Prospective Cohort Validation Study of a Novel Foot Offloading Device.
Ontology highlight
ABSTRACT:
SUBMITTER: Lubarsky R
PROVIDER: S-EPMC8613341 | biostudies-literature |
REPOSITORIES: biostudies-literature
Similar Datasets
Project description:Prospective cohort carriage study
| PRJEB53187 | ENA
Project description:To test whether depression is associated with an increased risk of incident diabetic foot ulcers.The Pathways Epidemiologic Study is a population-based prospective cohort study of 4839 patients with diabetes in 2000-2007. The present analysis included 3474 adults with type 2 diabetes and no prior diabetic foot ulcers or amputations. Mean follow-up was 4.1 years. Major and minor depression assessed by the Patient Health Questionnaire-9 were the exposures of interest. The outcome of interest was incident diabetic foot ulcers. We computed the hazard ratio and 95% confidence interval (CI) for incident diabetic foot ulcers, comparing patients with major and minor depression with those without depression and adjusting for sociodemographic characteristics, medical comorbidity, glycosylated hemoglobin, diabetes duration, insulin use, number of diabetes complications, body mass index, smoking status, and foot self-care. Sensitivity analyses also adjusted for peripheral neuropathy and peripheral arterial disease as defined by diagnosis codes.Compared with patients without depression, patients with major depression by Patient Health Questionnaire-9 had a 2-fold increase in the risk of incident diabetic foot ulcers (adjusted hazard ratio 2.00; 95% CI, 1.24-3.25). There was no statistically significant association between minor depression by Patient Health Questionnaire-9 and incident diabetic foot ulcers (adjusted hazard ratio 1.37; 95% CI, 0.77-2.44).Major depression by Patient Health Questionnaire-9 is associated with a 2-fold higher risk of incident diabetic foot ulcers. Future studies of this association should include better measures of peripheral neuropathy and peripheral arterial disease, which are possible confounders or mediators.
| S-EPMC2913143 | biostudies-literature
Project description:Background:In laparoscopic surgery, the Veress needle technique is most often used to initiate a pneumoperitoneum. Although low, entry-related injuries of the intestines and major vascular structures occur in 0.04-0.1% of cases. Up to 50% of these injuries remain undiagnosed at the time of surgery, resulting in mortality rates between 2.5 and 30%. In an effort to minimize such injuries we objectively assessed a novel abdominal wall entry suction device (AWESD) that was hypothesized to lift the abdominal wall and create an additional post-peritoneum safe margin for safer Veress needle introduction. Materials and methods:A prospective pilot study was conducted in which CT-scans with and without AWESD application (centered above the umbilicus) were assessed to determine its effect on the distance from the linea alba to the intestines, vena cava and abdominal aorta. Paired measurements were subjected to the Wilcoxon signed rank test. Results:Twelve participants were included. The AWESD significantly increased the median distance towards the intestines in the axial and sagittal plane (P?=?0.01 and P?=?0.006) from 0.93 (Inter Quartile Range (IQR): 0.33-1.51) and 0.85 (IQR: 0.32-1.47) to 1.35 (IQR: 0.39-2.27) and 1.25 (IQR: 0.42-2.10) centimeters, respectively. Similarly, for the median axial distances towards the vena cava and abdominal aorta (both P?=?0.002) that were increased from 10.00 (IQR: 7.18-11.12) and 9.33 (IQR: 6.55-10.28) to 13.23 (IQR: 11.76-14.31) and 12.49 (IQR: 10.98-13.32) centimeters, respectively. Conclusion:The AWESD significantly increased the distances between the peritoneum and main intra-abdominal structures. However, conclusions on subsequent increased safety cannot be drawn as high-volume studies are required to determine its clinical relevance.
| S-EPMC6804323 | biostudies-literature
Project description:BackgroundDespite its importance to women's reproductive health and its impact on women's daily lives, the menstrual cycle, its regulation, and its impact on health remain poorly understood. As conventional clinical trials rely on infrequent in-person assessments, digital studies with wearable devices enable the collection of longitudinal subjective and objective measures.ObjectiveThe study aims to explore the technical feasibility of collecting combined wearable and digital questionnaire data and its potential for gaining biological insights into the menstrual cycle.MethodsThis prospective observational cohort study was conducted online over 12 weeks. A total of 42 cisgender women were recruited by their local gynecologist in Berlin, Germany, and given a Fitbit Inspire 2 device and access to a study app with digital questionnaires. Statistical analysis included descriptive statistics on user behavior and retention, as well as a comparative analysis of symptoms from the digital questionnaires with metrics from the sensor devices at different phases of the menstrual cycle.ResultsThe average time spent in the study was 63.3 (SD 33.0) days with 9 of the 42 individuals dropping out within 2 weeks of the start of the study. We collected partial data from 114 ovulatory cycles, encompassing 33 participants, and obtained complete data from a total of 50 cycles. Participants reported a total of 2468 symptoms in the daily questionnaires administered during the luteal phase and menses. Despite difficulties with data completeness, the combined questionnaire and sensor data collection was technically feasible and provided interesting biological insights. We observed an increased heart rate in the mid and end luteal phase compared with menses and participants with severe premenstrual syndrome walked substantially fewer steps (average daily steps 10,283, SD 6277) during the luteal phase and menses compared with participants with no or low premenstrual syndrome (mean 11,694, SD 6458).ConclusionsWe demonstrate the feasibility of using an app-based approach to collect combined wearable device and questionnaire data on menstrual cycles. Dropouts in the early weeks of the study indicated that engagement efforts would need to be improved for larger studies. Despite the challenges of collecting wearable data on consecutive days, the data collected provided valuable biological insights, suggesting that the use of questionnaires in conjunction with wearable data may provide a more complete understanding of the menstrual cycle and its impact on daily life. The biological findings should motivate further research into understanding the relationship between the menstrual cycle and objective physiological measurements from sensor devices.
| S-EPMC10966447 | biostudies-literature
Project description:In the last few years, multicast device-to-device (D2D) cellular networks has become a highly attractive area of research. However, a particularly challenging class of issues in this area is data traffic, which increases due to increase in video and audio streaming applications. Therefore, there is need for smart spectrum management policies. In this paper, we consider a fractional frequency reuse (FFR) technique which divides the whole spectrum into multiple sections and allows reusing of spectrum resources between the conventional cellular users and multicast D2D users in a non-orthogonal scenario. Since conventional cellular users and multicast D2D users shared same resources simultaneously, they generate severe data traffic and high communication overhead. To overcome these issues, in this paper we propose Lagrange relaxation technique to solve the non-convex problem and combinatorial auction-based matching algorithm to select the most desirable resource reuse partners by fulfilling the quality of service (QoS) requirements for both the conventional cellular users and multicast D2D users. Then, we formulate an optimization problem to maximize the overall system performance with least computational complexity. We demonstrate that our method can exploit a higher data rate, spectrum efficiency, traffic offload rate, coverage probability, and lower computational complexity.
| S-EPMC7070976 | biostudies-literature
Project description:BackgroundOffloading is key to preventing or healing plantar neuropathic foot ulcers in diabetes. Total contact casts or walkers rendered irremovable are recommended in guidelines as first-line options for offloading, however the use of such devices has been found to be low. This study aimed to investigate offloading practices for diabetes-related plantar neuropathic ulcers.MethodsAn online survey of closed and open-ended questions was administered via SurveyMonkey®. Forty-one podiatrists experienced in high-risk foot practice, from 21 high-risk foot services around Australia, were approached to participate.ResultsThe response rate was 88%. Participants reported using 21 modalities or combinations of modalities, for offloading this ulcer type. The most frequently used modalities under the forefoot and hallux were felt padding, followed by removable casts or walkers, then non-removable casts or walkers. Participants indicated that many factors were considered when selecting offloading modality, including: compliance, risk of adverse effects, psycho-social factors, restrictions on activities of daily living, work needs and features of the wound. The majority of participants (83%) considered non-removable casts or walkers to be the gold-standard for offloading this ulcer type, however they reported numerous, particularly patient-related, barriers to their use.ConclusionsSelecting offloading for the management of foot ulceration is complex. Felt padding, not the gold-standard non-removable cast or walker, was reported as the most commonly selected modality for offloading plantar neuropathic ulceration. However, further evaluation of felt padding in high quality clinical trials is required to ascertain its effectiveness for ulcer healing.
| S-EPMC4332025 | biostudies-literature
Project description:BACKGROUND: In 2010, we observed children with atypical presentations of hand-foot-mouth disease (HFMD), such as rashes on earlobes and faces, or bullae on trunks and bilateral limbs. Hyperpigmentation later developed as the bullous lesions crusted. Thus, we intended to study the etiology of the illness and the phylogeny of the pathogens. METHOD: Patients were prospectively enrolled in a tertiary medical center in Taipei, Taiwan. The definition of atypical HFMD includes symptoms of acute viral infection with either of the following presentations: (1) maculopapular rashes presenting on the trunks, buttocks or facial areas, or (2) large vesicles or bullae on any sites of the body. Patients were classified into two groups according to vesicle sizes by two pediatricians at different points in time. The large vesicle group was defined as having vesciculobullous lesions ? 1 cm in diameter; the small rashes group had maculopapular rashes < 1cm in diameter. Two throat swabs were collected from each patient for virus isolation and reverse transcription polymerase chain reactions. RESULTS: We enrolled 101 patients between March and December 2010. The mean age of the participants was 3.3 ± 3.0 years (median age: 2.5 years, range: 21 days-13.5 years). The ratio of males to females was 1.8 to 1. All samples were enterovirus-positive, including coxsackievirus A6 (80%), coxsackievirus A16 (6%), enterovirus 71 (1%), coxsackievirus A5 (1%) and 12 non-typable enterovirus (12%). Bullous fluid aspirated from 2 patients also grew coxsackievirus A6. Among the patients infected with coxsackievirus A6, 54% (45/81) had bullae, compared to 25% (5/20) of those having non-coxsackievirus A6 infections (P=0.02). Fourteen cases had myoclonic jerks and one boy was diagnosed with febrile convulsions. None had complications or sequelae. Phylogenetic analysis showed the strains in Taiwan in 2010 shared more commonality with strains from Finland in 2009 (GenBank: FJ870502-FJ870508), and were close to those circulating in Japan in 2011 (GenBank: AB649286-AB649291). CONCLUSIONS: Coxsackievirus A6 infections may cause atypical manifestations of HFMD, including vesicles or papules on faces or bullae on trunks. These features could provide valuable information to distinguish this versatile enterovirus infection from other virus-induced vesiculobullous diseases.
| S-EPMC3717056 | biostudies-literature
Project description:The offloading is crucial to heal neuropathic diabetic foot ulcer (DFU). Removable offloading are the most used devices. Orthèse diabète is a new customized removable knee-high offloading device immobilizing foot and ankle joints, with some specific and innovative features that may improve offloading. We aimed to evaluate the efficiency of this device in DFU healing. The evaluation of Offloading using a new removable ORTHOsis in DIABetic foot study is a French multicenter (13 centers) randomized controlled trial with blinded end points evaluation. Adults with neuropathic DFU were randomly assigned to either Orthèse Diabète (experimental device), or any type of conventional (usually used in France) removable offloading devices (control group). The primary outcome was the 3-month proportion of patients with fully healed DFU. Among 112 randomized patients (men 78%, age 62±10 years), the primary outcome occurred in 19 (33%) participants using conventional device vs 19 (35%) Orthèse Diabète users (p=0.79). Study groups were also comparable in terms of prespecified secondary end points including occurrence of new DFU (25% vs 27% in conventional and experimental groups), ipsilateral lower-limb amputation (4% vs 10%) or infectious complications (14% vs 13%) (p>0.05 for all). Adverse events were comparable between groups, including 4 deaths unrelated to study allocation (1 sudden death, 2 ventricular arrhythmias and 1 pancreatic cancer). Adverse events believed to be related to the device were higher in the Orthèse Diabète group than in the control group (15% vs 4%). Orthèse Diabète was less frequently worn than conventional devices (46% vs 66%, p=0.04). Orthèse Diabète, a new removable offloading orthosis immobilizing foot and ankle joints did not show superiority compared with conventional removable devices in neuropathic DFU healing and cannot be recommended to heal DFU. NCT01956162.
| S-EPMC7223015 | biostudies-literature
Project description:BackgroundTelemedicine technology is a growing field, especially in the context of the COVID-19 pandemic. Consult Station (Health for Development) is the first telemedicine device enabling completely remote medical consultations, including the concurrent collection of clinical parameters and videos.ObjectiveOur aim was to collect data on the multisite urban and suburban implementation of the Consult Station for primary care and assess its contribution to health care pathways in areas with a low density of medical services.MethodsIn a proof-of-concept multisite prospective cohort study, 2134 consecutive patients had teleconsultations. Consultation characteristics were analyzed from both the patient and practitioner perspective.ResultsIn this study, the main users of Consult Station were younger women consulting for low-severity seasonal infections. Interestingly, hypertension, diabetes, and preventive medical consultations were almost absent, while they accounted for almost 50% of consultations with a general practitioner (GP). We showed that for all regions where the Consult Station was implemented, the number of consultations increased as GP density decreased. The study of practitioner characteristics showed GPs from metropolitan areas are motivated to work with this device remotely, with a high level of technology acceptability.ConclusionsThe multisite implementation of Consult Station booths is suitable for primary care and could also address the challenge of "medical deserts." In addition, further studies should be performed to evaluate the possible contribution of Consult Station booths to limiting work absenteeism.
| S-EPMC9157322 | biostudies-literature
Project description:Identification of blood biomarkers that prospectively predict progression of Mycobacterium tuberculosis infection to tuberculosis disease might lead to interventions that combat the tuberculosis epidemic. We aimed to assess whether global gene expression measured in whole blood of healthy people allowed identification of prospective signatures of risk of active tuberculosis disease. RESULTS:Between July 6, 2005, and April 23, 2007, we enrolled 6363 from the ACS study and 4466 from independent South African and Gambian cohorts. 46 progressors and 107 matched controls were identified in the ACS cohort. A 16 gene signature of risk was identified. The signature predicted tuberculosis progression with a sensitivity of 66·1% (95% CI 63·2–68·9) and a specificity of 80·6% (79·2–82·0) in the 12 months preceding tuberculosis diagnosis. The risk signature was validated in an untouched group of adolescents (p=0·018 for RNA sequencing and p=0·0095 for qRT-PCR) and in the independent South African and Gambian cohorts (p values <0·0001 by qRT-PCR) with a sensitivity of 53·7% (42·6–64·3) and a specificity of 82·8% (76·7–86) in 12 months preceding tuberculosis. Interpretation: The whole blood tuberculosis risk signature prospectively identified people at risk of developing active tuberculosis, opening the possibility for targeted intervention to prevent the disease.
2016-03-22 | GSE79362 | GEO