The unique multidisciplinarity of diabetes-related foot disease.

Few diseases globally require treatment from so many different disciplines as diabetes-related foot disease. At least 25 different professionals may be involved: casting technicians, dermatologists, diabetes (educator) nurses, diabetologists, dieticians, endocrinologists, general practitioners, human movement scientists, infectious diseases experts, microbiologists, nuclear medicine physicians, orthopaedic surgeons, orthotists, pedorthists, physical therapists, plastic surgeons, podiatric surgeons, podiatrists, prosthetists, psychologists, radiologists, social workers, tissue viability physicians, vascular surgeons, and wound care nurses. A shared vocabulary and shared treatment goals and recommendations are then essential. The International Working Group on the Diabetic Foot (IWGDF) has produced guidelines and supporting documents to stimulate and support shared and multidisciplinary evidence-based treatment in diabetes-related foot disease. In this special virtual issue of Diabetes/Metabolism Research and Reviews, all 21 documents of the 2023 update of the IWGDF Guidelines are bundled, added with a further 6 reviews from multidisciplinary experts to drive future research and clinical innovations, based on their contributions to the International Symposium on the Diabetic Foot. We hope the readers will enjoy this special virtual issue, and widely implement the knowledge shared here in their daily clinical practice and research endeavours with the goal to improve the care for people with diabetes-related foot disease.

Podcast on How to Classify Foot Ulcers in People with Diabetes (2023 Update of the IWGDF Guidelines on Classification).

INTRODUCTION: In this podcast, we present the result of the 2023 scheduled update of the 2019 guidelines of the International Working Group of the Diabetic Foot (IWGDF) addressing the use of systems to classify foot ulcers in people with diabetes in routine clinical practice. METHODS: These guidelines were based on a systematic review of the available literature that identified 28 classifications addressed in 149 articles and, subsequently, expert opinion using the Grading of Recommendations, Assessment, Development, and Evaluations (GRADE) methodology. We first assessed the value of each system independently and, in the second stage, chose the best one or two to be used in each clinical scenario. RESULTS: We recommend (1) for communication among healthcare professionals to use the Site, Ischaemia, Neuropathy, Bacterial infection, Area, Depth (SINBAD) classification (first option) or consider using Wound, Ischaemia, foot Infection (WIfI) system (alternative option, when the required equipment and level of expertise are available and it is considered feasible) and in each case the individual variables that compose the systems should be described rather than a total score; (2) for predicting the outcome of an ulcer in a specific individual: no existing system could be recommended; (3) for characterising a person with an infected ulcer: the use of the IDSA (Infection Diseases Society of America)/IWGDF (first option) classification or consider using the WIfI system (alternative option, when the required equipment and level of expertise are available and it is considered as feasible); (4) for characterising a person with peripheral artery disease: consider using the WIfI system as a means to stratify healing likelihood and amputation risk; (5) for the audit of outcome(s) of populations: the use of the SINBAD score. CONCLUSION: Although there is no classification that fits all purposes, it is crucial that healthcare professionals standardize the way they characterise diabetes-related foot ulcers and guide their decision-making process by using validated classification systems.

Estimating Type 2 Diabetes Prevalence: A Model of Drug Consumption Data.

Observational, cross-sectional prevalence studies are costly and time-consuming. The development of indirect methods estimating prevalence used to obtain faster, less-expensive, and more robust results would be an advantage for several healthcare applications. This study aimed to use the drug dispensing data from community pharmacies to estimate the prevalence of Type 2 Diabetes mellitus (T2DM) in the Portuguese population. A cross-sectional study was conducted using a database of dispensed medicines with an indication for Diabetes mellitus in 2018 and 2021, stratified by geographic region. The methodology was based on a sequential method of acquiring prevalence estimates obtained through exposure to medicines using the daily doses defined per thousand inhabitants per day and adjusted to the rate of adherence to therapy, prescription patterns, and concomitance of antidiabetic drugs. The estimated overall T2DM prevalence in 2018 was 13.9%, and it was 14.2% for 2021. The results show the increased consumption of antidiabetic drugs, with fixed-dose combination antidiabetics and new antidiabetics being particularly important in 2021. This work allowed for the development of a model to obtain the estimated prevalence of T2DM based on drug consumption, using a simple, fast, and robust method that is in line with the available evidence. However, with the recent expanding indications for new antidiabetics, the inclusion of further data in the model needs to be studied.

A Comparison of Active Pharmacovigilance Strategies Used to Monitor Adverse Events to Antiviral Agents: A Systematic Review.

INTRODUCTION: The safety of antiviral agents in real-world clinical settings is crucial, as pre-marketing studies often do not capture all adverse events (AE). Active pharmacovigilance strategies are essential for detecting and characterising these AE comprehensively. OBJECTIVE: The aim of this study was to identify and characterise active pharmacovigilance strategies used in real-world clinical settings for patients under systemic antiviral agents, focusing on the frequency of AE and the clinical data sources used. METHODS: We conducted a systematic review by searching three electronic bibliographic databases targeting observational prospective active pharmacovigilance studies, phase IV clinical trials for post-marketing safety surveillance, and interventional studies assessing active pharmacovigilance strategies, focusing on individuals exposed to systemic antiviral agents. RESULTS: We included 36 primary studies, predominantly using Drug Event Monitoring (DEM), with a minority employing sentinel sites and registries. Human immunodeficiency virus (HIV) was the most common condition, with the majority using DEM. Within the DEM, there was a wide range of incidences of patients experiencing at least one AE, and most of these studies used one or two data sources. Sentinel site studies were less common, with two on hepatitis C virus (HCV) and one on HIV, each relying on one or two data sources. The single study using a registry focusing on HIV therapy reported using just one data source. Patient interviews were the most common data source, followed by medical records and laboratory tests. The quality of the studies was considered 'good' in 18/36, 'fair' in 1/36, and 'poor' in 17/36 studies. CONCLUSION: DEM was the predominant pharmacovigilance strategy, employing multiple data sources, and appears to increase the likelihood of detecting higher AE incidence. Establishing such a framework would facilitate a more detailed and consistent approach across different studies and settings.

COVID-19 crítico e disfunção neurológica - uma análise comparativa direta entre o SARS-CoV-2 e outros agentes infecciosos / Critical COVID-19 and neurological dysfunction - a direct comparative analysis between SARS-CoV-2 and other infectious pathogens

RESUMO Objetivo: Avaliar se a infecção grave pelo SARS-CoV-2 está mais comumente associada a sinais de disfunção do trato corticoespinhal e outros sinais, sintomas e síndromes neurológicas, em comparação com outros agentes infecciosos. Métodos: Este foi um estudo de coorte prospectivo com inclusão consecutiva de doentes admitidos a unidades de cuidados intensivos devido a síndrome do desconforto respiratório agudo infeccioso primário, com necessidade de ventilação mecânica invasiva por > 48 horas. Os doentes incluídos foram atribuídos aleatoriamente a três investigadores para a avaliação clínica, a qual incluía a pesquisa de sinais de disfunção do trato corticoespinhal. Os dados clínicos, incluindo outras complicações neurológicas e possíveis preditores, foram obtidos independentemente a partir dos registros clínicos. Resultados: Foram incluídos consecutivamente 54 doentes com síndrome do desconforto respiratório agudo, 27 devido a SARS-CoV-2 e 27 devido a outros agentes infecciosos. Os grupos eram comparáveis na maioria das características. Os doentes com COVID-19 apresentavam risco significativamente superior de complicações neurológicas (RR = 1,98; IC95% 1,23 - 3,26). Os sinais de disfunção do trato corticoespinhal tendiam a ser mais prevalentes em doentes com COVID-19 (RR = 1,62; IC95% 0,72 - 3,44). Conclusão: Este estudo foi a primeira análise comparativa visando avaliar disfunção neurológica, entre doentes com infecção SARS-CoV-2 e outros agentes infecciosos, em um contexto de unidade de cuidados intensivos. Reportamos um risco significativamente superior de disfunção neurológica em doentes com COVID-19. Como tal, sugere-se o rastreio sistemático de complicações neurológicas em doentes com COVID-19 crítico.

ABSTRACT Objective: To evaluate whether critical SARS-CoV-2 infection is more frequently associated with signs of corticospinal tract dysfunction and other neurological signs, symptoms, and syndromes, than other infectious pathogens. Methods: This was a prospective cohort study with consecutive inclusion of patients admitted to intensive care units due to primary infectious acute respiratory distress syndrome requiring invasive mechanical ventilation > 48 hours. Eligible patients were randomly assigned to three investigators for clinical evaluation, which encompassed the examination of signs of corticospinal tract dysfunction. Clinical data, including other neurological complications and possible predictors, were independently obtained from clinical records. Results: We consecutively included 54 patients with acute respiratory distress syndrome, 27 due to SARS-CoV-2 and 27 due to other infectious pathogens. The groups were comparable in most characteristics. COVID-19 patients presented a significantly higher risk of neurological complications (RR = 1.98; 95%CI 1.23 - 3.26). Signs of corticospinal tract dysfunction tended to be more prevalent in COVID-19 patients (RR = 1.62; 95%CI 0.72 - 3.44). Conclusion: Our study is the first comparative analysis between SARS-CoV-2 and other infectious pathogens, in an intensive care unit setting, assessing neurological dysfunction. We report a significantly higher risk of neurological dysfunction among COVID-19 patients. As such, we suggest systematic screening for neurological complications in severe COVID-19 patients.

Derivation of a clinical decision rule for predictive factors for the development of pharyngocutaneous fistula postlaryngectomy / Derivação de uma regra de decisão clínica para predição de desenvolvimento de fístula faringocutânea pós laringectomia

INTRODUCTION: Pharyngocutaneous fistula after larynx and hypopharynx cancer surgery can cause several damages. This study's aim was to derive a clinical decision rule to predict pharyngocutaneous fistula development after pharyngolaryngeal cancer surgery.METHODS: A retrospective cohort study was conducted, including all patients performing total laryngectomy/pharyngolaryngectomy (n = 171). Association between pertinent variables and pharyngocutaneous fistula development was assessed and a predictive model proposed.RESULTS: American Society of Anesthesiologists scale, chemoradiotherapy, and tracheotomy before surgery were associated with fistula in the univariate analysis. In the multivariate analysis, only American Society of Anesthesiologists maintained statistical significance. Using logistic regression, a predictive model including the following was derived: American Society of Anesthesiologists, alcohol, chemoradiotherapy, tracheotomy, hemoglobin and albumin pre-surgery, local extension, N-classification, and diabetes mellitus. The model's score area under the curve was 0.76 (95% CI 0.64-0.87). The high-risk group presented specificity of 93%, positive likelihood ratio of 7.10, and positive predictive value of 76%. Including the medium-low, medium-high, and high-risk groups, a sensitivity of 92%, negative likelihood ratio of 0.25, and negative predictive value of 89% were observed.CONCLUSION: A clinical decision rule was created to identify patients with high risk of pharyngocutaneous fistula development. Prognostic accuracy measures were substantial. Nevertheless, it is essential to conduct larger prospective studies for validation and refinement.

INTRODUÇÃO: Fístula faringocutânea após cirurgia de câncer de laringe e hipofaringe causa diversos danos. Nosso objetivo foi derivar uma regra de decisão clínica (RDC) para predizer o desenvolvimento da fístula faringocutânea após cirurgia.MÉTODO: Estudo de coorte retrospectivo incluindo todos os pacientes submetidos à laringectomia total e faringolaringectomia (n = 171). Analisou-se a associação entre as variáveis pertinentes e o desenvolvimento da fístula e foi proposto um modelo preditivo.RESULTADOS: Na análise univariada, a ASA, quimioradioterapia (QRT) e traqueostomia antes da cirurgia foram associadas à fístula. Na análise multivariada, somente a ASA manteve-se estatisticamente significante. Por regressão logística, derivamos um modelo preditivo incluindo: ASA, álcool, QRT, traqueostomia, hemoglobina e albumina pré-operatórias, extensão local, N, DM. A curva ROC do modelo foi 0,76 (95% CI 0,64−0,87). O grupo de alto risco teve especificidade 93%, Likelihood positivo 7,10 e valor preditivo positivo 76%. Incluindo os grupos de médio baixo, médio alto e alto risco, temos sensibilidade de 92%, Likelihood negativo 0,25 e valor preditivo positivo 89%.CONCLUSÃO: Criamos uma RDC para identificar os pacientes de alto risco ao desenvolvimento da fístula faringocutânea. As medidas de acurácia prognóstica foram substanciais. Entretanto, é essencial conduzir estudos prospectivos maiores para validação/refinamento do modelo.