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Diverse diagnostic and management approaches for acute rheumatic fever in Australia and New Zealand: findings of a prospective clinical study

Por: Peiris · R. · Webb · R. · Bennett · J. · Yan · J. · Francis · J. R. · Remenyi · B. · Chan Mow · F. · Burgess · R. · Wilson · N. J. · Stanley · A. · Francis · L. · Holloway · R. · Westbury · R. · Lawrence · S. · Hernandez-Gomez · Y. · Broadhurst · D. · Moreland · N. J. · McGregor · R. · Mot
Objectives

To describe diagnostic and management characteristics of acute rheumatic fever (ARF) among participants in the ‘Searching for a Technology-Driven Acute Rheumatic Fever Test’ study, in order to answer clinical questions and determine epidemiological and practice differences in different settings.

Design

Multisite, prospective cohort study.

Setting

One hospital in northern Australia and two hospitals in New Zealand, 2018–2021.

Participants

143 episodes of definite, probable or possible ARF among 141 participants (median age 10 years, range 5–23; 98% Indigenous).

Primary and secondary outcome measures

Participant characteristics, clinical, biochemical and echocardiographic data were explored using descriptive data. Associations with length of stay were determined using multivariable regression analysis.

Results

ARF presentations were heterogeneous with the most common ARF ‘phenotype’ in 19% of cases being carditis with joint manifestations (polyarthritis, monarthritis or polyarthralgia), fever and PR prolongation. The total proportion of children with carditis was 61%. Australian compared with New Zealand participants more commonly had ARF recurrence (22% vs 0%), underlying RHD (48% vs 0%), possible/probable ARF (23% vs 9%) and were underweight (64% vs 16%). Erythrocyte sedimentation rate (ESR) provided an incremental diagnostic yield of 21% compared with C reactive protein. No instances of RHD were diagnosed among participants in New Zealand. Positive throat Group A Streptococcus culture was more common in New Zealand than in Australian participants (69% vs 3%). Children often required prolonged hospitalisation, with median hospital length-of-stay being 7 days (range 2–66). Significant predictors for length of stay in a multivariable regression model were valve disease (adjusted OR (aOR) 1.56, 95% CI 1.23 to 1.98, p

Conclusions

This study provides new knowledge on ARF characteristics and management and highlights international variation in diagnostic and management practice. Differing approaches need to be aligned. Meanwhile, locally specific information can help guide patient expectations after ARF diagnosis.

Re‐infection after treatment for moderate and severe diabetic foot infections

Abstract

To investigate risk factors for re-infection and compare the outcomes in people with diabetic foot infections. A retrospective chart review was conducted, and 294 hospitalised patients with moderate to severe diabetic foot infections (DFIs) were analysed for this study. The diagnosis and classification of the severity of infection was based on the International Working Group on the Diabetic Foot (IWGDF) infection guidelines. Skin and soft tissue infections were diagnosed based on clinical observations as per IWGDF classification in addition to ruling out any suspected osteomyelitis (OM) through negative bone culture, MRI or WBC SPECT CT. OM was confirmed by bone culture or histopathology. Clinical outcomes were based on a 12-month follow-up period. All dichotomous outcomes were compared using χ 2 with an alpha of 0.05. The result of this study shows a 48% rate of re-infection in people admitted to our hospital with moderate and severe diabetic foot infections (DFI). Patients with osteomyelitis present during the index admission were 2.1 times more likely to experience a re-infection than patients with soft tissue infection (56.7% vs. 38.0% respectively). In the univariate analysis, risk factors for re-infection included osteomyelitis, non-healing wounds, prolonged wound healing, antidepressants and leukocytosis. In the regression analysis, the only risk factor for re-infection was wounds that were not healed >90 days (HR =2.0, CI: 1.5, 2.7, p = 0.001). Re-infection is very common in patients with moderate and severe diabetic foot infections. Risk factors include osteomyelitis, non-healing wound, prolonged wound healing, antidepressants and leukocytosis.

A purified reconstituted bilayer matrix shows improved outcomes in treatment of non‐healing diabetic foot ulcers when compared to the standard of care: Final results and analysis of a prospective, randomized, controlled, multi‐centre clinical trial

Abstract

As the incidence of diabetic foot ulcers (DFU) increases, better treatments that improve healing should reduce complications of these ulcers including infections and amputations. We conducted a randomized controlled trial comparing outcomes between a novel purified reconstituted bilayer membrane (PRBM) to the standard of care (SOC) in the treatment of non-healing DFUs. This study included 105 patients who were randomized to either of two treatment groups (n = 54 PRBM; n = 51 SOC) in the intent to treat (ITT) group and 80 who completed the study per protocol (PP) (n = 47 PRBM; n = 33 SOC). The primary endpoint was the percentage of wounds closed after 12 weeks. Secondary outcomes included percent area reduction, time to healing, quality of life, and cost to closure. The DFUs that had been treated with PRBM healed at a higher rate than those treated with SOC (ITT: 83% vs. 45%, p = 0.00004, PP: 92% vs. 67%, p = 0.005). Wounds treated with PRBM also healed significantly faster than those treated with SOC with a mean of 42 versus 62 days for SOC (p = 0.00074) and achieved a mean wound area reduction within 12 weeks of 94% versus 51% for SOC (p = 0.0023). There were no adverse events or serious adverse events that were related to either the PRBM or the SOC. In comparison to the SOC, DFUs healed faster when treated with PRBM. Thus, the use of this PRBM is an effective option for the treatment of chronic DFUs.

The infected diabetic foot: Modulation of traditional biomarkers for osteomyelitis diagnosis in the setting of diabetic foot infection and renal impairment

Abstract

The objective of this paper was to investigate erythrocyte sedimentation rate (ESR) and c-reactive protein (CRP) in diagnosing pedal osteomyelitis (OM) in patients with and without diabetes, and with and without severe renal impairment (SRI). This was a retrospective cohort study of patients with moderate and severe foot infections. We evaluated three groups: Subjects without diabetes (NDM), subjects with diabetes and without severe renal insufficiency (DM-NSRI), and patients with diabetes and SRI (DM-SRI). SRI was defined as eGFR <30. We evaluated area under the curve (AUC), cutoff point, sensitivity and specificity to characterize the accuracy of ESR and CRP to diagnose OM. A total of 408 patients were included in the analysis. ROC analysis in the NDM group revealed the AUC for ESR was 0.62, with a cutoff value of 46 mm/h (sensitivity, 49.0%; specificity, 76.0%). DM-NSRI subjects showed the AUC for ESR was 0.70 with the cutoff value of 61 mm/h (sensitivity, 68.9%; specificity 61.8%). In DM-SRI, the AUC for ESR was 0.67, with a cutoff value of 119 mm/h (sensitivity, 46.4%; specificity, 82.40%). In the NDM group, the AUC for CRP was 0.55, with a cutoff value of 6.4 mg/dL (sensitivity, 31.3%; specificity, 84.0%). For DM-NSRI, the AUC for CRP was 0.70, with a cutoff value of 8 mg/dL (sensitivity, 49.2%; specificity, 80.6%). In DM-SRI, the AUC for CRP was 0.62, with a cutoff value of 7 mg/dL (sensitivity, 57.1%; specificity, 67.7%). While CRP demonstrated relatively consistent utility, ESR's diagnostic cutoff points diverged significantly. These results highlight the necessity of considering patient-specific factors when interpreting ESR results in the context of OM diagnosis.

Near‐infrared spectroscopy data for foot skin oxygen saturation in healthy subjects

Abstract

Our objective was to evaluate normative data for near-infrared spectroscopy (NIRS) in 110 healthy volunteers by Fitzpatrick skin type (FST) and region of the foot. We obtained measurements of the dorsum and plantar foot using a commercially available device (SnapshotNIR, Kent Imaging, Calgary Canada). On the dorsum of the foot, people with FST6 had significantly lower oxygen saturation compared to FST1-5 (p < 0.001), lower oxyhaemoglobin compared to FST2-5 (p = 0.001), but there was no difference in deoxyhaemoglobin. No differences were found on the plantar foot. When comparing dorsal and plantar foot, there was higher oxyhaemoglobin (0.40 ± 0.09 vs. 0.51 ± 0.12, p < 0.001) and deoxyhaemoglobin (0.16 ± 0.05 vs. 0.21 ± 0.05, p < 0.001) on the plantar foot, but no differences in oxygen saturation (dorsal 70.7 ± 10.8, plantar 70.0 ± 9.5, p = 0.414). In 6.4% of feet, there were black areas, for which no NIRS measurements could be generated. All areas with no data were on the dorsal foot and only found in FST 5–6. People with FST6 had significantly larger areas with no data compared to FST 5 (22.2 cm2 ± 20.4 vs. 1.9 cm2 ± 0.90, p = 0.007). These findings should be considered when using NIRS technology. Skin pigmentation should be evaluated in future NIRS studies.

Success of transmetatarsal amputation for limb salvage in patients with peripheral artery disease

Abstract

Limb salvage is a difficult path for patients to travel as there is no guarantee of the outcome, often the major factor is perfusion. For patients who underwent transmetatarsal amputation (TMA), success rate is crucial as the next option is most likely a major amputation. We performed a 10 years (2010–2020) retrospective review of patients that underwent a TMA and had an angiogram or computed tomography angiography (CTA) perioperatively at the Dallas VA Medical Center. Failure after TMA was defined as a patient requiring a proximal amputation within 1 year. There were 125 TMAs performed between 2010 and 2020 at the institution. Forty-four (35.2%) patients had an angiogram/CTA peri-operative and met the inclusion criteria. Seventeen subjects (38.6%) had a higher level of amputation. Of the 17 failures, 2 (11.8%) patients had no patent vessel runoff to the foot, 9 (52.9%) had one vessel, 4 (23.5%) had two vessels, and 2 (11.8%) had three vessels runoff. One vessel runoff to the foot yielded a high rate of poor outcomes (56.3%) defined as a higher level of amputation. Two or more vessels runoff to the foot had over 75% success of limb salvage with a TMA.

A multicenter, randomized controlled clinical trial evaluating the effects of a novel autologous heterogeneous skin construct in the treatment of Wagner one diabetic foot ulcers: Final analysis

Abstract

A novel autologous heterogeneous skin construct (AHSC) was previously shown to be effective versus standard of care (SOC) treatment in facilitating complete wound healing of Wagner 1 diabetic foot ulcers in an interim analysis of 50 patients previously published. We now report the final analysis of 100 patients (50 per group), which further supports the interim analysis findings. Forty-five subjects in the AHSC treatment group received only one application of the autologous heterogeneous skin construct, and five received two applications. For the primary endpoint at 12 weeks, there were significantly more diabetic wounds closed in the AHSC treatment group (35/50, 70%) than in the SOC control group (17/50, 34%) (p = 0.00032). A significant difference in percentage area reduction between groups was also demonstrated over 8 weeks (p = 0.009). Forty-nine subjects experienced 148 adverse events: 66 occurred in 21 subjects (42%) in the AHSC treatment group versus 82 in 28 SOC control group subjects (56.0%). Eight subjects were withdrawn due to serious adverse events. Autologous heterogeneous skin construct was shown to be an effective adjunctive therapy for healing Wagner 1 diabetic foot ulcers.

Deficiencies in reporting inclusion/exclusion criteria and characteristics of patients in randomized controlled trials of therapeutic interventions in pressure injuries: a systematic methodological review

Abstract

Wound care is a complex procedure and the related research may include many variables. Deficiencies in the sample inclusion and exclusion criteria may limit the generalizability of randomized controlled trials (RCTs) for wound patients in the real world. This study aimed to evaluate deficiencies in reporting the inclusion and exclusion criteria and the characteristics of patients in RCTs of pressure injuries (PI) therapeutic interventions. We conducted a systematic methodological review in which 40 full text RCTs of PI treatment interventions published in English, from 2008 to 2020, were identified. Data on the general characteristics of the included RCTs and data about inclusion/exclusion criteria and characteristics of patients were collected. The inclusion/exclusion criteria were categorized into five domains (definition of disease, precision, safety, ethical/legal and administrative). Study duration (in weeks) was 8.0 (quartile 1: 2.0; quartile 3: 48.0); only 5.0% of the trials mentioned race, skin colour or ethnicity, and 37.5% reported the duration of the wound. Only 9 (22.5%) studies reported the drugs that the included patients were using and 10 (25.0%) RCTs reported adverse events. The presence of the five domains was observed only in 12.5% of RCTs and only 12 (30.0%) had the precision domain. Much more research is required in systematic assessments of the external validity of trials because there is substantial disparity between the information that is provided by RCTs and the information that is required by clinicians. We concluded that there are deficiencies in reporting of data related to inclusion/exclusion criteria and characteristics of patients of RCTs assessing PI therapeutic interventions.

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