The Stress of Measuring Plantar Tissue Stress in People with Diabetes-Related Foot Ulcers: Biomechanical and Feasibility Findings from Two Prospective Cohort Studies.

Reducing high mechanical stress is imperative to heal diabetes-related foot ulcers. We explored the association of cumulative plantar tissue stress (CPTS) and plantar foot ulcer healing, and the feasibility of measuring CPTS, in two prospective cohort studies (Australia (AU) and The Netherlands (NL)). Both studies used multiple sensors to measure factors to determine CPTS: plantar pressures, weight-bearing activities, and adherence to offloading treatments, with thermal stress response also measured to estimate shear stress in the AU-study. The primary outcome was ulcer healing at 12 weeks. Twenty-five participants were recruited: 13 in the AU-study and 12 in the NL-study. CPTS data were complete for five participants (38%) at baseline and one (8%) during follow-up in the AU-study, and one (8%) at baseline and zero (0%) during follow-up in the NL-study. Reasons for low completion at baseline were technical issues (AU-study: 31%, NL-study: 50%), non-adherent participants (15% and 8%) or combinations (15% and 33%); and at follow-up refusal of participants (62% and 25%). These underpowered findings showed that CPTS was non-significantly lower in people who healed compared with non-healed people (457 [117; 727], 679 [312; 1327] MPa·s/day). Current feasibility of CPTS seems low, given technical challenges and non-adherence, which may reflect the burden of treating diabetes-related foot ulcers.

Prescribing Home Digital Thermometry Coupled with Activity Dosing and Optimized Offloading to Prolong Diabetic Foot Remission: A Case Report.

People with a history of diabetic foot ulcers (DFUs) experience diminished health-related quality of life and are at a 40% annual risk of DFU recurrence. Due to a fear of DFU recurrence, people in DFU remission participate less in physical activity and moderate-intensity exercise when compared to people with diabetes who have not had wounds. There is novel evidence to suggest that too little activity during DFU remission contributes to only low magnitudes of repetitive tissue loading creating a higher susceptibility to skin trauma during inadvertent high-activity bouts. Conversely, a hasty return to too much activity could lead to rapid recurrence. There is now high-level evidence from multiple meta-analyses to indicate that home-based foot temperature monitoring, coupled with activity modification and daily inspection of the feet for impending signs of ulceration, could reduce the risk of ulcer recurrence by 50%. There is little evidence, however, to guide the decision-making regarding the appropriate quantity and frequency of physical activity during DFU remission and the acceptability from the patient perspective. This has resulted in limited uptake of this novel intervention in clinical practice. Earlier, we proposed that activity can be dosed for people in foot ulcer remission, just like insulin or medication is dosed. Here, we describe a patient-centered approach to implementing home foot temperature monitoring coupled with daily foot checks and dosage-based return to physical activity in a patient in DFU remission, including his perspective. We believe using such an approach could maximize ulcer-free days in remission, thereby improving quality of life.

Objective assessment of mobility among adults with diabetes and end-stage renal disease using walking aid: A cross-sectional cohort study.

BACKGROUND: This cross-sectional study aimed to compare physical activity levels, plantar sensation, and fear of falling between individuals with diabetes undergoing hemodialysis, with or without walking aids. METHODS: Sixty-four participants were recruited, with 37 not using walking aids (age = 65.8 ± 0.7 years, 46% female) and 27 using walking aids (age = 69.2 ± 1.2 years, 63% female). Physical activity was measured using validated pendant sensors over two consecutive days. Concern for falling and plantar numbness were assessed using the Falls Efficacy Scale-International and vibration perception threshold test, respectively. FINDINGS: Participants using walking aids exhibited a greater fear of falling (84% vs. 38%, p < 0.01) and fewer walking bouts (p < 0.01, d = 0.67) and stand-to-walk transitions (p < 0.01, d = 0.72) compared to those not using walking aids. The number of walking bouts was negatively correlated with concern for falling scores (ρ = -0.35, p = 0.034) and vibration perception threshold (R = -0.411, p = 0.012) among individuals not using walking aids. However, these correlations were not significant among those using the walking aid. There was no significant group difference in active behavior (walking + standing %) and sedentary behavior (sitting + lying %). INTERPRETATION: Those undergoing hemodialysis often lead sedentary lives, with mobility affected by fear of falling and plantar numbness. Using walking aids can help, but it doesn't guarantee more walking. A combined psychosocial and physical therapy approach is key for managing fall concerns and improving mobility.

Perceptions of Australians with diabetes-related foot disease on requirements for effective secondary prevention.

INTRODUCTION: Secondary prevention is essential in reducing recurrence of diabetes-related foot disease (DFD) but is frequently poorly implemented in clinical practice. OBJECTIVE: To explore the perceptions of people with diabetes-related foot disease (DFD) on their self-perceived knowledge in managing DFD, facilitators and barriers influencing their DFD care, and ideas and preferences for a secondary prevention program. DESIGN: Sixteen people with a history of DFD from Queensland and Victoria, Australia, underwent semi-structured interviews. Interviews were audio-recorded over telephone and transcribed and analysed following a thematic framework. Participants were asked about their experiences and perceptions relating to DFD and factors influencing the care they receive for DFD relevant to the development of a secondary prevention program for DFD. FINDINGS AND DISCUSSION: Participants had high self-perceived knowledge in managing DFD, especially in implementing healthy lifestyle changes and conducting daily foot checks and foot care, though most received support from family members acting as carers. However, issues with access and adherence to offloading footwear, and a lack of clear education received on footwear and other aspects of DFD care were perceived as major barriers. Improved patient education, provided in a consistent manner by proactive clinicians was perceived as an essential part of secondary prevention. Telehealth was perceived positively through facilitating faster care and considered a good adjunct to standard care. Health and technological literacy were considered potentially major barriers to the effectiveness of remote care. CONCLUSION: People with DFD require improved access to offloading footwear and education about secondary prevention, which could be provided by telehealth with adequate support.

Patient Perspectives on the Burden and Prevention of Diabetes-Related Foot Disease.

PURPOSE: The purpose of the study was to understand patient perspectives about the impact and prevention of diabetes-related foot disease (DFD). METHODS: An online survey was distributed to patients with a history of DFD during 2020. The survey was designed alongside clinical specialists and DFD patients and utilized the health belief model. It asked about the impact of DFD on health, perceptions on preventive strategies, perceived need for additional support, and patient preferences for telehealth in DFD management. Quantitative data were summarized descriptively and compared between groups. Open-text responses were analyzed using conceptual content analysis. RESULTS: Of 80 participants with a history of DFD, foot ulcers were the complication most often experienced, with over two-thirds having been admitted to hospital for a DFD-related issue and over one-third having a DFD-related amputation. Participants had ranging perceptions on the effect of DFD on health, from minimal to crippling. Those with previous severe DFD complications leading to hospital admission found a lack of mobility and independence the consequences of most concern. Using offloading footwear was perceived as very important for preventing DFD complications, although the use of offloading footwear was low, with participants citing issues relating to cost, comfort, appearance, and access to footwear as barriers to better adherence. Perceptions on telehealth were mixed, with many participants not having access to or being comfortable with the use of digital technologies. CONCLUSIONS: Patients with DFD require additional supports for effective prevention, including offloading footwear.

Frailty in People with Chronic Limb Threatening Ischemia and Diabetes-Related Foot Ulcers: A Systematic Review.

BACKGROUND: Frailty represents a state of multisystem impairment that may adversely impact people presenting with chronic limb-threatening ischemia (CLTI) and diabetes-related foot ulcers (DFUs). The aim of this systematic review was to explore the association between frailty and outcomes from CLTI and DFUs. METHODS: We performed a systematic literature search of electronic databases to find studies using a validated measure of frailty in individuals with CLTI and/or DFUs. The primary outcomes were the impact of frailty on the severity of initial clinical presentation and unfavorable follow-up outcomes including readmissions, major limb amputation, cardiovascular events, revascularization, and wound healing. RESULTS: Ten cohort studies were included. Two studies had a low risk of bias, 1 was unable to be assessed, 5 had moderate risk of bias, and 2 high risk of bias. The prevalence of frailty in people presenting with CLTI ranged from 27% to 88% and was 71% in people with DFUs. The presence of frailty in both people with CLTI and DFUs was associated with substantially increased severity at presentation (severity of ischemia and tissue loss) and poorer outcomes at follow-up (risk of readmission, limb amputation, and all-cause mortality). CONCLUSIONS: The presence of frailty in both people with CLTI and DFUs is likely associated with substantially higher complexity at presentation followed by a greater risk for readmission, amputation, and death during follow-up. Heterogeneity in the tools used to screen for frailty, poor definition of frailty, and unclear evaluation of exposure and outcomes limit further interpretation of findings.

Remotely Delivered Monitoring and Management of Diabetes-Related Foot Disease: An Overview of Systematic Reviews.

BACKGROUND: Diabetes-related foot disease (DFD) management requires input from multiple healthcare professionals, and has worse outcomes for people living in remote localities by comparison to urban areas. Remotely delivered healthcare may reduce this disparity. This overview summarizes current evidence on the effectiveness, stakeholder perceptions, and cost-effectiveness of remotely delivered healthcare for DFD. METHODS: A search of 5 databases was conducted to identify systematic reviews published between January 2000 and June 2020. Eligible reviews were those evaluating remotely delivered monitoring or management of patients at risk of or with active DFD, or clinicians managing these patients. Risk of bias was assessed using the AMSTAR-2 tool. RESULTS: Eight reviews were eligible for inclusion, including 88 primary studies and 8509 participants, of which 36 studies involving 4357 participants evaluated remotely delivered monitoring or management of DFD. Only one review had a low risk of bias, with most reviews demonstrating limited search strategies and poor reporting of participants. Evidence on effectiveness was mixed, with meta-analyses demonstrating long-term ulcer healing and mortality were not significantly different between telehealth and standard care groups, although the lower-limb amputation rate was significantly decreased in one meta-analysis. Perceptions of telehealth by patients and clinicians were generally positive, whilst acknowledging limitations relating to access and use. Cost-effectiveness data were limited, with poor reporting preventing clear conclusions. CONCLUSIONS: Remotely delivered healthcare of DFD is well received by patients and clinicians, but its effectiveness is unclear. High quality trials are needed to evaluate the risks and benefits of remotely delivered DFD management.

Evolution of WIfI: Expansion of WIfI Notation After Intervention.

Nearly a decade ago, the Society for Vascular Surgery (SVS)'s wound, ischemia, and foot Infection (WIfI) classification was first developed to help assess overall limb threat. However, managing conditions such as diabetic foot ulcer and chronic limb-threatening ischemia can be complex. For instance, certain investigative findings might initially be pending such as the level of ischemia or extent of infection before the final classification is established. In addition, wounds evolve rapidly, and the current classification does not allow for tracking their progression over time during treatment. Therefore, we propose a supplemental consistent notation for scoring WifI re-assessment during treatment of a threatened limb inspired by the cancer staging before and after neoadjuvant treatment classification system. Thus, we describe the re-scoring system and how to use it. Our suggestion supports a coherent method to longitudinally communicate characteristics of a threatened limb. This has potential to support high quality interdisciplinary, patient-centered care and enhance the use of this classification in research. Further work is required to validate this modification of a common language of risk.

Current Management of Peripheral Artery Disease: Focus on Pharmacotherapy.

Peripheral artery disease (PAD) is the occlusion or narrowing of the arteries supplying the lower extremities. Peripheral artery disease has been estimated to affect approximately 240 million people worldwide, approximately 70% of whom are within low- or middle-income countries. Due to the ageing population and diabetes epidemic, the prevalence of PAD is rapidly rising. The symptoms of PAD are heterogeneous and thus a high index of suspicion is needed to prevent delays in diagnosis and treatment. Measurement of ankle brachial pressure index or arterial duplex ultrasound are traditionally used to diagnose PAD. Patients with PAD have a high risk of major adverse cardiovascular events. Early diagnosis and implementation of secondary cardiovascular prevention is therefore critical. This includes therapies to reduce low-density lipoprotein cholesterol, such as statins, ezetimibe and proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors, blood-pressure reducing medications and anti-thrombotic drugs. Treatments to facilitate smoking cessation and control blood sugar if relevant and an exercise programme are also critical in reducing cardiovascular risk. Currently, these treatments are not well implemented. This review summarises the clinical presentation, risk factors and medical management of PAD. Global efforts are needed to reduce the burden from the growing PAD epidemic by implementing best practices and improving outcomes through further research.

The Application of Digital Frailty Screening to Triage Nonhealing and Complex Wounds.

OBJECTIVE: We investigated the association between the complexity of diabetic foot ulcers (DFUs) and frailty. RESEARCH DESIGN AND METHODS: Individuals (n = 38) with Grade 2 Wagner DFU were classified into 3 groups based on the Society for Vascular Surgery risk-stratification for major limb amputation as Stage 1 at very low risk (n = 19), Stage 2 at low risk (n = 9), and Stage 3 to 4 at moderate-to-high risk (n = 10) of major limb amputation. Frailty status was objectively assessed using a validated digital frailty meter (FM). The FM works by quantifying weakness, slowness, rigidity, and exhaustion over a 20-second repetitive elbow flexion-extension exercise using a wrist-worn sensor. FM generates a frailty index (FI) ranging from 0 to 1; higher values indicate progressively greater severity of frailty. Skin perfusion pressure (SPP), albumin, and tissue oxygenation level (SatO2) were also measured. One-way analysis of variance (ANOVA) was used to identify group effect for wound complexity. Pearson's correlation coefficient was used to assess the associations with frailty and clinical endpoints. RESULTS: Frailty index was higher in Stage 3 and 4 as compared to Stage 1 (d = 1.4, P < .01) and Stage 2 (d = 1.2, P < .01). Among assessed frailty phenotypes, exhaustion was correlated with SPP (r = -0.63, P < .01) and albumin (r = -0.5, P < .01). CONCLUSION: Digital biomarkers of frailty may predict complexity of DFU and thus triage individuals who can be treated more simply in their primary clinic versus higher risk patients who require prompt referral to multidisciplinary, more complex care.

Health Professionals' Opinions About Secondary Prevention of Diabetes-Related Foot Disease.

PURPOSE: The purpose of this study was to explore the perceptions of health professionals regarding the ideal design of a remotely delivered diabetes-related foot disease (DFD) secondary prevention program. METHODS: A qualitative study involving 33 semistructured phone interviews was conducted with health professionals with experience managing DFD. Interviews discussed the role of health professionals in managing DFD, their experience in using telehealth, perceived management priorities, preferences for a secondary prevention management program, and perceived barriers and facilitators for such a program. Interviews were audio-recorded and transcribed, and inductive thematic analysis was used to derive key themes. RESULTS: Three themes were derived: (1) barriers in current model of DFD care, (2) facilitators and ideas for a remotely delivered secondary prevention program, and (3) potential challenges in implementation. DFD care remains acute-care focused, with variability in access to care and a lack of "clinical ownership." Patients were perceived as often having poor knowledge and competing priorities, meaning engagement in self-care remains poor. Participants felt a remote secondary prevention program should be simple to follow and individualized to patients' context, with embedded support from a case manager and local multidisciplinary service providers. Challenges to implementation included limited DFD awareness, poor patient motivation, patient-related issues with accessing and using technology, and the inability to accurately assess and treat the foot over telehealth. CONCLUSIONS: Health professionals felt that an ideal remotely delivered secondary prevention program should be tailored to patients' needs with embedded support from a case manager and complemented with multidisciplinary collaboration with local service providers.

Corrigendum: Effectiveness of Remotely Delivered Interventions to Simultaneously Optimize Management of Hypertension, Hyperglycemia and Dyslipidemia in People With Diabetes: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

[This corrects the article DOI: 10.3389/fendo.2022.848695.].

Efficacy of at home monitoring of foot temperature for risk reduction of diabetes-related foot ulcer: A meta-analysis.

AIMS: To perform an updated systematic review of randomised controlled trials examining the efficacy of at-home foot temperature monitoring in reducing the risk of a diabetes-related foot ulcer (DFU). METHODS: Systematic review performed according to Preferred Reporting Items for Systematic reviews and Meta-Analyses guidelines. Risk-of-bias was assessed using version 2 of the Cochrane risk-of-bias tool. Meta-analyses were performed using random effect models. Leave-one-out sensitivity analyses and a sub-analysis excluding trials considered at high risk-of-bias assessed the consistency of the findings. The certainty of the evidence was assessed with GRADE. RESULTS: Five randomised controlled trials involving 772 participants meeting the International Working Group on the Diabetic Foot (IWGDF) risk category 2 or 3 were included. All trials reported instructing participants to measure skin temperature at-home at six or more sites on each foot using a hand-held infra-red thermometer at least daily and reduce ambulatory activity in response to hotspots (temperature differences >2.2°C on two consecutive days between similar locations in both feet). One, one, and three trials were considered at low, moderate and high risk-of-bias, respectively. Participants allocated to at-home foot temperature monitoring had a reduced risk of developing a DFU (relative risk 0.51, 95% CI 0.31-0.84) compared to controls. Sensitivity and sub-analyses suggested that the significance of this finding was consistent. The GRADE assessment suggested a low degree of certainty in the finding. CONCLUSIONS: At-home daily foot temperature monitoring and reduction of ambulatory activity in response to hotspots reduce the risk of a DFU in moderate or high risk people with a low level of certainty.

Australian guideline on offloading treatment for foot ulcers: part of the 2021 Australian evidence-based guidelines for diabetes-related foot disease.

BACKGROUND: Pressure offloading treatment is critical for healing diabetes-related foot ulcers (DFU). Yet the 2011 Australian DFU guidelines regarding offloading treatment are outdated. A national expert panel aimed to develop a new Australian guideline on offloading treatment for people with DFU by adapting international guidelines that have been assessed as suitable to adapt to the Australian context. METHODS: National Health and Medical Research Council procedures were used to adapt suitable International Working Group on the Diabetic Foot (IWGDF) guidelines to the Australian context. We systematically screened, assessed and judged all IWGDF offloading recommendations using best practice ADAPTE and GRADE frameworks to decide which recommendations should be adopted, adapted or excluded in the Australian context. For each recommendation, we re-evaluated the wording, quality of evidence, strength of recommendation, and provided rationale, justifications and implementation considerations, including for geographically remote and Aboriginal and Torres Strait Islander peoples. This guideline, along with five accompanying Australian DFU guidelines, underwent public consultation, further revision and approval by ten national peak bodies (professional organisations). RESULTS: Of the 13 original IWGDF offloading treatment recommendations, we adopted four and adapted nine. The main reasons for adapting the IWGDF recommendations included differences in quality of evidence ratings and clarification of the intervention(s) and control treatment(s) in the recommendations for the Australian context. For Australians with plantar DFU, we recommend a step-down offloading treatment approach based on their contraindications and tolerance. We strongly recommend non-removable knee-high offloading devices as first-line treatment, removable knee-high offloading devices as second-line, removable ankle-high offloading devices third-line, and medical grade footwear as last-line. We recommend considering using felted foam in combination with the chosen offloading device or footwear to further reduce plantar pressure. If offloading device options fail to heal a person with plantar DFU, we recommend considering various surgical offloading procedures. For people with non-plantar DFU, depending on the type and location of the DFU, we recommend using a removable offloading device, felted foam, toe spacers or orthoses, or medical grade footwear. The six new guidelines and the full protocol can be found at: https://diabetesfeetaustralia.org/new-guidelines/ . CONCLUSIONS: We have developed a new Australian evidence-based guideline on offloading treatment for people with DFU that has been endorsed by ten key national peak bodies. Health professionals implementing these offloading recommendations in Australia should produce better DFU healing outcomes for their patients, communities, and country.

Health Professionals' Opinions About Secondary Prevention of Diabetes-Related Foot Disease.

This study explored health professionals' perceptions of current issues and opportunities for the secondary prevention of diabetes-related foot disease (DFD), and potential strategies for improving DFD care. From May to October 2020, relevant Australian health professionals completed an online survey which used ordinal scales, ranking questions, and open text fields to assess perceptions about the importance of aspects of secondary prevention for DFD and elements for a prevention program. Quantitative data were summarised and compared between professions using non-parametric tests, and qualitative data was analysed using conceptual content analysis to identify emerging themes. Perceptions from 116 health professionals with experience in managing patients with DFD were obtained, including 69 podiatrists, 21 vascular surgeons, 16 general practitioners, and ten nurses. Access and adherence to appropriate offloading footwear was perceived as a key element for effective DFD care, and believed to be affected by social and economic factors, such as the cost of footwear, as well as patient-related factors, such as motivation to wear footwear and adhere to other medical therapies. In addition to a lack of patient motivation and financial limitations, health professionals also believed patients lacked an understanding of the likelihood and severity of DFD recurrence. Several elements of care were perceived as missing from practice, including psychological support and ways to improve footwear adherence, with health professionals identifying several strategies for the design and implementation of an effective secondary prevention program. Prospective trials evaluating secondary prevention programs are required to determine the most effective means for preventing DFD recurrence.

Effectiveness of Remotely Delivered Interventions to Simultaneously Optimize Management of Hypertension, Hyperglycemia and Dyslipidemia in People With Diabetes: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

Background: Remotely delivered interventions may be more efficient in controlling multiple risk factors in people with diabetes. Purpose: To pool evidence from randomized controlled trials testing remote management interventions to simultaneously control blood pressure, blood glucose and lipids. Data Sources: PubMed/Medline, EMBASE, CINAHL and the Cochrane library were systematically searched for randomized controlled trials (RCTs) until 20th June 2021. Study Selection: Included RCTs were those that reported participant data on blood pressure, blood glucose, and lipid outcomes in response to a remotely delivered intervention. Data Extraction: Three authors extracted data using a predefined template. Primary outcomes were glycated hemoglobin (HbA1c), total cholesterol (TC), low-density lipoprotein cholesterol (LDL-c), systolic and diastolic blood pressure (SBP & DBP). Risk of bias was assessed using the Cochrane collaboration RoB-2 tool. Meta-analyses are reported as standardized mean difference (SMD) with 95% confidence intervals (95%CI). Data Synthesis: Twenty-seven RCTs reporting on 9100 participants (4581 intervention and 4519 usual care) were included. Components of the remote management interventions tested were identified as patient education, risk factor monitoring, coaching on monitoring, consultations, and pharmacological management. Comparator groups were typically face-to-face usual patient care. Remote management significantly reduced HbA1c (SMD -0.25, 95%CI -0.33 to -0.17, p<0.001), TC (SMD -0.17, 95%CI -0.29 to -0.04, p<0.0001), LDL-c (SMD -0.11, 95%CI -0.19 to -0.03, p=0.006), SBP (SMD -0.11, 95%CI -0.18 to -0.04, p=0.001) and DBP (SMD -0.09, 95%CI -0.16 to -0.02, p=0.02), with low to moderate heterogeneity (I²= 0 to 75). Twelve trials had high risk of bias, 12 had some risk and three were at low risk of bias. Limitations: Heterogeneity and potential publication bias may limit applicability of findings. Conclusions: Remote management significantly improves control of modifiable risk factors. Systematic Review Registration: [https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=258433], identifier PROSPERO (CRD42021258433).

Opinions about the most appropriate surgical management of diabetes-related foot infection: a cross-sectional survey.

BACKGROUND: There is a lack of high quality evidence to guide the optimal management of diabetes-related foot infection, particularly in cases of severe diabetes-related foot infection and diabetes-related foot osteomyelitis. This study examined the opinions of surgeons about the preferred management of severe diabetes-related foot infection. METHODS: Vascular and orthopaedic surgeons in Australia and New Zealand were invited to complete an online survey via email. The survey included multi-choice and open-ended questions on clinical management of diabetes-related foot infection. Responses of vascular surgeons and orthopaedic surgeons were compared using non-parametric statistical tests. Open-text responses were examined using inductive content analysis. RESULTS: 29 vascular and 20 orthopaedic surgeons completed the survey. One-third (28.6%) used best-practice guidelines to assist in decisions about foot infection management. Areas for guideline improvement identified included more specific advice regarding the indications for available treatments, more recommendations about non-surgical patient management and advice on how management can be varied in regions with limited health service resource. The probe-to-bone test and magnetic resonance imaging were the preferred methods of diagnosing osteomyelitis. Approximately half (51.2%) of respondents indicated piperacillin combined with tazobactam as the preferred antibiotic choice for empirical treatment of severe diabetes-related foot infection. Negative pressure wound therapy was the most common way of managing a wound following debridement. All vascular surgeons (100%) made revascularisation decisions based on the severity of ischemia while most orthopaedic surgeons (66.7%) were likely to refer to vascular surgeons to make revascularisation decisions. Vascular surgeons preferred using wound swabs while orthopaedic surgeons favoured tissue or bone biopsies to determine the choice of antibiotic. Respondents perceived a moderate variation in management decisions between specialists and supported the need for randomised controlled trials to test different management pathways. CONCLUSIONS: Most vascular and orthopaedic surgeons do not use best-practice guidelines to assist in decisions about management of diabetes-related foot infection. Vascular and orthopaedic surgeons appear to have different preferences for wound sampling to determine choice of antibiotic. There is a need for higher quality evidence to clarify best practice for managing diabetes-related foot infection.

Cytomegalovirus infection in a single-centre Australian neonatal cohort.

AIM: Congenital cytomegalovirus (cCMV) is the most common infectious cause of congenital malformation, non-genetic sensorineural hearing loss and neurodevelopmental sequelae in childhood. The primary aim of this retrospective cohort study was to identify the birth and neurodevelopmental outcomes of neonates diagnosed with symptomatic and asymptomatic cCMV in a large regional tertiary referral hospital. METHODS: This was a retrospective cohort study of laboratory-based cCMV diagnoses in neonates born at a single study centre between January 2005 and January 2020. Audit of medical records was undertaken to evaluate maternal characteristics, symptom patterns, radiological and neurodevelopmental outcomes of neonates meeting the laboratory diagnostic criteria during the first 24 months. RESULTS: There were 45 neonates with proven CMV infection and 27 mothers with proven infection with an associated pregnancy outcome. Nineteen neonates were born at term (>37 weeks). Of these, 32 (71.1%) neonates had a significant intercurrent comorbidity and 22 (48.9%) neonates were reported to have a degree of delay in one or more developmental domains. A large proportion (77.3%) of the symptomatic untreated neonates had an unknown history of maternal infection compared to the asymptomatic (10.0%) and symptomatic treated (53.8%) neonates (P = 0.001). CONCLUSION: Up to half of the neonates with cCMV were at risk of developing a degree of developmental delay at our centre. Whether these outcomes are related primarily to CMV infection or are confounded by the co-existence of prematurity is unclear and needs further evaluation in prospective studies.

Meta-analysis of the association between angiotensin pathway inhibitors and COVID-19 severity and mortality.

BACKGROUND: Conflicting findings and the analysis of unpublished and retracted data have led to controversy on the safety of angiotensin-converting enzyme inhibitors and angiotensin receptor blockers in people with COVID-19 infection. This meta-analysis examined the association of prescription of angiotensin-converting enzyme inhibitors (ACEI) and angiotensin receptor blockers (ARB) with the outcome from COVID-19. METHODS: A systematic search was conducted to find published studies that reported the outcome of COVID-19 in relation to prescription of ACEI or ARB. Two authors (MF and AD) independently screened and extracted data and assessed study quality and strength of association using standardised tools. The endpoints for the meta-analyses were severe or critical disease outcome and mortality based on standardised criteria. RESULTS: Twenty-six studies including 8389 people prescribed ACEI or ARB and 20,989 people not prescribed these medications were included. The quality of studies varied, and the overall strength of association was poor with a high risk of confounding bias. Patients prescribed ACEI or ARB had a greater prevalence of risk factors. Meta-analysis found an association between prescription of ACEI or ARB with severe or critical disease outcome (risk ratio, RR, 1.23, 95% confidence interval, CI, 1.06 to 1.42, p = 0.006, I2 = 88%) but this association was lost in sensitivity analyses. There was no association between ACEI or ARB prescription and mortality (RR 1.18, 95% CI 0.92 to 1.50, p = 0.19, I2 = 82%). CONCLUSIONS: This meta-analysis suggests that people prescribed ACEI or ARB more commonly had severe or critical disease outcome, but not mortality, in published cohorts of patients diagnosed with COVID-19. This finding is most likely due to a greater prevalence of risk factors in these patients rather than due to exposure to angiotensin pathway inhibitors.

Relationship between requirement to stop during a six-minute walk test and health-related quality of life, physical activity and physical performance amongst people with intermittent claudication.

AIM: A simple objective test is required to identify people with impaired physical aspects of health-related quality of life (QOL) due to intermittent claudication. This study assessed the relationship of QOL, function and physical activity to the need to stop during a six-minute walking test (6MWT) amongst people with intermittent claudication. METHOD: This was a prospective case-control study conducted at two centers in Australia. 173 participants with a history of intermittent claudication and peripheral artery disease diagnosed by ankle brachial pressure index <0.9, completed two 6MWTs one week apart. QOL was assessed with the short form (SF)-36. Physical activity was assessed by an accelerometer to record step count, stepping time and energy expenditure over 7 days. Physical performance was assessed by the Short Physical Performance Battery (SPPB) test. The associations of the need to stop at least once during the 6MWT with QOL, function and activity were assessed using Mann Whitney U test and analysis of covariates. RESULTS: Participants that had to stop at least once during the two 6MWTs (46; 26.6%) had significantly lower scores for three of the domains (physical functioning, role-physical and bodily pain) and the physical component summary (PCS) measure of the SF-36 compared to those who did not need to stop (n = 127; 73.4%). After adjusting for the risk factor co-variates (diabetes, hypertension and ankle brachial pressure index) which were significantly unequally distributed, needing to stop during the 6MWTs was significantly associated with a lower PCS score (adjusted mean 36.5, standard error 0.8 vs. 30.5, standard error 1.3; F = 14.0; P < 0.001; partial eta squared 0.077). Participants that had to stop at least once during the two 6MWTs had significantly lower 7-day step count, time stepping and energy expenditure, but not total SPPB score, compared to those who did not need to stop. CONCLUSIONS: Needing to stop during a 6MWT identified participants with intermittent claudication with poorer QOL and less physical activity compared to those that do not need to stop.