Tag: statistics

Chronic Obstr Pulm Dis. 2022 Apr 9. doi: 10.15326/jcopdf.2021.0263. Online ahead of print.

ABSTRACT

RATIONALE: It has been suggested that patients with COPD experience considerable daily respiratory symptom fluctuation. A standardized measure is needed to quantify and understand the implications of day-to-day symptom variability.

OBJECTIVES: To compare standard deviation with other statistical measures of symptom variability and identify characteristics of subjects with higher symptom variability.

METHODS: Individuals in the Subpopulations and Intermediate Outcome Measures in COPD Study (SPIROMICS) Exacerbations sub-study completed an Evaluating Respiratory Symptoms in COPD (E-RS) daily questionnaire. We calculated within-subject standard deviation (WS-SD) for each patient at week 0 and correlated this with measurements obtained four weeks later using Pearson’s r and Bland Altman plots. Median WS-SD value dichotomized participants into higher versus lower variability groups. Association between WS-SD and exacerbation risk during four follow up weeks was explored.

MEASUREMENTS AND MAIN RESULTS: Diary completion rates were sufficient in 140 (68%) of 205 sub-study participants. Reproducibility (r) of the WS-SD metric from baseline to week four was 0.32. Higher variability participants had higher St. George’s Respiratory Questionnaire (SGRQ) scores (47.3 ± 20.3 vs 39.6 ± 21.5, p=.04) than lower variability participants. Exploratory analyses found no relationship between symptom variability and HCRU exacerbations.

CONCLUSIONS: WS-SD of the E-RS can be used as a measure of symptom variability in studies of patients with COPD. Patients with higher variability have worse health-related quality of life. WS-SD should be further validated as a measure to understand the implications of symptom variability.

PMID:35403414 | DOI:10.15326/jcopdf.2021.0263

Zhongguo Zhen Jiu. 2022 Apr 12;42(4):385-9. doi: 10.13703/j.0255-2930.20210426-0003.

ABSTRACT

OBJECTIVE: To assess the efficacy on relieving pain and improving the range of motion of shoulder joint in post-stroke shoulder-hand syndrome of phlegm-stasis obstruction in treatment of the combined therapy of eye acupuncture, Tengliao (Chinese herbal warm dressing technique) and rehabilitation training (eye acupuncture + Tengliao + rehabilitation) as compared with the combined treatment of Tengliao and rehabilitation training (Tengliao + rehabilitation) and the simple rehabilitation training (rehabilitation).

METHODS: A total of 356 patients with post-stroke shoulder-hand syndrome of phlegm-stasis obstruction were randomized into an eye acupuncture + Tengliao + rehabilitation group (group A, 122 cases, 2 cases dropped off), a Tengliao + rehabilitation group (group B, 120 cases, 3 cases dropped off) and a rehabilitation group (group C, 114 cases, 1 case dropped off). In the group C, the basic treatment was combined with routine rehabilitation training. In the group B, on the base of the treatment as the group C, Tengliao was exerted. A medical bag composed of over 20 Chinese herbal materials was heated and dressed at the affected area, 30 min each time, 5 times weekly. In the group A, besides the treatment as the group B, eye acupuncture was applied to heart region, kidney region, upper jiao region and lower jiao region, 30 min each time, 5 times weekly. The treatment lasted 28 days in all of three groups. Separately, before treatment, in 7, 14, 21 and 28 days of treatment, as well as in 14 days after treatment of follow-up, the score of visual analogue scale (VAS) for pain, the score of guides to evaluation of permanent impairment (GEPI) and the score of National Institutes of Health stroke scale (NIHSS) were observed in each group.

RESULTS: The scores of VAS, GEPI and NIHSS were all improved with the treatment lasting in the three groups (P<0.000 1). In 7, 14, 21 and 28 days of treatment and in follow-up as well, VAS scores in the group A were all lower than the group C (P<0.05). After 14 days of treatment, GEPI score showed increasing trend, while NIHSS score showed decreasing trend in the group A compared with the group B. Before treatment, GEPI score was lower and NIHSS score was higher in the group A compared with the group C (P<0.05). It was suggested that the illness was slightly serious in the group A. After propensity score matching, in 14, 21 and 28 days as well as in follow-up, GEPI scores in the group A were higher than the group C respectively (P<0.05). Regarding NIHSS score at each time point, the difference had no statistical significance between the group A and the group C (P>0.05).

CONCLUSION: The combined therapy of eye acupuncture, Tengliao and rehabilitation training obtains a better efficacy on post-stroke shoulder-hand syndrome of phlegm-stasis obstruction as compared with rehabilitation training.

PMID:35403396 | DOI:10.13703/j.0255-2930.20210426-0003

Acta Ophthalmol. 2022 Apr 11. doi: 10.1111/aos.15156. Online ahead of print.

ABSTRACT

PURPOSE: To evaluate neuroretinal integrity in different subtypes of optical coherence tomography (OCT)-graded partial-thickness macular holes.

METHODS: Fovea-centred SD-OCT images (Cirrus, Carl Zeiss Meditec AG; Spectralis, Heidelberg Engineering GmbH) and visual acuity (VA) acquired at every visit were analysed by two retina specialists retrospectively in 71 eyes of 65 patients. Partial-thickness macular holes were classified as lamellar macular hole (LMH), epiretinal membrane foveoschisis (ERMF) or macular pseudohole (MPH).

RESULTS: Lamellar macular hole, ERMF and MPH were diagnosed in 33 (47%), 31 (43%) and 7 (10%) eyes with a VA of 0.18 ± 0.25, 0.15 ± 0.2, and 0.06 ± 0.08 (p = 0.323), respectively. Median follow-up time was 11 (interquartile range 4-32.5), 10 (interquartile range 5-18) and 19 (interquartile range 8-24) months in LMH, ERMF and MPH. In all subgroups, VA remained stable during the follow-up (p = 0.652, p = 0.915 and p = 1.000). Epiretinal proliferations (EP) were present in 12 LMH and 3 ERMF. At baseline, eyes with EP had significantly worse VA (p < 0.001), wider foveal cavities (p = 0.007) and thinner foveal floors (p < 0.001) compared with eyes without EP. Twelve out of 15 eyes with EP showed exudative cystoid spaces. Among all 71 eyes, 51 remained morphologically and functionally stable during follow-up.

CONCLUSION: In our study cohort, EP are associated with worse VA and advanced neuroretinal tissue loss presenting with wider foveal cavities and thinner foveal floors. During the follow-up period, VA remained stable in all entities of partial-thickness macular holes.

PMID:35403361 | DOI:10.1111/aos.15156

Obesity (Silver Spring). 2022 Apr 10. doi: 10.1002/oby.23395. Online ahead of print.

ABSTRACT

OBJECTIVE: This study sought to evaluate the effect of 52 weeks of exenatide extended release (XR) on the maintenance of meal replacement therapy (MRT)-induced BMI reduction in adolescents with severe obesity.

METHODS: In this randomized, double-blind, placebo-controlled trial, 100 participants aged 12 to 18 years with BMI ≥ 1.2 × 95th percentile were enrolled in a short-term MRT run-in phase. Those who achieved ≥5% BMI reduction during the run-in were then randomized to 52 weeks of exenatide XR 2.0 mg or placebo weekly. Both groups also received lifestyle therapy. The prespecified primary end point was mean percent change in BMI from randomization (post run-in) to 52 weeks in the intention-to-treat population.

RESULTS: A total of 100 participants were enrolled, and 66 (mean age 16 = [SD 1.5] years; 47% female) achieved ≥5% BMI reduction with MRT and were randomized (33 to exenatide XR and 33 to placebo). From randomization (post run-in) to 52 weeks, mean BMI increased 4.6% and 10.1% in the exenatide XR and placebo groups, respectively. The placebo-subtracted exenatide XR treatment effect was -4.1% (95% CI: -8.6% to 0.5%, p = 0.078).

CONCLUSIONS: Although not achieving statistical significance, exenatide XR, compared with placebo, may partly mitigate the propensity toward BMI rebound in adolescents who achieved initial weight loss with dietary intervention.

PMID:35403350 | DOI:10.1002/oby.23395

Infancy. 2022 Apr 11. doi: 10.1111/infa.12467. Online ahead of print.

ABSTRACT

Interaction with unfamiliar partners is a component of social life from infancy onward. Yet little is known about preverbal communication with strangers. This study compared the development of infant communication with strangers to communication with mothers and fathers and examined the contribution of temperament to partner-specific communication patterns. A sample of 58 infants was observed at four and eight months during separate home-based face-to-face interactions with three partners (mother, father, and stranger). Infant visual, facial, and vocal communication behaviors were coded microanalytically. Each parent reported on infant temperament at both ages. Multilevel regression analyses indicated that infants gazed longer at strangers than at fathers, exhibited less smiling to strangers than to mothers, and produced fewer vocalizations with strangers than with either parent. Both age and temperament moderated these differences. Vocal communication with fathers became more frequent at eight months; smiling to mothers was accentuated among infants with higher levels of temperamental surgency. Importantly, levels of communication behaviors with strangers were concurrently and longitudinally associated with those with mothers and fathers. Overall, findings suggest that infant emotional communication patterns are modulated by individual temperamental differences and are reproduced in and over time, though at different levels, when interacting with novel partners.

PMID:35403337 | DOI:10.1111/infa.12467

Transbound Emerg Dis. 2022 Apr 10. doi: 10.1111/tbed.14556. Online ahead of print.

ABSTRACT

Porcine reproductive and respiratory syndrome (PRRS) is among the most devastating diseases affecting the pig industry. Despite vaccines having been available for decades, the remarkable genetic variability of this virus, leading to poor cross-protection, has limited their efficacy and other measures must be adopted to effectively control the viral circulation. Some recent studies have investigated the factors involved in viral spreading and persistence, at least at local level. However, despite the topic’s relevance, no statistically grounded evidence is currently available evaluating the variables more involved in PRRSV epidemiological success at a broader scale, like the European one. In the present study, an extensive phylodynamic and phylogeographic analysis was performed on more than one thousand ORF5 sequences to investigate the history, dynamics and spreading patterns of PRRSV within European borders. Moreover, several potential predictors, representative of swine population features and trade, human population, economy and geographic characteristics, were evaluated through a specifically designed generalized linear model (GLM) to assess their weight on viral migration rate between countries over time. Although pig stock density, mean PRRSV strains genetic diversity, investments in agriculture (including a likely role of vaccination) and farmer education were involved to a certain extent, the major determinant was proven to be by far the live pig trade. Providing a robust depiction of PRRSV European molecular epidemiology patterns and determinants, the present study could contribute to a more rational allocation of limited resources based on an effective prioritization of control measures This article is protected by copyright. All rights reserved.

PMID:35403349 | DOI:10.1111/tbed.14556

J Clin Lab Anal. 2022 Apr 11:e24429. doi: 10.1002/jcla.24429. Online ahead of print.

ABSTRACT

OBJECTIVE: The aim of this study was to investigate the diagnostic value of peripheral blood neutrophil-to-lymphocyte ratio (NLR) combined with the thyroid imaging reporting and data system (TIRADS) for benign and malignant thyroid nodules.

METHODS: A total of 585 adults were enrolled in the study. The receiver operating characteristic curves were used to determine the optimal cut-off values for NLR and Kwak TIRADS (K-TIRADS) grades, which were 1.87 and 4a, respectively. Thyroid nodules were scored as follows: NLR-K-TIRADS score is 2 (both elevated K-TIRADS grade and NLR), NLR-K-TIRADS score is 1 (one of these was elevated) and NLR-k-TIRADS score is 0 (neither were elevated).

RESULTS: The proportions of malignant nodules with NLR-K-TIRADS scores of 2, 1 and 0 were 98.59%, 69.62% and 10.19%, and the difference was statistically significant (p < 0.001). In terms of the sensitivity of diagnosis of malignant nodules, NLR-K-TIRADS 1 tends to increase relative to K-TIRADS grades ≥ 4a; in terms of specificity and positive predictive value for the diagnosis of malignant nodules, NLR-K-TIRADS 2 was significantly higher than K-TIRADS grades ≥ 4a (all p < 0.05).

CONCLUSIONS: NLR combined with K-TIRADS grades may be a novel method for screening benign and malignant thyroid nodules.

PMID:35403307 | DOI:10.1002/jcla.24429

Stat Med. 2022 Apr 30;41(9):1728-1732. doi: 10.1002/sim.9123.

NO ABSTRACT

PMID:35403287 | DOI:10.1002/sim.9123

J Clin Pharmacol. 2022 Apr 10. doi: 10.1002/jcph.2061. Online ahead of print.

ABSTRACT

BROCADE3 is a Phase 3 study, evaluating veliparib in combination with carboplatin/paclitaxel with continuation as monotherapy if carboplatin/paclitaxel is discontinued in patients with germline BRCA1/2 mutation-associated, advanced HER2-negative breast cancer. The objective of the current analysis was to characterize the veliparib exposure-response relationships for efficacy (progression-free survival; PFS) and safety in this study. Exposure-efficacy analyses of PFS were conducted using Kaplan-Meier plots and Cox Proportional Hazards (CPH) models using treatment alone or both treatment and exposure as time-dependent predictors to estimate the effect of veliparib in combination with carboplatin/paclitaxel and as monotherapy. The CPH model with only treatment as the time-varying predictor estimated a statistically significant benefit of veliparib monotherapy compared to placebo monotherapy (HR = 0.49 [95% CI, 0.33-0.73]) and a modest, non-statistically significant benefit (HR = 0.81 [95% CI, 0.62-1.05]) of adding veliparib to carboplatin/paclitaxel. Inclusion of exposure as an additional time-varying predictor in the CPH model indicated a flat exposure-response relationship between the veliparib exposure and PFS when veliparib was administered in combination with carboplatin/paclitaxel or as monotherapy. The exposure-safety analysis did not reveal any meaningful exposure-dependent trend in the incidence of adverse events of interest. These analyses support the dose regimen of veliparib (120 mg twice daily) in combination with carboplatin/paclitaxel and continuation of veliparib (300 to 400 mg twice daily) as monotherapy if carboplatin/paclitaxel were discontinued before disease progression in this patient population. This study is registered with ClinicalTrials.gov with a registration ID: NCT02163694. This article is protected by copyright. All rights reserved.

PMID:35403245 | DOI:10.1002/jcph.2061

Proteins. 2022 Apr 10. doi: 10.1002/prot.26343. Online ahead of print.

ABSTRACT

The startling diversity in αβ T cell receptor (TCR) sequences and structures complicates molecular-level analyses of the specificity and sensitivity determining T cell immunogenicity. A number of 3D structures are now available of ternary complexes between TCRs and peptide:major histocompatibility complexes (pMHC). Here, to glean molecular-level insights we analyze structures of TCRs bound to human class I nonamer peptide-MHC complexes. Residues at peptide positions 4 to 8 are found to be particularly important for TCR binding. About 90% of the TCRs hydrogen bond with one or both of the peptide residues at positions 4 and 8 presented by MHC allele HLA-A2, and this number is still ~79% for peptides presented by other MHC alleles. Residue 8, which lies outside the previously-identified central peptide region, is crucial for TCR recognition of class I MHC-presented nonamer peptides. The statistics of the interactions also sheds light on the MHC residues important for TCR binding. The present analysis will aid in the structural modeling of TCR:pMHC complexes and has implications for the rational design of peptide-based vaccines and T cell-based immunotherapies.

PMID:35403257 | DOI:10.1002/prot.26343