Tag: nevin manimala

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

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

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

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

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

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

Ann Hepatobiliary Pancreat Surg. 2023 Apr 24. doi: 10.14701/ahbps.22-127. Online ahead of print.

ABSTRACT

BACKGROUNDS/AIMS: Laparoscopic cholecystectomy within one week of acute cholecystitis is considered safe and advantageous. Surgery beyond first week is reserved for non-resolving attack or complications. To compare clinical outcomes of patients undergoing laparoscopic cholecystectomy in the first week and between two to six weeks of an attack of acute cholecystitis.

METHODS: In an analysis of a prospectively maintained database, all patients who underwent laparoscopic cholecystectomy for acute cholecystitis were divided into two groups: group A, operated within one week; and group B, operated between two to six weeks of an attack. Main variables studied were mean operative time, conversion to open cholecystectomy, morbidity profile, and duration of hospital stay.

RESULTS: A total of 116 patients (74 in group A and 42 in group B) were included. Mean interval between onset of symptoms & surgery was five days (range, 1-7 days) in group A and 12 days (range, 8-20 days) in group B. Operative time and incidence of subtotal cholecystectomy were higher in group B (statistically not significant). Mean postoperative stay was 2 days in group A and 3 days in group B. Laparoscopy was converted to open cholecystectomy in two patients in each group. There was no incidence of biliary injury. One patient in group B died during the postoperative period due to continued sepsis and multiorgan failure.

CONCLUSIONS: In tertiary care setting, with adequate surgical expertise, laparoscopic cholecystectomy can be safely performed in patients with acute cholecystitis irrespective of the time of presentation.

PMID:37088998 | DOI:10.14701/ahbps.22-127

Adv Kidney Dis Health. 2023 May;30(3):285-293. doi: 10.1053/j.akdh.2022.12.009.

ABSTRACT

This article describes the use of prognostic, predictive, and response biomarkers that have been developed for autosomal dominant polycystic kidney disease and their use in clinical care or drug development. We focus on biochemical markers that can be assayed in patients’ blood and urine and their association with the outcome of decreased glomerular filtration rate. There have been several studies on prognostic biomarkers. The most promising ones have been markers of tubular injury, inflammation, metabolism, or the vasopressin-urinary concentration axis. So far, none have been shown to be superior to kidney volume-based biomarkers. Several biomarkers are additive to kidney volume and genotype in prognostic models, but there have been few direct comparisons between the biochemical markers to identify the best ones. Moreover, there is a lack of uniformity in the statistical tools used to assess and compare biomarkers. There have been few reports of predictive and response biomarkers, and none are suitable surrogate endpoints. The U.S. Food and Drug Administration’s Biomarker Qualification Program provides a regulatory pathway to approve biomarkers for use across multiple drug-development programs.

PMID:37088529 | DOI:10.1053/j.akdh.2022.12.009

Behav Ther. 2023 May;54(3):476-495. doi: 10.1016/j.beth.2022.11.005. Epub 2022 Dec 19.

ABSTRACT

Stepped care approaches have been developed to increase treatment accessibility for individuals with posttraumatic stress disorder (PTSD). However, despite guidelines recommending stepped care, it is currently unclear how the approach compares to other treatments for PTSD in terms of symptom reduction, cost, and client-rated acceptability. We conducted a systematic review and meta-analysis of randomized controlled and open trials evaluating stepped care prevention (i.e., targeting those with recent trauma exposure at risk of developing PTSD) and treatment approaches for adults and adolescents/children with PTSD. Eight prevention and four treatment studies were included. There was considerable variation in the sample types, stepped approaches, and control conditions. Most studies found no significant differences between stepped care (both prevention and treatment) and control (active and usual care) in terms of PTSD severity, loss of PTSD diagnosis, depression severity, and quality of life at the final follow-up. There was some evidence to suggest that stepped care was more cost-effective, and as acceptable or more acceptable compared to controls. Interpretations were tempered by high statistical heterogeneity, risk of bias, and lack of recommended evidence-based treatments. Stepped care can make PTSD treatment more accessible; however, more high-quality research is needed comparing stepped care to active controls.

PMID:37088505 | DOI:10.1016/j.beth.2022.11.005

Cancer Nurs. 2023 Apr 24. doi: 10.1097/NCC.0000000000001231. Online ahead of print.

ABSTRACT

BACKGROUND: Mind-body therapies (MBTs) have gained popularity among patients with cancer as a supportive therapy. To date, no systematic reviews have assessed the effect of MBTs on the health outcomes in women with gynecological cancer.

OBJECTIVE: This systematic review and meta-analysis aimed to synthesize the effectiveness of MBTs on quality of life, anxiety, depression, cancer-related pain, and fatigue among women with gynecological cancer.

METHODS: We searched and screened randomized controlled trials in 7 databases, trial registries, and gray literature from the databases’ inception to December 2021. Data were extracted from eligible studies, with each study’s quality assessed using the Cochrane risk-of-bias tool. Meta-analyses were conducted using RevMan 5.4. Sensitivity and subgroup analyses were performed. The quality of evidence across the studies was assessed using the Grading of Recommendations Assessment, Development and Evaluation approach.

RESULTS: Nine trials were included. Statistically significant effects of MBTs on depression (standardized mean difference, -0.56; 95% confidence interval, -1.01 to -0.11; P = .01), pain (standardized mean difference, -1.60; 95% confidence interval, -3.14 to -0.07; P = .04), and fatigue (standardized mean difference, -1.17; 95% confidence interval, -2.16 to -0.18; P = .02) were observed, but not on quality of life and anxiety. The quality of evidence was low due to the high risks of bias and high heterogeneity among the studies.

CONCLUSIONS: Mind-body therapies were effective in reducing depression, pain, and fatigue of women with gynecological cancer. However, the low quality of the evidence implies the need for more future studies with better methodologies.

IMPLICATIONS FOR PRACTICE: Mind-body therapies may be used as an additional strategy to help manage depressive mood, pain, and fatigue among women with gynecological cancer.

PMID:37088901 | DOI:10.1097/NCC.0000000000001231