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Nevin Manimala Statistics

Analysis of the Risk Factors for Free Flap Necrosis in Soft Tissue Reconstruction of the Lower Limbs

Orthop Surg. 2023 Apr 24. doi: 10.1111/os.13727. Online ahead of print.

ABSTRACT

OBJECTIVE: Free flaps are widely used for the repair of soft tissue defects in the lower limbs, but there is still a specific rate of necrosis. Few clinical retrospective studies have analyzed the nontechnical risk factors for lower limb free flap necrosis. This study aimed to analyze the nontechnical causes of flap necrosis in lower limb soft tissue reconstruction in order to identify risk factors and improve the survival rate of free flaps.

METHODS: Clinical data from 244 cases of soft tissue defects of the leg or foot that were repaired with a free flap from January 2011 to June 2020 were retrospectively analyzed. The flap results were divided into complete survival and necrosis groups. The patients’ general information, smoking history, soft tissue defect site, Gustilo-Anderson classification, shock after injury, type and size of the flap, and time from injury to flap coverage were recorded. A logistic regression model was used to analyze the correlations between flap necrosis and possible risk factors.

RESULTS: Of the 244 flaps, 32 suffered from partial or total necrosis, and 212 completely survived. Univariate analysis showed that age, smoking history, soft tissue defect site, and time from injury to flap coverage were significantly correlated with flap necrosis (p ≤ 0.2). Multivariate logistic regression analysis showed that moderate-to-severe smoking history (p < 0.001, odds ratio [OR] = 10.259, 95% confidence interval [CI] = 2.886-36.468), proximal leg defect (p = 0.006, OR = 7.095, 95% CI = 1.731-29.089), and time from injury to flap coverage >7 days (p = 0.003, OR = 12.351, 95% CI = 2.343-65.099) were statistically significant risk factors for flap necrosis (p < 0.05), and age was excluded (p = 0.666; p = 0.924).

CONCLUSION: The risk of flap necrosis was significantly increased when the soft tissue defect was located in the proximal leg, the time from injury to flap coverage was >7 days, and the patient had a moderate-to-severe smoking history. These three risk factors have an increased influence on flap necrosis and have guiding significance in predicting flap prognosis.

PMID:37092532 | DOI:10.1111/os.13727

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Nevin Manimala Statistics

Effect of Bone Cement Thickness on the Risk of Scalded Skin in Joint Surgery

Orthop Surg. 2023 Apr 24. doi: 10.1111/os.13700. Online ahead of print.

ABSTRACT

OBJECTIVE: Bone cement releases a large amount of heat as it polymerizes. Skin burns caused by discarded bone cement are not well understood during arthroplasty. It is important to study the correlates and mechanisms of scalding and to accurately evaluate the severity of burns to guide treatment decisions.

METHODS: Standardized burns were created in eight anesthetized rabbits using different thicknesses of bone cement. Bone cement was uniformly stirred to make thicknesses of 1 mm, 4 mm, 8 mm, 12 mm, 16 mm, and 20 mm and a 20 × 40 mm cuboid. Bone cement samples were then placed on the back of a rabbit, and the temperature changes were recorded with an industrial digital thermometer. One hour later, the appearance of scalded skin was observed, and the rabbits were euthanized. The scalded parts were cut to make pathological sections and stained with HE, and the differences in the depth of the scalded skin caused by different thicknesses of bone cement were observed under a light microscope.

RESULTS: Damage caused by 1 mm-, 4 mm-, 8 mm-, 12 mm-, 16 mm-, and 20 mm-thick bone cement samples mainly involved the epidermis, the papillary dermis, the reticular dermis layer, and the full thickness of the skin and the subcutaneous tissue. The maximum temperature of 1 mm, 4 mm, 8 mm, and 12 mm bone cementation had a statistically significant difference (p < 0.001), while there was no significant difference between 12 mm, 16 mm, and 20 mm samples (p = 0.856). The time to severe scalding with bone cement at temperatures above 70°C was significantly different between different thicknesses (p < 0.001).

CONCLUSION: The heat released by different thicknesses of bone cement leads to different maximum temperatures and the duration of severe burns, resulting in different degrees of skin burns. Attention should be paid to discarded bone cement to prevent this potential complication in knee arthroplasty.

PMID:37092381 | DOI:10.1111/os.13700

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Nevin Manimala Statistics

Psychosocial safety climate: Measurement and relationship with well-being in a four-wave longitudinal study during remote work

Scand J Psychol. 2023 Apr 24. doi: 10.1111/sjop.12917. Online ahead of print.

ABSTRACT

To create healthy workplaces, organizations need tools for assessing factors contributing to employee well-being. Psychosocial safety climate (PSC) refers to shared perceptions regarding the extent to which psychological health and safety are prioritized in organizations; it is operationalized in the PSC scale. We evaluated the factor structure of the Finnish version of the PSC-4 scale, its invariance across time and concurrent and predictive relationships with perceived stress, job exhaustion, and work engagement. Moreover, the mean-level changes in PSC and well-being during enforced remote work were studied. Participants were 442 higher education employees who completed a well-being survey four times between April 2020 and February 2021. The longitudinal factor structure of the PSC-4 and well-being indicators were investigated using confirmatory factor analysis and structural equation modeling. The statistical analyses supported the one-factor structure of the PSC-4 and its measurement invariance across time. PSC was negatively associated with concurrent stress and job exhaustion and positively associated with concurrent work engagement at each measurement. Moreover, PSC predicted subsequent stress between each time point. Cross-lagged effects were also evident for job exhaustion at T2-T3 and T3-T4 and for work engagement at T1-T2. The mean level of PSC decreased during enforced remote work. To conclude, the Finnish PSC-4 is a valid tool for evaluating perceived psychosocial safety climate in organizations. PSC predicted well-being over time and showed subsequent relationships with job exhaustion and work engagement, which is a new contribution to PSC theory and literature. Organizations need to design interventions to improve it, especially during stressful times.

PMID:37092361 | DOI:10.1111/sjop.12917

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Nevin Manimala Statistics

Impact of Multi-point Nursing Strategies Under a Clinical Problem-Solving Framework on Adverse Events Associated With Thyroid Nodule Resection

Eval Health Prof. 2023 Apr 24:1632787231172277. doi: 10.1177/01632787231172277. Online ahead of print.

ABSTRACT

The impact of multi-point nursing strategies drawing on a problem-solving clinical framework to examine adverse events associated with thyroid nodule resection was investigated. Patients (n = 98) who underwent thyroid nodule resection were divided into observation and control groups. Patients in the control group received conventional care, and patients in the observation group received a multi-point care strategy under a clinical problem-solving framework. The length of stay (p < .001), hospitalization cost (p < .001), nursing satisfaction scores (p < .001) of the observation group were longer or higher and statistically significant. The incidence of complications in the observation group (8.16%) was lower than that in the control group (22.45%). The incidence of adverse events in the observation group (2.04%) was lower than that in the control group (14.29%), and statistically significant (p < .05). The multi-point nursing strategy using a clinical problem-solving framework provided evidence that it shortened the length of stay, reduce hospitalization costs, improve psychological status, increase nursing satisfaction, and reduce complications and adverse events in patients undergoing thyroid nodule resection.

PMID:37092358 | DOI:10.1177/01632787231172277

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Nevin Manimala Statistics

Time to benefit of heart rate reduction with ivabradine in patients with heart failure and reduced ejection fraction

Eur J Heart Fail. 2023 Apr 24. doi: 10.1002/ejhf.2870. Online ahead of print.

ABSTRACT

AIMS: In the SHIFT (Systolic Heart failure treatment with the If inhibitor ivabradine Trial, ISRCTN70429960) study, ivabradine reduced cardiovascular death or heart failure (HF) hospitalizations in patients with heart failure and reduced ejection fraction (HFrEF) in sinus rhythm and with a heart rate (HR) ≥70 bpm. In this study, we sought to determine the clinical significance of the time durations of heart rate reduction and the significant treatment effect on outcomes among patients with HFrEF.

METHODS AND RESULTS: The time to statistically significant reduction of the primary outcome (HF hospitalization and cardiovascular death) and its components, all-cause death, and HF death, were assessed in a post-hoc analysis of the SHIFT trial in the overall population (HR ≥70 bpm) and at HR ≥75 bpm, representing the approved label in many countries. Compared to placebo, the primary outcome and HF hospitalizations were significantly reduced at 102 days, while there was no effect on cardiovascular death, all-cause death, and HF death at HR ≥70 bpm. In the population with a baseline HR ≥75 bpm, a reduction of the primary outcome occurred after 67 days, HF hospitalization after 78 days, cardiovascular death after 169 days, death from HF after 157 days and all-cause death after 169 days.

CONCLUSION: Treatment with ivabradine should not be deferred in patients in sinus rhythm with a HR of ≥70 bpm to reduce the primary outcome and HF hospitalizations, in particular in patients with HR ≥75 bpm. At HR ≥75 bpm, the time to risk reduction was shorter for reduction of hospitalization and mortality outcomes in patients with HFrEF after initiation of guideline-directed medication, including beta blockers at maximally tolerated doses.

PMID:37092340 | DOI:10.1002/ejhf.2870

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Nevin Manimala Statistics

The microbiome in adolescents with irritable bowel syndrome and changes with percutaneous electrical nerve field stimulation

Neurogastroenterol Motil. 2023 Apr 24:e14573. doi: 10.1111/nmo.14573. Online ahead of print.

ABSTRACT

BACKGROUND: Irritable bowel syndrome (IBS), a disorder of the gut-brain axis, is affected by the microbiome. Microbial studies in pediatric IBS, especially for centrally mediated treatments, are lacking. We compared the microbiome between pediatric IBS patients and healthy controls (HC), in relation to symptom severity, and with percutaneous electrical nerve field stimulation (PENFS), a non-invasive treatment targeting central pain pathways.

METHODS: We collected a stool sample, questionnaires and a 1-2 week stool and pain diary from 11 to 18 years patients with IBS. A patient subset completed 4 weeks of PENFS and repeated data collection immediately after and/or 3 months after treatment. Stool samples were collected from HC. Samples underwent metagenomic sequencing to evaluate diversity, composition, and abundance of species and MetaCyc pathways.

KEY RESULTS: We included 27 cases (15.4 ± 2.5 year) and 34 HC (14.2 ± 2.9 year). Twelve species including Firmicutes spp., and carbohydrate degradation/long-chain fatty acid (LCFA) synthesis pathways, were increased in IBS but not statistically significantly associated with symptom severity. Seventeen participants (female) who completed PENFS showed improvements in pain (p = 0.012), disability (p = 0.007), and catastrophizing (p = 0.003). Carbohydrate degradation and LCFA synthesis pathways decreased post-treatment and at follow-up (FDR p-value <0.1).

CONCLUSIONS AND INFERENCES: Firmicutes, including Clostridiaceae spp., and LCFA synthesis pathways were increased in IBS patients suggesting pain-potentiating effects. PENFS led to marked improvements in abdominal pain, functioning, and catastrophizing, while Clostridial species and LCFA microbial pathways decreased with treatment, suggesting these as potential targets for IBS centrally mediated treatments.

PMID:37092330 | DOI:10.1111/nmo.14573

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Nevin Manimala Statistics

Revisiting the benefits of isovolemic hemodilution red cell exchange for sickle cell disease

J Clin Apher. 2023 Apr 24. doi: 10.1002/jca.22054. Online ahead of print.

ABSTRACT

BACKGROUND: Isovolemic hemodilution red cell exchange (IHD-RCE) is a modified form of the standard red cell exchange (STD-RCE), intended to reduce red cell requirements in patients with sickle cell disease (SCD). This retrospective crossover analysis of nine patients aims to add to the limited existing literature on IHD-RCE and address the equipoise regarding whether the benefits of (a) decreased RBC usage per exchange and (b) increased interprocedure interval (via lower fraction of cells remaining, FCR) can be observed at the same time, in the same patient.

METHODS: At a single center, we identified 37 patients with SCD undergoing chronic RCE between 2014 and 2021. We excluded those patients who did not have at least six consecutive procedures of each type (STD- and IHD-RCE), arriving at nine patients for analysis.

RESULTS: When using greater decreases in hematocrit than previously published, we did not find that IHD-RCE resulted in any clinically apparent adverse events. We did find greater decreases in diastolic blood pressure and increases in heart rate in some patients, as compared to STD-RCE. After correcting for total blood volume, seven of the nine patients had significantly reduced red cell requirements with each IHD-RCE. Because the pattern of achieving a lower FCR than programmed was seen to an equal extent with both IHD-RCE and STD-RCE, none of the nine patients showed any statistical difference in actual FCR between procedure types.

DISCUSSION: Our data do not support the observation of both IHD-RCE benefits, decreased red cell usage per exchange and lower FCR/increased interprocedure interval, simultaneously.

PMID:37092306 | DOI:10.1002/jca.22054

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Nevin Manimala Statistics

Prediction Models for Intravenous Immunoglobulin Resistance in Kawasaki Disease: A Meta-analysis

Pediatrics. 2023 Apr 24:e2022059175. doi: 10.1542/peds.2022-059175. Online ahead of print.

ABSTRACT

CONTEXT: Approximately 10% to 20% of patients with Kawasaki disease (KD) are refractory to initial intravenous immunoglobulin (IVIG) therapy. KD is mainly associated with coronary artery abnormalities.

OBJECTIVES: To identify and evaluate all developed prediction models for IVIG resistance in patients with KD and synthesize evidence from external validation studies that evaluated their predictive performances.

DATA SOURCES: PubMed Medline, Dialog Embase, the Cochrane Central Register of Controlled Trials, the World Health Organization International Clinical Trials Registry Platform, and ClinicalTrials.gov were searched from inception until October 5, 2021.

STUDY SELECTION: All cohort studies that reported patients diagnosed with KD who underwent an initial IVIG of 2 g/kg were selected.

DATA EXTRACTION: Study and patient characteristics and model performance measures. Two authors independently extracted data from the studies.

RESULTS: The Kobayashi, Egami, Sano, Formosa, and Harada scores were the only prediction models with 3 or more external validation of the161 model analyses in 48 studies. The summary C-statistics were 0.65 (95% confidence interval [CI]: 0.57-0.73), 0.63 (95% CI: 0.55-0.71), 0.58 (95% CI: 0.55-0.60), 0.50 (95% CI: 0.36-0.63), and 0.63 (95% CI: 0.44-0.78) for the Kobayashi, Egami, Sano, Formosa, and Harada models, respectively. All 5 models showed low positive predictive values (0.14-0.39) and high negative predictive values (0.85-0.92).

LIMITATIONS: Potential differences in the characteristics of the target population among studies and lack of assessment of calibrations.

CONCLUSIONS: None of the 5 prediction models with external validation accurately distinguished between patients with and without IVIG resistance.

PMID:37092277 | DOI:10.1542/peds.2022-059175

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Nevin Manimala Statistics

EXPRESS: Does Animacy Affect Visual Statistical Learning? Revisiting the Effects of Selective Attention and Animacy on Visual Statistical Learning

Q J Exp Psychol (Hove). 2023 Apr 24:17470218231173883. doi: 10.1177/17470218231173883. Online ahead of print.

ABSTRACT

Animates receive preferential attentional processing over inanimates because, from an evolutionary perspective, animates are important to human survival. We investigated whether animacy affects visual statistical learning-the detection and extraction of regularities in visual information from our rich, dynamic, and complex environment. Participants completed a selective-attention task, in which regularities were embedded in two visual streams, an attended and an unattended visual stream. The attended visual stream always consisted of line-drawings of non-objects, while the unattended visual stream consisted of line-drawings of either animates or inanimates. Participants then completed a triplet-discrimination task, which assessed their ability to extract regularities from the attended and unattended visual streams. We also assessed participants’ awareness of regularities in the visual statistical learning task, and asked if any learning strategies were used. We were specifically interested in whether the animacy status of line-drawings in the unattended visual stream would affect visual statistical learning. There were four key findings. First, selective attention modulates visual statistical learning, with greater visual statistical learning for attended than for unattended information. Second, animacy does not affect visual statistical learning, with no differences found in visual statistical learning performance between the animate and inanimate condition. Third, awareness of regularities was associated with visual statistical learning of attended information. Fourth, participants used strategies (e.g., naming or labelling stimuli) during the visual statistical learning task. Further research is required to understand whether visual statistical learning is one of the adaptive functions that evolved from ancestral environments.

PMID:37089088 | DOI:10.1177/17470218231173883

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Nevin Manimala Statistics

Vitamin D supplementation increases objective response rate and prolongs progression-free time in patients with advanced melanoma undergoing anti-PD1 therapy

Cancer. 2023 Apr 24. doi: 10.1002/cncr.34718. Online ahead of print.

ABSTRACT

BACKGROUND: Vitamin D3 is a prohormone with pleiotropic effects, including modulating the functions of the immune system and may affect the effectiveness of anti-PD-1 treatment in patients with cancer. According to the literature, the potential mechanism of vitamin D’s influence on the effectiveness of therapy is most likely related to the amount and activity of tumor-infiltrating lymphocytes. There are data showing the effect of vitamin D on cells regulating the activity of CD8 lymphocytes.

METHODS: A total of 200 patients with advanced melanoma were included in the study. All patients received anti-PD-1 immunotherapy (nivolumab or pembrolizumab) as first-line treatment. Serum vitamin D levels were measured in patients both before and every 12 weeks during treatment. Part of the group had vitamin D measured retrospectively from the preserved serum. The other part of the supplementation group was tested prospectively.

RESULTS: The response rate in the group with low vitamin D levels and not supplemented was 36.2%, whereas in the group with normal baseline levels or a normal level obtained with supplementation was 56.0% (p = .01). Moreover, progression-free survival in these groups was 5.75 and 11.25 months, respectively (p = .03). In terms of overall survival, there was also a difference in favor of the group with normal vitamin D levels (27 vs. 31.5 months, respectively; p = .39).

CONCLUSIONS: In our opinion, maintaining the vitamin D level within the normal range during anti-PD-1 immunotherapy in advanced melanoma patients should be a standard procedure allowing the improvement of treatment outcomes.

PMID:37089083 | DOI:10.1002/cncr.34718