is important to ensure the information in square brackets after the title is included in this citation. The direct URL for this report is: https://hrbopenresearch.org/articles/7-18/v2#referee-response-42925 keyboard_arrow_left Back to all reports Reviewer Report 0 Views copyright © 2024 Marques R. This is an open access peer review report 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. 21 Nov 2024 | for Version 2 Raquel Marques , Universidade Católica Portuguesa, Institute of Health Sciences, Porto, Portugal 0 Views copyright © 2024 Marques R. This is an open access peer review report 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. format_quote Cite this report speaker_notes Responses (1) Approved With Reservations info_outline 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 Thank you for reviewing the article. However, there are several aspects that require further clarification, including: According to JBI recommendations, preliminary research should be carried out to understand whether other reviews have been carried out in this area, “As a result of the limited number of RCTs available, there is a high risk of bias so conclusions cannot be drawn”. However, this limitation alone does not constitute a valid justification for conducting a scoping review. It is crucial to recognize that systematic reviews of the literature, particularly those based on RCTs, represent the highest level of evidence in the hierarchy of scientific research. These reviews synthesize data from well-designed studies to provide robust and reliable conclusions. That said, it is also important to note that there are thematic areas or research contexts where conducting RCTs is either impractical or ethically unfeasible. In such cases, alternative approaches, including other types of primary research or evidence synthesis, may be necessary. Therefore, a scoping review should only be undertaken when its objectives are clearly defined and aligned with the need to explore or map a research field, not merely as a response to the absence of RCTs. Eligibility criteria must be defined by the PCC Competing Interests No competing interests were disclosed. Reviewer Expertise Wound care, complex wound, assessment wound. 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. reply Respond to this report Responses (1) Author Response 05 Mar 2025 Michelle Hanlon, Thank you very much for taking the time to review our article and for highlighting the need for preliminary research to be conducted before starting a review such as this. Apologies that we did not make this clear in our initial writeup. A thorough review of existing literature on the topic was indeed conducted prior to initiating our scoping review. We appreciate your guidance in emphasizing the importance of this preliminary research and have now updated our article to clarify this. We have also provided further justification on why a scoping review was conducted instead of a systematic review and have clarified the context of our study within the existing literature. Thank you for helping us enhance the rigor of our work. View more View less Competing Interests No competing interests were disclosed. reply Respond Report a concern Marques R. Peer Review Report For: A Protocol for a Scoping Review to assess the influence of psychological factors on the development and progression of diabetes-related foot ulcers [version 3; peer review: 6 approved with reservations, 2 not approved] . HRB Open Res 2025, 7 :18 ( https://doi.org/10.21956/hrbopenres.15331.r42597) NOTE: it is important to ensure the information in square brackets after the title is included in this citation. The direct URL for this report is: https://hrbopenresearch.org/articles/7-18/v2#referee-response-42597 keyboard_arrow_left Back to all reports Reviewer Report 0 Views copyright © 2024 Vileikyte L. This is an open access peer review report 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. 21 Jun 2024 | for Version 1 Loretta Vileikyte , The University of Manchester, Manchester, England, UK 0 Views copyright © 2024 Vileikyte L. This is an open access peer review report 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. format_quote Cite this report speaker_notes Responses (1) Not Approved info_outline 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 Hanlon and colleagues describe a protocol for a scoping review of the bi-directional relationship between diabetic foot ulcer healing and mental factors. Specifically, they aim to identify: 1) emotional and psychosocial burden of living with DFU and (b) psychological variables that may lead to poor outcomes in DFU. I do not believe that a scoping review is the way to answer the bi-directionality question. There are already more published reviews (systematic, scoping etc) than there are original, high-quality studies. An overview of systematic reviews in this area ( Crawford, F et al. Reliability of the evidence to guide decision-making in foot ulcer prevention in diabetes: an overview of systematic reviews. BMC Med Res Methodol 22 , 274 (2022) identified 30 reviews that collectively assessed 26 largely poor-quality RCTs with substantial overlap. Most of these systematic reviews are at high risk of bias and fail to provide reliable evidence for decision-making. To answer the research question regarding the bi-directional relationships between psychological/emotional factors and DFUs, the authors should conduct a longitudinal, adequately powered study of well-defined (DFU and psychological factors) population to determine: analysis 1: the incidence of DFUs and the associated risk with psychological factors (e.g., depression), and analysis 2: the incidence of e.g., depression and associated risk with DFUs. See [1] Is the rationale for, and objectives of, the study clearly described? Partly Is the study design appropriate for the research question? No Are sufficient details of the methods provided to allow replication by others? Partly Are the datasets clearly presented in a useable and accessible format? Not applicable References 1. Golden SH, Lazo M, Carnethon M, Bertoni AG, et al.: Examining a bidirectional association between depressive symptoms and diabetes. JAMA . 2008; 299 (23): 2751-9 PubMed Abstract | Publisher Full Text Competing Interests No competing interests were disclosed. Reviewer Expertise The role of psychological/behavioral factors in patient adaptation to diabetic neuropathy and foot ulceration I confirm that I have read this submission and believe that I have an appropriate level of expertise to state that I do not consider it to be of an acceptable scientific standard, for reasons outlined above. reply Respond to this report Responses (1) Author Response 03 Oct 2024 Michelle Hanlon, Thank you very much for agreeing to review our paper. We really appreciate your feedback, and the time and consideration that you put in to your response and suggested amendments. This piece of work is being conducted as part of a PhD study. Therefore, it would not be feasible due to time and cost restraints to conduct a longitudinal study. In terms of methodology, we believe that a scoping review is an appropriate means of laying the foundations for an empirical study, as it allows us to scope the full literature to inform the design of the next phase of the research. Thank you very much again for taking the time to offer the suggestion and perhaps we can revisit it for further postdoctoral research studies on the topic. View more View less Competing Interests No competing interests were disclosed. reply Respond Report a concern Vileikyte L. Peer Review Report For: A Protocol for a Scoping Review to assess the influence of psychological factors on the development and progression of diabetes-related foot ulcers [version 3; peer review: 6 approved with reservations, 2 not approved] . HRB Open Res 2025, 7 :18 ( https://doi.org/10.21956/hrbopenres.15047.r40226) NOTE: it is important to ensure the information in square brackets after the title is included in this citation. The direct URL for this report is: https://hrbopenresearch.org/articles/7-18/v1#referee-response-40226 keyboard_arrow_left Back to all reports Reviewer Report 0 Views copyright © 2024 Marques R. This is an open access peer review report 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. 15 May 2024 | for Version 1 Raquel Marques , Universidade Católica Portuguesa, Institute of Health Sciences, Porto, Portugal 0 Views copyright © 2024 Marques R. This is an open access peer review report 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. format_quote Cite this report speaker_notes Responses (1) Approved With Reservations info_outline 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 Thank you for submitting this work. These types of studies are needed to contribute to the improvement of care provided to patients with wounds. The protocol is well-written and easy to follow, with a logical structure. I have a few comments for the authors: In the title add the word protocol I suggest choosing different keywords from the title, so your study has more scope, for example: wounds and injuries; Review the literature. The introduction of the protocol could explore the challenges of living with a complex wound, the process of healing such wounds, and some risk factors for delayed healing, instead of explaining what diabetes is. In the methodology, clearly define the PCC. Review the exclusion criteria, it is not enough to deny the inclusion criteria. The discussion can be enriched with what already exists in the literature on the topic. References, to mention as 2023 IWGDF Guidelines instead of 2019. 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? Partly Are the datasets clearly presented in a useable and accessible format? Yes Competing Interests No competing interests were disclosed. Reviewer Expertise Wound care, complex wound, assessment wound. 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. reply Respond to this report Responses (1) Author Response 03 Oct 2024 Michelle Hanlon, Thank you very much for taking the time to review our paper. The authors have made significant revisions based on your suggestions and are very grateful for the constructive feedback and valuable insights. View more View less Competing Interests No competing interests were disclosed. reply Respond Report a concern Marques R. Peer Review Report For: A Protocol for a Scoping Review to assess the influence of psychological factors on the development and progression of diabetes-related foot ulcers [version 3; peer review: 6 approved with reservations, 2 not approved] . HRB Open Res 2025, 7 :18 ( https://doi.org/10.21956/hrbopenres.15047.r39739) NOTE: it is important to ensure the information in square brackets after the title is included in this citation. The direct URL for this report is: https://hrbopenresearch.org/articles/7-18/v1#referee-response-39739 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. 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