Tag: statistics

Asia Pac J Clin Oncol. 2022 Mar 14. doi: 10.1111/ajco.13687. Online ahead of print.

ABSTRACT

AIMS: To investigate the implications of soluble programmed cell death-ligand 1 (sPD-L1) in hepatocellular carcinoma (HCC) patients treated with transarterial chemoembolization (TACE) and to evaluate the potential value of sPD-L1 to guide selection of the optimal time to begin combination therapy with TACE and immune checkpoint inhibitors (ICIs).

MATERIALS AND METHODS: Thirty-one HCC patients suitable for TACE and 55 healthy volunteers were enrolled in this study. Three milliliters of peripheral venous blood of patients were collected on 1 day before TACE and 3, 7, and 30 days after TACE respectively for assay of sPD-L1 using enzyme-linked immunosorbent assay. The associations of the sPD-L1 level with the clinical features, outcomes, and the fluctuation of sPD-L1 during the treatment were analyzed.

RESULTS: The initial sPD-L1 level of patients was significantly higher than that of the control group. And it was significantly associated with BCLC stage, portal venous invasion, tumor size, and number of foci. The sPD-L1 levels of 3 and 7 days after TACE were both significantly higher than the initial level. And that of 30 days after TACE was lower than the initial level, but the difference was not statistically significant. There was no significant difference of sPD-L1 level after embolization with embolic beads of different size. The level of sPD-L1 of CR patients was lower than that of PR, SD patients, but the differences were not significant.

CONCLUSION: The level of sPD-L1 was associated with tumor aggressiveness and outcomes, suggesting its role as a possible predictive biomarker. The increases in sPD-L1 after TACE suggests that combined treatment with TACE and ICIs may be a promising therapeutic strategy in HCC. One week after TACE might be a suitable time to begin the administration of immunotherapy.

PMID:35289092 | DOI:10.1111/ajco.13687

Clin Otolaryngol. 2022 Mar 15. doi: 10.1111/coa.13929. Online ahead of print.

ABSTRACT

OBJECTIVES: To identify paediatric intracapsular Coblation tonsillectomy procedures from routine administrative data in England, and determine their safety.

DESIGN: Retrospective observational cohort study of four ENT centres using routine data from Hospital Episode Statistics (HES).

SETTING: Acute NHS trusts in England conducting exclusively intracapsular Coblation tonsillectomy PARTICIPANTS: Children (≤16 years old) undergoing bilateral intracapsular Coblation tonsillectomy MAIN OUTCOME MEASURES: Number of procedures, readmissions for pain, readmissions for bleeding and requirement for additional surgery for regrowth.

RESULTS: 5525 procedures were identified. The median patient age was 4 (IQR 2-5). In-hospital complications occurred in 1%, with 0.1% returning to theatre for arrest of primary tonsil bleeding. Almost half of the procedures were conducted as a day-case (44%), with only a small proportion staying in hospital more than one night (7%). Within 28 days, 1.2% of patients were readmitted with bleeding, 0.7% with infection and 0.3% with pain. 0.2% of patients required return to theatre for control of secondary haemorrhage. Longitudinal follow-up has found that revision tonsil surgery is 0.3% at 1 year (n=4498), 1.1% at 2 years (n=2938), 1.7% at 3 years (n=1781), 1.9% at 4 years (n=905), 2.2% at 5 years (n=305) CONCLUSIONS: Intracapsular coblation tonsillectomy safety outcomes in this study show primary and secondary bleed rates and emergency return to theatre rates are lower than all tonsillectomy techniques reported in the National Prospective Tonsillectomy Audit and also lower than previously published Hospital Episode Statistics analysis of tonsillectomy procedures.

PMID:35289094 | DOI:10.1111/coa.13929

J Thromb Haemost. 2022 Mar 15. doi: 10.1111/jth.15699. Online ahead of print.

ABSTRACT

INTRODUCTION: Symptomatic venous thromboembolism (VTE) is diagnosed in 3-14% of patients during pediatric acute lymphoblastic leukemia (ALL) therapy. There are well-known risk factors, but the role of others as inherited thrombophilia is still controversial. Prophylaxis with low molecular weight heparin (LMWH) has been described, but its use is not globally accepted.

METHODS: A retrospective multicentric study in ALL patients 1-18 years old following SEHOP-PETHEMA-2013 treatment guideline was performed to evaluate VTE rate, anticoagulant treatment, outcome, risk factors, and safety and usefulness of LMWH administration as primary thromboprophylaxis in children with inherited thrombophilia.

RESULTS: A total of 652 patients were included in the study. VTE incidence was 8.7%. Most of the cases occurred during induction therapy, associated to central venous catheter. Univariant analysis showed that family history of thrombosis, presence of mediastinal mass, high-risk treatment group and inherited thrombophilia were statistically significant risk factors. LMWH administration seemed to decrease VTE rate in patients with inherited thrombophilia and those with T-ALL phenotype.

CONCLUSION: Most of VTE cases occurred in patients without inherited thrombophilia, but when it is present, VTE risk is higher. LMWH administration was useful to decrease VTE in these patients.

PMID:35289066 | DOI:10.1111/jth.15699

Dyslexia. 2022 Mar 14. doi: 10.1002/dys.1711. Online ahead of print.

ABSTRACT

The assumption that statistical learning is affected in dyslexia has generally been evaluated in children and adults with diagnosed dyslexia, not in pre-literate children with a family risk (FR) of dyslexia. In this study, four-to-five-year-old FR children (n = 25) and No-FR children (n = 33) completed tasks of emerging literacy (phoneme awareness and RAN). They also performed an online non-adjacent dependency learning (NADL) task, based on the Serial Reaction Time (SRT) task paradigm. Children’s accuracy (hits), signal sensitivity (d’) and reaction times were measured. The FR group performed marginally more poorly on phoneme awareness and significantly more poorly on RAN than the No-FR group. Regarding NADL outcomes, the results were less straightforward: the data suggested successful statistical learning for both groups, as indicated by the hit and reaction time curves found. However, the FR group was less accurate and slower on the task than the No-FR group. Furthermore, unlike the No-FR group, performance in the FR group varied as a function of the specific stimulus presented. Taken together, these findings fail to show a robust difference in statistical learning between children with and without an FR of dyslexia at preschool age, in line with earlier work on older children and adults with dyslexia.

PMID:35289019 | DOI:10.1002/dys.1711

BJOG. 2022 Mar 14. doi: 10.1111/1471-0528.17138. Online ahead of print.

ABSTRACT

OBJECTIVE: To quantify parents’ experiences of respectful care around stillbirth globally.

DESIGN: Multi-country, online, cross-sectional survey.

SETTING AND POPULATION: Self-identified bereaved parents (n=3769) of stillborn babies from 44 high- and middle-income countries.

METHODS: Parents’ perspectives of 7 aspects of care quality, factors associated with respectful care, and 7 bereavement care practices were compared across geographical regions using descriptive statistics. Respectful care was compared between country income groups using multivariable logistic regression.

MAIN OUTCOME MEASURES: Self-reported experience of care around the time of stillbirth RESULTS: A quarter (25.4%) of 3769 respondents reported disrespectful care after stillbirth and 23.5% reported disrespectful care of their baby. Gestation <30 weeks, and primiparity were associated with disrespect. Reported respectful care was lower in middle-income countries (MICs) than in high-income countries (HICs) (aOR=0.35, 95%CI (0.29-0.42), p <0.01). In many countries, aspects of care quality need improvement, such as ensuring families have enough time with providers. Participating respondents from Latin America and Southern Europe reported lower satisfaction across all aspects of care quality compared to Northern Europe. Unmet need for memory-making activities in MICs is high.

CONCLUSIONS: Many parents experience disrespectful care around stillbirth. Provider training, and system-level support to address practical barriers are urgently needed. However, some practices (which are important to parents) can be readily implemented such as memory-making activities and referring to the baby by name.

PMID:35289061 | DOI:10.1111/1471-0528.17138

J Magn Reson Imaging. 2022 Mar 15. doi: 10.1002/jmri.28150. Online ahead of print.

ABSTRACT

BACKGROUND: Diffusion kurtosis imaging (DKI) is used to differentiate between benign and malignant breast lesions. DKI fits are performed either on voxel-by-voxel basis or using volume-averaged signal.

PURPOSE: Investigate and compare DKI parameters’ diagnostic performance using voxel-by-voxel and volume-averaged signal fit approach.

STUDY TYPE: Retrospective.

STUDY POPULATION: A total of 104 patients, aged 24.1-86.4 years.

FIELD STRENGTH/SEQUENCE: A 3 T Spin-echo planar diffusion-weighted sequence with b-values: 50 s/mm² , 750 s/mm² , and 1500 s/mm² . Dynamic contrast enhanced (DCE) sequence.

ASSESSMENT: Lesions were manually segmented by M.P. under supervision of S.O. (2 and 5 years of experience in breast MRI). DKI fits were performed on voxel-by-voxel basis and with volume-averaged signal. Diagnostic performance of DKI parameters DK (kurtosis corrected diffusion coefficient) and kurtosis K was compared between both approaches.

STATISTICAL TESTS: Receiver operating characteristics analysis and area under the curve (AUC) values were computed. Wilcoxon rank sum and Students t-test tested DKI parameters for significant (P <0.05) difference between benign and malignant lesions. DeLong test was used to test the DKI parameter performance for significant fit approach dependency. Correlation between parameters of the two approaches was determined by Pearson correlation coefficient.

RESULTS: DKI parameters were significantly different between benign and malignant lesions for both fit approaches. Median benign vs. malignant values for voxel-by-voxel and volume-averaged approach were 2.00 vs. 1.28 ( DK in μm² /msec), 2.03 vs. 1.26 ( DK in μm² /msec), 0.54 vs. 0.90 ( K ), 0.55 vs. 0.99 ( K ). AUC for voxel-by-voxel and volume-averaged fit were 0.9494 and 0.9508 ( DK ); 0.9175 and 0.9298 ( K ). For both, AUC did not differ significantly (P = 0.20). Correlation of values between the two approaches was very high (r = 0.99 for DK and r = 0.97 for K ).

DATA CONCLUSION: Voxel-by-voxel and volume-averaged signal fit approach are equally well suited for differentiating between benign and malignant breast lesions in DKI.

EVIDENCE LEVEL: 3 TECHNICAL EFFICACY: Stage 3.

PMID:35289015 | DOI:10.1002/jmri.28150

Mycoses. 2022 Mar 15. doi: 10.1111/myc.13437. Online ahead of print.

ABSTRACT

BACKGROUND: The sudden surge of mucormycosis cases which happened during the second wave of Covid-19 pandemic was a significant public health problem in India.

OBJECTIVES: To analyse the clinico-epidemicological characteristics of the mucormycosis cases to determine the changes that had occurred due to Covid -19 pandemic.

METHODOLOGY: A retrospective cross-sectional study was conducted at the Department of Otolaryngology Head and Neck Surgery, PGIMER, Chandigarh, India. Patients diagnosed with Rhino-orbital mucormycosis were categorized into the following groups: Pre- pandemic(May 2019 to April 2020), Pandemic Pre-epidemic (May 2020 to April 2021), and Epidemic (May 1, 2021, to July 12, 2021). The epidemiological, clinical and surgical data of all the patients were retrieved from the hospital records and analyzed.

RESULTS: The epidemic period had 370 cases, compared to 65 during pandemic period and 42 in the pre-pandemic period. Diabetes mellitus was seen in 87% of cases during epidemic period, 92.9% in the pre-pandemic period and 90.8% in the pre-pandemic pre-epidemic period. The proportion of patients suffering from vision loss, restricted extra-ocular movements, palatal ulcer and nasal obstruction was higher in the pre-epidemic groups and the difference was significant (p, <0.01). There was no history of oxygen use in 85.9% of patients and no steroid use in 76.5%. The death rates were the lowest during epidemic (10%).

CONCLUSION: Covid -19 has caused a statistically significant increase in the number of mucormycosis infections. The mortality and morbidity which showed an increase during the first wave of Covid-19 decreased significantly during the epidemic period.

PMID:35289000 | DOI:10.1111/myc.13437

Stat Med. 2022 Mar 14. doi: 10.1002/sim.9375. Online ahead of print.

ABSTRACT

The marginal Fine-Gray proportional subdistribution hazards model is a popular approach to directly study the association between covariates and the cumulative incidence function with clustered competing risks data, which often arise in multicenter randomized trials or multilevel observational studies. To account for the within-cluster correlations between failure times, the uncertainty of the regression parameters estimators is quantified by the robust sandwich variance estimator, which may have unsatisfactory performance with a limited number of clusters. To overcome this limitation, we propose four bias-corrected variance estimators to reduce the negative bias of the usual sandwich variance estimator, extending the bias-correction techniques from generalized estimating equations with noncensored exponential family outcomes to clustered competing risks outcomes. We further compare their finite-sample operating characteristics through simulations and two real data examples. In particular, we found the Mancl and DeRouen (MD) type sandwich variance estimator generally has the smallest bias. Furthermore, with a small number of clusters, the Wald t -confidence interval with the MD sandwich variance estimator carries close to nominal coverage for the cluster-level effect parameter. The t -confidence intervals based on the sandwich variance estimator with any one of the three types of multiplicative bias correction or the z -confidence interval with the Morel, Bokossa and Neerchal (MBN) type sandwich variance estimator have close to nominal coverage for the individual-level effect parameter. Finally, we develop a user-friendly R package crrcbcv implementing the proposed sandwich variance estimators to assist practical applications.

PMID:35288959 | DOI:10.1002/sim.9375

Aust Occup Ther J. 2022 Mar 15. doi: 10.1111/1440-1630.12795. Online ahead of print.

ABSTRACT

INTRODUCTION: This study was conducted to examine the impact of a group cognitive rehabilitation program for people with dementia on everyday memory function and quality of life.

METHODS: Participants included in the study were community-dwelling adults with a diagnosis of dementia. The intervention was a 5-week occupational therapy lead group cognitive rehabilitation program delivered once a week for 1.5 h. Outcome measures included standardised memory tests, subjective everyday memory function and quality of life ratings. The measures were completed at baseline, post-intervention and 3-month post-intervention.

RESULTS: Outcome measures were completed with 58 participants. Statistically significant improvements in standardised memory scores were noted following the intervention. Similarly, self-rated everyday memory function and quality of life scores significantly improved following the intervention. All standardised scores and subjective ratings were maintained at 3-month follow-up.

CONCLUSION: Group-based cognitive rehabilitation programs can positively impact the quality of life and everyday memory function among people with dementia.

PMID:35288954 | DOI:10.1111/1440-1630.12795

Thromb Haemost. 2022 Mar 14. doi: 10.1055/s-0042-1743475. Online ahead of print.

ABSTRACT

BACKGROUND: Patients hospitalized with coronavirus disease-2019 (COVID-19) are at high risk of deep venous thrombosis (DVT) and pulmonary embolism (PE).

OBJECTIVES: The aims were to provide time trends in the 2020 nation-wide prevalence of venous thromboembolism (VTE) in patients hospitalized with a COVID-19 diagnosis in France, and to describe in-hospital and up to 30-day postdischarge death.

METHODS: All patients hospitalized in France with a COVID-19 diagnosis in 2020 were selected. Crude and age-adjusted prevalence of VTE and PE was computed by 4-week intervals and for the overall study period using Poisson regression. Time trends in in-hospital and 30-day postdischarge case-fatality rates were evaluated by comparing each 4-week intervals to weeks 10 to 14 corresponding to the first part of the first lockdown using logistic regression models.

RESULTS: Among the 287,638 patients hospitalized with a COVID-19 diagnosis in 2020 in France, 14,985 (5.2%) had a concomitant VTE, with 10,453 (3.6%) having PE and 4,532 (1.6%) having DVT. In patients admitted to intensive care units, the crude prevalence of VTE and PE reached 16.1 and 11.0% respectively during the first lockdown. After adjustment, the prevalence of VTE and PE decreased during the year 2020 but a rebound was observed during the second lockdown. In-hospital case-fatality rates among hospitalized COVID-19 patients with PE globally decreased between the first and the second epidemic waves.

CONCLUSION: Our study showed a decrease in the incidence of symptomatic VTE and PE in hospitalized COVID-19 patients, and a decreased time trend of outcomes during the second wave compared with the first one.

PMID:35288889 | DOI:10.1055/s-0042-1743475