Tag: statistics

J Clin Oncol. 2022 May 25:JCO2102558. doi: 10.1200/JCO.21.02558. Online ahead of print.

ABSTRACT

The approval of tisagenlecleucel and axicabtagene ciloleucel in 2017 marked a milestone in the development of oncology therapies. Since 2017, the breakthrough in treatment or even cure of previously intractable diseases represented by this new class of cancer treatments has continued with subsequent chimeric antigen receptor T (CAR T)-cell approvals. To date, the US Food and Drug Administration has approved five autologous CAR T-cell products for seven indications. A feature of autologous CAR T-cell products that differentiates them from traditional oncology drugs is that they need to be manufactured specifically for each patient. This feature has implications in study design, statistical analyses, and interpretation of study results. In this article, we share our experiences in the statistical review of CAR T-cell products and provide considerations for the design and statistical analyses of CAR T-cell trials. We also describe how the newly adopted estimand framework for clinical trials can help clarify nuanced issues in CAR T-cell trial design.

PMID:35613410 | DOI:10.1200/JCO.21.02558

Breastfeed Med. 2022 May 25. doi: 10.1089/bfm.2021.0371. Online ahead of print.

ABSTRACT

Background: The etiology of necrotizing enterocolitis (NEC) is controversially discussed. One of the most recently proposed causes of NEC is an allergy to cow’s milk protein. This study was designed to evaluate the effect of a maternal diet without bovine protein on the incidence of any NEC in very low birth weight (VLBW) infants. Materials and Methods: A pilot randomized controlled clinical trial was performed at Akbarabadi Hospital, Tehran, Iran, from December 2019 to July 2020, in women with VLBW infants. One hundred twenty mothers with VLBW neonates were randomly assigned to the intervention or the control group (60 in each). In the intervention group, mothers were given a dairy-free diet during the first 14 days after the newborn’s onset of feeding. No special diet was given to the control group. The primary outcome of the study was the rate of any NEC in neonates, which was compared between groups. Any NEC was defined as Bell stage I or greater. Results: The minimum and maximum gestational ages were 26 and 33 weeks, respectively. The minimum birth weight of neonates was 700 g. The two groups did not differ significantly in terms of demographic and preinterventional clinical characteristics. Any NEC was reported in 0% and 10% (5/52) of neonates in the intervention and control groups, respectively; the difference was statistically significant (p = 0.028). The NEC symptoms began ∼34 days after birth. Four cases of NEC were classified as Bell stage I, and one was classified as Bell stage II. No statistical association was registered between sex, gestational age, birth weight, and the onset of feeding with the incidence of any NEC. Conclusion: The use of a cow’s milk protein-free diet in mothers and exclusive breastfeeding in preterm VLBW infants may reduce the incidence of NEC. We recommend further studies with larger sample sizes in a multicenter setting. The study was registered at the Iranian Registry of Clinical Trials (IRCT20200415047086N1).

PMID:35613385 | DOI:10.1089/bfm.2021.0371

Nano Lett. 2022 May 25. doi: 10.1021/acs.nanolett.2c00395. Online ahead of print.

ABSTRACT

Emerging twistronics based on van der Waals (vdWs) materials has attracted great interest in condensed matter physics. Recently, more neoteric three-dimensional (3D) architectures with interlayer twist are realized in germanium sulfide (GeS) crystals. Here, we further demonstrate a convenient way for tailoring the twist rate of helical GeS crystals via tuning of the growth temperature. Under higher growth temperatures, the twist angles between successive nanoplates of the GeS mesowires (MWs) are statistically smaller, which can be understood by the dynamics of the catalyst during the growth. Moreover, we fabricate self-assembled helical heterostructures by introducing germanium selenide (GeSe) onto helical GeS crystals via edge epitaxy. Besides the helical architecture, the moiré superlattices at the twisted interfaces are also inherited. Compared with GeS MWs, helical GeSe/GeS heterostructures exhibit improved electrical conductivity and photoresponse. These results manifest new opportunities in future electronics and optoelectronics by harnessing 3D twistronics based on vdWs materials.

PMID:35613359 | DOI:10.1021/acs.nanolett.2c00395

Klin Lab Diagn. 2022 May 21;67(5):301-308. doi: 10.51620/0869-2084-2022-67-5-301-308.

ABSTRACT

A research objective – to study tumor tissues of primary and recurrent patients with cancer of the oropharyngeal region for the frequency of occurrence of four types of anaerobic periodontogens and their associations by two methods: real-time PCR and cultural. There is speculation that bacteria can influence the pathogenesis of cancer. A comparative assessment of the content of four anaerobic periodontogens (Porphyromonas gingivalis, Prevotella intermedia, Tannerella forsythensis, Treponema denticola) in the tumor tissue and in the healthy tissue of the oral mucosa of patients with oropharyngeal cancer was carried out. It was found that the identification of odontopathogens by the real-time PCR method is much more informative than the traditional culture method, with the exception of P. intermedia, for the identification of which the traditional culture method was more effective. In 33.3% of patients, both primary and secondary, the composition of microorganisms was the same in both healthy and tumor tissue. In 20% of primary patients and in 13.3% of repeat patients, no associations of microorganisms included in the study were found in healthy tissue. Associations of 4 bacteria were recorded only in tumor tissue in both primary and repeated patients, and in repeated patients – statistically significantly more often. In 53.3% of repeat patients, associations of 4 bacteria were recorded in tumor tissue, whereas in primary patients, only in one case. P. gingivalis from tumor tissue in repeat patients was statistically significantly more often than in primary patients. T. forsythensis in primary patients was found statistically significantly more often in healthy tissues than in repeat patients, in which T. forsythensis was found statistically significantly more often from tumor tissue than in healthy tissue). T. denticola in healthy tissue was detected in both primary and repeated patients in isolated cases. T. denticola in tumor tissue was found statistically significantly more frequently in both primary and repeated patients compared to healthy tissue. P. gingivalis, T. forsythensis, and T. denticola should perhaps be considered risk indicators indicating the level of significance of their associations with oropharyngeal cancer.

PMID:35613350 | DOI:10.51620/0869-2084-2022-67-5-301-308

Endocr Relat Cancer. 2022 May 1:ERC-22-0038. doi: 10.1530/ERC-22-0038. Online ahead of print.

ABSTRACT

Radioiodine (RAI) is selectively recommended for intermediate-risk differentiated thyroid carcinomas (DTC). The information gleaned from pretherapy stimulated thyroglobulin levels (sTg) and diagnostic 131I whole body scans (DxWBS) to guide therapy remains controversial. The present study aimed at evaluating the impact of preablation sTg and DxWBS in the management of intermediate-risk DTC. A retrospective analysis of 301 intermediate-risk DTC patients submitted to total thyroidectomy and RAI therapy was performed. Pretherapy sTg and DxWBS and post-therapy WBS (RxWBS) findings were analyzed and compared to outcomes. Fifty-two patients (17.3%) had metastases diagnosed by DxWBS and/or RxWBS. The DxWBS identified 10.6% of patients with functioning metastases, including unexpected distant metastases. If combined with SPECT-CT, DxWBS detected RAI-avid metastases more frequently, particularly lymph node metastases (13.1% vs. 4.2% planar WBS, p=0.015). The DxWBS findings modified patient management in 8.3%. A pretherapy sTg <1 ng/mL was associated with a low false-negative rate for the presence of metastases (5.2%), and its performance in excluding metastasis was improved by a negative DxWBS (2.7%) of patients with both negative exams had metastases in RxWBS). A sTg <1 ng/mL predicted statistically significant lower rates of recurrent/persistent disease and biochemical/structural incomplete responses. In conclusion, preablation sTg and DxWBS contribute to the detection of unknown or persistent metastatic disease in intermediate-risk DTC patients. A sTg <1 ng/mL in combination with a negative DxWBS is highly suggestive of the absence of remaining malignant disease, and one may consider deferring RAI ablation if both exams are negative. A stunning effect is rarely observed and it does not impair proper treatment of metastases.

PMID:35613335 | DOI:10.1530/ERC-22-0038

Am J Hum Biol. 2022 May 25:e23771. doi: 10.1002/ajhb.23771. Online ahead of print.

ABSTRACT

OBJECTIVE: A Smedley hand dynamometer is one of the standard devices for measuring handgrip strength (HGS) for children and adults. The aim was to compare the HGS values using two different types of dynamometers (Grip-A or Grip-D) in young children. To enable comparison between the two devices, we have redesigned the Grip-D (i.e., modified Grip-D).

METHODS: Twenty-five preschool children (10 girls and 15 boys) performed maximal voluntary HGS in the right hand using two different types of dynamometers. We ran a paired sample t-test on the difference in HGS between the two devices.

RESULTS: The measured values of HGS were 9.95 kg for Grip-A and 8.56 kg for modified Grip-D, and the difference between the two devices [1.39 (SD 0.65) kg] was greater than we expected (95% limits of agreement: 0.11, 2.6 kg). Thus, we then calibrated both dynamometers ourselves using known weights. The measured values were corrected if there was an error between the known weight and each dynamometer. Following adjustment, there was still a statistical difference (p < 0.001) in HGS between Grip-A [10.65 (SD 1.52) kg] and modified Grip-D [9.98 (SD 1.85) kg]. However, the difference between the two devices was 0.67 (SD 0.69) kg with the 95% limits of agreement between -0.68 and 2.0 kg.

CONCLUSION: It is concluded that the HGS values of children measured with the company-calibrated new Grip-A and modified Grip-D could provide reasonably close estimates.

PMID:35613332 | DOI:10.1002/ajhb.23771

Rev Lat Am Enfermagem. 2022;30:e3565. doi: 10.1590/1518-8345.5653.3565.

ABSTRACT

OBJECTIVE: as a health care profession focused on caring for people, Nursing requires sound communication skills. Based on an international expert consensus, a proposal on learning outcomes in clinical communication for undergraduate Nursing education curricula in Spanish speaking countries is presented.

METHOD: a steering committee, consisting of 5 nurses and experts in communication in health care sciences, drew up the first list of communication skills specific to the Nursing degree. Their proposal was reviewed and improved by a committee of 7 international scientific advisers. 70 experts from 14 countries were selected using a snowball sampling procedure and invited to participate in a distance modified Delphi consensus process in two survey rounds. Statistical analysis was carried out to establish the final consensus level for each item.

RESULTS: a questionnaire with 68 learning outcomes in clinical communications was submitted for panel assessment. In the first Delphi round, the panel reached a statistical consensus on all the items assessed. There was no need for a second round to reconcile positions.

CONCLUSION: an academic proposal, approved by a high level of international consensus, is presented to guide and unify the learning outcomes on the clinical communication curriculum for undergraduate Nursing studies in Spanish speaking countries.

PMID:35613251 | DOI:10.1590/1518-8345.5653.3565

Dental Press J Orthod. 2022 May 23;27(2):e22205. doi: 10.1590/2177-6709.27.2.e22205.oar. eCollection 2022.

ABSTRACT

OBJECTIVE: The present study aimed to assess the morphology of symphysis and alveolar bone thickness (ABT) surrounding mandibular incisors in thalassemic patients, as compared to unaffected individuals.

METHODS: This case-control study was conducted on lateral cephalograms of 60 thalassemic and 60 unaffected patients with Class II malocclusion seeking orthodontic treatment at Dental School, Shiraz University of Medical Sciences. The sample was divided into three subgroups including hyperdivergent, normodivergent, and hypodivergent, according to the Jarabak index. Symphysis dimensions and alveolar bone thickness surrounding mandibular incisors were measured using AutoCad software. Finally, the correlation between alveolar bone thickness and symphysis morphology was assessed.

RESULTS: In general, chin dimensions and bone thickness at different levels of mandibular incisor roots (cervical, middle, apical) were smaller in thalassemic adolescents than controls. Concerning the total sample as well as the normodivergent subgroup, significantly lower values were observed in thalassemic patients for symphysis width, total ABT at the cervical, and lingual ABT at the apical root area compared to controls (p < 0.05). The hypodivergent growth pattern was not associated with any statistical differences between the groups (p> 0.05). In both thalassemic and control subjects, symphysis width showed a weak to moderate positive correlation with ABT of lower incisors (p< 0.05), whereas symphysis height showed a moderate positive correlation with cervical ABT in only ß-thalassemia patients (p< 0.05).

CONCLUSIONS: Compared to controls, ß-thalassemia patients showed thinner alveolar bone at different levels of lower incisor roots and smaller symphysis dimensions. There were significant correlations between symphysis dimensions and alveolar bone thickness of mandibular incisors in the sample.

PMID:35613245 | DOI:10.1590/2177-6709.27.2.e22205.oar

Dental Press J Orthod. 2022 May 23;27(2):e2220367. doi: 10.1590/2177-6709.27.2.e2220367.oar. eCollection 2022.

ABSTRACT

OBJECTIVE: To introduce newly structured and developed orofacial myofunctional therapy (OFMFT) protocols named Bio-Exercise (BioEx), and evaluate the treatment effect of this method, using lateral cephalometric analysis on malocclusion with low tongue posture in young patients.

METHODS: A retrospective preliminary study was performed using orthodontic records from 28 patients (mean age of 8.41±1.45-year-old, 13 males, 15 females) treated with BioEx therapy using tongue elevators for 18.14±9.04 months (range: 6 to 37 months). Pretreatment (T0) and post-BioEx therapy (T1) lateral cephalograms were subsequently analyzed for tongue posture changes by linear, anteroposterior and vertical measurements. The data were analyzed by paired t-test, considering a 5% significance level.

RESULTS: The tongue length (TGL) and tongue height (TGH) increased statistically significant between T0 and T1. The decrease of the dorsum of the tongue perpendicular to the palatal plane (Td-PP value) was statistically significant. The increase of the tip of the tongue perpendicular to the pterygomaxillary vertical line (TT-PMV) was not statistically significant.

CONCLUSIONS: These preliminary cephalometric results indicate that BioEx can be an effective OFMFT modality in increasing the tonicity of the tongue muscles to establish more normalized tongue position at rest.

PMID:35613244 | DOI:10.1590/2177-6709.27.2.e2220367.oar

Rev Gaucha Enferm. 2022 May 23;43:e20210088. doi: 10.1590/1983-1447.2022.20210088.en. eCollection 2022.

ABSTRACT

OBJECTIVE: To analyze how university students self-evaluate their academic performance during the COVID-19 pandemic in a public university in southern Brazil.

METHOD: A cross-sectional study was carried out with 527 students of undergraduate courses in the health field. Descriptive statistical analyses and the chi-square test were performed to assess associations.

RESULTS: For 49.5% of participants their academic performance was insufficient; for 24.1%, sufficient; 19.40%, good; 5.90% very good; and 1.10% excellent. It was found that there was an association between the variables, course (p=0.034), form of enrollment into the institution (p=0.016) and work activity (p=0.010) in academic performance during the COVID-19 pandemic.

CONCLUSION: Academic performance during the suspension of face-to-face classes is insufficient for many students, and groups of students from the occupational therapy course, who entered the university through the system of quotas and who work in addition to studying showed an inferior academic performance during the COVID-19 pandemic.

PMID:35613241 | DOI:10.1590/1983-1447.2022.20210088.en