Effectiveness of bedside investigations to diagnose peripheral artery disease among people with diabetes mellitus: A systematic review.

As a progressive disease process, early diagnosis and ongoing monitoring and treatment of lower limb peripheral artery disease (PAD) is critical to reduce the risk of diabetes-related foot ulcer (DFU) development, non-healing of wounds, infection and amputation, in addition to cardiovascular complications. There are a variety of non-invasive tests available to diagnose PAD at the bedside, but there is no consensus as to the most diagnostically accurate of these bedside investigations or their reliability for use as a method of ongoing monitoring. Therefore, the aim of this systematic review was to first determine the diagnostic accuracy of non-invasive bedside tests for identifying PAD compared to an imaging reference test and second to determine the intra- and inter-rater reliability of non-invasive bedside tests in adults with diabetes. A database search of Medline and Embase was conducted from 1980 to 30 November 2022. Prospective and retrospective investigations of the diagnostic accuracy of bedside testing in people with diabetes using an imaging reference standard and reliability studies of bedside testing techniques conducted in people with diabetes were eligible. Included studies of diagnostic accuracy were required to report adequate data to calculate the positive likelihood ratio (PLR) and negative likelihood ratio (NLR) which were the primary endpoints. The quality appraisal was conducted using the Quality Assessment of Diagnostic Accuracy Studies and Quality Appraisal of Reliability quality appraisal tools. From a total of 8517 abstracts retrieved, 40 studies met the inclusion criteria for the diagnostic accuracy component of the review and seven studies met the inclusion criteria for the reliability component of the review. Most studies investigated the diagnostic accuracy of ankle -brachial index (ABI) (N = 38). In people with and without DFU, PLRs ranged from 1.69 to 19.9 and NLRs from 0.29 to 0.84 indicating an ABI <0.9 increases the likelihood of disease (but the extent of the increase ranges from a small to large amount) and an ABI within the normal range (≥0.90 and <1.3) does not exclude PAD. For toe-brachial index (TBI), a threshold of <0.70 has a moderate ability to rule PAD in and out; however, this is based on limited evidence. Similarly, a small number of studies indicate that one or more monophasic Doppler waveforms in the pedal arteries is associated with the presence of PAD, whereas tri- or biphasic waveform suggests that PAD is less likely. Several forms of bedside testing may also be useful as adjunct tests and 7 studies were identified that investigated the reliability of bedside tests including ABI, toe pressure, TBI, transcutaneous oxygen pressure (TcPO2 ) and pulse palpation. Inter-rater reliability was poor for pulse palpation and moderate for TcPO2. The ABI, toe pressure and TBI may have good inter- and intra-rater reliability, but margins of error are wide, requiring a large change in the measurement for it to be considered a true change rather than error. There is currently no single bedside test or a combination of bedside tests that has been shown to have superior diagnostic accuracy for PAD in people with diabetes with or without DFU. However, an ABI <0.9 or >1.3, TBI of <0.70, and absent or monophasic pedal Doppler waveforms are useful to identify the presence of disease. The ability of the tests to exclude disease is variable and although reliability may be acceptable, evidence of error in the measurements means test results that are within normal limits should be considered with caution and in the context of other vascular assessment findings (e.g., pedal pulse palpation and clinical signs) and progress of DFU healing.

Effectiveness of revascularisation for the ulcerated foot in patients with diabetes and peripheral artery disease: A systematic review.

INTRODUCTION: Peripheral artery disease (PAD) is associated with an increased likelihood of delayed or non-healing of a diabetes-related foot ulcer, gangrene, and amputation. The selection of the most effective surgical technique for revascularisation of the lower limb in this population is challenging and there is a lack of conclusive evidence to support the choice of intervention. This systematic review aimed to determine, in people with diabetes and tissue loss, if direct revascularisation is superior to indirect revascularisation and if endovascular revascularisation is superior to open revascularisation for the outcomes of wound healing, minor or major amputation, and adverse events including mortality. METHODS: Title and abstract searches of Medline, Embase, PubMed, and EBSCO were conducted from 1980 to 30th November 2022. Cohort and case-control studies and randomised controlled trials reporting comparative outcomes of direct (angiosome) revascularisation (DR) and indirect revascularisation (IR) or the comparative outcomes of endovascular revascularisation and open or hybrid revascularisation for the outcomes of healing, minor amputation, and major amputation in people with diabetes, PAD and tissue loss (including foot ulcer and/or gangrene) were eligible. Methodological quality was assessed using the Cochrane risk-of-bias tool for randomised trials, the ROBINS-I tool for non-randomised studies, and Newcastle-Ottawa Scale for observational and cohort studies where details regarding the allocation to intervention groups were not provided. RESULTS: From a total 7086 abstracts retrieved, 26 studies met the inclusion criteria for the comparison of direct angiosome revascularisation (DR) and indirect revascularisation (IR), and 11 studies met the inclusion criteria for the comparison of endovascular and open revascularisation. One study was included in both comparisons. Of the included studies, 35 were observational (31 retrospective and 4 prospective cohorts) and 1 was a randomised controlled trial. Cohort study quality was variable and generally low, with common sources of bias related to heterogeneous participant populations and interventions and lack of reporting of or adjusting for confounding factors. The randomised controlled trial had a low risk of bias. For studies of DR and IR, results were variable, and it is uncertain if one technique is superior to the other for healing, prevention of minor or major amputation, or mortality. However, the majority of studies reported that a greater proportion of participants receiving DR healed compared with IR, and that IR with collaterals may have similar outcomes to DR for wound healing. For patients with diabetes, infrainguinal PAD, and an adequate great saphenous vein available for use as a bypass conduit who were deemed suitable for either surgical procedure, an open revascularisation first approach was superior to endovascular therapy to prevent a major adverse limb event or death (Hazard Ratio: 0.72; 95% CI 0.61-0.86). For other studies of open and endovascular approaches, there was generally no difference in outcomes between the interventions. CONCLUSIONS: The majority of available evidence for the effectiveness of DR and IR and open and endovascular revascularisation for wound healing and prevention of minor and major amputation and adverse events including mortality in people with diabetes, PAD and tissue loss is inconclusive, and the certainty of evidence is very low. Data from one high quality randomised controlled trial supports the use of open over endovascular revascularisation to prevent a major limb event and death in people with diabetes, infrainguinal disease and tissue loss who have an adequate great saphenous vein available and who are deemed suitable for either approach.

Performance of non-invasive bedside vascular testing in the prediction of wound healing or amputation among people with foot ulcers in diabetes: A systematic review.

INTRODUCTION: The presence of peripheral artery disease (PAD) confers a significantly increased risk of failure to heal and major lower limb amputation for people with diabetes-related foot ulcer (DFU). Determining performance of non-invasive bedside tests for predicting likely DFU outcomes is therefore key to effective risk stratification of patients with DFU and PAD to guide management decisions. The aim of this systematic review was to determine the performance of non-invasive bedside tests for PAD to predict DFU healing, healing post-minor amputation, or need for minor or major amputation in people with diabetes and DFU or gangrene. METHODS: A database search of Medline and Embase was conducted from 1980 to 30 November 2022. Prospective studies that evaluated non-invasive bedside tests in patients with diabetes, with and without PAD and foot ulceration or gangrene to predict the outcomes of DFU healing, minor amputation, and major amputation with or without revascularisation, were eligible. Included studies were required to have a minimum 6-month follow-up period and report adequate data to calculate the positive likelihood ratio (PLR) and negative likelihood ratio for the outcomes of DFU healing, and minor and major amputation. Methodological quality was assessed using the Quality in Prognosis Studies tool. RESULTS: From 14,820 abstracts screened 28 prognostic studies met the inclusion criteria. The prognostic tests evaluated by the studies included: ankle-brachial index (ABI) in 9 studies; ankle pressures in 10 studies, toe-brachial index in 4 studies, toe pressure in 9 studies, transcutaneous oxygen pressure (TcPO2 ) in 7 studies, skin perfusion pressure in 5 studies, continuous wave Doppler (pedal waveforms) in 2 studies, pedal pulses in 3 studies, and ankle peak systolic velocity in 1 study. Study quality was variable. Common reasons for studies having a moderate or high risk of bias were poorly described study participation, attrition rates, and inadequate adjustment for confounders. In people with DFU, toe pressure ≥30 mmHg, TcPO2 ≥25 mmHg, and skin perfusion pressure of ≥40 mmHg were associated with a moderate to large increase in pretest probability of healing in people with DFU. Toe pressure ≥30 mmHg was associated with a moderate increase in healing post-minor amputation. An ABI using a threshold of ≥0.9 did not increase the pretest probability of DFU healing, whereas an ABI <0.5 was associated with a moderate increase in pretest probability of non-healing. Few studies investigated amputation outcomes. An ABI <0.4 demonstrated the largest increase in pretest probability of a major amputation (PLR ≥10). CONCLUSIONS: Prognostic capacity of bedside testing for DFU healing and amputation is variable. A toe pressure ≥30 mmHg, TcPO2 ≥25 mmHg, and skin perfusion pressure of ≥40 mmHg are associated with a moderate to large increase in pretest probability of healing in people with DFU. There are little data available evaluating the prognostic capacity of bedside testing for healing after minor amputation or for major amputation in people with DFU. Current evidence suggests that an ABI <0.4 may be associated with a large increase in risk of major amputation. The findings of this systematic review need to be interpreted in the context of limitations of available evidence, including varying rates of revascularisation, lack of post-revascularisation bedside testing, and heterogenous subpopulations.

Definitions and criteria for diabetes-related foot disease (IWGDF 2023 update).

Multiple disciplines are involved in the management of diabetes-related foot disease and a common vocabulary is essential for clear communication. Based on the systematic reviews of the literature that form the basis of the International Working Group on the Diabetic Foot (IWGDF) Guidelines, the IWGDF has developed a set of definitions and criteria for diabetes-related foot disease. This document describes the 2023 update of these definitions and criteria. We suggest these definitions be used consistently in both clinical practice and research, to facilitate clear communication with people with diabetes-related foot disease and between professionals around the world.

The intersocietal IWGDF, ESVS, SVS guidelines on peripheral artery disease in people with diabetes and a foot ulcer.

Diabetes related foot complications have become a major cause of morbidity and are implicated in most major and minor amputations globally. Approximately 50% of people with diabetes and a foot ulcer have peripheral artery disease (PAD) and the presence of PAD significantly increases the risk of adverse limb and cardiovascular events. The International Working Group on the Diabetic Foot (IWGDF) has published evidence based guidelines on the management and prevention of diabetes related foot complications since 1999. This guideline is an update of the 2019 IWGDF guideline on the diagnosis, prognosis and management of peripheral artery disease in people with diabetes mellitus and a foot ulcer. For this guideline the IWGDF, the European Society for Vascular Surgery and the Society for Vascular Surgery decided to collaborate to develop a consistent suite of recommendations relevant to clinicians in all countries. This guideline is based on three new systematic reviews. Using the Grading of Recommendations, Assessment, Development, and Evaluation framework clinically relevant questions were formulated, and the literature was systematically reviewed. After assessing the certainty of the evidence, recommendations were formulated which were weighed against the balance of benefits and harms, patient values, feasibility, acceptability, equity, resources required, and when available, costs. Through this process five recommendations were developed for diagnosing PAD in a person with diabetes, with and without a foot ulcer or gangrene. Five recommendations were developed for prognosis relating to estimating likelihood of healing and amputation outcomes in a person with diabetes and a foot ulcer or gangrene. Fifteen recommendations were developed related to PAD treatment encompassing prioritisation of people for revascularisation, the choice of a procedure and post-surgical care. In addition, the Writing Committee has highlighted key research questions where current evidence is lacking. The Writing Committee believes that following these recommendations will help healthcare professionals to provide better care and will reduce the burden of diabetes related foot complications.

The intersocietal IWGDF, ESVS, SVS guidelines on peripheral artery disease in people with diabetes mellitus and a foot ulcer.

Diabetes related foot complications have become a major cause of morbidity and are implicated in most major and minor amputations globally. Approximately 50% of people with diabetes and a foot ulcer have peripheral artery disease (PAD) and the presence of PAD significantly increases the risk of adverse limb and cardiovascular events. The International Working Group on the Diabetic Foot (IWGDF) has published evidence based guidelines on the management and prevention of diabetes related foot complications since 1999. This guideline is an update of the 2019 IWGDF guideline on the diagnosis, prognosis, and management of peripheral artery disease in people with diabetes mellitus and a foot ulcer. For this updated guideline, the IWGDF, the European Society for Vascular Surgery, and the Society for Vascular Surgery decided to collaborate to develop a consistent suite of recommendations relevant to clinicians in all countries. This guideline is based on three new systematic reviews. Using the Grading of Recommendations, Assessment, Development and Evaluation framework clinically relevant questions were formulated, and the literature was systematically reviewed. After assessing the certainty of the evidence, recommendations were formulated which were weighed against the balance of benefits and harms, patient values, feasibility, acceptability, equity, resources required, and when available, costs. Through this process five recommendations were developed for diagnosing PAD in a person with diabetes, with and without a foot ulcer or gangrene. Five recommendations were developed for prognosis relating to estimating likelihood of healing and amputation outcomes in a person with diabetes and a foot ulcer or gangrene. Fifteen recommendations were developed related to PAD treatment encompassing prioritisation of people for revascularisation, the choice of a procedure and post-surgical care. In addition, the Writing Committee has highlighted key research questions where current evidence is lacking. The Writing Committee believes that following these recommendations will help healthcare professionals to provide better care and will reduce the burden of diabetes related foot complications.

Factors influencing diabetes-related foot ulcer healing in Australian adults: A prospective cohort study.

OBJECTIVE: Diabetes-related foot ulceration (DFU) is a common limb-threatening condition, which is complex and subsequently challenging to manage. The aim of this study was to determine the contribution of a range of clinical and social factors to the healing of diabetes-related foot ulceration in an Australian population. RESEARCH DESIGN AND METHODS: This was a prospective cohort study of individuals with diabetes-related foot ulceration (DFU). Age, sex, medical history, medications, dietary supplementation (e.g. vitamin C intake) and smoking history were elicited at baseline. The index of relative socio-economic disadvantage (IRSD) was calculated. The Australian Eating Survey and International Physical Activity Questionnaire-short were administered. Wound history, size, grade, time to healing and infection were captured and monitored over 6 months. Logistic regression was performed to determine the relationship between healing and diet quality, toe systolic pressure, wound size at, IRSD, infection and previous amputation. RESULTS: A total of 117 participants were included. The majority were male n = 96 (82%), socio-economically disadvantaged (mean IRSD 965, SD 60), and obese (BMI 36 kg/m2 , SD 11) with a long history of diabetes (20 years, SD 11). Wounds were predominantly neuropathic (n = 85, 73%) and classified 1A (n = 63, 54%) on the University of Texas wound classification system with few infections (n = 23, 16%). Dietary supplementation was associated with 4.36 increased odds of healing (95% 1.28-14.84, p = 0.02), and greater levels of socio-economic advantage were also associated with increased odds of healing (OR 1.01, 95% CI 1.01-1.02, p = 0.03). CONCLUSIONS: In this cohort study of predominantly neuropathic, non-infected DFU, individuals who had greater levels of socio-economic advantage had significantly greater odds of DFU healing. Diet quality was poor in most participants, with individuals taking supplementation significantly more likely to heal.

The Intersocietal IWGDF, ESVS, SVS Guidelines on Peripheral Artery Disease in People With Diabetes Mellitus and a Foot Ulcer.

Diabetes related foot complications have become a major cause of morbidity and are implicated in most major and minor amputations globally. Approximately 50% of people with diabetes and a foot ulcer have peripheral artery disease (PAD) and the presence of PAD significantly increases the risk of adverse limb and cardiovascular events. The International Working Group on the Diabetic Foot (IWGDF) has published evidence based guidelines on the management and prevention of diabetes related foot complications since 1999. This guideline is an update of the 2019 IWGDF guideline on the diagnosis, prognosis, and management of peripheral artery disease in people with diabetes mellitus and a foot ulcer. For this updated guideline, the IWGDF, the European Society for Vascular Surgery, and the Society for Vascular Surgery decided to collaborate to develop a consistent suite of recommendations relevant to clinicians in all countries. This guideline is based on three new systematic reviews. Using the Grading of Recommendations, Assessment, Development and Evaluation framework clinically relevant questions were formulated, and the literature was systematically reviewed. After assessing the certainty of the evidence, recommendations were formulated which were weighed against the balance of benefits and harms, patient values, feasibility, acceptability, equity, resources required, and when available, costs. Through this process five recommendations were developed for diagnosing PAD in a person with diabetes, with and without a foot ulcer or gangrene. Five recommendations were developed for prognosis relating to estimating likelihood of healing and amputation outcomes in a person with diabetes and a foot ulcer or gangrene. Fifteen recommendations were developed related to PAD treatment encompassing prioritisation of people for revascularisation, the choice of a procedure and post-surgical care. In addition, the Writing Committee has highlighted key research questions where current evidence is lacking. The Writing Committee believes that following these recommendations will help healthcare professionals to provide better care and will reduce the burden of diabetes related foot complications.

The Use of mHealth Apps for the Assessment and Management of Diabetes-Related Foot Health Outcomes: Systematic Review.

BACKGROUND: Globally, diabetes affects approximately 500 million people and is predicted to affect up to 700 million people by 2045. In Australia, the ongoing impact of colonization produces inequity in health care delivery and inequality in health care outcomes for First Nations Peoples, with diabetes rates 4 times those of non-Indigenous Australians. Evidence-based clinical practice has been shown to reduce complications of diabetes-related foot disease, including ulceration and amputation, by 50%. However, factors such as a lack of access to culturally safe care, geographical remoteness, and high costs associated with in-person care are key barriers for First Nations Peoples in accessing evidence-based care, leading to the development of innovative mobile health (mHealth) apps as a way to increase access to health services and improve knowledge and self-care management for people with diabetes. OBJECTIVE: This study aims to evaluate studies investigating the use of mHealth apps for the assessment and management of diabetes-related foot health in First Nations Peoples in Australia and non-Indigenous populations globally. METHODS: PubMed, Informit's Indigenous Collection database, Ovid MEDLINE, Embase, CINAHL Complete, and Scopus were searched from inception to September 8, 2022. Hand searches of gray literature and reference lists of included studies were conducted. Studies describing mHealth apps developed for the assessment and management of diabetes-related foot health were eligible. Studies must include an evaluation (qualitative or quantitative) of the mHealth app. No language, publication date, or publication status restrictions were used. Quality appraisal was performed using the revised Cochrane risk-of-bias tool for randomized trials and the Health Evidence Bulletins Wales checklists for observational, cohort, and qualitative studies. RESULTS: No studies specifically including First Nations Peoples in Australia were identified. Six studies in non-Indigenous populations with 361 participants were included. Foot care education was the main component of all mHealth apps. Of the 6 mHealth apps, 2 (33%) provided functionality for participants to enter health-related data; 1 (17%) included a messaging interface. The length of follow-up ranged from 1-6 months. Of the 6 studies, 1 (17%) reported high levels of acceptability of the mHealth app content for self-care by people with diabetes and diabetes specialists; the remaining 5 (83%) reported that participants had improved diabetes-related knowledge and self-management skills after using their mHealth app. CONCLUSIONS: The findings from this systematic review provide an overview of the features deployed in mHealth apps and indicate that this type of intervention can improve knowledge and self-care management skills in non-Indigenous people with diabetes. Future research needs to focus on mHealth apps for populations where there is inadequate or ineffective service delivery, including for First Nations Peoples and those living in geographically remote areas, as well as evaluate direct effects on diabetes-related foot disease outcomes. TRIAL REGISTRATION: PROSPERO CRD42022349087; https://tinyurl.com/35u6mmzd.

Sensitivity and Specificity of Pulse Oximetry for Identification of Peripheral Artery Disease: A Systematic Review.

BACKGROUND: Lower limb peripheral artery disease (PAD) is associated with poor outcomes including ulceration, gangrene, amputations, and mortality. Clinicians therefore routinely perform point-of-care tests in high-risk populations to identify PAD and subsequently implement cardiovascular management and appropriate interventions. Pulse oximetry has been suggested as a useful adjunct test for identifying PAD. OBJECTIVE: The aim of this systematic review was to determine the sensitivity and specificity of pulse oximetry in the lower limb for identifying PAD. METHODS: MEDLINE, EMBASE, and CINAHL were searched up until January 10, 2023, to identify studies of sensitivity and specificity of pulse oximetry that used criterion standard diagnostic imaging as a reference standard. Two authors screened articles for inclusion and appraised quality of included studies using the Quality Appraisal for Diagnostic Accuracy Studies, version 2. RESULTS: A total of 6371 records were screened, and 4 were included. The included studies had a total of 471 participants, with an age range of 41 to 80.6 years. All studies were cross-sectional and conducted in hospital settings. Sensitivity values for pulse oximetry compared with diagnostic imaging in identifying PAD ranged from 44% to 76%, and specificity values ranged from 85% to 96%. There was no consensus regarding measurement techniques and diagnostic thresholds for pulse oximetry, which precluded meta-analysis. CONCLUSIONS: There is currently inadequate evidence to support the use of pulse oximetry for identifying PAD. Current evidence suggests that pulse oximetry has low levels of sensitivity and is therefore likely to miss PAD when it is present.

Factors influencing lower extremity amputation outcomes in people with active foot ulceration in regional Australia: A retrospective cohort study.

Australia has the second highest rate of non-traumatic lower extremity amputation (LEA) globally. Australia's large geographical size is one of the biggest challenges facing limb preservation services and may be contributing to LEA. The aim of this study was to determine what factors contribute to the likelihood of LEA in people with active foot ulceration in regional Australia. This retrospective cohort study audited patients with active foot ulceration in a multidisciplinary high risk foot service (HRFS) in regional Australia. Neurological, vascular and wound characteristics were systematically extracted, along with demographic information. Participants were followed for at least 12 months until healing or LEA occurred. Correlations between LEA and clinical and demographic characteristics were assessed using the Pearson's product moment correlation coefficient and chi squared test for independence. Significant variables (p < 0.05) were included in the model. Direct logistic regression assessed the independent contribution of significantly correlated variables on the likelihood of LEA. Of note, 1876 records were hand screened with 476 participants (25%) meeting the inclusion criteria. Geographical distance from the HRFS, toe systolic pressure (TSP), diabetes and infection were all significantly correlated with LEA and included in the logistic regression model. TSP decrease of 1 mmHg (OR 1.02, 95% CI 1.01-1.03), increased geographical distance (1 km) from HRFS (OR 1.006, 95% CI 1.001-1.01) infection (OR 2.08, 95% CI 1.06-4.07) and presence of diabetes (OR 3.77, 95% CI 1.12-12.65) were all significantly associated with increased likelihood of LEA. HRFS should account for the disparity in outcomes between patients living in close proximity to their service, compared to those in rural areas. Optimal management of diabetes, vascular perfusion and control of infection may also contribute to preventing LEA in people with active foot ulceration.

The relationship between foot and ankle joint flexibility measures and barefoot plantar pressures in healthy older adults: a cross-sectional study.

BACKGROUND: Restriction in foot and ankle joint range of motion, such as an ankle equinus, has been associated with increased plantar pressure and its complications. However, previous research is limited by its scope of measures and study populations. The aim of this study was to investigate the relationship between foot and ankle joint range of motion on barefoot plantar pressures during walking in healthy older adults. METHODS: This cross-sectional study recruited 49 older adults. Participants underwent measures of foot (first metatarsophalangeal dorsiflexion range of motion, and navicular drop and drift) and ankle joint range of motion, foot posture, body mass index, and plantar pressure during barefoot walking. Spearman Rank Order Correlations were used to explore the relationship between foot and ankle measures, body mass index, and plantar pressure, with significant correlations explored in a hierarchical regression analysis. A Mann-Whitney U test was performed to compare plantar pressure values between those with and without ankle equinus per region of the foot. RESULTS: Mean (SD) age and BMI were 72.4 years (5.2) and 29.8 kg/m2 (5.9) respectively. A total of 32 of the 49 participants (65%) identified as female sex. Mean (SD) ankle joint range of motion was 32.7 (6.4) degrees with 17/49 (34.7%) participants classified as having an ankle equinus (defined as < 30 degrees of ankle joint dorsiflexion range of motion). We found that an ankle equinus predicted a statistically significant amount of peak forefoot plantar pressure (p = 0.03). Participants with an ankle equinus displayed significantly higher forefoot peak pressure 677.8 kPa (589.9 to 810.4) compared to those with no equinus 565.58 kPa (447.3 to 651.2), p = 0.02. A statistically significant correlation was found between body mass index and midfoot peak pressure (p < 0.01) and pressure-time integral (p < 0.01). No other significant correlations were found. CONCLUSION: Clinicians should consider screening for an ankle equinus and body mass index as a simple way to identify which healthy older adults may be at risk of pressure-related complications in the mid- and forefoot.

Outcomes of participation in parkrun, and factors influencing why and how often individuals participate: A systematic review of quantitative studies.

The primary objective of this systematic review was to synthesise peer-reviewed quantitative research of outcomes associated with participation in parkrun. The secondary objective was to synthesise the quantitative research of factors influencing why, and how often, individuals participate in parkrun. Studies were identified via electronic search of Medline, AMED, CINAHL, Cochrane Library, Informit, PsychInfo, SportDiscus, and Web of Science, to 30 March 2021. Two reviewers independently assessed methodological quality. Eleven studies (18,203 participants) were included. Limited evidence from pre-post measure single-group prospective studies suggests parkrun participation promotes improvements in fitness, body mass index, physical activity levels, mood, and personal wellbeing. Individuals with non-running backgrounds generally had higher levels of participation. The main motivators to participate were to improve fitness and social interaction. Future attendance was most strongly correlated with historical attendance. There is a small evidence base for improvements in broad measures of physical and mental health from participation in parkrun. In addition, the study found improving physical fitness and social wellbeing were the main self-reported factors for participation in parkrun. Further research is needed to strengthen the knowledge base of the effects of parkrun to determine its efficacy as a health intervention strategy for physical and mental health.

Degree of adiposity and obesity severity is associated with cutaneous microvascular dysfunction in type 2 diabetes.

BACKGROUNDS AND AIMS: Obesity and diabetes independently contribute to cutaneous microvascular dysfunction via pathological processes that are not fully understood. We sought to determine if obesity severity is associated with cutaneous microvascular dysfunction and measures of peripheral arterial disease in adults with type 2 diabetes in cross-sectional observational study design. METHODS AND RESULTS: Primary outcomes were post-occlusive reactive hyperaemia as determined by laser-Doppler fluxmetry (peak flux post-occlusion, time to peak flux post-occlusion, peak as a percentage of baseline, and area under the curve [AuC] index post-occlusion to pre-occlusion). Secondary outcomes were ankle- and toe-brachial indices (ABI and TBI) and systolic toe pressure. Thirty-six participants (20 men, 16 women) with mean age 55 ± 8 years, BMI of 36 ± 5 kg/m2 and duration of diabetes 8 ± 6 years underwent measurements. After adjusting for age and duration of diabetes, SAT and total percentage body fat were able to explain 29% (p = 0.001) and 20% (p = 0.01) of variance of AuC index models, as well as 29% (p = 0.02) and 18% (p = 0.02) of peak as a percentage of baseline models, respectively. Though TBI demonstrated moderate, significant correlations with SAT (r:0.37, p = 0.04) and total percentage body fat (r:0.39, p = 0.03), these were not upheld by regression analyses. Neither ABI nor systolic toe pressure significantly correlated with any measure of adiposity or obesity. CONCLUSION: These findings demonstrate impairment in cutaneous microvascular function related to adiposity and obesity severity in adults with type 2 diabetes, suggesting that obesity may pathologically effect cutaneous microvascular function in the absence of overt macrovascular disease, warranting further investigation.

Correlates of night-time and exercise-associated lower limb cramps in healthy adults.

INTRODUCTION/AIMS: We explored correlates of night-time and exercise-associated lower limb cramps in participants of the 1000 Norms Project. METHODS: A volunteer community sample of healthy people aged ≥18 y underwent assessment of motor function and physical performance, and were questioned about muscle cramps in the previous 3 mo. RESULTS: Of 491 (221 female) participants age 18-101 y (mean: 59.12; SD: 18.03), about 1 in 3 experienced night-time lower limb cramps, and about 1 in 4 experienced exercise-associated lower limb cramps. For night-cramps, a one unit increase in Beighton score (greater whole-body flexibility) was associated with a 31% reduced odds of cramps (odds ratio [OR] = 0.69, 95% confidence interval [CI]:0.45, 0.99) and passing all three lesser-toe strength tests was associated with 50% reduced odds of cramps (OR = 0.50, 95% CI: 0.32, 0.78). For exercise-associated cramps, participants in the fourth (lowest arch) quartile of Foot Posture Index were 2.1 times (95% CI: 1.11, 3.95) more likely to experience cramps than participants in the first (highest arch) quartile. Odds of experiencing both types of cramps versus no cramps were lower with passing all three lesser-toe strength tests (OR = 0.40, 95% CI: 0.19, 0.85) and better performance in the six-minute walk test (OR = 0.997, 95% CI: 0.996, 0.998). DISCUSSION: People who experienced both exercise-associated and night-time cramps were less functional. The association between night-time cramps with less whole-body flexibility and reduced lesser-toe flexor strength should be explored to determine causation. Planovalgus (low-arched) foot type was independently associated with exercise-associated cramps. The effectiveness of foot orthoses for secondary prevention of exercise-associated cramps in people with low-arched feet should be explored.

Non-drug therapies for the secondary prevention of lower limb muscle cramps.

BACKGROUND: Lower limb muscle cramps are common and painful. They can limit exercise participation, and reduce quality of sleep, and quality of life. Many interventions are available for lower limb cramps; some are controversial or could cause harm, and often, people experience no benefit from the interventions used. This is an update of a Cochrane Review first published in 2012. We updated the review to incorporate new evidence. OBJECTIVES: To assess the effects of non-drug, non-invasive therapies for lower limb muscle cramps. SEARCH METHODS: In August 2018 and May 2020, we searched the Cochrane Neuromuscular Specialised Register, CENTRAL, MEDLINE, Embase, the World Health Organization International Clinical Trials Registry Platform, ClinicalTrials.gov, and reference lists of included studies. We imposed no restrictions by language or publication date. SELECTION CRITERIA: We included all randomised controlled trials (RCTs) of non-drug, non-invasive interventions tested over at least four weeks, for lower limb muscle cramps in any group of people, except pregnant women. The primary outcome was cramp frequency. Secondary outcomes were cramp pain severity, cramp duration, health-related quality of life, quality of sleep, participation in activities of daily living, proportion of participants reporting lower limb muscle cramps, and adverse events. DATA COLLECTION AND ANALYSIS: Two review authors independently selected trials, assessed risk of bias, and cross-checked data extraction and analyses according to standard Cochrane procedures. MAIN RESULTS: We included three trials, with 201 participants, all 50 years of age and older; none had neurological disease. All trials evaluated a form of stretching for lower limb muscle cramps. A combination of daily calf and hamstring stretching for six weeks may reduce the severity of night-time lower limb muscle cramps (measured on a 10 cm visual analogue scale (VAS) where 0 = no pain and 10 cm = worst pain imaginable) in people aged 55 years and older, compared to no intervention (mean difference (MD) -1.30, 95% confidence interval (CI) -1.74 to -0.86; 1 RCT, 80 participants; low-certainty evidence). The certainty of evidence was very low for cramp frequency (change in number of cramps per night from week zero to week six) comparing the stretching group and the no intervention group (MD -1.2, 95% CI -1.8 to -0.6; 80 participants; very low-certainty evidence). Calf stretching alone for 12 weeks may make little to no difference to the frequency of night-time lower limb muscle cramps in people aged 60 years and older (stretching group median number of cramps in the last four weeks (Md) 4, interquartile range (IQR) 8; N = 48; sham stretching group Md 3, IQR 7.63; N = 46) (U = 973.5, z = -0.995, P = 0.32, r = 0.10; 1 RCT, 94 participants; low-certainty evidence). This trial did not report cramp severity. The evidence is very uncertain about the effects of a combination of daily calf, quadriceps, and hamstring stretching on the frequency and severity of leg cramps in 50- to 60-year-old women with metabolic syndrome (N = 24). It was not possible to fully analyse the frequency data and the scale used to measure cramp severity is not validated. No study reported health-related quality of life, quality of sleep, or participation in activities of daily living. No participant in these three studies reported adverse events. The evidence for adverse events was of moderate certainty as the studies were too small to detect uncommon events. In two of the three studies, outcomes were at risk of recall bias, and tools used to measure outcomes were not validated. Due to limitations in study designs that led to risks of bias, and imprecise findings with wide CIs, we cannot be certain that findings of future studies will be similar to those presented in this review. AUTHORS' CONCLUSIONS: A combination of daily calf and hamstring stretching for six weeks may reduce the severity of night-time lower limb muscle cramps in people aged 55 years and older, but the effect on cramp frequency is uncertain. Calf stretching alone compared to sham stretching for 12 weeks may make little or no difference to the frequency of night-time lower limb muscle cramps in people aged 60 years and older. The evidence is very uncertain about the effects of a combination of daily calf, quadriceps, and hamstring stretching on the frequency and severity of leg cramps in 50- to 60-year-old women with metabolic syndrome. Overall, use of unvalidated outcome measures and inconsistent diagnostic criteria make it difficult to compare the studies and apply findings to clinical practice. Given the prevalence and impact of lower limb muscle cramps, there is a pressing need to carefully evaluate many of the commonly recommended and emerging non-drug therapies in well-designed RCTs across all types of lower limb muscle cramps. A specific cramp outcome tool should be developed and validated for use in future research.

An exploratory study investigating the effect of foot type and foot orthoses on gluteus medius muscle activity.

BACKGROUND: Abnormal gluteus medius muscle activity is associated with a number of musculoskeletal conditions. Research investigating the effect of foot type and foot orthoses on gluteus medius muscle activity is both conflicting and limited. The primary aim was to investigate the relationship between foot type and gluteus medius muscle activity during shod walking. The secondary aims of this study were to explore the effect and amount of usage of a pair of unmodified prefabricated foot orthoses on gluteus medius muscle activity during shod walking. METHODS: Foot type was determined using the foot posture index and gluteus medius muscle activity was measured with surface electromyography in 50 healthy adults during shod walking. Participants were then fitted with prefabricated foot orthoses and required to return after 4 weeks. Pearson's correlation and one-way ANOVA were used to determine effect of foot type. Paired t-tests and ANCOVA were used to determine effect of foot orthoses. RESULTS: Participants with a cavus foot type demonstrated significantly more gluteus medius mean (p = 0.04) and peak amplitude (p = 0.01), and a greater range in amplitude (p = 0.01) compared to participants with a neutral foot type. Compared to a planus foot type, participants with a cavus foot type demonstrated significantly larger mean (p = 0.02) and peak amplitude (p = 0.01), and a greater range in amplitude (p = 0.01). Prefabricated foot orthoses did not change the gluteus medius muscle activity. CONCLUSION: When assessing healthy adults with a cavus foot type, clinicians and researchers should be aware that these participants may display higher levels of gluteus medius muscle activity during gait compared to neutral and planus type feet. Additionally, clinicians and researchers should be aware that the type of prefabricated foot orthoses used did not change gluteus medius muscle activity over 4 weeks. Future research should aim to explore this relationship between foot type and gluteus medius muscle activity in larger sample sizes, consider the potential role of other lower extremity muscles and biomechanical variables, and investigate if these findings also occur in people with pathology.

Exercise alone and exercise combined with education both prevent episodes of low back pain and related absenteeism: systematic review and network meta-analysis of randomised controlled trials (RCTs) aimed at preventing back pain.

OBJECTIVES: We aimed to investigate which prevention strategies for low back pain (LBP) are most effective. DESIGN: We completed a Bayesian network meta-analysis to summarise the comparative effectiveness of LBP prevention strategies. The primary outcomes were an episode of LBP and LBP-associated work absenteeism represented as ORs with associated 95% credibility intervals (CrIs). We ranked all prevention strategies with surface under the cumulative ranking curve (SUCRA) analysis. DATA SOURCES: PubMed, EMBASE and CENTRAL databases were searched along with manual searches of retrieved articles. We only included randomised controlled trials (RCTs) that reported an episode of LBP and/or LBP-associated work absenteeism evaluating LBP prevention strategies were included. ELIGIBILITY CRITERIA FOR SELECTING STUDIES: Data were independently extracted by two investigators, and RCT quality was assessed using the Cochrane Risk of Bias tool. RESULTS AND SUMMARY: Forty RCTs were included. Exercise combined with education (OR: 0.59, CrI: 0.41 to 0.82) and exercise alone (OR: 0.59, CrI: 0.36 to 0.92) both prevented LBP episodes; exercise combined with education and education alone both had large areas under the curve (SUCRA: 81.3 and 79.4, respectively). Additionally, exercise (OR: 0.04, CrI: 0.00 to 0.34) prevented LBP-associated work absenteeism, with exercise and the combination of exercise and education ranking highest (SUCRA: 99.0 and 60.2, respectively). CONCLUSIONS: Exercise alone and exercise combined with education can prevent episodes of LBP and LBP-related absenteeism. TRIAL REGISTRATION NUMBER: PROSPERO 42017056884.

Gluteus medius muscle function in people with and without low back pain: a systematic review.

INTRODUCTION: Globally, low back pain (LBP) is one of the greatest causes of disability. In people with LBP, dysfunction of muscles such as the gluteus medius have been demonstrated to increase spinal loading and reduce spinal stability. Differences in gluteus medius function have been reported in those with LBP compared to those without, although this has only been reported in individual studies. The aim of this systematic review was to determine if adults with a history, or current LBP, demonstrate differences in measures of gluteus medius function when compared to adults without LBP. METHODS: MEDLINE, EMBASE, AMED, PsycINFO, PubMED, Pro Quest Database, CINAHL and SPORTDiscus were searched from inception until December 2018 for published journal articles and conference abstracts. No language restrictions were applied. Only case-control studies with participants 18 years and over were included. Participants could have had any type and duration of LBP. Studies could have assessed gluteus medius function with any quantifiable clinical assessment or measurement tool, with the participant non-weight bearing or weight bearing, and during static or dynamic activity. Quality appraisal and data extraction were independently performed by two authors. RESULTS: The 24 included articles involved 1088 participants with LBP and 998 without LBP. The gluteus medius muscle in participants with LBP tended to demonstrate reduced strength and more trigger points compared to the gluteus medius muscle of those without LBP. The level of activity, fatigability, time to activate, time to peak activation, cross sectional area, and muscle thickness showed unclear results. Meta-analysis was not performed due to the heterogeneity of included studies. CONCLUSION: Clinically, the findings from this systematic review should be considered when assessing and managing patients with LBP. Future studies that clearly define the type and duration of LBP, and prospectively assess gluteus medius muscle function in those with and without LBP are needed. TRIAL REGISTRATION: PROSPERO ( CRD42017076773 ).