The Psychometric Properties of the Relaxation/Meditation/Mindfulness (RMM) Tracker t Inventory in an Iranian Population

Background. A growing body of research has examined the psychometric properties of popular mindfulness inventories for different population. The present study is aimed at exploring the psychometric properties and factor structure of the Relaxation/Meditation/Mindfulness (RMM) Tracker t Inventory in Iran. Method. This was a cross-sectional and methodological study that conducted in Kerman, southeast Iran. Fifty, 300, and 163 Iranian adult participants were participated in the pilot, exploratory, and confirmatory phase, respectively. Face, content, and structural validities, Cronbach’s alpha, and Omega coefficient were used to validate the Persian scale. Results. The results showed that the “Persian version of RMM t” had acceptable content and face validities. The Principal Axis Factoring (PAF) with Promax Rotation showed that the P-RMM t has 3 scales of “Mindful Love, Thankfulness, and Transcendence,” “Relaxation,” and “Mindful Deepening” which further confirmed with confirmatory factor analysis. The internal consistency of all three scales was acceptable (Cronbach’s alpha coefficients > 80 ). Conclusion. The Persian version of RMM Tracker t seems to be a valid and reliable questionnaire to assess the levels of mindfulness in the Iranian general population.

Assessing university guidance and tutoring in higher education: Validating a questionnaire on Ecuadorian students

This study was intended to explore and confirm the factorial structure and to analyze the psychometric properties of an instrument for university guidance and tutoring, apply it, and detect differences between sociodemographic variables. A total of 1,048 students from five universities in the province of Manabi (Ecuador) participated. The study was divided into two phases with differentiated samples. An exploratory phase, made up of 200 subjects (19.1%), and another confirmatory phase, made up of 848 (80.9%), where the questionnaire was also applied. The results supported the three-factor structure of the instrument called “Questionnaire for the Assessment of Guidance and Tutoring in Higher Education” (Q-AGT), with of a total of 21 items. The indices of goodness of fit, reliability and internal consistency of the model were considered satisfactory. The application of the questionnaire did not show statistically significant differences in the assessment of university guidance and tutoring between men and women, with a high value given by both sexes to the importance of tutoring, the demands and the competences of the teaching staff in the university. The differences were mainly found between universities and branches of knowledge. Among the main conclusions, what stands out is the achievement of a valid and reliable instrument to measure the development of guidance and tutoring in Latin American universities. This contributes to the assessment of university guidance and tutoring as a strategy for the integral development of the student- personally, academically and professionally- and as a possible protective factor against academic dropout.

Advances and Controversies With Checkpoint Inhibitors in Bladder Cancer

Immune checkpoint inhibitors have revolutionized the treatment of bladder urothelial cancers and have wide application in almost all disease states. Although several drugs have initially been shown to be beneficial in the second-line metastatic setting, there are still ongoing controversies and debate, including voluntary withdrawals of durvalumab and atezolizumab, along with the approval of agents in the first-line setting in the cisplatin-ineligible state based on inconsistent confirmatory phase III trials. As novel immunotherapy drugs are discovered and studied in various phases of clinical trials, these agents will continue to change the treatment landscape for bladder cancer patients. This review will discuss current available evidence and information and key pivotal trials using checkpoint inhibitors in bladder cancer.

Educational Change - Easy to Say, Hard to Do: Teachers’ Perceptions towards Introducing Innovative Teaching Approaches

"Computers, communication, and internet technologies have led to significant changes in learning and teaching. The constructivist approach in education puts learners at the center of the teaching process and actively makes them construct their knowledge, developing 21st century skills required for tomorrow’s world. Despite advances in the process of integrating technology into teaching, a significant gap still exists between promise and actual reality. Implementation of computer technologies depends on many complex factors, one of which is teachers’ perceptions of assimilating computerization into their teaching methods. This research is part of a broader study examining techno-pedagogical change in a high school in Israel. The current study focuses on the process of constructing, testing, and validating a questionnaire examining teachers’ attitudes toward pedagogical innovation and assimilating technological skills into teaching. The validation process was done by an exploratory factor analysis to detect cases with low variability and explore the dimensionality of each survey instrument. This was complemented by a confirmatory phase. The results showed high reliability and stable dimensions in the instruments. This study's importance is in constructing an original instrument that examines the extent to which high school teachers adopt innovative pedagogies assimilating technological tools. This study may have a universal contribution because the instrument can be used across countries and cultures."

Adding flexibility to clinical trial designs: an example-based guide to the practical use of adaptive designs

Adaptive designs for clinical trials permit alterations to a study in response to accumulating data in order to make trials more flexible, ethical, and efficient. These benefits are achieved while preserving the integrity and validity of the trial, through the pre-specification and proper adjustment for the possible alterations during the course of the trial. Despite much research in the statistical literature highlighting the potential advantages of adaptive designs over traditional fixed designs, the uptake of such methods in clinical research has been slow. One major reason for this is that different adaptations to trial designs, as well as their advantages and limitations, remain unfamiliar to large parts of the clinical community. The aim of this paper is to clarify where adaptive designs can be used to address specific questions of scientific interest; we introduce the main features of adaptive designs and commonly used terminology, highlighting their utility and pitfalls, and illustrate their use through case studies of adaptive trials ranging from early-phase dose escalation to confirmatory phase III studies.

A Mixed Methods–Grounded Theory Design for Producing More Refined Theoretical Models

Current literature lacks explication of how traditional grounded theory and mixed methods–grounded theory (MM-GT) are similar/different and specific explication of how to construct MM-GT designs—our purpose is to do this. We illustrate the design process using a published study. Exploratory Phase 1 involves creation of a formative–theoretical model based on multiple implicit or explicit models identified in the literature, which are then combined into a single model using meta-modeling integration. Also, in Phase 1, a traditional grounded theory is developed “independently” using interview data. These two models are integrated into a combined/meta-model at the end of Phase 1. Confirmatory Phase 2 involves testing of the final Phase 1 meta-model using a mixed methods experiment. In Phase 3, the Phase 1 and Phase 2 results are integrated, producing the “final” meta-model. This article contributes to the field of mixed methods research by showing how to design an MM-GT study that is focused on theory development and testing.

MicroRNA Profile of Patients with Chronic Limb-Threatening Ischemia

Chronic limb-threatening ischemia (CLTI) results in devastating complications such as lower-limb amputations. In this study, a genome-wide plasma microRNAs (miRNA) sequencing was performed to identify miRNA(s) associated with CLTI. Blood samples were collected from early stage CLTI patients (ABI < 0.9) and non-PAD controls (ABI ≥ 0.9) for 3 experiments: discovery phase (n = 23), confirmatory phase (n = 52) and validation phase (n = 20). In the discovery phase, next generation sequencing (NGS) was used to identify miRNA circulating in the plasma CLTI (n = 13) patients, compared to non-PAD controls (n = 10). Two down-regulated miRNAs (miRNA-6843-3p and miRNA-6766-5p) and three upregulated miRNAs (miRNA-1827, miRNA-320 and miRNA-98-3p) were identified (≥2-fold change). In the confirmatory phase, these 5 deregulated miRNAs were further investigated in non-PAD (n = 21) and CTLI (n = 31) patients using qRT-PCR. Only miRNA-1827 was found to be significantly upregulated (≥3-fold, p-value < 0. 001) in the CLTI group. Lastly, to minimize the influence of confounding factors, miRNA-1827 plasma levels were validated in a third cohort of CLTI patients (n = 10) matched to non-PAD controls (n = 10). Our analysis demonstrated that miRNA-1827 expression was increased in the CLTI cohort (≥2-folds, p-value < 0.001). In summary, circulating miRNA-1827 is significantly elevated in patients with CLTI.

A Randomized Phase 3 Clinical Trial of the Combination of Plinabulin (plin) + Pegfilgrastim (peg) Versus (vs) Peg Alone for Tac (docetaxel, doxorubicin, cyclophosphamide) Induced Neutropenia (cin)

Trial in Progress: Granulocyte colony stimulating factors (G-CSFs) (including Peg) reduce, but do not completely ameliorate CIN. Plinabulin is a novel, small molecule, single-dose-per cycle therapy, with equal activity against docetaxel CIN vs. Peg, but with several advantages: Plin has 1. Less bone pain, 2. Anticancer effects, and 3. Dosing 30 min after chemotherapy (chemo). The CIN nadir with Plin occurs in week 2 and with Peg in week 1 of the chemo cycle. All these features suggest a mechanism of action (MoA) with Plin that is different from Peg (Blayney, ASCO 2018; IASLC 2018). Neutrophil demargination with Plin and a reduced neutrophil transit time consistent with IL-6 signaling, and reversal of a LSK block in bone marrow, suggest protective rather than a stimulatory MoA for Plin in CIN (Blayney, SLB 2018; Ghosh, AACR 2018, Suwa, Am J Physiol 2000). Due to their differences in MoA, there is a strong rationale to combine Plin and Peg, as this offers the potential of better protection against CIN in both week 1 and 2 in the chemo cycle. In the Phase II portion of study BPI2358-106 (Study 106., NCT03294577), we evaluated the effects of the Plin combined with Peg on CIN and Bone Pain. Study 106 treated breast cancer (BC) patients with TAC with 6 mg Peg alone (Peg6), or Peg6+Plin. Plin dose was 20 mg/m2. Grade (Gr) 3 and 4 neutropenia frequency, duration of Gr 3 and 4 neutropenia (DSMN), and neutrophil nadir was based on absolute neutrophil counts, obtained on days 0, 1, 3, 6, 7, 8, 9, 10, 11, 12, 13, 15. Bone pain was assessed by a validated questionnaire on days 1, 2, 3, 4, 6, 7, 8, 9, and expressed as % of patients reporting bone pain. Phase II Results. The confirmatory phase 3 portion of study 106 will test addition of Plin to Peg6, which may offer superior protection against TAC CIN vs Peg alone without bone pain. The Plin/Peg combination is a novel CIN approach with the potential to optimize chemotherapy, by minimizing chemotherapy dose modifications due to CIN or bone pain.*p&lt;0.05; **p&lt;0.001; ***P&lt;0.01 Peg+Plin vs Peg 6mg Table Disclosures Blayney: BeyondSpring Pharmaceuticals: Research Funding. Huang:BeyondSpring Pharmaceuticals: Employment. Mohanlal:BeyondSpring Pharmaceuticals: Employment.

Single-arm confirmatory trial of postoperative concurrent chemoradiotherapy using intensity modulated radiation therapy for patients with high-risk uterine cervical cancer: Japan Clinical Oncology Group study (JCOG1402)

A single-arm confirmatory phase III clinical trial of postoperative concurrent chemoradiotherapy using intensity modulated radiation therapy for patients with high-risk uterine cervical cancer (JCOG1402)