Tag: statistics

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

J Clin Monit Comput. 2023 Apr 24. doi: 10.1007/s10877-023-01005-5. Online ahead of print.

ABSTRACT

Clinical utility of perfusion index (PI) has entered a new realm as a non-invasive, quantitative index of stress response to endotracheal intubation. Transoral robotic surgery (TORS) involves F-K retractor aided docking of the surgical robot producing haemodynamic and stress responses akin to laryngoscopy. We compared the stress response to videolaryngoscopy with that due to docking of da Vinci surgical robot using PI, heart rate and mean arterial pressure evaluated at specific time points post-laryngoscopy and post-docking. Twenty-six adult patients, scheduled for TORS under general endotracheal anaesthesia were included in this prospective, observational, single-centric cohort study. Statistical analysis included paired samples t-test, dotted box-whisker plots, trendlines and correlograms for comparative analysis of two stressors, laryngoscopy and docking. Baseline PI was 4.14. PI values increased post-midazolam (4.23), 1 min (5.69) and 3 min (6.25) post anaesthetic-induction, plummeted at laryngoscopy (3.24), remained low at 1 min (3.68), 3 min (4.69) thereafter, and were highest at 10 min (6.17) post-laryngoscopy and predocking (6.84). Docking witnessed a fall in PI (4.1), which remained low at 1 min (4.02), 3 min (4.31) and 10 min (4.79) post-docking. PI was significantly higher at laryngoscopy compared with PI at docking (p = 0.0044). At 1 min and 3 min post-laryngoscopy and post-docking, respectively, the differences in PI were statistically insignificant. PI at 10 min post-laryngoscopy was significantly lower than PI at 10 min post-docking (p < 0.0001). As non-invasively quantified by PI, videolaryngoscopic stress response is more intense but shorter-lived versus that due to docking. PI displays a negative correlation with haemodynamic variables. PI at laryngoscopy is a good predictor of PI at docking, enabling pre-emptive measures (fentanyl bolus; deepening of volatile anaesthesia from MAC-maintenance to MAC-intubation) anticipating the docking-induced stress response.Trial registration http://ctri.nic.in ; Identifier: CTRI/2019/11/022091.

PMID:37088851 | DOI:10.1007/s10877-023-01005-5

World J Surg Oncol. 2023 Apr 24;21(1):135. doi: 10.1186/s12957-023-02996-w.

ABSTRACT

OBJECTIVE: Although synchronous multiple primary lung cancers (sMPLCs) are common in clinical practice, the choice of surgical modalities for the main lesion is still at the stage of exploration. This study is designed to analyze the prognosis of sMPLCs and single primary lung cancers with similar tumor stages and to explore whether sublobar resection has a similar prognosis as lobectomy for sMPLCs.

METHODS: One-hundred forty-one cases of sMPLCs were selected, including the following: 65 cases underwent lobectomy for main lesions, and 76 cases underwent sublobar resection for main lesions. One thousand one hundred forty-four cases of single primary lung cancer were matched at 1:1 by propensity score matching. Then, the patients with sMPLCs were divided into a lobectomy group and a sublobar group according to the first tumor stage. Ninety-eight cases of patients with sMPLCs were matched. The short-term perioperative effect, 5-year disease-free survival (DFS) rate, and 5-year overall survival (OS) rate between the two groups were compared.

RESULTS: There was no significant difference in OS between sMPLCs and single primary lung cancer after lobectomy (77.1% vs. 77.2%, P = 0.157) and sublobar resection (98.7% vs. 90.7%, P = 0.309). There was no significant difference in OS (86.7% vs. 83.9%, P = 0.482) or DFS (67.6 vs. 87.7%, P = 0.324) between the lobectomy group and sublobar group with sMPLCs. The sublobar resection group obtained a lower incidence of postoperative complications (40.8% vs. 16.3%, P = 0.007) and shorter postoperative hospital stay (11.22 vs. 9.27, P = 0.049).

CONCLUSION: The prognosis of patients with sMPLCs generally depends on the main tumor state, which has no statistical difference regardless of sublobar resection or lobectomy, and the perioperative period of sublobar resection is safer than that of lobectomy.

PMID:37088839 | DOI:10.1186/s12957-023-02996-w

Thromb J. 2023 Apr 24;21(1):47. doi: 10.1186/s12959-023-00470-x.

ABSTRACT

The first case of Vaccine-Induced Thrombotic Thrombocytopenia (VITT) was reported in the letter-to-editor submission in the journal of Indian Journal of Hematology and Blood Transfusion which was published online on 29th Sep 2021. Whereas, an article published in your journal on 04th Mar 2022 has been titled as first report of VITT from India which is a very conflicting statistic. The former article under reference has been diagnosed by a confirmatory functional assay as per the recommended guidelines and is thus genuinely the first case reported in this country.

PMID:37088835 | DOI:10.1186/s12959-023-00470-x