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Hurst\" } ], \"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\": \" Background Diabetes Mellitus (DM) and Chronic Kidney Disease (CKD) prevalence has increased and has raised multiple secondary concerns. Both conditions independently, and unanimously, contribute to the elevated morbidity and mortality rates in people with DM, increasing demands on healthcare systems. Patients presenting with CKD have greater levels of foot disease outcomes, including foot ulceration, amputation and subsequent mortality. These individuals are impacted with significant and complex clinical concerns with severe complications. However, the intricate interplay between CKD and diabetes-related foot disease outcomes in the context of social deprivation has not been investigated from an evidence synthesis perspective Aim We aim to identify if there is an association between social deprivation and foot disease outcomes in individuals with DM and CKD. Methods and analysis In accordance with the Preferred Reporting Items for Systematic Review and Meta-analyses, this protocol is reported in line with PRISMA-P guidelines. Three databases will be utilised to identify eligible studies reporting foot disease outcomes in people with DM and CKD. A MEDLINE search strategy was adapted to improve sensitivity and specificity for social deprivation-focused studies. Endnote and Covidence will manage records, with blinded screening and independent data extraction by three reviewers, with discrepancies resolved through discussion with a fourth reviewer. We will assess the risk of bias at both the study and outcome levels using established tools: the MOOSE Guidelines for meta-analysis in Observational studies and the JBI Manual for Evidence synthesis. Pooled odds ratios and standardised mean differences with 95% confidence intervals for nominal and continuous data will be calculated employing either a fixed-effects or random-effects model based on heterogeneity (I² &lt; 50% for fixed-effects and I² &gt; 50% for random-effects models). Sensitivity analyses will address missing data and heterogeneity, and GRADE will evaluate the quality of the evidence. PROSPERO registration number: CRD42024542991 Registration The systematic review protocol was published with the International Prospective Register of Systematic Review on the 12th of August, 2024 (registration number: CRD42024542991). \" } { \"@context\": \"http://schema.org\", \"@type\": \"BreadcrumbList\", \"itemListElement\": [ { \"@type\": \"ListItem\", \"position\": \"1\", \"item\": { \"@id\": \"https://hrbopenresearch.org/\", \"name\": \"Home\" } }, { \"@type\": \"ListItem\", \"position\": \"2\", \"item\": { \"@id\": \"https://hrbopenresearch.org/browse/articles\", \"name\": \"Browse\" } }, { \"@type\": \"ListItem\", \"position\": \"3\", \"item\": { \"@id\": \"https://hrbopenresearch.org/articles/8-64/v1\", \"name\": \"Social deprivation and foot disease outcomes in people with Diabetes...\" } } ] } Home Browse Social deprivation and foot disease outcomes in people with Diabetes... ALL Metrics - Views Downloads Get PDF Get XML Cite How to cite this article Al-Bader J, M Buckley C, McIntosh C et al. Social deprivation and foot disease outcomes in people with Diabetes Mellitus and Chronic Kidney Disease: A Systematic Reviews and Meta-Analysis Protocol [version 1; peer review: 1 approved with reservations] . HRB Open Res 2025, 8 :64 ( https://doi.org/10.12688/hrbopenres.13994.1 ) NOTE: If applicable, it is important to ensure the information in square brackets after the title is included in all citations of this article. Close Copy Citation Details Export Export Citation Sciwheel EndNote Ref. Manager Bibtex ProCite Sente EXPORT Select a format first Track Share ▬ ✚ Study Protocol Social deprivation and foot disease outcomes in people with Diabetes Mellitus and Chronic Kidney Disease: A Systematic Reviews and Meta-Analysis Protocol [version 1; peer review: 1 approved with reservations] Jana Al-Bader https://orcid.org/0009-0002-1067-2591 1 , Clare M Buckley https://orcid.org/0000-0002-3174-7022 2 , Caroline McIntosh https://orcid.org/0000-0003-1801-9554 1,3 , [...] Caoimhe Casey https://orcid.org/0000-0002-5968-3649 2,4 , Tomás P Griffin 3,5 , Ellen Kirwan https://orcid.org/0000-0003-1169-8232 1 , Joanne E. Hurst 1 Jana Al-Bader https://orcid.org/0009-0002-1067-2591 1 , Clare M Buckley https://orcid.org/0000-0002-3174-7022 2 , [...] Caroline McIntosh https://orcid.org/0000-0003-1801-9554 1,3 , Caoimhe Casey https://orcid.org/0000-0002-5968-3649 2,4 , Tomás P Griffin 3,5 , Ellen Kirwan https://orcid.org/0000-0003-1169-8232 1 , Joanne E. Hurst 1 PUBLISHED 06 Jun 2025 Author details Author details 1 Discipline of Podiatric Medicine, School of Health Sciences, University of Galway, Galway, County Galway, Ireland 2 University College Cork School of Public Health, Cork, County Cork, Ireland 3 Alliance for Research and Innovation in Wounds (ARIW), College of Medicine, Nursing and Health Sciences, University of Galway, Galway, County Galway, Ireland 4 Endocrinology and Diabetes and Metabolism, Galway University Hospital, Galway, County Galway, Ireland 5 Centre for Diabetes, Endocrinology, and Metabolism, Galway University Hospital, Galway, County Galway, Ireland Jana Al-Bader Roles: Conceptualization, Data Curation, Formal Analysis, Funding Acquisition, Investigation, Methodology, Project Administration, Resources, Software, Validation, Visualization, Writing – Original Draft Preparation, Writing – Review & Editing Clare M Buckley Roles: Conceptualization, Data Curation, Formal Analysis, Investigation, Methodology, Project Administration, Resources, Supervision, Validation, Writing – Original Draft Preparation, Writing – Review & Editing Caroline McIntosh Roles: Conceptualization, Formal Analysis, Investigation, Methodology, Project Administration, Resources, Software, Supervision, Writing – Original Draft Preparation, Writing – Review & Editing Caoimhe Casey Roles: Conceptualization, Formal Analysis, Methodology, Project Administration, Resources, Supervision, Validation, Writing – Original Draft Preparation, Writing – Review & Editing Tomás P Griffin Roles: Conceptualization, Data Curation, Formal Analysis, Investigation, Methodology, Project Administration, Resources, Supervision, Validation, Writing – Original Draft Preparation, Writing – Review & Editing Ellen Kirwan Roles: Conceptualization, Data Curation, Formal Analysis, Investigation, Methodology, Project Administration, Resources, Supervision, Validation, Writing – Original Draft Preparation, Writing – Review & Editing Joanne E. Hurst Roles: Conceptualization, Data Curation, Formal Analysis, Funding Acquisition, Investigation, Methodology, Project Administration, Resources, Software, Supervision, Validation, Visualization, Writing – Original Draft Preparation, Writing – Review & Editing OPEN PEER REVIEW DETAILS REVIEWER STATUS Abstract Background Diabetes Mellitus (DM) and Chronic Kidney Disease (CKD) prevalence has increased and has raised multiple secondary concerns. Both conditions independently, and unanimously, contribute to the elevated morbidity and mortality rates in people with DM, increasing demands on healthcare systems. Patients presenting with CKD have greater levels of foot disease outcomes, including foot ulceration, amputation and subsequent mortality. These individuals are impacted with significant and complex clinical concerns with severe complications. However, the intricate interplay between CKD and diabetes-related foot disease outcomes in the context of social deprivation has not been investigated from an evidence synthesis perspective Aim We aim to identify if there is an association between social deprivation and foot disease outcomes in individuals with DM and CKD. Methods and analysis In accordance with the Preferred Reporting Items for Systematic Review and Meta-analyses, this protocol is reported in line with PRISMA-P guidelines. Three databases will be utilised to identify eligible studies reporting foot disease outcomes in people with DM and CKD. A MEDLINE search strategy was adapted to improve sensitivity and specificity for social deprivation-focused studies. Endnote and Covidence will manage records, with blinded screening and independent data extraction by three reviewers, with discrepancies resolved through discussion with a fourth reviewer. We will assess the risk of bias at both the study and outcome levels using established tools: the MOOSE Guidelines for meta-analysis in Observational studies and the JBI Manual for Evidence synthesis. Pooled odds ratios and standardised mean differences with 95% confidence intervals for nominal and continuous data will be calculated employing either a fixed-effects or random-effects model based on heterogeneity ( I ² < 50% for fixed-effects and I ² > 50% for random-effects models). Sensitivity analyses will address missing data and heterogeneity, and GRADE will evaluate the quality of the evidence. PROSPERO registration number: CRD42024542991 Registration The systematic review protocol was published with the International Prospective Register of Systematic Review on the 12th of August, 2024 (registration number: CRD42024542991). READ ALL READ LESS Plain Language Summary Summary Background The number of people with Diabetes and Chronic Kidney Disease (CKD) is growing, which is causing more health problems. Each of these conditions, on their own or together, increase the risk of serious complications, including death. People with CKD are more likely to have serious foot problems, such as wounds, amputations, and even higher risk of death. These patients often face complex and severe health issues. However, we do not fully understand how social deprivation might influence these foot problems in people with both Diabetes and CKD, as it has not been fully explored in the literature previously. Aim We want to find out whether social deprivation is linked to worse foot disease outcomes in people who have both Diabetes and CKD. Methods and Analysis This review will search the relevant literature tofind studies about foot problems in people with Diabetes and CKD with respect to social deprivation. Three reviewers will look at the studies independently, and a fourth reviewer will help if any disagreements are made. Using established frameworks, we willassess the quality of the evidence.This study has been registered on a systematic review database, which is linked here - PROSPERO Registration Number: CRD42024542991 READ ALL READ LESS Keywords Chronic Kidney Disease, Diabetes-Related Foot Disease, Social Deprivation Corresponding Author(s) Joanne E. Hurst ( [email protected] ) Close Corresponding author: Joanne E. Hurst Competing interests: CC received funding from Novo Nordisk for attending diabetes conferences both nationally and internationally. TG received honoraria for speaking engagements and advisory board roles from multiple companies, including; Novo Nordisk, Sanofi Aventis, Mundipharma Pharmaceuticals, Dexcom, Abbott Diabetes Care, AbbVie, Astra Zeneca, and Eli Lilly. Grant information: Health Research Board [ SS-2024-045]. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. Copyright: © 2025 Al-Bader J 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: Al-Bader J, M Buckley C, McIntosh C et al. Social deprivation and foot disease outcomes in people with Diabetes Mellitus and Chronic Kidney Disease: A Systematic Reviews and Meta-Analysis Protocol [version 1; peer review: 1 approved with reservations] . HRB Open Res 2025, 8 :64 ( https://doi.org/10.12688/hrbopenres.13994.1 ) First published: 06 Jun 2025, 8 :64 ( https://doi.org/10.12688/hrbopenres.13994.1 ) Latest published: 06 Jun 2025, 8 :64 ( https://doi.org/10.12688/hrbopenres.13994.1 ) Introduction The prevalence of diabetes mellitus (DM) and chronic kidney disease (CKD) has significantly increased, leading to multiple secondary health concerns. DM is the leading cause of end-stage renal disease (ESRD) in most developed countries, and the increase in the number of people with ESRD has paralleled the increase in DM 1 . These two conditions independently and collectively contribute to elevated morbidity and mortality rates among vulnerable populations, thereby placing substantial demands on healthcare systems. Individuals with concomitant DM and CKD are at an increased risk of developing diabetic foot disease, including diabetes-related foot ulcers (DFUs) that require major amputations, compared to those with DM alone 2 , 3 . Approximately 40% of patients with DM develop CKD, and 19–34% develop DFU 4 . In a study conducted in Northern Europe, Griffin et al . found a high prevalence of CKD among adults with DM; specifically, 42% of adults attending a hospital-based diabetes clinic had CKD, with a higher prevalence in type 2 DM (47.9%) than in type 1 DM (23.4%) 5 . This study underscores the significant risk of complicated and severe adverse outcomes due to rapid progression of the disease, referred to as “rapid decline,” even within a well-managed cohort of adults 5 . Bonnet et al . suggested that the commonality in pathophysiology between the development of ESRD and DFU lies within 1) reduced arterial perfusion, 2) uremic neuropathy, and 3) nutritional status 4 . Guidelines have incorporated renal impairment into the clinical assessment of DFU. In 2023, The International Working Group on the Diabetic Foot (IWGDF) stratification classification tool categorized ESRD as stage III in terms of the risk of developing DFU, even without a prior history of foot complications, indicating a high-risk cohort where primary prevention is crucial 6 . Socioeconomic deprivation is increasingly recognized as both a modifier and independent risk factor for the development of CKD 7 . The impact of social deprivation is multidimensional, frequently unexplored, and under-recognized by clinicians 8 . Individuals with CKD and DM are notably more susceptible to adverse foot health outcomes. Exposure to social deprivation exacerbates the risk of developing foot disease, making people more susceptible to ulceration, loss of sensation, ischemia, and minor trauma 9 . Given the critical link between CKD, DM, and foot health, understanding the multifaceted factors that contribute to adverse outcomes is essential. The interplay between CKD and diabetes-related foot diseases in the context of social deprivation remains underexplored. This pronounced disparity highlights the urgent need for targeted public health interventions and the optimization of prevention and treatment strategies by healthcare professionals and policymakers to mitigate the adverse effects associated with deprivation in this vulnerable population. The risk of developing DFU is influenced by a variety of factors, which can be categorised as patient-related, limb-related, or ulcer-related. These factors collectively contribute to the likelihood of complications such as hospitalisation, LEA (lower extremity amputation), and mortality 10 . The development and progression of foot ulcers are complex and multifactorial, and the impact of individual factors varies significantly across the different strata of social deprivation. Patient-related factors, such as comorbidities and socioeconomic status, can exacerbate the risk of developing DFUs, whereas limb-related factors, such as peripheral arterial disease, can affect the healing potential and increase the risk of severe outcomes, including the development of diabetes-related foot infections (DFIs), which can lead to a cascade of amputation 11 . DFIs are a critical ulcer-related factor in the prognosis of foot ulcers; if left uncontrolled, DFIs can lead to more severe outcomes, such as LEA and/or subsequent mortality. DFIs are the most common diabetes-related complications that require hospitalisation. In a large prospective study conducted across England over a one-year period, only 46% of ulcers healed, with a recurrence rate of 10%. Additionally, 17% of patients required LEA and 15% of patients died 12 . The presence of infection not only hinders the healing process but also significantly increases the likelihood of severe outcomes, including non-traumatic LEA and subsequent mortality. Furthermore, in a retrospective study, patients with CKD undergoing dialysis with DFUs/DFIs were more likely to undergo major LEA. CKD exacerbates the likelihood of adverse clinical outcomes, increases subsequent morbidity, and has a substantial economic impact 13 . Social deprivation is associated with higher rates of comorbidities, diminished access to healthcare, and reduced health literacy, which collectively exacerbate patient-related factors. Additionally, it adversely affects limb health by limiting access to preventive care and timely interventions, while influencing ulcer-related outcomes through inadequate management of DFIs and foot care. The interactions among patient-related, limb-related, and ulcer-related factors underscore the necessity for targeted public health interventions in vulnerable populations. Addressing social deprivation is crucial as it often intensifies challenges related to patient health, limb integrity, and ulcer management, ultimately affecting patient outcomes. The prevalence of DFU is increasing rapidly in low- and middle-income countries (LMICs), with up to one in three individuals developing foot ulcers in their lifetime 10 , 14 . In high-income countries (HICs), although the prevalence of DFUs remains a significant concern, its incidence is generally lower than that of LMICs. This is primarily due to inadequate knowledge among patients with DM regarding foot care, inefficient primary healthcare systems, and low socioeconomic status 15 , 16 . In the United States, between 2001 and 2010, the LEA rate among hospitalised DFU patients was approximately 16.5% (34.8% of these were major amputations and 61.2% were minor amputations) 17 . By systematically measuring and classifying foot ulcerations, healthcare providers can better address the specific needs and challenges faced by their patient populations. This understanding is essential for tailoring prevention and treatment strategies to reduce the burden of diabetes-related foot disease. Individuals exposed to social disadvantages often face barriers to timely access to healthcare services, including preventive foot care and early intervention for foot ulcers. As a result, these individuals may experience longer hospital stays owing to delayed presentation, more advanced disease at admission, and potentially more complex treatment requirements. Social determinants and health disparities are critical independent predictors of the onset and management of foot complications in individuals with DM and CKD. Hurst et al . demonstrated the spatial distribution of foot disease outcomes in patients with diabetes within a large health administrative area in Scotland, highlighting the association between social deprivation and increased episodes of adverse health outcomes 18 , 19 . Access to healthcare services, including secondary prevention, expert foot healthcare, and education, are crucial components that could potentially mitigate these disparities but are often hindered by socioeconomic barriers 18 . Despite these findings, the synergistic effects of biological factors related to foot disease outcomes, CKD, and social disadvantages have not been previously reported. This systematic review and meta-analysis aimed to fill this gap by investigating the influence of social deprivation on foot disease outcomes in individuals with DM and CKD. By synthesising existing evidence, this review provides a comprehensive understanding of the complex interactions between social deprivation, CKD, and diabetes-related foot disease outcomes. This will inform strategies for better prevention and management in this high-risk population, fostering a multidisciplinary approach to address the intricate intersection of medical conditions and social determinants for improved patient outcomes and health equity. Through evidence synthesis, healthcare professionals and policymakers can develop informed, targeted interventions to improve health outcomes and reduce disparities in this vulnerable population. Step 1: objective The primary objective of this systematic review was to investigate the association between social deprivation, CKD, and foot disease outcomes in patients with DM. This review aims to underscore the complex relationship between foot health outcomes and socioeconomic factors in predicting substantial and clinically significant outcomes within the domain of foot health in this vulnerable population by addressing the following question: Primary question Is there an association between higher levels of social deprivation and foot disease outcomes in individuals with diabetes and chronic kidney disease? Objectives 1) To determine the prevalence of foot disease in individuals with DM and CKD across different levels of social deprivation. 2) This study aimed to evaluate the impact of specific socioeconomic factors (e.g., income, education, and employment status) on foot disease outcomes in individuals with DM and CKD. 3) To compare foot disease outcomes between individuals experiencing social deprivation and those from higher socioeconomic backgrounds with the aim of identifying disparities and potential contributing factors. 4) To develop evidence-based recommendations for healthcare policies and clinical practice to improve foot disease outcomes in individuals with DM and CKD. Principal terminology definitions & methodology Diabetes-related foot disease The consensus definition from the International Working Group on the Diabetic Foot (IWGDF) refers to conditions affecting the foot of an individual with a past or present diagnosis of Diabetes Mellitus and includes one or more of the following 20 : 1) Peripheral Neuropathy 2) Peripheral artery disease 3) Infection 4) Ulcer(s) 5) Neuro-osteoarthropathy 6) Gangrene 7) Non-traumatic Amputation Diabetes-related Foot Ulcer (DFUs) Recognised by the IWGDF, DFUs are severe complications of DM, defined as break(s) of the skin at the foot that can range from superficial involvement of the epidermis to deeper penetration into the dermis, in individuals with a past or present diagnosis of Diabetes Mellitus. It is usually associated with loss of protective sensation (LOPS), foot deformity, and/or peripheral artery disease in the lower extremities. Secondary outcome measures investigating the severity of DFU: Certain classification systems will be used. In line with the IWGDF Guidelines, the classification system used for measuring the severity of DFU are 6 ; - The priority wound classification system is SINBAD (site, ischemia, neuropathy, bacterial infection, ulcer area, and depth). - The second line is WIFi (wound, ischemia, and foot infection), when additional equipment exists and for peripheral artery disease. - In the presence of infection, the IDSA/IWGDF system. The IWGDF strongly recommends six out of 28 foot disease classification systems—DIAFORA, IDSA/IWGDF, SINBAD, University of Texas Classification System (UTWCS), Wagner, and WIFi— because of their accuracy, moderate desirable effects, and minimal undesirable effects, making them suitable for clinical practice. Despite the low certainty of the evidence, these systems were favoured for their overall balance of effects. Although accepted for this study, DIAFORA, UTWCS, and Wagner were not selected for specific clinical use or audits because of limitations, such as lower reliability, applicability, or comprehensiveness in certain clinical scenarios 6 . Amputations 1) Major Amputations: Any resection proximal to the ankle, whether transtibial, knee articulation, transfemoral, hip articulation, or transpelvic amputation 21 . 2) Minor Amputations: Any resection at or distal to the ankle, toe, metatarsal-phalangeal disarticulation, transmetatarsal, tarso-metatarsal disarticulation, midtarsal disarticulation, or ankle disarticulation amputations 21 . Mortality Mortality is directly or indirectly associated with the development of diabetes-related foot complications 21 . Diabetes-related foot disease hospitalisation Admission of an inpatient to a hospital primarily or secondarily due to diabetes-related foot disease 21 . Chronic kidney disease Renal or kidney damage can arise from both microvascular damage (diabetic kidney disease) and arterial damage (renovascular damage) 22 . In this study, we will characterise CKD as abnormalities of kidney structure or function with a sustained decrease in estimated glomerular filtration rate (eGFR) ≥59 or urine albumin-creatinine ratio (uACR)) >3 subsequent to hyperglycemia on two occasions for greater than three months 23 . It is categorised into five stages determined by GFR (G1-G5), and albuminuria category (A1-A3). The first stage is indicated by albuminuria or other abnormalities in kidney function, whereas the remaining four stages are marked by reductions in the GFR to below 90, 60, 30, and 15 ml/minute/ 1.73m 2 ( Table 1 ) 23 . Table 1. Stages of CKD based on UAE and estimated GFR (eGFR) adapted from KDIGO 23 . A1 A2 A3 Normal to mildly increased Moderately increased Severely increased <30 mg/g <3 mg/mmol 30-300 mg/g 3-30 mg/mmol >300 mg/g >30 mg/mmol G1 Normal or high ≥90 Low risk Moderate risk High risk G2 Mildly decreased 60–89 Low risk Moderate risk High risk G3a Mildly to moderately decreased 45–59 Moderate risk High risk Very High risk G3b Moderate to severely decreased 30–44 High risk Very High risk Very High risk G4 Severely decreased 15–29 Very High risk Very High risk Very High risk G5 Kidney Failure <15 Very High risk Very High risk Very High risk Progression of Disease: Green color : No consider to be CKD unless there is other evidence of kidney damage Yellow : Mild CKD (due to mildly or moderately change kidney function and urine protein levels Orange : CKD Red : End-stage Kidney Disease Social deprivation Social deprivation is conceptualised and operationalised in different ways internationally. Townsend regarded deprivation as a barrier to resources such as ‘diet, clothing, housing, household facilities and fuel and environmental, education, working and social conditions, activities, and facilities, which are deemed necessities and heavily hinder an individual’s living conditions 24 . The foundation for multiple deprivation was adapted from Townsend 24 , 25 . It considers seven main domains: income, employment, education, health, crime, access to housing and services, and living environment, where low income is a proxy for material deprivation 24 , 26 . Therefore, we defined social deprivation as the reduction or absence of social and economic resources, opportunities, and access to essential services. It is not limited to a single factor but encompasses multiple dimensions, such as ethnicity, unemployment, poor education and skills, low income, poor housing, living environment, social exclusion, crime, family breakdown, and barriers to healthcare/service that hinder the physical and mental health of individuals. While there are different strata of social deprivation, some individuals may experience one form of deprivation, whereas others may face multiple or particularly severe forms of social deprivation, making them more likely to be exposed to the broader impacts of social deprivation. Hence, because of the complexity and multifaceted nature of social deprivation, two or more dimensions must be considered when measuring it to capture some of its numerous interconnected characteristics and their impact on inequalities, disadvantages, and discrimination 27 . Methods In accordance with the Preferred Reporting Items for Systematic Review and Meta-analyses (PRISMA-P), we conducted a systematic review and meta-analysis 28 . The systematic review protocol was published with the International Prospective Register of Systematic Reviews (PROSPERO) on 12th August, 2024 (registration number CRD42024542991). This protocol was reported in accordance with the PRISMA-P guidelines. The completed PRISMA-P checklist can be found on the Open Science Framework 29 . Step 2: eligibility criteria Population Adults aged 18 years and older Individuals diagnosed with DM (type 1, type 2, or other) and CKD (regardless of the CKD stage). There were no restrictions based on sex, race, or ethnicity. To measure the prevalence and incidence rates of diabetes-related foot disease (DFD), including DFU, nontraumatic amputation, and mortality, we will include individuals with and without DFD. Studies will be excluded if they do not focus on patients with CKD, DM, and DFD or if they focus on other comorbidities without separate analysis for DM and CKD. Additionally, studies were excluded if CKD was not a consequence of DM. Exposure/Intervention Studies reporting on the influence of social deprivation factors, including but not limited to 1) socioeconomic status (SES), 2) poverty, 3) Low Income, and 4) deprivation index or similar measures. Using validated measures or indices, such as the index of multiple deprivation or socioeconomic status scales, such as Plobal HP, Townsend, or Carstairs. Studies that do not assess the complexity of social deprivation and/or use one variable (household income) as a proxy for measuring social deprivation will be excluded. Comparison/Control Studies investigating the influence of social deprivation on foot disease outcomes have associated exposure to social disadvantages among individuals with DM and CKD. First, this will include observational studies, given the nature of the primary aim. Studies without a clear comparison of groups or gradient of social deprivation were excluded. In addition, studies that do not provide a comparative analysis or report only a single level of deprivation without comparison. Outcome Endpoints that are critical for decision-making are of primary interest. The primary outcomes have been prioritised based on their direct impact on patient health and the severity of complications associated with diabetes-related foot disease in individuals with CKD. We will prioritise the analysis and grading of the primary outcomes: 1) incidence and prevalence of foot ulcers, 2) frequency of non-traumatic lower extremity amputations (both minor and major), and 3) mortality. The secondary outcomes provide additional insights into the burden on the healthcare system and the effectiveness of management strategies. Secondary outcomes of interest included 1) Severity of DFU, 2) hospital admission (duration of hospital stay), 3) frequency of lower limb health interventions and care, and 4) healing time for diabetes-related foot ulcers (DFUs) with a focus on infection. These secondary outcomes provide additional insights into the broader implications of diabetes-related foot complications on healthcare resources and patients’ quality of life. Studies that did not report foot disease outcomes or only reported general health outcomes unrelated to foot disease were excluded. Studies with outcomes that are not clearly defined, measured, or that use validated measurement tools will be excluded. Across all healthcare settings, including hospitals, outpatient clinics, and community settings, the investigation primarily included observational studies (e.g., cohort studies, case-control studies, and cross-sectional studies). Additionally, interventional studies (e.g., randomised controlled trials, quasi-experimental studies), systematic reviews, and meta-analyses relevant to the primary and secondary outcomes will be considered, as well as grey literature. There will be no restriction on geographical location to capture potential differences in the social determinants of the impact of health and healthcare systems on foot disease outcomes. The review will include studies published between the retrospective starting date and search. Further eligibility criteria require that studies must meet a minimum quality threshold based on a standardised assessment tool, including the MOOSE Guidelines for meta-analyses in observational studies and the JBI Manual for Evidence Synthesis 30 , 31 . Information sources We will use sensitive topic-based strategies tailored for each database, searching each one from its starting date until the commencement of our search. Medical databases MEDLINE (OVID interface), University of Galway Library, PubMed, Embase, Cochrane Library, CINAHL, Scopus Social. Science database PsycINFO, SocINDEX Grey literature sources OpenGrey, ProQuest Dissertations and Theses Global, Google Scholar, ClinicalTrials.gov, WHO Global Health Library (LILACS, AIM) Search strategy The draft of the MEDLINE (Ovid Interface) search was adapted from the general approach described by Hausner et al . and Chapter 4 of the Cochrane Guidelines 32 , 33 . Search terms were added to the social deprivation-focused search strategy to improve sensitivity, whereas others were removed to increase specificity. The draft search strategy was peer-reviewed, updated, and validated towards the end of the review to ensure that the MEDLINE strategy effectively yielded a high proportion of eligible studies. Study design Data management To manage the records and data throughout the systematic review, we implemented a structured approach using several tools and processes. Initially, comprehensive literature searches will be conducted across multiple databases, such as Endnote and Covidence databases. Endnotes will be used to organise and store all extracted data and related documentation. Covidence will be used to manage screening and data extraction processes, allowing for blinded and independent review by reviewers and tracking decisions and justifications for inclusion or exclusion of studies. Step 3: selection process We will implement a rigorous approach in each phase of the review to ensure a robust and transparent selection process for the studies. Calibration exercises will be conducted prior to the formal screening process to maintain consistency among reviewers. In the screening phase, two independent reviewers (JH and JA) will examine the titles and abstracts of all retrieved references using Covidence against the inclusion criteria 33 . The initial screening was aimed at eliminating studies that did not meet the inclusion criteria. Reviewers will conduct this process blindly to each other's decisions, minimising the potential for bias. Any disagreements between the reviewers were resolved through discussion with a third reviewer, arbitrating if consensus could not be reached. In the eligibility phase, full-text screening will be conducted for studies that have passed the initial screening. Each reviewer will independently assess whether the study meets the eligibility criteria, focusing on key factors, such as the study population, interventions, comparators, and outcomes. We will request additional information from the authors to resolve queries regarding eligibility. Any further discrepancies between reviewers will be addressed through discussion or consultation with a third reviewer to ensure consistency and accuracy in decision-making. All excluded studies will be recorded for this reason. To ensure literature saturation, we reviewed the reference lists of the included studies. Additionally, we scanned the personal files of the authors to ensure that all pertinent materials have been captured. The review culminates in a comprehensive report following the PRISMA guidelines, including a flow diagram to illustrate the selection process and detailed descriptions of all review stages. Step 4: data extraction Upon completion of the eligibility phase, eligible studies will undergo further assessment. Data extraction will be carried out using a standardised form by two independent reviewers to maintain precision and reliability (Electronic Supplementary Material available from Albader et al . 29 ). The form captures key information, including study characteristics (e.g., author, year, study design) and participant demographics, methodology, interventions, comparison, outcomes, and results. This form includes predefined fields to facilitate consistent data collection and ensure that all relevant information is captured. In line with the JBI Guidelines, the data extraction form will also be piloted on ten samples of the included studies to identify any ambiguities or gaps in the form 31 . Feedback will be implemented, and the data extraction form will be refined and finalised, ensuring that it is comprehensive and user-friendly. After independent extraction, data collected by the two reviewers were compared to ensure accuracy. Discrepancies and inconsistencies were discussed and resolved. If necessary, a third reviewer will be consulted to intervene and make a final decision. Regular quality checks were conducted throughout the data extraction process to ensure consistent, accurate, and complete data extraction. Reviewers will crosscheck their entries and resolve any flagged issues collaboratively. The inter-rater reliability was calculated using Cohen’s kappa coefficient to evaluate the extent of agreement between the reviewers. When necessary, efforts will be made to obtain additional data or clarifications from the authors. This may involve contacting the authors to request missing data, clarify study methods, or confirm findings. If this cannot be obtained, we will assess the potential impact on our results by performing a sensitivity analysis. For dichotomous outcomes, we performed best-case and worst-case scenario analyses. For continuous outcomes, we used the last observation carried forward (LOCF) or multiple imputation to handle missing data, depending on the extent and nature of the missing data. Any additional information obtained will then be documented, verified, and incorporated into the data-extraction process. Risk of bias Our approach involves assessing the risk of bias at both the study and outcome levels using established tools: the MOOSE Guidelines for meta-analysis in Observational studies and the JBI Manual for Evidence Synthesis 30 , 31 . If details are insufficient, bias will be rated as ‘unclear,’ and the study investigators will be contacted for clarification. These judgments will be made independently by the two review authors, with disagreements resolved through discussion with a third reviewer. Visual representations of potential biases within and across studies were generated using RevMan 5.1 (Review Manager 5.1). Each domain in the risk of bias assessment was considered independently without an overall score. To evaluate publication bias across the included studies, funnel plots were used when at least 10 studies were available for a particular outcome. An asymmetrical funnel plot suggests the presence of publication bias. Additionally, we will employ statistical tests, such as Egger’s regression test, to formally assess the presence of publication bias. To further mitigate publication bias, we will search for gray literature, including conference abstracts, theses, and reports, to include studies that might not be published in peer-reviewed journals. However, we critically appraised the quality and methodology of these studies, acknowledging the inherent limitations associated with grey literature, such as variability in study design and quality. We will also assess for any reporting bias by comparing findings from gray literature with those from peer-reviewed sources. We will compare the outcomes reported in published studies with the outcomes listed in their protocols or trial registries, if available. Discrepancies were noted as potential indicators of selective reporting biases. We will also check for the completeness of outcome reporting by assessing whether all prespecified outcomes are reported in the study findings and addressing potential biases specific to observational research methodologies. We will use the Grading of Recommendations Assessment, Development and Evaluation (GRADE) framework to assess the quality of evidence across the included studies 34 , 35 . Each outcome included in the PICO will be evaluated for certainty using GRADE criteria. Evidence begins with a high-quality rating for randomized trials and a low-quality rating for observational studies, which may be downgraded based on factors such as the risk of bias, inconsistency, indirectness, imprecision, and publication bias. Alternatively, evidence may be upgraded if factors such as a large effect size, a clear dose-response relationship, or indications that plausible confounding would reduce the strength of an effect suggest that the true effect may be greater than initially estimated. We conducted sensitivity analyses to assess the robustness of our findings. This will include re-running analyses by excluding studies with a high risk of bias, or those identified as outliers. Additionally, we used the trim-and-fill method to adjust for publication bias. Stage 5: interpretation of data At the full-text review stage, a PRISMA flow diagram was used to visually depict the study selection process and document the reasons for exclusion. The results are presented in both visual and aggregate formats, as well as detailed narrative summaries. The ability to conduct meta-analyses will be based on the diversity of study populations, interventions, outcomes, or trial conduct, as described with reference to our PICO criteria, which may preclude statistical synthesis if substantial heterogeneity exists among the included studies. If studies are sufficiently homogeneous in these respects, we will proceed with meta-analyses using a random-effects model to derive the pooled estimates. Quantitatively synthesising the study data in our systematic review will be contingent on several critical factors to ensure the robustness and validity of the findings. Primarily, we needed to ensure the homogeneity of the included studies in terms of study design (randomized controlled trials or observational studies) and comparators (similar interventions or control groups) to ensure consistency. Additionally, the comparability of outcomes reported across studies focused specifically on diabetes-related foot disease outcomes, such as our primary and secondary outcomes (e.g., DFUs, LEA, mortality, hospital duration, severity of DFU, previous intervention, and healing time of DFUs). This includes consistency in the definition and measurement of outcomes related to diabetes-related foot disease complications (e.g., the unanimous use of a particular classification tool to measure the severity of DFU across studies). Population characteristics, including factors such as age, sex, diabetes type, and CKD stage, must also exhibit sufficient similarity across studies to facilitate meaningful comparisons. Recognising the variability in how social deprivation is defined and measured across studies, we will consider studies that provide clear definitions and use validated measures or indices, such as socioeconomic status scales (e.g., Plobal HP, Townsend, Carstairs) or deprivation indices (e.g., index of multiple deprivation). This variability introduces heterogeneity into the data, which may complicate the pooling of the results across studies. Therefore, careful consideration and assessment of the methods used to measure social deprivation in each study should be conducted to determine whether a meta-analysis is feasible and appropriate. Data synthesis Residual heterogeneity will be evaluated using the I 2 statistic and the corresponding chi-square tests. Outcomes will be combined and calculated using RevMan 5.1, and calculations will adhere to the Cochrane Handbook for Systematic Review of Interventions Guidelines to ensure standardised and rigorous methods 33 . If there was no significant heterogeneity among the studies, the Mantel-Haenszel method was used within a fixed effect model. If statistical heterogeneity is observed, indicated by an I 2 statistic of ≥50% or a P-value of <0.1, a random-effects model will be used. In cases where substantial heterogeneity is present (I 2 >75%), a meta-analysis will not be conducted because of the high variability among the study results. Instead, a qualitative narrative synthesis is used to provide a comprehensive summary of the findings. I 2 values will be interpreted as follows - 0% to 40%; may not be significant - 30% to 60%; may present moderate heterogeneity - 50% to 90%; may present substantial heterogeneity - 75%–100%; considerable heterogeneity If high levels of heterogeneity are observed (I² statistic of ≥50% or a P-value of <0.1), we will analyse the study design and characteristics of the included studies to identify potential sources of variability. Sensitivity and subgroup analyses were conducted to explore the impact of varying definitions and measures on the results. In cases where quantitative synthesis is inappropriate due to substantial heterogeneity in the study population, intervention, comparison, outcomes, or study methodology, we will use qualitative narrative synthesis to summarise the findings. Narrative synthesis is structured to convey a comprehensive understanding of the data collected, even when statistical aggregation is not feasible. In line with the guidelines of the Centre for Reviews and Dissemination 36 , we will explore the relationship and findings both within and across the included studies. The results are presented according to the key questions addressed in this review. For each key question, the primary outcomes are discussed before the secondary outcomes. Information will be prioritised to reflect the overall patient groups first, followed by subgroups defined by sociodemographic factors (e.g., age, sex, ethnicity, socioeconomic status) and clinical characteristics (e.g., type 1 DM or Type 2 DM and severity of CKD). Primary health outcomes (e.g., rates of lower-extremity amputation and mortality) will be prioritised over intermediate outcomes. Patient-related outcomes directly affecting patient health and well-being will be discussed before the utilisation outcomes (e.g., previous intervention and duration of hospital admissions). Studies with a high risk of bias will be identified and discussed separately from those with a low or moderate risk. We will highlight the studies retained for certain key questions or outcomes based on their risk of bias and methodological quality. Given the nature of the primary aim, results from observational studies will be presented first, supplemented by data from randomised controlled trials where available. Information will be stratified based on key methodological aspects, such as the blinding of investigators, patients, and outcome assessors. Reliable and valid instruments used to measure outcomes (e.g., validated tools for assessing foot ulcer severity) are emphasised. Tables and diagrams will be used extensively to summarise the characteristics of the studies, focusing on those with a low or moderate risk of bias, and principal comparisons and key outcomes will be tabulated to provide a clear overview. We will conduct subgroup analyses based on key covariates, including patient characteristics (such as age, sex, and ethnicity), differentiation between type 1 DM and Type 2 DM, stages of CKD (with consideration of grouping stages into broader categories if necessary), and DFU severity (mild, moderate, severe). Social deprivation levels will also be assessed using validated indices to distinguish between high and low socioeconomic status. Additionally, interventions will be categorized into surgical, vascular, podiatric, wound care, and offloading. Each subgroup will be clearly defined, and a random-effects model will be used to accommodate the variability within and between subgroups. Subgroup analysis will be conducted independently to explore variability based on predefined criteria, such as patient characteristics (age, sex, socioeconomic status), type of intervention, type of diabetes (type 1 DM vs. type 2 DM), and stages of chronic kidney disease (early stage CKD vs. late-stage CKD). Dichotomous outcomes For Dichotomous outcomes (presence or absence of DFU/amputation/infection, whether a DFU has healed completely, whether a patient has been hospitalised due to diabetes-related foot complications), we will calculate the risk ratios (RRs) with 95% confidence intervals (CIs) for each study. We will combine the results from individual studies using a random-effects model to account for the variability among studies. If heterogeneity was low (I2 <50%), a fixed-effect model was used. Continuous outcomes For Continuous outcomes (severity of foot ulcers measured by a specific classification system or the duration of ulcer healing), we will calculate the mean difference (MDs) or standardised mean difference (SMDs) with 95% confidence intervals, depending on whether the outcomes are measured using the same or different scales across the studies. The results were pooled using a random-effects model and a fixed-effects model if heterogeneity was low. Amendments In the event that any amendments to this protocol are necessary, we will document the date of each amendment, outline the changes made, and provide a rationale. These changes were not incorporated into the protocol. Ethics and consent Ethical approval and consent were not required. Data availability statement Underlying data No underlying data are associated with this article. Extended data The following information is available on the Open Science Framework: Social deprivation and foot disease outcomes in people with Diabetes Mellitus and Chronic Kidney Disease: A Systematic Review and Meta-Analysis Protocol ( https://doi.org/10.17605/OSF.IO/UH3TM ) 29 . The project contains the following data: 1. PRISMA-P-SystRev-checklistFINAL.pdf (PRISMA-P-Systematic Review and MetaAnalsis Checklist) 2. Electronic Supplementary Material.pdf (Table outlining a description of the outcome measures extracted) 3. Alabader Search Strategy.pdf (Search strategy from Medline) Data are available under the terms of the Creative Commons Zero “No rights reserved” data waiver (CC0 1.0 Public domain dedication) ( http://creativecommons.org/publicdomain/zero/1.0/ ). Author contribution JH was the guarantor of this study. JA and JH drafted the manuscript. All authors contributed to the development of the selection criteria, the risk of bias assessment strategy, and the data extraction criteria. JA and JH developed the search strategy for this study. JH, CC, and CB provided expertise on social deprivation. CMcI, JH, and EK provided expertise in podiatry. TG, CB, and CC provided expertise in diabetes and endocrinology. CMcI and CB provided experience and expertise in the evidence synthesis. All authors have read, provided feedback, and approved the final manuscript. All authors contributed to data interpretation and article drafts. Faculty Opinions recommended References 1. Liyanage T, Ninomiya T, Jha V: Worldwide access to treatment for end-stage kidney disease: a systematic review. Lancet. 2015; 385 (9981): 1975–82. PubMed Abstract | Publisher Full Text 2. Game FL, Selby NM, McIntyre CW: Chronic kidney disease and the foot in diabetes - is inflammation the missing link? Nephron Clin Pract. 2013; 123 (1–2): 36–40. 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Reference Source Comments on this article Comments (0) Version 1 VERSION 1 PUBLISHED 06 Jun 2025 ADD YOUR COMMENT Comment Author details Author details 1 Discipline of Podiatric Medicine, School of Health Sciences, University of Galway, Galway, County Galway, Ireland 2 University College Cork School of Public Health, Cork, County Cork, Ireland 3 Alliance for Research and Innovation in Wounds (ARIW), College of Medicine, Nursing and Health Sciences, University of Galway, Galway, County Galway, Ireland 4 Endocrinology and Diabetes and Metabolism, Galway University Hospital, Galway, County Galway, Ireland 5 Centre for Diabetes, Endocrinology, and Metabolism, Galway University Hospital, Galway, County Galway, Ireland Jana Al-Bader Roles: Conceptualization, Data Curation, Formal Analysis, Funding Acquisition, Investigation, Methodology, Project Administration, Resources, Software, Validation, Visualization, Writing – Original Draft Preparation, Writing – Review & Editing Clare M Buckley Roles: Conceptualization, Data Curation, Formal Analysis, Investigation, Methodology, Project Administration, Resources, Supervision, Validation, Writing – Original Draft Preparation, Writing – Review & Editing Caroline McIntosh Roles: Conceptualization, Formal Analysis, Investigation, Methodology, Project Administration, Resources, Software, Supervision, Writing – Original Draft Preparation, Writing – Review & Editing Caoimhe Casey Roles: Conceptualization, Formal Analysis, Methodology, Project Administration, Resources, Supervision, Validation, Writing – Original Draft Preparation, Writing – Review & Editing Tomás P Griffin Roles: Conceptualization, Data Curation, Formal Analysis, Investigation, Methodology, Project Administration, Resources, Supervision, Validation, Writing – Original Draft Preparation, Writing – Review & Editing Ellen Kirwan Roles: Conceptualization, Data Curation, Formal Analysis, Investigation, Methodology, Project Administration, Resources, Supervision, Validation, Writing – Original Draft Preparation, Writing – Review & Editing Joanne E. Hurst Roles: Conceptualization, Data Curation, Formal Analysis, Funding Acquisition, Investigation, Methodology, Project Administration, Resources, Software, Supervision, Validation, Visualization, Writing – Original Draft Preparation, Writing – Review & Editing Competing interests CC received funding from Novo Nordisk for attending diabetes conferences both nationally and internationally. TG received honoraria for speaking engagements and advisory board roles from multiple companies, including; Novo Nordisk, Sanofi Aventis, Mundipharma Pharmaceuticals, Dexcom, Abbott Diabetes Care, AbbVie, Astra Zeneca, and Eli Lilly. Grant information Health Research Board [ SS-2024-045]. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. Article Versions (1) version 1 Published: 06 Jun 2025, 8:64 https://doi.org/10.12688/hrbopenres.13994.1 Copyright © 2025 Al-Bader J 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 Al-Bader J, M Buckley C, McIntosh C et al. Social deprivation and foot disease outcomes in people with Diabetes Mellitus and Chronic Kidney Disease: A Systematic Reviews and Meta-Analysis Protocol [version 1; peer review: 1 approved with reservations] . HRB Open Res 2025, 8 :64 ( https://doi.org/10.12688/hrbopenres.13994.1 ) NOTE: If applicable, it is important to ensure the information in square brackets after the title is included in all citations of this article. 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 1 VERSION 1 PUBLISHED 06 Jun 2025 Views 0 Cite How to cite this report: Russell D. Reviewer Report For: Social deprivation and foot disease outcomes in people with Diabetes Mellitus and Chronic Kidney Disease: A Systematic Reviews and Meta-Analysis Protocol [version 1; peer review: 1 approved with reservations] . HRB Open Res 2025, 8 :64 ( https://doi.org/10.21956/hrbopenres.15360.r49239 ) The direct URL for this report is: https://hrbopenresearch.org/articles/8-64/v1#referee-response-49239 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 16 Sep 2025 David Russell , University of Leeds, Leeds, UK Approved with Reservations VIEWS 0 https://doi.org/10.21956/hrbopenres.15360.r49239 Thank you for the opportunity to review this systematic review protocol addressing an interesting topic of impact of social deprivation on prevalence and outcome of DFU in people with diabetes and chronic renal impairment. Overall, the article is well written ... Continue reading READ ALL Thank you for the opportunity to review this systematic review protocol addressing an interesting topic of impact of social deprivation on prevalence and outcome of DFU in people with diabetes and chronic renal impairment. Overall, the article is well written but the style could be more concise in areas to reduce the overall length. I have the following comments: The manuscript moves between future and past tense which makes it difficult to read, but also implies that the SR has already been done in large volumes of the text. As a protocol paper, it should be in future tense. In the abstract you mention you will search 3 databases. You also state that selection and data extraction will be done by 3 reviewers with a 4 th as arbitrator. The databases should ideally be named in the abstract as many readers won’t read the body of the text. However, neither the number of databases or reviewers is consistent with the main text, so this discrepancy needs to be resolved. Some of the introduction is not directly relevant to the review e.g. paragraph 5 starts with a section on the impact of infection on foot outcomes. This is not a focus of your review and I struggled to see the direct relevance of this. Would it make more sense for objective 3 to come before objective 2? If there is no difference in outcomes with overall social deprivation (outcome 3), there is less value in looking at the role of individual components of deprivation (outcome 2). The terminology section is too long. It does not need e.g. a discussion on the reasons why IWGDF made the recommendations on classification systems, only which classifications you are going to include quoting IWDGF recommendations as your justification. Your CKD definition is complex and going to be challenging to apply within the review as this detail is often not reported in study manuscripts. Why exclude studies where CKD is not due to DM, as long as the population has both CKD and DM? In the first paragraph on CKD definitions state CKD as decrease in eGFR ≥59. I found the wording confusing but should this be eGFR <59? PICO control – the final sentence in this paragraph seems to be unfinished. Should it have “are excluded” at the end? Searches: What date are you starting your literature search from? Why search Pubmed and OVID Medline? Is the MEDLINE search within the Pubmed search not being duplicated in OVID? Data management: You state that “Initially, comprehensive literature searches will be conducted across multiple databases, such as Endnote and Covidence databases.” Do you really mean this, or do you mean that you will use these software to manage the selection and data extraction? You are using multiple methods for data imputation of missing data. How will you manage this in the analysis (e.g. how will you manage potentially discrepant results between reported data, best- and worst-case scenario)? Will this be included in sensitivity analysis as you have not stated that. Given there is likely to be significant differences in study populations, duration of follow-up, outcome measures and how these are defined, do you really foresee any scenario where it would be suitable to use a fixed effect model, irrespective of the I 2 result? You state that you will conduct subgroup analyses including for mild, moderate and severe DFUs. How will you divide ulcers into these categories as it doesn’t translate readily from any of the classification systems you are including? Is the rationale for, and objectives of, the study clearly described? Yes Is the study design appropriate for the research question? Yes Are sufficient details of the methods provided to allow replication by others? Yes Are the datasets clearly presented in a useable and accessible format? Not applicable Competing Interests: No competing interests were disclosed. Reviewer Expertise: Diabetes related foot disease; systematic review methods I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above. Close READ LESS CITE CITE HOW TO CITE THIS REPORT Russell D. Reviewer Report For: Social deprivation and foot disease outcomes in people with Diabetes Mellitus and Chronic Kidney Disease: A Systematic Reviews and Meta-Analysis Protocol [version 1; peer review: 1 approved with reservations] . HRB Open Res 2025, 8 :64 ( https://doi.org/10.21956/hrbopenres.15360.r49239 ) The direct URL for this report is: https://hrbopenresearch.org/articles/8-64/v1#referee-response-49239 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 Comments on this article Comments (0) Version 1 VERSION 1 PUBLISHED 06 Jun 2025 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 Version 1 06 Jun 25 read David Russell , University of Leeds, Leeds, UK 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 Russell D. 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. 16 Sep 2025 | for Version 1 David Russell , University of Leeds, Leeds, UK 0 Views copyright © 2025 Russell D. 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 Thank you for the opportunity to review this systematic review protocol addressing an interesting topic of impact of social deprivation on prevalence and outcome of DFU in people with diabetes and chronic renal impairment. Overall, the article is well written but the style could be more concise in areas to reduce the overall length. I have the following comments: The manuscript moves between future and past tense which makes it difficult to read, but also implies that the SR has already been done in large volumes of the text. As a protocol paper, it should be in future tense. In the abstract you mention you will search 3 databases. You also state that selection and data extraction will be done by 3 reviewers with a 4 th as arbitrator. The databases should ideally be named in the abstract as many readers won’t read the body of the text. However, neither the number of databases or reviewers is consistent with the main text, so this discrepancy needs to be resolved. Some of the introduction is not directly relevant to the review e.g. paragraph 5 starts with a section on the impact of infection on foot outcomes. This is not a focus of your review and I struggled to see the direct relevance of this. Would it make more sense for objective 3 to come before objective 2? If there is no difference in outcomes with overall social deprivation (outcome 3), there is less value in looking at the role of individual components of deprivation (outcome 2). The terminology section is too long. It does not need e.g. a discussion on the reasons why IWGDF made the recommendations on classification systems, only which classifications you are going to include quoting IWDGF recommendations as your justification. Your CKD definition is complex and going to be challenging to apply within the review as this detail is often not reported in study manuscripts. Why exclude studies where CKD is not due to DM, as long as the population has both CKD and DM? In the first paragraph on CKD definitions state CKD as decrease in eGFR ≥59. I found the wording confusing but should this be eGFR <59? PICO control – the final sentence in this paragraph seems to be unfinished. Should it have “are excluded” at the end? Searches: What date are you starting your literature search from? Why search Pubmed and OVID Medline? Is the MEDLINE search within the Pubmed search not being duplicated in OVID? Data management: You state that “Initially, comprehensive literature searches will be conducted across multiple databases, such as Endnote and Covidence databases.” Do you really mean this, or do you mean that you will use these software to manage the selection and data extraction? You are using multiple methods for data imputation of missing data. How will you manage this in the analysis (e.g. how will you manage potentially discrepant results between reported data, best- and worst-case scenario)? Will this be included in sensitivity analysis as you have not stated that. Given there is likely to be significant differences in study populations, duration of follow-up, outcome measures and how these are defined, do you really foresee any scenario where it would be suitable to use a fixed effect model, irrespective of the I 2 result? You state that you will conduct subgroup analyses including for mild, moderate and severe DFUs. How will you divide ulcers into these categories as it doesn’t translate readily from any of the classification systems you are including? Is the rationale for, and objectives of, the study clearly described? Yes Is the study design appropriate for the research question? Yes Are sufficient details of the methods provided to allow replication by others? Yes Are the datasets clearly presented in a useable and accessible format? Not applicable Competing Interests No competing interests were disclosed. Reviewer Expertise Diabetes related foot disease; systematic review methods I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above. reply Respond to this report Responses (0) Russell D. Peer Review Report For: Social deprivation and foot disease outcomes in people with Diabetes Mellitus and Chronic Kidney Disease: A Systematic Reviews and Meta-Analysis Protocol [version 1; peer review: 1 approved with reservations] . HRB Open Res 2025, 8 :64 ( https://doi.org/10.21956/hrbopenres.15360.r49239) 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/8-64/v1#referee-response-49239 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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