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Spinal Cord Injury (SCI) results in a permanent or temporary alteration of the motor, sensory and/or autonomic functions, frequently leading to neuropathic pain. To deal with this comorbidity, several non-pharmacological and non-surgical (NP-NS) interventions have been developed. However, their efficacy is still uncertain. The aim of this study was to systematically synthetize the available evidence assessing the efficacy of NP-NS interventions for treating neuropathic pain in people with SCI. Thus, an electronic search was conducted in five databases (Pubmed, Scopus, Cochrane Central, Web of Science and EBSCO) and trials registry databases, in addition to a manual search strategy to retrieve additional records. The review included randomized controlled trials with adults with SCI, in any stage of the condition. Data on the efficacy of the interventions was narratively synthetized. Once the research was completed, of 4853 identified references, 24 were included with a total of 653 participants with SCI and neuropathic pain, mostly male and with paraplegia. These studies investigated the effect of 13 types of NP-NS interventions with different protocols and methodological limitations. Seven different assessment scales were analyzed, with neuropathic pain being the primary outcome in 21 studies. Such high heterogeneity impaired the conduction of meta-analysis for any of the interventions. Although promising results were found regarding analgesic effect of NP-NS on neuropathic pain in people with SCI, it is not yet possible to safely state that these interventions are in fact effective. Further studies with homogeneous protocols and methodological quality are still needed. PERSPECTIVE: This article presents a review of existing studies on the effectiveness of NP-NS interventions in neuropathic pain in SCI. This synthesis could potentially alert and motivate clinicians to develop studies on this topic, so that interventions can be objectively evaluated and recommendations for an evidence-based practice be created.

Background Renal replacement therapy (RRT) is essential in the presence of life-threatening complications associated with acute kidney injury (AKI). In the absence of urgent indications, the optimal timing for RRT initiation is still under debate. This meta-analysis aims to compare the benefits between early and late RRT initiation strategies in critically ill patients with AKI. Methods Studies were obtained from three databases [Medical Literature Analysis and Retrieval System Online (MEDLINE), Cochrane Central Register of Controlled Trials (CENTRAL) and Scopus], searched from inception to May 2021. The selected primary outcome was 28-day mortality. Secondary outcomes included overall mortality, recovery of renal function (RRF) and RRT-associated adverse events. A random-effects model was used for summary measures. Heterogeneity was assessed through Cochrane I2 test statistics. Potential sources of heterogeneity for the primary outcome were sought using sensitivity analyses. Further subgroup analyses were conducted based on RRT modality and study population. Results A total of 13 randomized controlled trials including 5193 participants were analysed. No significant differences were found between early and late RRT initiation regarding 28-day mortality [risk ratio (RR) 1.00; 95% confidence interval (CI) 0.89–1.12, I² = 30%], overall mortality (RR 1.00; 95% CI 0.90–1.12, I² = 42%) and RRF (RR 1.02; 95% CI 0.92–1.13, I² = 53%). However, early RRT initiation was associated with a significantly higher incidence of hypotensive (RR 1.34; 95% CI 1.17–1.53, I² = 6%) and infectious events (RR 1.83; 95% CI 1.11–3.02, I² = 0%). Conclusions Early RRT initiation does not improve the 28-day and overall mortality, nor the likelihood of RRF, and increases the risk for RRT-associated adverse events, namely hypotension and infection.

Screening diabetic retinopathy, a major cause of blindness, is time-consuming for ophthalmologists and has some constrains in achieving full coverage and attendance. The handheld fundus camera EyeFundusScope was recently developed to expand the scale of screening, drawing on images acquired in primary care and telescreening made by ophthalmologists or a computer-aided diagnosis (CADx) system. This study aims to assess the diagnostic accuracy of the interpretation of images captured using EyeFundusScope and perform its technical evaluation, including image quality, functionality, usability, and acceptance in a real-world clinical setting. Physicians and nurses without training in ophthalmology will use EyeFundusScope to take pictures of the retinas of patients with diabetes and the images will be classified for the presence or absence of diabetic retinopathy and image quality by a panel of ophthalmologists. A subgroup of patients will also be examined with the reference standard tabletop fundus camera. Screening results provided by the CADx system on images taken with EyeFundusScope will be compared against the ophthalmologists’ analysis of images taken with the tabletop fundus camera. Diagnostic accuracy measures with 95% confidence intervals (CIs) will be calculated for positive and negative test results. Proportion of each category of image quality will be presented. Usability and acceptance results will be presented qualitatively.

Background: Most interventions to prevent foot ulcers in people with diabetes do not seek to reverse the foot abnormalities that led to the ulcer. Foot-ankle exercise programs target these clinical and biomechanical factors, such as protective sensation and mechanical stress. Multiple RCTs exist investigating the effectiveness of such programs, but these have never been summarised in a systematic review and meta-analysis. Methods: We searched the available scientific literature in PubMed, EMBASE, CINAHL, Cochrane databases and trial registries for original research studies on foot-ankle exercise programs for people with diabetes at risk of foot ulceration. Both controlled and non-controlled studies were eligible for selection. Two independent reviewers assessed the risk of bias of controlled studies and extracted data. Meta-analysis (using Mantel-Haenszel's statistical method and random effect models) was performed when >2 RCTs were available that met our criteria. Evidence statements, including the certainty of evidence, were formulated according to GRADE. Results: We included a total of 29 studies, of which 16 were RCTs. A foot-ankle exercise programme of 8–12 weeks duration for people at risk of foot ulceration results in: (a) no increase or decrease risk of foot ulceration or pre-ulcerative lesion (Risk Ratio (RR): 0.56 (95% CI: 0.20–1.57)); (b) no increase or decrease risk of adverse events (RR: 1.04 (95% CI: 0.65–1.67)); (c) not increase or decrease barefoot peak plantar pressure during walking (Mean Difference (MD): −6.28 kPa (95% CI: −69.90–57.34)); (d) no increase or decrease health-related quality of life (no meta-analysis possible). Likely results in increases in ankle joint and first metatarsalphalangeal joint range of motion (MD: 1.49° (95% CI: −0.28–3.26)) may result in improvements in neuropathy signs and symptoms (MD: −1.42 (95% CI: −2.95-0.12)), may result in a small increase in daily steps in some people (MD: 131 steps (95% CI: -492-754)), and may not increase or decrease foot and ankle muscle strength and function (no meta-analysis was possible). Conclusions: In people at risk of foot ulceration, a foot-ankle exercise programme of 8–12 weeks duration may not prevent or cause diabetes-related foot ulceration. However, such a programme likely improves the ankle joint and first metatarsalphalangeal joint range of motion and neuropathy signs and symptoms. Further research is needed to strengthen the evidence base, and should also focus on the effects of specific components of foot-ankle exercise programs.

To quantify and understand how to assess the quality of life and health-related QoL of parents with children with congenital abnormalities. We conducted a systematic review with meta-analysis. The search was carried out in 5 bibliographic databases and in ClinicalTrials.gov. No restriction on language or date of publication was applied. This was complemented by references of the studies found and studies of evidence synthesis, manual search of abstracts of relevant congresses/scientific meetings and contact with experts. We included primary studies (observational, quasi-experimental and experimental studies) on parents of children with CA reporting the outcome quality of life (primary outcome) of parents, independently of the intervention/exposure studied. We included 75 studies (35 observational non-comparatives, 31 observational comparatives, 4 quasi-experimental and 5 experimental studies). We identified 27 different QoL instruments. The two most frequently used individual QoL instruments were WHOQOL-Bref and SF-36. Relatively to family QoL tools identified, we emphasized PedsQL FIM, IOFS and FQOL. Non-syndromic congenital heart defects were the CA most frequently studied. Through the analysis of comparative studies, we verified that parental and familial QoL were impaired in this population. This review highlights the relevance of assessing QoL in parents with children with CA and explores the diverse QoL assessment tools described in the literature. Additionally, results indicate a knowledge gap that can help to draw new paths to future research. It is essential to assess QoL as a routine in healthcare providing and to implement strategies that improve it.

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.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 ventilation48 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.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).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.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.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 por48 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.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).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.

Inappropriate prescribing, which encompasses the prescription of potentially inappropriate medications (PIMs) and potential prescribing omissions (PPOs), is a common problem for older people. The STOPP/START tool enables general practitioners, who are the main prescribers, to identify and reduce the incidence of PIMs and PPOs and appraise an older patient’s prescribed drugs during the diagnosis process to improve the clinical care quality. This study aimed to translate and validate the STOPP/START screening tool to enable its use by Portuguese physicians. A translation-back translation method including the validation of the obtained Portuguese version was used. Intra- and inter-rater reliability and agreement analyses were used in the validation process. A dataset containing the information of 334 patients was analyzed by one GP twice within a 2-week interval, while a dataset containing the information of 205 patients was independently analyzed by three GPs. Intra-rater reliability assessment led to a Kappa coefficient (κ) of 0.70 (0.65–0.74) for the STOPP criteria and 0.60 (0.52–0.68) for the START criteria, considered to be substantial and moderate values, respectively. The results of the inter-rater reliability rating were almost perfect for all combinations of raters (κ > 0.93). The version of the STOPP/START criteria translated into Portuguese represents an improvement in managing the medications prescribed to the elderly. It provides clinicians with a screening tool for detecting potentially inappropriate prescribing in patients older than 65 years old that is reliable and easy to use.

BACKGROUND American Academy of Sleep Medicine guidelines suggests that clinical prediction algorithms can be used to screen obstructive sleep apnea (OSA) patients without replacing polysomnography (PSG) – the gold standard. OBJECTIVE We aimed to identify, gather, and analyze existing machine learning approaches that are being used for disease screening in adult patients suspected of OSA. METHODS We searched MEDLINE, Scopus and ISI Web of Knowledge databases for evaluating the validity of different machine learning techniques, with PSG as the gold standard outcome measures. This systematic review was registered in PROSPERO under reference CRD42021221339. RESULTS Our search retrieved 5479 articles, of which 63 articles were included. We found 23 studies performing diagnostic models’ development alone, 26 with added internal validation, and 14 applying the clinical prediction algorithm to an independent sample (although not all reporting the most common discrimination metrics - sensitivity and/or specificity). Logistic regression was applied in 35 studies, linear regression in 16, support vector machine in 9, neural networks in 8, decision trees in 6, and Bayesian networks in 4. Random forest, discriminant analysis, classification and regression tree, and nomogram were each performed in 2 studies, while Pearson correlation, adaptative neuro-fuzzy inference system, artificial immune recognition system, genetic algorithm, supersparse linear integer models, and k-nearest neighbors’ algorithm each in 1 study. The best AUC was .98 [.96-.99] for age, waist circumference, Epworth somnolence, and oxygen saturation as predictors in a logistic regression. CONCLUSIONS Although high values were obtained, they still lack external validation results in large cohorts and a standard OSA criteria definition.

BACKGROUND AND AIMS Renal replacement therapy (RRT) is consensual in the presence of life-threatening complications associated with acute kidney injury (AKI). In the absence of urgent indications, the optimal timing for RRT initiation is still under debate. This systematic review with meta-analysis aims to compare the benefits between early and late RRT initiation strategies in critically ill patients with AKI. METHOD Studies were obtained from three databases (MEDLINE, CENTRAL and SCOPUS), searched from inception to May 2021. The selected primary outcome was 28-day mortality. Secondary outcomes included overall mortality, recovery of renal function (RRF) and RRT-associated adverse events. A random-effects model was used for summary measures. Heterogeneity was assessed through Cochrane I2 test statistics. Potential sources of heterogeneity for the primary outcome were sought using sensitivity analyses. Further subgroup analyses were conducted based on the RRT modality. RESULTS A total of 13 randomized controlled trials, including 5193 participants, were analyzed. No significant differences were found between early and late RRT initiation regarding 28-day mortality [risk ratio (RR) 1.00, 95% confidence interval (95% CI) 0.89–1.12; I² = 30%], overall mortality (RR 1.00, 95% CI 0.90–1.12; I² = 42%) and RRF (RR 1.02, 95% CI 0.92–1.13; I² = 53%). However, early RRT initiation was associated with a significantly higher incidence of hypotensive (RR 1.34, 95% CI 1.17–1.53; I² = 6%) and infectious events (RR 1.83, 95% CI 1.11–3.02; I² = 0%). CONCLUSION Early RRT initiation does not improve the 28-day or overall mortality, nor the likelihood of RRF and increases the risk for RRT-associated adverse events, namely hypotension and infection.

info:eu-repo/semantics/publishedVersion

Background American Academy of Sleep Medicine guidelines suggest that clinical prediction algorithms can be used to screen patients with obstructive sleep apnea (OSA) without replacing polysomnography, the gold standard. Objective We aimed to identify, gather, and analyze existing machine learning approaches that are being used for disease screening in adult patients with suspected OSA. Methods We searched the MEDLINE, Scopus, and ISI Web of Knowledge databases to evaluate the validity of different machine learning techniques, with polysomnography as the gold standard outcome measure and used the Prediction Model Risk of Bias Assessment Tool (Kleijnen Systematic Reviews Ltd) to assess risk of bias and applicability of each included study. Results Our search retrieved 5479 articles, of which 63 (1.15%) articles were included. We found 23 studies performing diagnostic model development alone, 26 with added internal validation, and 14 applying the clinical prediction algorithm to an independent sample (although not all reporting the most common discrimination metrics, sensitivity or specificity). Logistic regression was applied in 35 studies, linear regression in 16, support vector machine in 9, neural networks in 8, decision trees in 6, and Bayesian networks in 4. Random forest, discriminant analysis, classification and regression tree, and nomogram were each performed in 2 studies, whereas Pearson correlation, adaptive neuro-fuzzy inference system, artificial immune recognition system, genetic algorithm, supersparse linear integer models, and k-nearest neighbors algorithm were each performed in 1 study. The best area under the receiver operating curve was 0.98 (0.96-0.99) for age, waist circumference, Epworth Somnolence Scale score, and oxygen saturation as predictors in a logistic regression. Conclusions Although high values were obtained, they still lacked external validation results in large cohorts and a standard OSA criteria definition. Trial Registration PROSPERO CRD42021221339; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=221339

IntroductionThe aim of the study was to develop and validate a clinical prediction rule (CPR) for foot ulceration in people with diabetes.Research design and methodsDevelopment of a CPR using individual participant data from four international cohort studies identified by systematic review, with validation in a fifth study. Development cohorts were from primary and secondary care foot clinics in Europe and the USA (n=8255, adults over 18 years old, with diabetes, ulcer free at recruitment). Using data from monofilament testing, presence/absence of pulses, and participant history of previous ulcer and/or amputation, we developed a simple CPR to predict who will develop a foot ulcer within 2 years of initial assessment and validated it in a fifth study (n=3324). The CPR’s performance was assessed with C-statistics, calibration slopes, calibration-in-the-large, and a net benefit analysis.ResultsCPR scores of 0, 1, 2, 3, and 4 had a risk of ulcer within 2 years of 2.4% (95% CI 1.5% to 3.9%), 6.0% (95% CI 3.5% to 9.5%), 14.0% (95% CI 8.5% to 21.3%), 29.2% (95% CI 19.2% to 41.0%), and 51.1% (95% CI 37.9% to 64.1%), respectively. In the validation dataset, calibration-in-the-large was −0.374 (95% CI −0.561 to −0.187) and calibration slope 1.139 (95% CI 0.994 to 1.283). The C-statistic was 0.829 (95% CI 0.790 to 0.868). The net benefit analysis suggested that people with a CPR score of 1 or more (risk of ulceration 6.0% or more) should be referred for treatment.ConclusionThe clinical prediction rule is simple, using routinely obtained data, and could help prevent foot ulcers by redirecting care to patients with scores of 1 or above. It has been validated in a community setting, and requires further validation in secondary care settings.

BackgroundHigh-quality data is crucial for guiding decision making and practicing evidence-based healthcare, especially if previous knowledge is lacking. Nevertheless, data quality frailties have been exposed worldwide during the current COVID-19 pandemic. Focusing on a major Portuguese surveillance dataset, our study aims to assess data quality issues and suggest possible solutions.MethodsOn April 27th 2020, the Portuguese Directorate-General of Health (DGS) made available a dataset (DGSApril) for researchers, upon request. On August 4th, an updated dataset (DGSAugust) was also obtained. The quality of data was assessed through analysis of data completeness and consistency between both datasets.ResultsDGSAugust has not followed the data format and variables as DGSApril and a significant number of missing data and inconsistencies were found (e.g. 4,075 cases from the DGSApril were apparently not included in DGSAugust). Several variables also showed a low degree of completeness and/or changed their values from one dataset to another (e.g. the variable ‘underlying conditions’ had more than half of cases showing different information between datasets). There were also significant inconsistencies between the number of cases and deaths due to COVID-19 shown in DGSAugust and by the DGS reports publicly provided daily.ConclusionsThe low quality of COVID-19 surveillance datasets limits its usability to inform good decisions and perform useful research. Major improvements in surveillance datasets are therefore urgently needed - e.g. simplification of data entry processes, constant monitoring of data, and increased training and awareness of health care providers - as low data quality may lead to a deficient pandemic control.

Aims To assess the impact of diabetic foot care delivery in preventing lower extremity amputation (LEA). Methods We systematically searched the MEDLINE database for research evaluating the association between any aspect of diabetic foot care delivery and risk of LEA. Meta-analysis was conducted by calculating a pooled odds ratio through a random effects model. Results Our search retrieved 5093 articles. In total, 58 articles were included: 9 addressing healthcare access, 4 educating health professionals, 2 implementing guidelines, 6 receiving chiropody/podiatry care services and 37 implementing structured diabetic foot care services (SDFC). All of these aspects of diabetic foot care seemed to have a positive impact on preventing LEA. Only SDFC literature met criteria for performing a meta-analysis. For SDFC impact on preventing overall and major LEA but not for minor LEA compelling evidence was observed [aggregated odds ratio (OR) of 0.45 (95% CI 0.37–0.57), 0.40 (95% CI 0.32–0.51), and 0.87 (95% CI 0.67–1.14), respectively]. However, high heterogeneity (superior to 60%) was observed for all outcomes. Conclusions Results support a reduction in diabetic LEA frequency in association with structured diabetic foot care, and, in particular, major LEA. Less evidence is available for the remaining aspects of diabetic foot care delivery.

ObjectivesOur research question was: what are the most frequent baseline clinical characteristics in adult patients with COVID-19? Our major aim was to identify common baseline clinical features that could help recognise adult patients at high risk of having COVID-19.DesignWe conducted a scoping review of all the evidence available at LitCovid, until 23 March 2020.SettingStudies conducted in any setting and any country were included.ParticipantsStudies had to report the prevalence of sociodemographic characteristics, symptoms and comorbidities specifically in adults with a diagnosis of infection by SARS-CoV-2.ResultsIn total, 1572 publications were published on LitCovid. We have included 56 articles in our analysis, with 89% conducted in China and 75% containing inpatients. Three studies were conducted in North America and one in Europe. Participants’ age ranged from 28 to 70 years, with balanced gender distribution. The proportion of asymptomatic cases were from 2% to 79%. The most common reported symptoms were fever (4%–99%), cough (4%–92%), dyspnoea/shortness of breath (1%–90%), fatigue (4%–89%), myalgia (3%–65%) and pharyngalgia (2%–61%), while regarding comorbidities, we found cardiovascular disease (1%–40%), hypertension (0%–40%) and cerebrovascular disease (1%–40%). Such heterogeneity impaired the conduction of meta-analysis.ConclusionsThe infection by COVID-19 seems to affect people in a very diverse manner and with different characteristics. With the available data, it is not possible to clearly identify those at higher risk of being infected with this condition. Furthermore, the evidence from countries other than China is, at the moment, too scarce.

We read with great interest the article by Nogueira P [...]

Purpose: To evaluate the diagnostic accuracy of a diagnostic system software for the automated screening of diabetic retinopathy (DR) on digital colour fundus photographs, the 2019 Convolutional Neural Network (CNN) model with Inception-V3. Methods: In this cross-sectional study, 295 fundus images were analysed by the CNN model and compared to a panel of ophthalmologists. Images were obtained from a dataset acquired within a screening programme. Diagnostic accuracy measures and respective 95% CI were calculated. Results: The sensitivity and specificity of the CNN model in diagnosing referable DR was 81% (95% CI 66–90%) and 97% (95% CI 95–99%), respectively. Positive predictive value was 86% (95% CI 72–94%) and negative predictive value 96% (95% CI 93–98%). The positive likelihood ratio was 33 (95% CI 15–75) and the negative was 0.20 (95% CI 0.11–0.35). Its clinical impact is demonstrated by the change observed in the pre-test probability of referable DR (assuming a prevalence of 16%) to a post-test probability for a positive test result of 86% and for a negative test result of 4%. Conclusion: A CNN model negative test result safely excludes DR, and its use may significantly reduce the burden of ophthalmologists at reading centres.

ObjectivesTo describe baseline clinical characteristics of adult patients with COVID-19.MethodsWe conducted a scoping review of the evidence available at LitCovid, until March 23th, 2020, and selected articles that reported the prevalence of socio-demographic characteristics, symptoms and co-morbidities in adults with COVID-19.ResultsIn total, 1 572 publications were published on LitCovid. We have included 56 articles in our analysis, with 89% conducted in China, and 75% contained inpatients. Three studies were conducted in North America and one in Europe. Participants’ age ranged from 28 to 70 years, with balanced gender distribution. Proportion of asymptomatic cases were from 2 to 79%. The most common reported symptoms were fever [4-99%], cough [4-92%], dyspnoea/shortness of breath [1-90%], fatigue 4-89%], myalgia [3-65%], and pharyngalgia [2-61%], while regarding co-morbidities we found cardiovascular disease [1-40%], hypertension [0-40%] and cerebrovascular disease [1-40%]. Such heterogeneity impairs the conduction of meta-analysis.ConclusionThe infection by COVID-19 seems to affect people in a very diverse manner and with different characteristics. With the available data it is not possible to clearly identify those at higher risk of being infected with this condition. Furthermore, the evidence from countries other than China is, at the day, too scarce.

Diabetic foot disease greatly impacts both affected patients and society, but remains the “Cinderella” of diabetes‐related complications. However, recent progress in research and guideline development have led to increased awareness of the problem and improved clinical outcomes. Thus, it is time for a shift in global perception of this increasingly prevalent problem. In this special issue, we present 7 up‐to‐date clinical guidelines and 10 systematic reviews developed by the International Working Group on the Diabetic Foot, together with 17 informative and stimulating related papers. These guidelines offer new recommendations on ulcer classification, diagnosis of infection severity, and vascular assessment, to assist in ulcer risk stratification, diagnosis and interdisciplinary communication. Key developments include providing guidance on methodological assessment of research papers; expanding the evidence base for ulcer treatment by the use of wound products and offloading treatment and suggestions for improving ulcer prevention through technological advances in patient monitoring of risk factors and footwear. The 17 invited papers discuss related topics ranging from stem cell research to patient psychology and describe the way forward in diabetic foot care. While there is much more to learn, the new knowledge of underlying pathways, advancements in diagnosis, treatment and prevention presented in this supplement should help improve outcomes and reduce the great and growing burden of diabetic foot disease.

The International Working Group on the Diabetic Foot (IWGDF) has published evidence-based guidelines on the prevention and management of diabetic foot disease since 1999. This guideline is on the prevention of foot ulceration in persons with diabetes and updates the 2015 IWGDF prevention guideline. We followed the GRADE methodology to devise clinical questions and critically important outcomes in the PICO format, to conduct a systematic review of the medical-scientific literature, and to write recommendations and their rationale. The recommendations are based on the quality of evidence found in the systematic review, expert opinion where evidence was not available, and a weighing of the benefits and harms, patient preferences, feasibility and applicability, and costs related to the intervention. We recommend to screen a person at very low risk for ulceration annually for loss of protective sensation and peripheral artery disease and persons at higher risk at higher frequencies for additional risk factors. For preventing a foot ulcer, educate the at-risk patient about appropriate foot self-care and treat any pre-ulcerative sign on the foot. Instruct moderate-to-high risk patients to wear accommodative properly fitting therapeutic footwear, and consider instructing them to monitor foot skin temperature. Prescribe therapeutic footwear that has a demonstrated plantar pressure relieving effect during walking to prevent plantar foot ulcer recurrence. In patients that fail non-surgical treatment for an active or imminent ulcer, consider surgical intervention; we suggest not to use a nerve decompression procedure. Provide integrated foot care for high-risk patients to prevent ulcer recurrence. Following these recommendations will help health care professionals to provide better care for persons with diabetes at risk of foot ulceration, to increase the number of ulcer-free days, and to reduce the patient and health care burden of diabetic foot disease.

The International Working Group on the Diabetic Foot (IWGDF) has been publishing evidence-based guidelines on the prevention and management of diabetic foot disease since 1999. This publication represents a new guideline addressing the use of classifications of diabetic foot ulcers in routine clinical practice and reviews those which have been published. We only consider systems of classification used for active diabetic foot ulcers and do not include those that might be used to define risk of future ulceration. The guidelines are based on a review of the available literature and on expert opinion leading to the identification of eight key factors judged to contribute most to clinical outcomes. Classifications are graded on the number of key factors included as well as on internal and external validation and the use for which a classification is intended. Key factors judged to contribute to the scoring of classifications are of three types: patient related (end-stage renal failure), limb-related (peripheral artery disease and loss of protective sensation), and ulcer-related (area, depth, site, single, or multiple and infection). Particular systems considered for each of the following five clinical situations: (a) communication among health professionals, (b) predicting the outcome of an individual ulcer, (c) as an aid to clinical decision-making for an individual case, (d) assessment of a wound, with/without infection, and peripheral artery disease (assessment of perfusion and potential benefit from revascularisation), and (d) audit of outcome in local, regional, or national populations. We recommend: (a) for communication among health professionals the use of the SINBAD system (that includes Site, Ischaemia, Neuropathy, Bacterial Infection and Depth); (b) no existing classification for predicting outcome of an individual ulcer; (c) the Infectious Diseases Society of America/IWGDF (IDSA/IWGDF) classification for assessment of infection; (d) the WIfI (Wound, Ischemia, and foot Infection) system for the assessment of perfusion and the likely benefit of revascularisation; and (e) the SINBAD classification for the audit of outcome of populations.

Classification and scoring systems can help both clinical management and audit outcomes of routine care. The aim of this study was to assess published systems of diabetic foot ulcers (DFUs) to determine which should be recommended for a given clinical purpose. Published classifications had to have been validated in populations of > 75% people with diabetes and a foot ulcer. Each study was assessed for internal and external validity and reliability. Eight key factors associated with failure to heal were identified from large clinical series and each classification was scored on the number of these key factors included. Classifications were then arranged according to their proposed purpose into one or more of four groups: (a) aid communication between health professionals, (b) predict clinical outcome of individual ulcers, (c) aid clinical management decision making for an individual case, and (d) audit to compare outcome in different populations. Thirty-seven classification systems were identified of which 18 were excluded for not being validated in a population of >75% DFUs. The included 19 classifications had different purposes and were derived from different populations. Only six were developed in multicentre studies, just 13 were externally validated, and very few had evaluated reliability.Classifications varied in the number (4 - 30), and definition of individual items and the diagnostic tools required. Clinical outcomes were not standardized but included ulcer-free survival, ulcer healing, hospitalization, limb amputation, mortality, and cost. Despite the limitations, there was sufficient evidence to make recommendations on the use of particular classifications for the indications listed above.

Prevention of foot ulcers in patients with diabetes is important to help reduce the substantial burden on both patient and health resources. A comprehensive analysis of reported interventions is needed to better inform healthcare professionals about effective prevention. The aim of this systematic review is to investigate the effectiveness of interventions to help prevent both first and recurrent foot ulcers in persons with diabetes who are at risk for this complication. We searched the available medical scientific literature in PubMed, EMBASE, CINAHL, and the Cochrane databases for original research studies on preventative interventions. We screened trial registries for additional studies not found in our search and unpublished trials. Two independent reviewers assessed data from controlled studies for methodological quality, and extracted and presented this in evidence and risk of bias tables. From the 13,490 records screened, 35 controlled studies and 46 non-controlled studies were included. Few controlled studies, which were of generally low to moderate quality, were identified on the prevention of a first foot ulcer. For the prevention of recurrent plantar foot ulcers, there is benefit for the use of daily foot skin temperature measurements, and for therapeutic footwear with demonstrated plantar pressure relief, provided it is consistently worn by the patient. For prevention of ulcer recurrence, there is some evidence for providing integrated foot care, and no evidence for a single session of education.Surgical interventions have been shown effective in selected patients, but the evidence base is small. Foot-related exercises do not appear to prevent a first foot ulcer. A small increase in the level of weight-bearing daily activities does not seem to increase the risk for foot ulceration. The evidence base to support the use of specific self-management and footwear interventions for the prevention of recurrent plantar foot ulcers is quite strong. The evidence is weak for the use of other, sometimes widely applied, interventions, and is practically non-existent for the prevention of a first foot ulcer and non-plantar foot ulcer.

Multiple disciplines are involved in the management of diabetic 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 diabetic foot disease. This document describes these definitions and criteria. We suggest these definitions be used consistently in both clinical practice and research to facilitate clear communication between professionals.

ObjectivesHigh-quality data are crucial for guiding decision-making and practising evidence-based healthcare, especially if previous knowledge is lacking. Nevertheless, data quality frailties have been exposed worldwide during the current COVID-19 pandemic. Focusing on a major Portuguese epidemiological surveillance dataset, our study aims to assess COVID-19 data quality issues and suggest possible solutions.SettingsOn 27 April 2020, the Portuguese Directorate-General of Health (DGS) made available a dataset (DGSApril) for researchers, upon request. On 4 August, an updated dataset (DGSAugust) was also obtained.ParticipantsAll COVID-19-confirmed cases notified through the medical component of National System for Epidemiological Surveillance until end of June.Primary and secondary outcome measuresData completeness and consistency.ResultsDGSAugust has not followed the data format and variables as DGSApril and a significant number of missing data and inconsistencies were found (eg, 4075 cases from the DGSApril were apparently not included in DGSAugust). Several variables also showed a low degree of completeness and/or changed their values from one dataset to another (eg, the variable ‘underlying conditions’ had more than half of cases showing different information between datasets). There were also significant inconsistencies between the number of cases and deaths due to COVID-19 shown in DGSAugust and by the DGS reports publicly provided daily.ConclusionsImportant quality issues of the Portuguese COVID-19 surveillance datasets were described. These issues can limit surveillance data usability to inform good decisions and perform useful research. Major improvements in surveillance datasets are therefore urgently needed—for example, simplification of data entry processes, constant monitoring of data, and increased training and awareness of healthcare providers—as low data quality may lead to a deficient pandemic control.

Objectives Anticholinergic drugs have several side effects, and they have been associated with adverse outcomes, particularly in older patients. The aim of this study was to analyze anticholinergic burden and its relationship to delirium and mortality in older acutely ill medical patients. Design Cohort study. Setting and Participants Patients 65 years of age and older who were admitted to an Internal Medicine ward between August 1 and December 31, 2016. Methods Anticholinergic drug use, outpatient and inpatient, was assessed using the Anticholinergic Cognitive Burden Scale (ACB). Prevalent delirium was diagnosed by the Short Confusion Assessment Method (Short-CAM). Results Of the 198 patients, 28.3% developed delirium. Mortality rate was 13.6% in-hospital and 45.6% at 12 months. In multivariate analysis, outpatient ACB was associated with delirium, with an odds ratio (OR) of 1.65 [95% confidence interval (CI) 1.09-2.51]. Those with delirium had longer hospital stays (median 13 vs 8 days; P = .01), received more drugs (median 18 vs 15; P = .02), and presented a higher inpatient ACB (mean 3.9 vs 3.1; P = .034). No increased risk was found for in-hospital or 12-month mortality with drug use, ACB, or delirium. Discussion In the population studied, we found an association between anticholinergic burden as measured by the ACB and the presence of delirium, but not with mortality at 12 months. A very high 12-month mortality rate might have been an obstacle for association recognition. Conclusions and Implications Clinician awareness of possible drug side effects, especially in older populations, is crucial. As part of medication reconciliation at the time of hospitalization, ACB of prehospitalization medications should be routinely calculated by inpatient pharmacy services and made available to medical teams.

BACKGROUND Older adults are more vulnerable to polypharmacy and prescriptions of potentially inappropriate medications. There are several ways to address polypharmacy to prevent its occurrence. We focused on computerized decision support tools. OBJECTIVE The available literature was reviewed to understand whether computerized decision support tools reduce potentially inappropriate prescriptions or potentially inappropriate medications in older adult patients and affect health outcomes. METHODS Our systematic review was conducted by searching the literature in the MEDLINE, CENTRAL, EMBASE, and Web of Science databases for interventional studies published through February 2018 to assess the impact of computerized decision support tools on potentially inappropriate medications and potentially inappropriate prescriptions in people aged 65 years and older. RESULTS A total of 3756 articles were identified, and 16 were included. More than half (n=10) of the studies were randomized controlled trials, one was a crossover study, and five were pre-post intervention studies. A total of 266,562 participants were included; of those, 233,144 participants were included and assessed in randomized controlled trials. Intervention designs had several different features. Computerized decision support tools consistently reduced the number of potentially inappropriate prescriptions started and mean number of potentially inappropriate prescriptions per patient. Computerized decision support tools also increased potentially inappropriate prescriptions discontinuation and drug appropriateness. However, in several studies, statistical significance was not achieved. A meta-analysis was not possible due to the significant heterogeneity among the systems used and the definitions of outcomes. CONCLUSIONS Computerized decision support tools may reduce potentially inappropriate prescriptions and potentially inappropriate medications. More randomized controlled trials assessing the impact of computerized decision support tools that could be used both in primary and secondary health care are needed to evaluate the use of medication targets defined by the Beers or STOPP (Screening Tool of Older People’s Prescriptions) criteria, adverse drug reactions, quality of life measurements, patient satisfaction, and professional satisfaction with a reasonable follow-up, which could clarify the clinical usefulness of these tools. CLINICALTRIAL International Prospective Register of Systematic Reviews (PROSPERO) CRD42017067021; https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42017067021

Background Prevention of diabetic foot ulcers is important. Preventative treatment mostly targets and aims to improve modifiable risk factors of foot ulceration. While effectiveness of interventions in ulcer prevention has been systematically reviewed, their effectiveness in improving modifiable risk factors is unknown. Methods The available medical scientific literature in PubMed, Excerpta Medica Database, and the Cochrane database was searched for original research studies on six interventions to treat modifiable risk factors for diabetic foot ulceration (ie, education for patients; education for professionals; self-management; pre-ulcer treatment; orthotic interventions; and foot- and mobility-related exercises). We assessed interventions for eight outcomes (ie, patients' knowledge; treatment adherence; professionals' knowledge; pre-ulcers; mechanical stress; neuropathy symptoms; foot/ankle joint mobility; and foot function). Both controlled and noncontrolled studies were selected. Data from controlled studies were assessed for methodological quality by two independent reviewers and extracted and presented in evidence and risk of bias tables. Results We included 72 publications (26 with a controlled study design and 46 noncontrolled). We found that structured education may improve foot self-care behaviour of patients, yearly foot examinations, and foot disease knowledge of health care professionals. Callus removal reduces peak plantar pressure. Custom-made therapeutic footwear can be effective in reducing plantar pressure and may reduce callus. Foot- and mobility-related exercises may improve neuropathy symptoms and foot and ankle joint range of motion, while they do not seem to reduce peak plantar pressure; evidence for their effect on foot strength is conflicting. Conclusions Structured education for patients and health care professionals, callus removal, custom-made therapeutic footwear, and foot- and mobility-related exercises may be beneficial for improving modifiable risk factors for foot ulceration. However, we generally found low quality of evidence for interventions targeting modifiable risk factors for ulceration in persons with diabetes, with frequently inconsistent or limited results available per intervention and outcome.

Aims/hypothesis The primary analysis of the Canagliflozin cardioVascular Assessment Study (CANVAS) Program showed canagliflozin to have a beneficial effect on cardiovascular and renal outcomes in people with type 2 diabetes at high cardiovascular risk, but also an unexpected increased risk of major or minor lower extremity amputation. These secondary analyses explore this finding in more detail. Methods The effect of canagliflozin on amputation risk in the CANVAS Program was calculated for amputations of different types and proximate aetiologies and different canagliflozin doses. Univariate and multivariate associations of baseline characteristics with amputation risk were determined and proportional and absolute effects of canagliflozin were compared across subgroups. Results There were 187 (1.8%) participants with atraumatic lower extremity amputations (minor 71%, major 29%); as previously published, rates were 6.30 vs 3.37 per 1000 participant-years with canagliflozin vs placebo (HR 1.97 [95% CI 1.41, 2.75]). Risk was similar for ischaemic and infective aetiologies and for 100 mg and 300 mg doses. Overall amputation risk was strongly associated with baseline history of prior amputation (major or minor) (HR 21.31 [95% CI 15.40, 29.49]) and other established risk factors. No interactions between randomised treatment and participant characteristics explained the effect of canagliflozin on amputation risk. For every clinical subgroup studied, numbers of amputation events projected were smaller than numbers of major adverse cardiovascular events averted. Conclusions/interpretation The CANVAS Program demonstrated that canagliflozin increased the risk of amputation (mainly minor) in this study population. Anticipated risk factors for amputation were identified, such as prior history of amputation, peripheral vascular disease and neuropathy, but no specific aetiological mechanism or at-risk subgroup for canagliflozin was identified. Electronic supplementary material The online version of this article (10.1007/s00125-019-4839-8) contains peer-reviewed but unedited supplementary material, which is available to authorised users.