Predicting diabetic foot ulceration using routinely collected data in a foot clinic. What level of prognostic accuracy can be achieved?

This study aimed to investigate the efficacy of using routinely collected clinical data in predicting the risk of diabetic foot ulcer (DFU). The first objective was to develop a prognostic model based on the most important risk factors objectively selected from a set of 39 clinical measures. The second objective was to compare the prediction accuracy of the developed model against that of a model based on only the 3 risk factors that were suggested in the systematic review and meta-analyses study (PODUS). In a cohort study, a set of 12 continuous and 27 categorical data from patients (n = 203 M/F:99/104) who attended a specialised diabetic foot clinic were collected at baseline. These patients were then followed-up for 24 months during which 24 (M/F:17/7) patients had DFU. Multivariate logistic regression was used to develop a prognostic model using the identified risk factors that achieved p < 0.2 based on univariate logistic regression. The final prognostic model included 4 risk factors (Adjusted-OR [95% CI]; p) in total. Impaired sensation (116.082 [12.06-1117.287]; p = 0.000) and presence of callus (6.257 [1.312-29.836]; p = 0.021) were significant (p < 0.05), while having dry skin (5.497 [0.866-34.89]; p = 0.071) and Onychomycosis (6.386 [0.856-47.670]; p = 0.071) that stayed in the model were not significant. The accuracy of the model with these 4 risk factors was 92.3%, where sensitivity and specificity were 78.9%, and 94.0% respectively. The 78.9% sensitivity of our prognostic 4-risk factor model was superior to the 50% sensitivity that was achieved when the three risk factors proposed by PODUS were used. Also our proposed model based on the above 4 risk factors showed to predict the DFU with higher overall prognostic accuracy. These findings have implications for developing prognostic models and clinical prediction rules in specific patient populations to more accurately predict DFU.

Prevalence of depression, anxiety and stress among private medical college students in South India: A cross-sectional study.

BACKGROUND: Medical education is competitive across the globe. The long duration of the medical and paramedical courses and exposure to clinical settings potentially causes mental health issues. The aim of this study was to estimate the prevalence of depression, anxiety and stress among undergraduate students in a private medical college in South India. MATERIALS AND METHODS: This cross-sectional study was conducted among paramedical and medical students at a private medical college hospital and research center in South India in the year 2021. The required sample size was calculated as 783 with an expected prevalence of 53%, 95% confidence interval (CI), design effect 2.0, and non-response of 10%. The study participants were selected based on simple random sampling. After obtaining informed consent, the data was collected using an email questionnaire. Standard data collection tools such as the Perceived Stress Scale (PSS); and the Depression, Anxiety and Stress Scale - 21 (DASS-21) questionnaire were used. The investigator computed the odds ratio (OR) and adjusted odds ratio (aOR) with a 95% CI. RESULTS: Out of 1200 students, 1015 (85%) responded to the email questionnaire. Among them, 639 were females (63%), and 925 were paramedics (91%). Prevalence of depression, anxiety and stress were 59%, 43% and 11%, respectively. Almost 95% of students experienced moderate-to-severe stress in the last one month. Prevalence was higher among females and students of medical courses. Students of final year of college (aOR = 2.0; 95% CI = 1.2-3.5) and students of medical course (aOR = 1.5; 95% CI = 1.1-2.4) were independently associated with stress among the study participants. CONCLUSION: There is high prevalence of depression, anxiety and stress among medical college students in south India. The final year of study and medical course were independently associated with higher stress than others. We recommend periodic assessment of mental health status and additional mental health care for final year students and medical students.

Digital personal assistants are smart ways for assistive technology to aid the health and wellbeing of patients and carers.

BACKGROUND: Digital health solutions such as assistive technologies create significant opportunities to optimise the effectiveness of both health and social care delivery. Assistive technologies include 'low-tech' items, such as memory aids and digital calendars or 'high-tech' items, like health tracking devices and wearables. Depending on the type of assistive devices, they can be used to improve quality of life, effect lifestyle improvements and increase levels of independence. Acceptance of technology among patients and carers depends on various factors such as perceived skills and competencies in using the device, expectations, trust and reliability. This service evaluation explored the impact of a pilot service redesign focused on improving health and wellbeing by the use of a voice-activated device 'smart speaker', Alexa Echo Show 8. METHODS: A service evaluation/market research was conducted for a pilot service redesign programme. Data were collected via a survey in person or telephone and from two focus groups of patients (n = 44) and informal carers (n = 7). The age of the study participants ranged from 50 to 90 years. Also, the participants belonged to two types of cohort: one specifically focused on diabetes and the other on a range of long-term health conditions such as multiple sclerosis, dementia, depression and others. RESULTS: The device had a positive impact on the health and social well-being of the users; many direct and indirect benefits were identified. Both patients and carers had positive attitudes towards using the device. Self-reported benefits included: reminders for medications and appointments improved adherence and disease control; increased independence and productivity; and for those living alone, the device helped combat their loneliness and low mood. CONCLUSION: The findings from the study help to realise the potential of assistive technology for empowering supporting health/social care. Especially, the season of COVID-19 pandemic has highlighted the need for remote management of health, the use of assistive technology could have a pivotal role to play with the sustainability of health/social care provision by promoting shared care between the care provider and service user. Further evaluation can explore the key drivers and barriers for implementing assistive technologies, especially in people who are ageing and with long-term health conditions.

The Role of Cutaneous Microcirculatory Responses in Tissue Injury, Inflammation and Repair at the Foot in Diabetes.

Diabetic foot syndrome is one of the most costly complications of diabetes. Damage to the soft tissue structure is one of the primary causes of diabetic foot ulcers and most of the current literature focuses on factors such as neuropathy and excessive load. Although the role of blood supply has been reported in the context of macro-circulation, soft tissue damage and its healing in the context of skin microcirculation have not been adequately investigated. Previous research suggested that certain microcirculatory responses protect the skin and their impairment may contribute to increased risk for occlusive and ischemic injuries to the foot. The purpose of this narrative review was to explore and establish the possible link between impairment in skin perfusion and the chain of events that leads to ulceration, considering the interaction with other more established ulceration factors. This review highlights some of the key skin microcirculatory functions in response to various stimuli. The microcirculatory responses observed in the form of altered skin blood flow are divided into three categories based on the type of stimuli including occlusion, pressure and temperature. Studies on the three categories were reviewed including: the microcirculatory response to occlusive ischemia or Post-Occlusive Reactive Hyperaemia (PORH); the microcirculatory response to locally applied pressure such as Pressure-Induced Vasodilation (PIV); and the interplay between microcirculation and skin temperature and the microcirculatory responses to thermal stimuli such as reduced/increased blood flow due to cooling/heating. This review highlights how microcirculatory responses protect the skin and the plantar soft tissues and their plausible dysfunction in people with diabetes. Whilst discussing the link between impairment in skin perfusion as a result of altered microcirculatory response, the review describes the chain of events that leads to ulceration. A thorough understanding of the microcirculatory function and its impaired reactive mechanisms is provided, which allows an understanding of the interaction between functional disturbances of microcirculation and other more established factors for foot ulceration.

A systematic evaluation of cutaneous microcirculation in the foot using post-occlusive reactive hyperemia.

OBJECTIVES: Cutaneous microcirculatory impairments are associated with skin injury to the foot. Post-Occlusive reactive hyperemia (PORH) is one of the quick and easy methods to assess microcirculatory function. However, there are variations in the protocols currently used. Hence, this study aimed to systematically investigate the reproducibility of PORH protocols with minimal occlusion time in the foot. METHODS: Post-Occlusive reactive hyperemia was measured using 12 different protocols (three occlusion times, two occlusion sites and with or without temperature control) in 25 healthy adults. Each of the 12 different protocols was repeated three times, and the intraclass correlation coefficient (ICC) was calculated. RESULTS: Intraclass correlation coefficient showed that that ankle level occlusion produced moderate to excellent reproducibility for most PORH measures. In the right foot, 30- and 60-s ankle level occlusion without temperature control showed ICC of >0.40 for all parameters except the area of hyperemia (ICC = -0.36) and biological zero to peak flow percent change (ICC = -0.46). In the left foot, 30-s ankle level occlusion without temperature control showed ICC of >0.40 for all parameters except time to latency (ICC = 0.29), after hyperemia (ICC = 0.37), and max (ICC = -0.01), and area of hyperemia (ICC = -0.36). But the 60-s protocol showed ICC > 0.40 for all except time to max (ICC = 0.38). In the hallux protocols, all three 10-, 30-, and 60-s protocols without temperature control showed moderate to excellent reproducibility (ICC > 0.40). In most cases, the temporal and area under the perfusion-time curve parameters showed poor reproducibility. CONCLUSION: Post-Occlusive reactive hyperemia can be tested efficiently with a minimal occlusion time of 10 s with hallux occlusion and 30 s with ankle occlusion in the foot. This can suggest that microcirculatory assessment is feasible in routine practice and can potentially be included for routine assessment of foot in people with diabetes.

Reliability and validity of an enhanced paper grip test; A simple clinical test for assessing lower limb strength.

BACKGROUND: The paper-grip-test (PGT) involves pulling a small card from underneath the participant's foot while asking them to grip with their hallux. The PGT is shown to be effective in detecting foot muscle-weakening but its outcome is operator-dependent. To overcome this limitation, an enhanced PGT (EPGT) is proposed that replaces the pass/fail outcome of the PGT with a continuous measurement of the pulling force that is needed to remove the card (EPGT-force). RESEARCH QUESTION: Is the EPGT-force an accurate, reliable and clinically applicable measurement of strength? METHODS: Reliability and clinical applicability were examined in two ways. Firstly, two examiners measured EPGT-force for twenty healthy volunteers in a test/retest set-up. EPGT force was measured using a dynamometer, the hallux grip force was measured using a pressure mat. The clinical applicability of the EPGT was tested in ten people with diabetes. Postural sway was also measured. RESULTS: Interclass correlation coefficients (ICC) revealed excellent inter-rater reliability (ICC > 0.75). Intra-rater reliability was excellent for the first examiner (ICC = 0.795) and good for the second (ICC = 0.703). Linear regression analysis indicated that hallux grip force accounted (on average) for 83 %±4 % of the variability in EPGT force. This strong relationship between EPGT force and hallux grip force remained when the test was performed in a clinical setting with the latter accounting for 88 % in EPGT force variability. Spearman rank order correlation showed that people with diabetes with a higher difference in EPGT force between limbs swayed more. SIGNIFICANCE: EPGT force is a reliable and accurate measurement of hallux grip force. Hallux grip force was previously found to be strongly correlated to the strength of all muscle groups of the foot and ankle and to the ability to maintain balance. The proposed EPGT could be used to monitor muscle weakness in clinics for better falls-risk assessment.

A Synoptic Overview of Neurovascular Interactions in the Foot.

Diabetes is a worldwide public health concern as it is associated with various complications. One of the major complications of diabetes is diabetic foot syndrome that results in catastrophic events such as ulceration and amputation. Therefore, the main four strategies of diabetic foot care involve risk prediction, prevention, and early diagnosis and prompt intervention. The drivers of ulceration are multifactorial, and importantly, include microcirculatory changes in the diabetic skin. Cutaneous microcirculation on the foot is greatly influenced by the small fibers which mediate thermal sensation and pain perception in addition to sympathetic activities such as thermoregulation and vasodilation. The interdependence between the neurovascular elements means with the loss of small fiber functions, the corresponding microcirculatory responses may be compromised. Thus, it can be hypothesized that the impairment of the microcirculation may follow the order of the corresponding small fiber nerve dysfunction or vice versa. In this review, select neurovascular investigations that inform the cutaneous microcirculatory and small fiber nerve function in response to pain, cold, and heat and pressure stimuli are reviewed and discussed in this order of sensory loss: the loss of pain, cold, warmth, touch and deep pressure sensation. We also discuss the neurological and vascular characteristics of each of these neurovascular responses. This review highlights the influence of small fibers on cutaneous microcirculation and the need for prospective studies that can determine the course of microcirculatory impairment over time. This, in turn, may help clarify the exact role of microcirculatory changes in the pathway of ulceration. The insights from this review can be pertinent to understand key microcirculatory disturbances and given that the microcirculatory impairment develops at an early stage, relevant interventions can be implemented to possibly reverse or regress the course of the disease. Therefore, knowledge of the neurovascular interactions aids to map the disease progression for early diagnosis and prevention of adverse complications.

The Challenges and Recommendations for Gestational Diabetes Mellitus Care in India: A Review.

Gestational diabetes mellitus (GDM) is a primary concern in India affecting approximately five million women each year. Existing literature indicate that prediabetes and diabetes affect approximately six million births in India alone, of which 90% are due to GDM. Studies reveal that there is no consensus among physicians and health-care providers in India regarding management of GDM prepartum and postpartum despite available guidelines. Also, there is no consensus among physicians as to when a woman should undergo oral glucose tolerance test after delivery. This clearly shows that management of GDM is challenging and controversial in India due to conflicting guidelines and treatment protocols, despite availability of straightforward protocols for screening and management. Also, a collaborative approach remains a key for GDM management, as patient compliance and proper educational interventions promote better pregnancy outcomes. Management of GDM plays a pivotal role, as women with GDM have an increased chance of developing diabetes mellitus 5-10 years after pregnancy. Also, children born in GDM pregnancies face an increased risk for obesity and type 2 diabetes. The cornerstone for the management of GDM is glycemic control and quality nutritional intake. GDM management is complex in India, and existing challenges are multifactorial. However, there are little published data outlining these challenges. This review gives an account of some of the key challenges from self-management and health-care provider perspective. The recommendations in this review provide insights for building a more structured model for GDM care in India. This research has several practical applications. First, it points out to reaching a consensus on approaches for screening, diagnosis, and treatment of care across clinical practices in the nation that can aid in overcoming certain challenges observed. Second, it highlights the importance to build capacities and capabilities, especially in resource-limited settings. Health education among pregnant women remains a priority to resolve issues related to self-management. More broadly, further research, specifically qualitative is vital to determine forthcoming challenges with respect to patients, caregivers, providers, and policy makers and to provide solutions fitted to practice setting and demographic background.

An overview of Compassionate Use Programs in the European Union member states.

The past decade witnessed rapid development of novel drugs and therapeutic biological agents. The marketing authorization for novel therapies is often time consuming and distressing for patients. Earlier clinical trials were the only way to access new drugs under development. However, not every patient meets the enrolment criteria, and participation is difficult for patients with life-threatening, long-lasting or seriously debilitating diseases like rare diseases. Early access programs like "Compassionate Use Program (CUP)" have generated alternative channels for such patients. The European Medical Agency provides regulations and recommendations for compassionate use, upon which every European Union (EU) member state has developed its own rules and regulations. Despite previous reviews and studies, the available information is limited and gaps exist. This literature review explores CUP in 28 EU member states. Data was collected through literature review and use of country-specific search terms from the healthcare domain. Data sources were not limited to databases and articles published in journals, but also included grey literature. The results implied that CUP was present in 20 EU member states (71%). Of 28 EU states, 18 (∼64%) had nationalized regulations and processes were well-defined. Overall, this review identified CUP and its current status and legislation in 28 EU member states. The established legislation for CUP in the EU member states suggest their willingness to adopt processes that facilitate earlier and better access to new medicines. Further research and periodic reviews are warranted to understand the contemporary and future regulatory trends in early access programs.