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Csorgő, M., Z. Y. Lin, and Q. M. Shao. "Randomization Moduli of Continuity for ℓ2-Norm Squared Ornstein-Uhlenbeck Processes." Canadian Journal of Mathematics 45, no. 2 (April 1, 1993): 269–83. http://dx.doi.org/10.4153/cjm-1993-013-3.
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Stankiewicz, Anna, and Sławomir Juściński. "How to Make the Stress Relaxation Experiment for Polymers More Informative." Polymers 15, no. 23 (December 2, 2023): 4605. http://dx.doi.org/10.3390/polym15234605.
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Different viscoelastic models and characteristics are commonly used to describe, analyze, compare and improve the mechanical properties of polymers. A time-dependent linear relaxation modulus next to frequency-domain storage and loss moduli are the basic rheological material functions of polymers. The exponential Maxwell model and the exponential stretched Kohlrausch–Williams–Watts model are, probably, the most known linear rheological models of polymers. There are different identification methods for such models, some of which are dedicated to specific models, while others are general in nature. However, the identification result, i.e., the best model, always depends on the specific experimental data on the basis of which it was determined. When the rheological stress relaxation test is performed, the data are composed of the sampling instants used in the test and on the measurements of the relaxation modulus of the real material. To build a relaxation modulus model that does not depend on sampling instants is a fundamental concern. The problem of weighted least-squares approximation of the real relaxation modulus is discussed when only the noise-corrupted time-measurements of the relaxation modulus are accessible for identification. A wide class of models, that are continuous, differentiable and Lipschitz with respect to parameters, is considered for the relaxation modulus approximation. The main results concern the models that are selected asymptotically as the number of measurements tends to infinity. It is shown that even when the true relaxation modulus description is completely unknown, the approximate optimal model parameters can be derived from the measurement data that are obtained for sampling instants that are selected randomly due to the appropriate randomization introduced whenever certain conditions regarding the adopted class of models are satisfied. It is shown that the most commonly used stress relaxation models, the Maxwell and Kohlrausch–Williams–Watts models, satisfy these conditions. Since the practical problems of the identification of relaxation modulus models are usually ill posed, Tikhonov regularization is applied to guarantee the stability of the regularized solutions. The approximate optimal model is a strongly consistent estimate of the regularized model that is optimal in the sense of the deterministic integral weighted square error. An identification algorithm leading to the best regularized model is presented. The stochastic-type convergence analysis is conducted for noise-corrupted relaxation modulus measurements, and the exponential convergence rate is proved. Numerical studies for different models of the relaxation modulus used in the polymer rheology are presented for the material described by a bimodal Gauss-like relaxation spectrum. Numerical studies have shown that if appropriate randomization is introduced in the selection of sampling instants, then optimal regularized models of the relaxation modulus being asymptotically independent of these time instants can be recovered from the stress relaxation experiment data. The robustness of the identification algorithm to measurement noises was demonstrated both by analytical and numerical analyses.
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Schwamb, Megan E., Jeremy Kubica, Mario Jurić, Drew Oldag, Maxine West, Melissa DeLucchi, and Matthew J. Holman. "Controlling Randomization in Astronomy Simulations." Research Notes of the AAS 8, no. 1 (January 19, 2024): 25. http://dx.doi.org/10.3847/2515-5172/ad1f6b.
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Abstract As the primary requirement, correctly implementing and controlling random number generation is vital for a range of scientific analyses and simulations across astronomy and planetary science. Beyond advice on how to set the seed, there is little guidance in the literature for how best to handle pseudo-random number generation in the current era of open-source astronomical software development. We present our methodology for implementing a pseudo-random number generation in astronomy simulations and software and share the short lines of python code that create the generator. Without sacrificing randomization at run time, our strategy ensures reproducibility on a per function/module basis for unit testing and for run time debugging where there may be multiple functions requiring lists of randomly generated values that occur before a specific function is executed.
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Sun, Shi-Hai, and Lin-Mei Liang. "Experimental demonstration of an active phase randomization and monitor module for quantum key distribution." Applied Physics Letters 101, no. 7 (August 13, 2012): 071107. http://dx.doi.org/10.1063/1.4746402.
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Wu, Jiayao, Chen He, Jiahui Xie, Xiaopeng Liu, and Minghui Zhang. "Twin-Field Quantum Digital Signature with Fully Discrete Phase Randomization." Entropy 24, no. 6 (June 18, 2022): 839. http://dx.doi.org/10.3390/e24060839.
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Quantum digital signatures (QDS) are able to verify the authenticity and integrity of a message in modern communication. However, the current QDS protocols are restricted by the fundamental rate-loss bound and the secure signature distance cannot be further improved. We propose a twin-field quantum digital signature (TF-QDS) protocol with fully discrete phase randomization and investigate its performance under the two-intensity decoy-state setting. For better performance, we optimize intensities of the signal state and the decoy state for each given distance. Numerical simulation results show that our TF-QDS with as few as six discrete random phases can give a higher signature rate and a longer secure transmission distance compared with current quantum digital signatures (QDSs), such as BB84-QDS and measurement-device-independent QDS (MDI-QDS). Moreover, we provide a clear comparison among some possible TF-QDSs constructed by different twin-field key generation protocols (TF-KGPs) and find that the proposed TF-QDS exhibits the best performance. Conclusively, the advantages of the proposed TF-QDS protocol in signature rate and secure transmission distance are mainly due to the single-photon interference applied in the measurement module and precise matching of discrete phases. Besides, our TF-QDS shows the feasibility of experimental implementation with current devices in practical QDS system.
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Zhao, Yizhou, and Hua Sun. "Expand-and-Randomize: An Algebraic Approach to Secure Computation." Entropy 23, no. 11 (November 4, 2021): 1461. http://dx.doi.org/10.3390/e23111461.
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We consider the secure computation problem in a minimal model, where Alice and Bob each holds an input and wish to securely compute a function of their inputs at Carol without revealing any additional information about the inputs. For this minimal secure computation problem, we propose a novel coding scheme built from two steps. First, the function to be computed is expanded such that it can be recovered while additional information might be leaked. Second, a randomization step is applied to the expanded function such that the leaked information is protected. We implement this expand-and-randomize coding scheme with two algebraic structures—the finite field and the modulo ring of integers, where the expansion step is realized with the addition operation and the randomization step is realized with the multiplication operation over the respective algebraic structures.
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Steffen, Alana D., Larisa A. Burke, Heather A. Pauls, Marie L. Suarez, Yingwei Yao, William H. Kobak, Miho Takayama, et al. "Double-blinding of an acupuncture randomized controlled trial optimized with clinical translational science award resources." Clinical Trials 17, no. 5 (July 10, 2020): 545–51. http://dx.doi.org/10.1177/1740774520934910.
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Background Clinical trial articles often lack detailed descriptions of the methods used to randomize participants, conceal allocation, and blind subjects and investigators to group assignment. We describe our systematic approach to implement and measure blinding success in a double-blind phase 2 randomized controlled trial testing the efficacy of acupuncture for the treatment of vulvodynia. Methods Randomization stratified by vulvodynia subtype is managed by Research Electronic Data Capture software’s randomization module adapted to achieve complete masking of group allocation. Subject and acupuncturist blinding assessments are conducted multiple times to identify possible correlates of unblinding. Results At present, 48 subjects have been randomized and completed the protocol resulting in 87 subject and 206 acupuncturist blinding assessments. Discussion Our approach to blinding and blinding assessment has the potential to improve our understanding of unblinding over time in the presence of possible clinical improvement.
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Didier, Gilles, Alberto Valdeolivas, and Anaïs Baudot. "Identifying communities from multiplex biological networks by randomized optimization of modularity." F1000Research 7 (July 10, 2018): 1042. http://dx.doi.org/10.12688/f1000research.15486.1.
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The identification of communities, or modules, is a common operation in the analysis of large biological networks. The Disease Module Identification DREAM challenge established a framework to evaluate clustering approaches in a biomedical context, by testing the association of communities with GWAS-derived common trait and disease genes. We implemented here several extensions of the MolTi software that detects communities by optimizing multiplex (and monoplex) network modularity. In particular, MolTi now runs a randomized version of the Louvain algorithm, can consider edge and layer weights, and performs recursive clustering. On simulated networks, the randomization procedure clearly improves the detection of communities. On the DREAM challenge benchmark, the results strongly depend on the selected GWAS dataset and enrichment p-value threshold. However, the randomization procedure, as well as the consideration of weighted edges and layers generally increases the number of trait and disease community detected. The new version of MolTi and the scripts used for the DMI DREAM challenge are available at: https://github.com/gilles-didier/MolTi-DREAM.
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Didier, Gilles, Alberto Valdeolivas, and Anaïs Baudot. "Identifying communities from multiplex biological networks by randomized optimization of modularity." F1000Research 7 (November 22, 2018): 1042. http://dx.doi.org/10.12688/f1000research.15486.2.
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The identification of communities, or modules, is a common operation in the analysis of large biological networks. The Disease Module Identification DREAM challenge established a framework to evaluate clustering approaches in a biomedical context, by testing the association of communities with GWAS-derived common trait and disease genes. We implemented here several extensions of the MolTi software that detects communities by optimizing multiplex (and monoplex) network modularity. In particular, MolTi now runs a randomized version of the Louvain algorithm, can consider edge and layer weights, and performs recursive clustering. On simulated networks, the randomization procedure clearly improves the detection of communities. On the DREAM challenge benchmark, the results strongly depend on the selected GWAS dataset and enrichment p-value threshold. However, the randomization procedure, as well as the consideration of weighted edges and layers generally increases the number of trait and disease community detected. The new version of MolTi and the scripts used for the DMI DREAM challenge are available at: https://github.com/gilles-didier/MolTi-DREAM.
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Baharsyah, Baharudin Adi, Endang Dian Setioningsih, Sari Luthfiyah, and Wahyu Caesarendra. "Analyzing the Relationship between Dialysate Flow Rate Stability and Hemodialysis Machine Efficiency." Indonesian Journal of Electronics, Electromedical Engineering, and Medical Informatics 5, no. 2 (May 30, 2023): 86–91. http://dx.doi.org/10.35882/ijeeemi.v5i2.276.
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Chronic kidney disease (CKD) is a condition characterized by impaired kidney function, leading to disruptions in metabolism, fluid balance, and electrolyte regulation. Hemodialysis serves as a supportive therapy for individuals with CKD, prolonging life but unable to fully restore kidney function. Factors influencing urea and creatinine levels in hemodialysis patients include blood flow velocity, dialysis duration, and dialyzer selection. This research aims to establish a standard for calculating the dialysate flow rate, thereby enhancing dialysis efficiency. The study employs a pre-experimental "one group post-test" design, lacking baseline measurements and randomization, although a control group was utilized. The design's weakness lies in the absence of an initial condition assessment, making conclusive results challenging. Measurement comparisons between the module and the instrument yielded a 5.30% difference, while the difference between the hemodialysis machine and standard equipment was 4.02%. Furthermore, six module measurements against three comparison tools showed a 0.17% difference for the hemodialysis machine with standard equipment, and a 0.18% difference for the module with standard equipment, with a 0.23% discrepancy between the two. Further analysis is necessary to understand the clinical significance and implications of these measurement variations on overall dialysis efficacy
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Yang, Hunmin, Jongoh Jeong, and Kuk-Jin Yoon. "FACL-Attack: Frequency-Aware Contrastive Learning for Transferable Adversarial Attacks." Proceedings of the AAAI Conference on Artificial Intelligence 38, no. 6 (March 24, 2024): 6494–502. http://dx.doi.org/10.1609/aaai.v38i6.28470.
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Deep neural networks are known to be vulnerable to security risks due to the inherent transferable nature of adversarial examples. Despite the success of recent generative model-based attacks demonstrating strong transferability, it still remains a challenge to design an efficient attack strategy in a real-world strict black-box setting, where both the target domain and model architectures are unknown. In this paper, we seek to explore a feature contrastive approach in the frequency domain to generate adversarial examples that are robust in both cross-domain and cross-model settings. With that goal in mind, we propose two modules that are only employed during the training phase: a Frequency-Aware Domain Randomization (FADR) module to randomize domain-variant low- and high-range frequency components and a Frequency-Augmented Contrastive Learning (FACL) module to effectively separate domain-invariant mid-frequency features of clean and perturbed image. We demonstrate strong transferability of our generated adversarial perturbations through extensive cross-domain and cross-model experiments, while keeping the inference time complexity.
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Bhatnagar, Rajan Bhatnagar, Aseem Tandon, and Rishi Pokhrel. "“Does Supplementing Traditional teaching with Computer Assisted Learning (CAL) Module Facilitates Understanding of Human Embryology in Medical Undergraduates? A Randomized Control Trial”." Medical Journal of Shree Birendra Hospital 13, no. 1 (July 19, 2015): 26–32. http://dx.doi.org/10.3126/mjsbh.v13i1.12997.
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Introduction: In present scenario when lesser time is being devoted to basic medical sciences, and at the same time knowledge and concepts required to be mastered by medical undergraduates increasing exponentially, structured modules and software have a potential role to play. Embryology in particular can be a subject for such modules owing to its complex dynamics and even less proportion of time available to master it. This study evaluates if supplementing traditional methods with computer-aided instruction improve students' understanding of human embryology. Methods: The study was conducted during revision sessions before university examinations. Subjects of study were first year medical undergraduates (n=128), divided into two equal groups by simple randomization. Demographic data and prior academic performance of students were collected from student profile register. Revision sessions for control group were conducted using traditional methods and for test group CAL module was used. Students were evaluated by pre and post-tests consisting of 50 multiple choice answers questions each and each question fetched 0.5 marks. Independent sample t test was used for comparison of means. Opinion of students and instructors were collected using anonymous questionnaire under heads of subject-interest, appropriateness of CAL module as teaching materials, overall satisfaction and its possible effectiveness as self-learning module. Results: Two groups showed no statistical difference in terms of sex ratio, age and prior academic performance. Pre-test showed no significant difference in mean scores of two groups, mean post-test scores on the other hand were significantly greater in test group as compared to the control group. Most of the students and instructors involved in the study graded the CAL-module as ‘excellent’. Conclusions: The study shows that traditional teaching methods supplemented with CAL module improves the understanding of developmental anatomy in medical undergraduates. Use of this module as a self-study material requires further evaluations.doi: http://dx.doi.org/10.3126/mjsbh.v13i1.12997
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Wu, Xinyi, Zhenyao Wu, Yuhang Lu, Lili Ju, and Song Wang. "Style Mixing and Patchwise Prototypical Matching for One-Shot Unsupervised Domain Adaptive Semantic Segmentation." Proceedings of the AAAI Conference on Artificial Intelligence 36, no. 3 (June 28, 2022): 2740–49. http://dx.doi.org/10.1609/aaai.v36i3.20177.
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In this paper, we tackle the problem of one-shot unsupervised domain adaptation (OSUDA) for semantic segmentation where the segmentors only see one unlabeled target image during training. In this case, traditional unsupervised domain adaptation models usually fail since they cannot adapt to the target domain with over-fitting to one (or few) target samples. To address this problem, existing OSUDA methods usually integrate a style-transfer module to perform domain randomization based on the unlabeled target sample, with which multiple domains around the target sample can be explored during training. However, such a style-transfer module relies on an additional set of images as style reference for pre-training and also increases the memory demand for domain adaptation. Here we propose a new OSUDA method that can effectively relieve such computational burden. Specifically, we integrate several style-mixing layers into the segmentor which play the role of style-transfer module to stylize the source images without introducing any learned parameters. Moreover, we propose a patchwise prototypical matching (PPM) method to weighted consider the importance of source pixels during the supervised training to relieve the negative adaptation. Experimental results show that our method achieves new state-of-the-art performance on two commonly used benchmarks for domain adaptive semantic segmentation under the one-shot setting and is more efficient than all comparison approaches.
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Wang, Yuanlin, Yan Fan, Yi Jiang, Enquan Wang, Yu Song, Hongguang Chen, Feier Xu, Keliang Xie, and Yonghao Yu. "APOA2: New Target for Molecular Hydrogen Therapy in Sepsis-Related Lung Injury Based on Proteomic and Genomic Analysis." International Journal of Molecular Sciences 24, no. 14 (July 11, 2023): 11325. http://dx.doi.org/10.3390/ijms241411325.
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Target biomarkers for H2 at both the protein and genome levels are still unclear. In this study, quantitative proteomics acquired from a mouse model were first analyzed. At the same time, functional pathway analysis helped identify functional pathways at the protein level. Then, bioinformatics on mRNA sequencing data were conducted between sepsis and normal mouse models. Differential expressional genes with the closest relationship to disease status and development were identified through module correlation analysis. Then, common biomarkers in proteomics and transcriptomics were extracted as target biomarkers. Through analyzing expression quantitative trait locus (eQTL) and genome-wide association studies (GWAS), colocalization analysis on Apoa2 and sepsis phenotype was conducted by summary-data-based Mendelian randomization (SMR). Then, two-sample and drug-target, syndrome Mendelian randomization (MR) analyses were all conducted using the Twosample R package. For protein level, protein quantitative trait loci (pQTLs) of the target biomarker were also included in MR. Animal experiments helped validate these results. As a result, Apoa2 protein or mRNA was identified as a target biomarker for H2 with a protective, causal relationship with sepsis. HDL and type 2 diabetes were proven to possess causal relationships with sepsis. The agitation and inhibition of Apoa2 were indicated to influence sepsis and related syndromes. In conclusion, we first proposed Apoa2 as a target for H2 treatment.
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Seidling, Hanna Marita, Cornelia Mahler, Beate Strauß, Aline Weis, Marion Stützle, Johannes Krisam, Joachim Szecsenyi, and Walter Emil Haefeli. "An Electronic Medication Module to Improve Health Literacy in Patients With Type 2 Diabetes Mellitus: Pilot Randomized Controlled Trial." JMIR Formative Research 4, no. 4 (April 28, 2020): e13746. http://dx.doi.org/10.2196/13746.
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Background In primary care, patients play a crucial role in managing care processes and handling drug treatment. A decisive factor for success is their health literacy, and several interventions have been introduced to support patients in fulfilling their responsibility. Objective The aim of this study is to assess the influence of such an intervention (ie, a medication module) within a patient-led electronic health record on patients’ health literacy. Methods We conducted a randomized controlled study among community-dwelling patients with type 2 diabetes mellitus. Patients were recruited from primary care practices. After randomization, patients either had access to an internet-based medication module allowing them to store their medication information, look up drug information, and print a medication schedule (intervention group), or they received an information brochure on the importance of medication schedules (control group). After 4-8 weeks, all patients were invited to attend a structured medication review (ie, follow-up visit). Data were collected via questionnaires before the start of the intervention and during the follow-up visit. The main outcome measure was the mean difference in health literacy between baseline and follow-up assessments of patients in the control and intervention groups. Results Of 116 recruited patients, 107 (92.2%) completed the follow-up assessment and were eligible for intention-to-treat analyses. Only 73 patients, of which 29 were in the intervention group, followed the study protocol and were eligible for per-protocol analysis. No differences in overall health literacy were observed in either the intention-to-treat or in the per-protocol cohorts. Reasons for a null effect might be that the cohort was not particularly enriched with participants with low health literacy, thus precluding measurable improvement (ie, ceiling effect). Moreover, the success of implementation was considered poor because both the correct application of the study procedure (ie, randomization according to the protocol and dropout of 29 patients) and the actual interaction with the medication module was modest (ie, dropout of 9 patients). Conclusions The conduct of this randomized controlled study was challenging, leaving it open whether inadequate implementation, too short of a duration, or insufficient efficacy of the intervention, as such, contributed to the null effect of this study. This clearly outlines the value of piloting complex interventions and the accompanying process evaluations.
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Brown, Menna, Nic Hooper, Phillip James, Darren Scott, Owen Bodger, and Ann John. "A Web-Delivered Acceptance and Commitment Therapy Intervention With Email Reminders to Enhance Subjective Well-Being and Encourage Engagement With Lifestyle Behavior Change in Health Care Staff: Randomized Cluster Feasibility Stud." JMIR Formative Research 4, no. 8 (August 7, 2020): e18586. http://dx.doi.org/10.2196/18586.
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Background Poor mental health and emotional well-being can negatively impact ability to engage in healthy lifestyle behavior change. Health care staff have higher rates of sickness and absence than other public sector staff, which has implications at both individual and societal levels. Individual efforts to self-manage health and well-being which add to the UK mental health prevention agenda need to be supported. Objective The objective of this study was to establish the feasibility and acceptability of the inclusion of a self-guided, automated, web-based acceptance and commitment therapy intervention in an existing health promotion program, to improve subjective well-being and encourage engagement with lifestyle behavior change. Methods For this 12-week, 4-armed, randomized controlled cluster feasibility study, we recruited participants offline and randomly allocated them to 1 of 3 intervention arms or control (no well-being intervention) using an automated web-based allocation procedure. Eligibility criteria were current health care staff in 1 Welsh health board, age≥18 years, ability to read English, and ability to provide consent. The primary researcher was blinded to cluster allocation. Feasibility outcomes were randomization procedure, acceptance of intervention, and adherence to and engagement with the wider program. We evaluated health and well-being data via self-assessment at 2 time points, registration and postintervention, using the 14-item Warwick-Edinburgh Mental Well-Being Scale, the 4-item Patient Health Questionnaire, and the 7-item Acceptance and Action Questionnaire—Revised. Results Of 124 participants who provided consent and were randomly allocated, 103 completed full registration and engaged with the program. Most participants (76/103) enrolled in at least one health behavior change module, and 43% (41/96) of those randomly allocated to an intervention arm enrolled in the well-being module. Adherence and engagement was low (7/103, 6.8%), but qualitative feedback was positive. Conclusions The procedure and randomization process proved feasible, and the addition of the well-being module proved acceptable to health care staff. However, participant engagement was limited, and no one completed the full 12-week program. User feedback should be used to develop the intervention to address poor engagement. Effectiveness should then be evaluated in a full-scale randomized controlled trial, which would be feasible with additional recruitment. Trial Registration International Standard Randomised Controlled Trial Number (ISRCTN) 50074817; http://www.isrctn.com/ISRCTN50074817
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Mithra, Prasanna, Bhaskaran Unnikrishnan, Rekha T, Nithin Kumar, Ramesh Holla, and Priya Rathi. "Module intervention to improve involvement and practices of fathers towards infant and young child feeding (IYCF) in Coastal South India - a randomized controlled trial." F1000Research 11 (July 5, 2022): 486. http://dx.doi.org/10.12688/f1000research.110851.2.
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Background: Overall child health depends on nutrition and its related practices. At the family level, responsibility of child feeding lies with both parents. There is no uniform and systematic way to determine and assess the practices of fathers in infant and young child feeding (IYCF). Also, there is a paucity of evidence related to interventions for fathers in improving their practices and involvement in the feeding of their infant or young child (aged less than two years). Methods: This was a community-based randomized control trial, conducted among 120 fathers with infants and/or young children in Dakshina Kannada District of Karnataka. Fathers with poor level of involvement and practices towards IYCF, during the initial assessment, were included as the study participants. For the intervention, a module in the flipchart format was developed. Simple randomization technique was used to allot the participants into two groups - intervention and control. Participants in the intervention group received module intervention, in addition to the care which they received routinely, and the control group received only routine care. The participants in the intervention group were paid a monthly visit to implement the module, for six months. The post-intervention assessment was done at the end of 6 months. Results: A total of 117 participants provided post-intervention data. The mean age was 34.7 (+/- 5.48) years in the intervention group and 34.36 years (+/- 5.26) in the control group. The intervention group showed significantly higher improvement in knowledge, attitude, and practice components at 6 months (p<0.05), in both unadjusted and adjusted models. Conclusions: The extent of increase in practice and involvement in child feeding was clearly higher among the intervention group. The module developed was successful in improving the practices of fathers in feeding their infants and young children. Clinical Trials Registry India: CTRI/2017/06/008936 (29/06/2017)
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Mithra, Prasanna, Bhaskaran Unnikrishnan, Rekha T, Nithin Kumar, Ramesh Holla, and Priya Rathi. "Module intervention to improve involvement and practices of fathers towards infant and young child feeding (IYCF) in Coastal South India - a randomized controlled trial." F1000Research 11 (May 3, 2022): 486. http://dx.doi.org/10.12688/f1000research.110851.1.
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Background: Overall child health depends on nutrition and its related practices. At the family level, responsibility of child feeding lies with both parents. There is no uniform and systematic way to determine and assess the practices of fathers in infant and young child feeding (IYCF). Also, there is a paucity of evidence related to interventions for fathers in improving their practices and involvement in the feeding of their infant or young child (aged less than two years). Methods: This was a community-based randomized control trial, conducted among 120 fathers with infants and/or young children in Dakshina Kannada District of Karnataka. Fathers with poor level of involvement and practices towards IYCF, during the initial assessment, were included as the study participants. For the intervention, a module in the flipchart format was developed. Simple randomization technique was used to allot the participants into two groups - intervention and control. Participants in the intervention group received module intervention, in addition to the care which they received routinely, and the control group received only routine care. The participants in the intervention group were paid a monthly visit to implement the module, for six months. The post-intervention assessment was done at the end of 6 months. Results: A total of 117 participants provided post-intervention data. The mean age was 34.7 (+/- 5.48) years in the intervention group and 34.36 years (+/- 5.26) in the control group. The intervention group had a significant improvement in knowledge, attitude, and practice components at 6 months. We noted higher change scores for the intervention group (p<0.05). Conclusions: The extent of increase in practice and involvement in child feeding was clearly higher among the intervention group. The module developed was successful in improving the practices of fathers in feeding their infants and young children. Clinical Trials Registry India: CTRI/2017/06/008936 (29/06/2017)
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Wang, Can, Yue Chong, Jiechun Zhang, Yili Cao, and Yanbo Wang. "The Efficacy of Extended Metacognitive Training on Neurocognitive Function in Schizophrenia: A Randomized Controlled Trial." Brain Sciences 12, no. 3 (March 21, 2022): 413. http://dx.doi.org/10.3390/brainsci12030413.
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The aim of this study was to evaluate the effect of metacognitive training (MCT) on improving the neurocognitive function of Chinese patients with schizophrenia. One hundred inpatients with schizophrenia were selected by regional group randomization and divided into the control (treated as usual, TAU) group (n = 50) and the TAU + MCT group (n = 50). In this study, a 10-module MCT was used and the intervention process lasted 30 days. Cognitive function was assessed blindly using the Repeatable Battery of Neuropsychological Status (RBANS) scale at baseline, 24 h post-treatment, and 12 weeks’ post-treatment. The differences between the total RBANS score and baseline (pre-test) for the post-test and 12-week-follow-up tests were used as the primary outcome, and the difference between the RBANS dimension scores and baseline (pre-test) were used as a secondary outcome in this study. The completion rate at follow-up was high in the TAU + MCT group (94%). Intention-to-treat analysis and per-protocol analysis showed a significant increase in total neurocognitive function scores and three-dimensional scores (delayed memory, visual breadth, and attention) in the TAU + MCT group immediately after the intervention and at the 12-week follow-up compared with baseline. This study provides support for the efficacy of 10 module MCT concerning neurocognition.
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Weiss, Elisabeth M., Siegmund Staggl, Bernhard Holzner, Gerhard Rumpold, Verena Dresen, and Markus Canazei. "Preventive Effect of a 7-Week App-Based Passive Psychoeducational Stress Management Program on Students." Behavioral Sciences 14, no. 3 (February 25, 2024): 180. http://dx.doi.org/10.3390/bs14030180.
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Passive psychoeducation is an easily accessible and cost-effective self-guided intervention that does not use elements of active psychotherapies or require homework. The present study aimed to investigate the acceptability and efficacy of a 7-week app-based passive psychoeducation stress management program to promote adaptive emotion regulation and coping skills in university students (i.e., 80% psychology students). Participants were tested via Lime-Survey® at pre- and post-test with the Depression Anxiety Stress Scale-21 (DASS-21), the Response Styles Questionnaire (RSQ), and the Emotion Regulation Questionnaire (ERQ). A stratified permutation block randomization by age, gender, and the DASS-21 stress subscale was performed. Each week, the psychoeducation group (n = 123) received different psychoeducation modules. At the end of each module, participants answered questions about their satisfaction with each module and adherence to psychoeducation. The control group (n = 130) received no intervention. The psychoeducation program led to a significant improvement in the adaptive emotion regulation strategy: “reappraisal” (p = 0.004) and a significant reduction in the dysfunctional coping style: “symptom-related rumination” (p = 0.01) but not to a significant reduction in depression, anxiety, and stress scores compared to the control group. Thus, the present study might demonstrate a preventive effect of an app-based passive psychoeducation program in students with low clinically relevant psychopathological symptoms.
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El Marghichi, Mouncef, and Ihssan abdelkoddous El Jadli. "Rapid parameter identification of three diode photovoltaic systems using the Cheetah optimizer." Acta IMEKO 12, no. 4 (November 23, 2023): 1–12. http://dx.doi.org/10.21014/actaimeko.v12i4.1587.
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This study focuses on accurate parameter identification for solar cells and photovoltaic module simulation using experimental data. To tackle the challenge of modelling these highly nonlinear systems, we propose the novel use of the Cheetah Optimizer (CO) algorithm, inspired by cheetah hunting strategies. The CO algorithm employs mathematical models and randomization parameters to balance exploration and exploitation, avoiding local optima by considering energy limitations. We demonstrate the CO algorithm's effectiveness by applying it to the three-diode model in solar photovoltaic systems, specifically the STP6-120/36 and Photowatt-PWP201 PV modules. Impressively, the CO algorithm achieves remarkably low root mean square error values of 0.0145 A and 0.0019 A, outperforming state-of-the-art methods and ensuring high accuracy. Additionally, it delivers the lowest power errors of 0.16054 W and 0.01484 W for the respective modules, highlighting its exceptional performance. The CO algorithm proves to be a promising tool for precise parameter extraction and optimization, leading to improved modelling and performance of solar photovoltaic systems.
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Wagenius, G., O. Brodin, J. Nyman, G. Greim, G. Hillerdal, H. Riska, S. Sundström, B. Grönberg, M. Wang, and H. Garmo. "Radiotherapy vs. temozolomide in the treatment of patients with lung cancer and brain metastases: A nordic randomized phase II study." Journal of Clinical Oncology 24, no. 18_suppl (June 20, 2006): 7136. http://dx.doi.org/10.1200/jco.2006.24.18_suppl.7136.
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7136 Background: Metastasis to the brain is the most common intracranial tumour and 20–40% of all cancer patients will develop brain metastases. Lung cancer is the most common primary tumour and compose of 40%-50% of all brain metasases. As the survival in many malignancies increases, brain metastases will be an increasing problem. It is therefore important to find new treatment options. The aim of this study was primary to study quality of life and to compare radiotherapy and Themozolomide in that context. Methods: Inclusion criterias were confirmed small cell or non-small cell lung cancer, multiple brain metastases, PS 0–2, no previous radiotherapy to the brain. Previous chemotherapy was allowed. Patients were randomized to arm A (radiotherapy 30 Gy over 10 fractions) or arm B (Temozolomide 200 mg/m2 day 1–5, new cycle on day 29). Quality of life (QoL) was measured with a general cancer module, EORTC QLQ-C30, and a brain cancer specific module, BCM20. The primary end-point was the proportion of patients in each treatment arm with maintained or better QoL score at 8 weeks compared to the base line evaluation. In this first analysis exclusion rate from the study at 8 weeks was used as a surrogate end-point. Results: 208 patients were included, 104 in arm A and 104 in arm B. 36 (17%) squamous cell, 97 (47%) adenocarcinomas, 10 (5%) large cell, 23 (11%) undifferentiated and 42 (20%) small-cell lung cancer were included. 93 (45%) patients were chemonaive. At 8 weeks, 79 patients were excluded from the study, 51 (49%) from the temozolomide arm and 28 (27%) from the radiotherapy arm. 53% of the patients with squamous cell carcinoma were excluded compared to 40% of small cell lung cancer, 33% of adenocarcinomas and 27% of large cell carcinomas. The exclusion rate at 8 weeks was higher among patients with symptoms at randomization compared to patients without symptoms. There were no difference in exclusion rate when comparing number or size of the metastases. Conclusion: The exclusion rate at 8 weeks was higher in the temozolomide arm compared to the radiotherapy arm. Histopathology and symptoms at randomization seems to be factors influencing the exclusion rate whereas number or size of metastases does not. Survival and quality of life data will be presented at the meeting. No significant financial relationships to disclose.
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Yassi, Annalee, Elizabeth A. Bryce, Deirdre Maultsaid, Helen Novak Lauscher, and Kun Zhao. "The Impact of Requiring Completion of an Online Infection Control Course on Health Professionals’ Intentions to Comply with Infection Control Guidelines: A Comparative Study." Canadian Journal of Infectious Diseases and Medical Microbiology 20, no. 1 (2009): 15–19. http://dx.doi.org/10.1155/2009/879357.
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BACKGROUND: Ensuring good infection control practice in health care facilities is a constant concern, yet evidence shows that the compliance of health care professionals with proper procedures is lacking, despite the existence of guidelines and training programs. An online infection control module was developed to provide ready access to training. Controversy exists about whether successfully completing such a course should be mandatory or strongly encouraged for all health care professionals. The objective of the present study was to compare the perception of safety culture and intention to comply with infection control guidelines in professionals who were required by their supervisors to take the course, and those who did so voluntarily.METHODS: Survey responses on learning environment, safety climate and intention to comply with infection control guidelines in health care professionals who were required to take the course (supervisor-required group [n=143]) and those who took the same course voluntarily (voluntary group [n=105]) were compared. Because randomization was thought to be too difficult to implement in the policy context in which the study was conducted, significant differences between the two groups were taken into account in the analysis.RESULTS: Those required to take the course had a significantly better perception of the institutional safety climate (P<0.001), and had a higher reported intention to comply with infection control guidelines (P=0.040) than those who took the course voluntarily.DISCUSSION: Requiring that staff complete a 30 min interactive online infection control module increased their intention to comply with infection control guidelines compared with those who voluntarily accessed this material based on promotional material. Consideration should be given to making the successful completion of an online infection control module a requirement for all health care professionals.
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Lee, Yura, Han Chen, Wei Chen, Qibin Qi, Majid Afshar, Jianwen Cai, Martha L. Daviglus, et al. "Metabolomic Associations of Asthma in the Hispanic Community Health Study/Study of Latinos." Metabolites 12, no. 4 (April 16, 2022): 359. http://dx.doi.org/10.3390/metabo12040359.
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Asthma disproportionally affects Hispanic and/or Latino backgrounds; however, the relation between circulating metabolites and asthma remains unclear. We conducted a cross-sectional study associating 640 individual serum metabolites, as well as twelve metabolite modules, with asthma in 3347 Hispanic/Latino background participants (514 asthmatics, 15.36%) from the Hispanic/Latino Community Health Study/Study of Latinos. Using survey logistic regression, per standard deviation (SD) increase in 1-arachidonoyl-GPA (20:4) was significantly associated with 32% high odds of asthma after accounting for clinical risk factors (p = 6.27 × 10−5), and per SD of the green module, constructed using weighted gene co-expression network, was suggestively associated with 25% high odds of asthma (p = 0.006). In the stratified analyses by sex and Hispanic and/or Latino backgrounds, the effect of 1-arachidonoyl-GPA (20:4) and the green module was predominantly observed in women (OR = 1.24 and 1.37, p < 0.001) and people of Cuban and Puerto-Rican backgrounds (OR = 1.25 and 1.27, p < 0.01). Mutations in Fatty Acid Desaturase 2 (FADS2) affected the levels of 1-arachidonoyl-GPA (20:4), and Mendelian Randomization analyses revealed that high genetically regulated 1-arachidonoyl-GPA (20:4) levels were associated with increased odds of asthma (p < 0.001). The findings reinforce a molecular basis for asthma etiology, and the potential causal effect of 1-arachidonoyl-GPA (20:4) on asthma provides an opportunity for future intervention.
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Shukla, Girja S., and David N. Krag. "Developing bifunctionalβ-lactamase molecules with built-in target-recognizing module for prodrug therapy: identification ofEnterobacter CloacaeP99 cephalosporinase loops suitable for randomization and phage-display selection." Journal of Molecular Recognition 22, no. 6 (November 2009): 425–36. http://dx.doi.org/10.1002/jmr.957.
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Mithra, Prasanna, Bhaskaran Unnikrishnan, Rekha Thapar, Nithin Kumar, Ramesh Holla, and Priya Rathi. "Modular intervention to improve paternal involvement and support for better infant and young child feeding in a district of coastal South India: a randomized controlled trial protocol." F1000Research 10 (May 10, 2021): 121. http://dx.doi.org/10.12688/f1000research.36376.2.
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Background: The major determinant to the well-being of infants and young children (IYC) is their feeding practices. These practices are the responsibility of both parents, meaning that fathers have an equal role to mothers. Fathers’ involvement can have an impact on the overall health of the children. Despite this, paternal involvement towards IYC feeding (IYCF) have not been studied adequately. Methods: This randomized control trial (n=120) will be conducted among fathers of infants (children aged <1 year) and young children (children aged 12-23 months) in selected households in Dakshina Kannada District of the southern Indian State of Karnataka. The study will be conducted after an initial baseline assessment on awareness, attitude and involvement of fathers in IYCF. Fathers with scores less than the 50th percentile in the practice component will be categorized as fathers with poor involvement and will be potential participants for the trial. A visual module will be developed and validated for improving paternal involvement in IYCF. Using a simple randomization technique, the participants will be allocated to modular intervention and control group (1:1 allocation). Each participant in the intervention arm will be visited once a month to implement the module, for six months on a one-to-one basis. Following the intervention, a post-test assessment will be done for both groups to measure the level of paternal involvement in IYCF. Ethics and dissemination: Approval has been obtained from the Institutional Ethics Committee of Kasturba Medical College, Mangalore, India. The dissemination plans include scientific conferences and publication in scientific journals. Registration: The study is registered with Clinical Trial Registry of India (CTRI/2017/06/008936).
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Mithra, Prasanna, Bhaskaran Unnikrishnan, Rekha Thapar, Nithin Kumar, Ramesh Holla, and Priya Rathi. "Modular intervention to improve paternal involvement and support for better infant and young child feeding in a district of coastal South India: a randomized controlled trial protocol." F1000Research 10 (February 17, 2021): 121. http://dx.doi.org/10.12688/f1000research.36376.1.
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Background: The major determinant to the well-being of infants and young children (IYC) is their feeding practices. These practices are the responsibility of both parents, meaning that fathers have an equal role to mothers. Fathers’ involvement can have an impact on the overall health of the children. Despite this, paternal involvement towards IYC feeding (IYCF) have not been studied adequately. Methods: This randomized control trial (n=120) will be conducted among fathers of infants (children aged <1 year) and young children (children aged 12-23 months) in selected households in Dakshina Kannada District of the southern Indian State of Karnataka. The study will be conducted after an initial baseline assessment on awareness, attitude and involvement of fathers in IYCF. Fathers with scores less than the 50th percentile in the practice component will be categorized as fathers with poor involvement and will be potential participants for the trial. A visual module will be developed and validated for improving paternal involvement in IYCF. Using a simple randomization technique, the participants will be allocated to modular intervention and control group (1:1 allocation). Each participant in the intervention arm will be visited once a month to implement the module, for six months on a one-to-one basis. Following the intervention, a post-test assessment will be done for both groups to measure the level of paternal involvement in IYCF. Ethics and dissemination: Approval has been obtained from the Institutional Ethics Committee of Kasturba Medical College, Mangalore, India. The dissemination plans include scientific conferences and publication in scientific journals. Registration: The study is registered with Clinical Trial Registry of India (CTRI/2017/06/008936).
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Rampogu, Shailima, Amir Zeb, Ayoung Baek, Chanin Park, Minky Son, and Keun Woo Lee. "Discovery of Potential Plant-Derived Peptide Deformylase (PDF) Inhibitors for Multidrug-Resistant Bacteria Using Computational Studies." Journal of Clinical Medicine 7, no. 12 (December 17, 2018): 563. http://dx.doi.org/10.3390/jcm7120563.
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Bacterial peptide deformylase (PDF) is an attractive target for developing novel inhibitors against several types of multidrug-resistant bacteria. The objective of the current study is to retrieve potential phytochemicals as prospective drugs against Staphylococcus aureus peptide deformylase (SaPDF). The current study focuses on applying ligand-based pharmacophore model (PharmL) and receptor-based pharmacophore (PharmR) approaches. Utilizing 20 known active compounds, pharmL was built and validated using Fischer’s randomization, test set method and the decoy set method. PharmR was generated from the knowledge imparted by the Interaction Generation protocol implemented on the Discovery Studio (DS) v4.5 and was validated using the decoy set that was employed for pharmL. The selection of pharmR was performed based upon the selectivity score and further utilizing the Pharmacophore Comparison module available on the DS. Subsequently, the validated pharmacophore models were escalated for Taiwan Indigenous Plants (TIP) database screening and furthermore, a drug-like evaluation was performed. Molecular docking was initiated for the resultant compounds, employing CDOCKER (available on the DS) and GOLD. Eventually, the stability of the final PDF–hit complexes was affirmed using molecular dynamics (MD) simulation conducted by GROMACS v5.0.6. The redeemed hits demonstrated a similar binding mode and stable intermolecular interactions with the key residues, as determined by no aberrant behaviour for 50 ns. Taken together, it can be stated that the hits can act as putative scaffolds against SaPDF, with a higher therapeutic value. Furthermore, they can act as fundamental structures for designing new drug candidates.
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Brousseau, David C., J. Paul Scott, Oluwakemi Badaki, Deepika S. Darbari, Corrie Chumpitazi, Gladstone E. Airewele, Angela M. Ellison, et al. "A Multi-Center Randomized Controlled Trial of Intravenous Magnesium for Sickle Cell Pain Crisis in Children." Blood 124, no. 21 (December 6, 2014): 88. http://dx.doi.org/10.1182/blood.v124.21.88.88.
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Abstract Introduction: There are approximately 18,000 hospitalizations and 75,000 hospitalization days annually in the United States for children experiencing sickle cell vasoocclusive crises. Despite advances in the management of other comorbidities of sickle cell disease, little has changed in the management of sickle cell pain crises. Magnesium, a known vasodilator, anti-inflammatory and pain reliever, has the potential to alter the pathophysiology of pain crises, shortening length of stay and decreasing opioid use. A previous pilot study showed IV magnesium shortened length of stay compared to historical controls. A randomized trial conducted in Canada showed no decrease in length of stay with the use of intravenous magnesium. In the MAGiC (MAGnesium for children in Crisis) study, we hypothesized that the addition of intravenous (IV) magnesium to standard therapy would shorten hospital length of stay, result in decreased opioid use and improve quality of life for pediatric patients hospitalized with sickle cell pain crises. Methods: The MAGiC study was a multi-center, randomized, double-blind, placebo-controlled trial of IV magnesium versus normal saline for the treatment of pediatric sickle cell pain crisis conducted at 8 sites. Participating sites were members of the Pediatric Emergency Care Applied Research Network (PECARN), and collaborations between Pediatric Emergency Medicine physicians and Pediatric sickle cell experts facilitated enrollment. Children aged 4 to 21 years, with hemoglobin SS or hemoglobin SB° thalassemia were eligible if they required inpatient hospitalization after failing emergency department (ED) management for pain. Enrollment occurred at 8 sites between December 2010 and December 2013, with a total of 217 eligible site enrollment months. Children received 40 mg/kg of IV magnesium every eight hours for a total of 6 doses or normal saline placebo of equivalent volume (1 ml/kg). Randomization was stratified by site, age and hydroxyurea use. The primary outcome was length of stay from the time of first drug infusion until 12 hours after the last IV opioid dose or time of discharge, whichever occurred first. Secondary outcomes included opioid use, recorded as morphine equivalents, and quality of life, as measured using the PedsQL Sickle cell disease specific module, fatigue module and generic module. Side effects, specifically hypotension, weakness, warmth on infusion, or the development of acute chest syndrome (ACS) were documented. Using an intention-to-treat analysis, we compared length of stay using a Van Elteren test, stratified by the same factors used to stratify randomization. Results: 208 children were enrolled. Four children were excluded prior to receipt of any study drug, resulting in 101 children receiving magnesium and 103 receiving placebo. The 2 groups were similar with respect to age, sex ,genotype, weight, history of ACS or asthma, previous hospitalizations within the past three years and days of pain prior to arrival. The median time from first ED opioid to first study drug infusion was 7.4 hours, similar between the two groups. The median (interquartile range) length of stay was 56.0 (27.0 - 109.0) hours in the magnesium group compared to 47.0 (24.0 - 99.0) hours in the placebo group, p = 0.264. Patients who received magnesium received 1.46 mg/kg of morphine equivalents compared to 1.28 mg/kg in the placebo group (p=0.11). Quality of life scores were similar between the two groups after 48 hours on study drug and one week after discharge (p > 0.10 at both time points). Safety analysis revealed no differences in hypotension (3% for magnesium versus 1% for placebo) or weakness (7% versus 4%) between the 2 groups. Of those who received magnesium, 26% reported warmth on infusion compared to 2% of children who received placebo, p < .0001. Other adverse events, serious adverse events, and rehospitalizations within 7 days were similar between the groups. Conclusion: Intravenous magnesium does not shorten length of stay, lessen opioid use or improve quality of life in children who require hospitalization for sickle cell pain crisis. Close collaboration between Pediatric Emergency Medicine physicians and Pediatric Hematologists allows for the successful enrollment of large numbers of children in an acute intervention trial for children with sickle cell disease. Disclosures Off Label Use: magnesium for sickle cell pain crisis.
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Feren, Neneh, Rekha Thapar, B. Unnikrishnan, Prasanna Mithra, Nithin Kumar, Ramesh Holla, Darshan BB, and Himani Kotian. "Effectiveness of multi-component modular intervention among adults with prehypertension in a village of Dakshina Kannada district - a community-based interventional study – protocol." F1000Research 12 (September 22, 2023): 667. http://dx.doi.org/10.12688/f1000research.129131.2.
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Introduction: The Joint National Committee (JNC 7) report on Prevention, Detection, Evaluation, and Treatment of Hypertension, defined "prehypertension," as individuals with a Systolic Blood Pressure (SBP) in the range of 120–139 mmHg and a (diastolic blood pressure) DBP of 80–89 mmHg. Prehypertension is directly linked with hypertension which is a precursor of CVDs. Owing to its high conversion rate to hypertension, it is important to identify individuals with blood pressures in this category and bring about lifestyle modifications in them that can prevent them from being hypertensive and from developing cardiovascular diseases later in life. Methods: This randomized controlled trial will be done among the selected pre-hypertensive adults of all genders residing in Kateel Gram panchayat, Dakshina Kannada district, Karnataka. A baseline survey will be done initially to assess the level of prehypertension among the study population. To study the effectiveness of the intervention, 142 individuals will be randomly allocated using block randomization technique to intervention and control groups. A multi-component module (educational intervention) will be developed, validated, and administered to participants in the intervention group, while the control group receives standard care. Each participant will then be followed up once in four months till the end of the study period of one year to assess for changes in SBP, DBP, WHR, BMI, stress levels, and usage of tobacco and alcohol. Ethics and dissemination: Institutional Ethics Committee approval was obtained from Kasturba Medical College in Mangalore, India. The plans for dissemination of findings include presenting at scientific conferences and publishing in scholarly journals.
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Feren, Neneh, Rekha Thapar, B. Unnikrishnan, Prasanna Mithra, Nithin Kumar, Ramesh Holla, Darshan BB, and Himani Kotian. "Effectiveness of multi-component modular intervention among adults with prehypertension in a village of Dakshina Kannada district - a community-based interventional study – protocol." F1000Research 12 (June 14, 2023): 667. http://dx.doi.org/10.12688/f1000research.129131.1.
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Introduction: The Joint National Committee (JNC 7) report on Prevention, Detection, Evaluation, and Treatment of Hypertension, defined "prehypertension," as individuals with a Systolic Blood Pressure (SBP) in the range of 120–139 mmHg and a (diastolic blood pressure) DBP of 80–89 mmHg. Prehypertension is directly linked with hypertension which is a precursor of CVDs. Owing to its high conversion rate to hypertension, it is important to identify individuals with blood pressures in this category and bring about lifestyle modifications in them that can prevent them from being hypertensive and from developing cardiovascular diseases later in life. Methods: This randomized controlled trial will be done among the selected pre-hypertensive adults of all genders residing in Kateel Gram panchayat, Dakshina Kannada district, Karnataka. A baseline survey will be done initially to assess the level of prehypertension among the study population. To study the effectiveness of the intervention, 142 individuals will be randomly allocated using block randomization technique to intervention and control groups. A multi-component module (educational intervention) will be developed, validated, and administered to participants in the intervention group, while the control group receives standard care. Each participant will then be followed up once in four months till the end of the study period of one year to assess for changes in SBP, DBP, WHR, BMI, stress levels, and usage of tobacco and alcohol. Ethics and dissemination: Institutional Ethics Committee approval was obtained from Kasturba Medical College in Mangalore, India. The plans for dissemination of findings include presenting at scientific conferences and publishing in scholarly journals.
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Brandberg, Yvonne, Helena Michelson, Bo Nilsson, Christina Bolund, Bjørn Erikstein, Päivi Hietanen, Stein Kaasa, et al. "Quality of Life in Women With Breast Cancer During the First Year After Random Assignment to Adjuvant Treatment With Marrow-Supported High-Dose Chemotherapy With Cyclophosphamide, Thiotepa, and Carboplatin or Tailored Therapy With Fluorouracil, Epirubicin, and Cyclophosphamide: Scandinavian Breast Group Study 9401." Journal of Clinical Oncology 21, no. 19 (October 1, 2003): 3659–64. http://dx.doi.org/10.1200/jco.2003.07.020.
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Purpose: To compare, in high-risk breast cancer patients, the effects on health-related quality of life (HRQoL) of two adjuvant treatments. Treatments were compared at eight points during the first year after random assignment to treatment with tailored fluorouracil, epirubicin, and cyclophosphamide (FEC) therapy for nine courses versus induction FEC therapy for three courses followed by high-dose chemotherapy with cyclophosphamide, thiotepa, and carboplatin (CTCb) supported by peripheral-blood stem cells. Patients and Methods: From March 1994 to March 1998, 525 breast cancer patients (estimated relapse risk > 70% within 5 years with standard therapy) were included in the Scandinavian Breast Group 9401 study. HRQoL evaluation, using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-C30 and EORTC Breast Cancer Module–23, included 408 of 446 eligible patients in Finland, Norway, and Sweden. Results: Eighty-four percent to 95% of the patients completed questionnaires at eight points of assessment. Nostatistically significant overall differences were found between the tailored FEC group and the CTCb group for any of the HRQoL variables. Statistically significant differences over time were found for all HRQoL variables. HRQoL in the CTCb group demonstrated a steeper decrease, but a faster recovery than in the tailored FEC group. Emotional functioning improved with increased time from randomization. Higher levels of problems in body image and arm symptoms were reported in the tailored FEC group compared with the CTCb group. Sexual functioning and satisfaction were impaired during the study period. Conclusion: Both treatments had a negative influence on HRQoL during the treatment period. Despite the aggressive therapies, the patient’s HRQoL returned to levels found at inclusion on most variables.
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Wagner, Birgit, Laurence Reuter, and Betteke Maria van Noort. "Internet-Based Prevention Program of Victimization for Youth in Care and Care Leavers (EMPOWER YOUTH): Protocol for a Randomized Controlled Trial." JMIR Research Protocols 11, no. 6 (June 14, 2022): e34706. http://dx.doi.org/10.2196/34706.
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Background The global estimate of the number of children in institutional care is around 5 million, with around 1 million of these children living in Europe. In Germany, about 75,000 children and adolescents find themselves in the foster care system and about 93,000 additional children and adolescents are living in institutions. Traumatic experiences and neglect in childhood are highly prevalent among these youth in care and are related to severe long-term effects. Childhood maltreatment and abuse can increase the risk of future victimization experiences. Although youth in care are at risk of victimization or revictimization, no specific evidence-based prevention program has been designed to address these specific needs. Objective This study aims to evaluate the efficacy of a newly developed 6-module internet-based prevention program of victimization for youth in care, named EMPOWER YOUTH. Methods In a randomized controlled trial, the intervention group will be compared to a waiting-list control group with an unblinded 1:1 allocation ratio. Assessments will take place before randomization (baseline) and at follow-up 18 weeks after baseline (ie, 12 weeks after finishing the last module of the program). The primary endpoint is the number of victimization, and online and offline bullying experiences (composite score) at the 18-week follow-up. Secondary endpoints are risk-taking behavior, aggressive tendencies, empathy, prosocial behavior, depressiveness, and loneliness at follow-up. The expected outcome requires a sample size of 156 subjects to achieve a power of 80%. Assuming a 30% dropout rate at follow-up, we require 225 participants to be allocated to the trial. Participants are youth in care, that is, adolescents in foster care, adopted adolescents, or young care leavers aged 14 to 21 years. Results Ethical approval was granted by the Ethics Committee of the Medical School Berlin in March 2021 (MSB-2021/55). Recruitment started in September 2021 and is planned until November 2022. The results are expected to be published in January 2023. Conclusions Given the increased likelihood for future victimization experiences among youth in care, there is a strong need for a low-threshold intervention specifically for this high-risk age group. There are no existing nationwide mental health programs exclusively for youth in care in Germany. Trial Registration German Clinical Trials Register DRKS00024749; https://tinyurl.com/tjaahayw International Registered Report Identifier (IRRID) DERR1-10.2196/34706
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Udayani, Wiwik, Muhammad Amin, and Makhfudli Makhfudli. "PENGARUH KOMBINASI TEKNIK PERNAPASAN BUTEYKO DAN LATIHAN BERJALAN TERHADAP KONTROL ASMA PADA PASIEN ASMA DEWASA." Jurnal Ilmiah Keperawatan (Scientific Journal of Nursing) 6, no. 1 (March 30, 2020): 6–12. http://dx.doi.org/10.33023/jikep.v6i1.331.
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ABSTRACT
Introduction: Poor control of asthma can reduce the quality of life of asthma patients. Doing breathing exercises and regular physical exercise can increase asthma control. Exercises that can be done are a combination of Buteyko breathing techniques and walking exercises. The purpose of this study was to analyze the effect of a combination of Buteyko breathing techniques and walking exercises on athma control. Methods: The design of this study was quasi experimental with pretest-posttest control group design. The location of the study was in the pulmonary clinic of Regional General Hospital of Sidoarjo Regency and Bangil Regional General Hospital in Pasuruan Regency, East Java. Respondents were selected by randomization by simple random sampling. Respondents in this study amounted to 76 respondents. Asthma control were measured using Asthma Control Test. The intervention group was given a combination exercise with Buteyko breathing technique and walking exercise for 8 weeks, 3x per week, 55 minutes every training session. Giving a combination of Buteyko breathing technique and walking exercises using module and video media. Asthma control measurements were carried out 3 times (pre test, week 4, week 8). Data were analyzed using SPSS 22 with GLM-RM (General Linear Model-Repeated Measure) ANOVA. Result: The research results showed a significant difference in the astma control value between before and after 4 weeks and 8 weeks of the intervention in the treatment group with p = 0.000(p <0.05). Discussion:The combination of Buteyko breathing techniques and walking exercise increase asthma control through the mechanism of increasing CO2 and producing nitric oxide which has bronchodilation effects and through decreasing inflammatory mediators so that it can reduce asthma symptoms. This exercise can be used as an alternative choice in supporting pharmacological therapy to improve asthma control.
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Cohen, Rinat, Gal Maydan, Shai Brill, and Jiska Cohen-Mansfield. "Improving Staff-Family End-of-Life Communication at Israeli Geriatric Facilities by Using a Mobile App." Innovation in Aging 5, Supplement_1 (December 1, 2021): 515. http://dx.doi.org/10.1093/geroni/igab046.1992.
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Abstract Family caregivers (FCs) of persons institutionalized at geriatric facilities present significant unmet communication needs regarding receiving regular updates about their loved one’s condition and having available healthcare professionals (HPs) to approach when needed. We developed and tested a mobile-app for staff-family communication with both parties having active roles in app planning to tailor it to their needs and abilities. The app includes a daily-update module for FCs and a chat option for FCs and HPs. App use was piloted at one geriatric-medical-center for 15 months (unit-level randomization resulted in one complex-care and one assisted-ventilation unit in each group- intervention and control) and one single-unit nursing-home for three months. Personal interviews were conducted with 55 FCs (28 from intervention-group and 27 FCs from control-group) before-and-after app use (with mean duration of use 1.6[S.D.=.6] months. Most participants were women and the children of the patients; their mean age was 55.9 years (S.D.=12.4). Repeated-measures Analysis-of-Variance for the end-of-life communication sub-scale on the Quality-of-communication questionnaire yielded a main effect for time (F(1,53)=8.31, p=.006) with both groups’ ratings increasing over time and an interaction effect (F(1,53)=4.78, p=.033) with a greater increase for intervention-group compared to control-group. Intervention-group participants rated the app as convenient to use. Qualitative data revealed that FCs perceived app use as improving quality of communication with the HPs who used it and improving their own well-being. The app offers a feasible and an effective mode of communication that incorporates technology in daily communication between FCs and HPs while addressing FCs’ unmet needs.
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Milbury, Kathrin, Jing Li, Shiao-Pei Weathers, Smitha Mallaiah, Terri Armstrong, Yisheng Li, Eduardo Bruera, and Lorenzo Cohen. "Pilot randomized, controlled trial of a dyadic yoga program for glioma patients undergoing radiotherapy and their family caregivers." Neuro-Oncology Practice 6, no. 4 (December 20, 2018): 311–20. http://dx.doi.org/10.1093/nop/npy052.
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Abstract Background While the use of behavioral medicine in managing glioma patients’ symptoms is not well studied, the high symptom burden in patients and their family caregivers is well established. We conducted a pilot randomized, controlled trial to examine the feasibility and preliminary efficacy of a dyadic yoga (DY) intervention as a supportive care strategy. Methods Glioma patients undergoing radiotherapy and their caregivers were randomized to a 12-session DY or waitlist control (WLC) group. Prior to radiotherapy and randomization, both groups completed measures of cancer-related symptoms (MD Anderson Symptom Inventory-Brain Tumor module), depressive symptoms (Center for Epidemiological Studies-Depression measure), fatigue (Brief Fatigue Inventory), and overall quality of life (QOL; Medical Outcomes Study 36-item short-form survey). Dyads were reassessed at the last day of radiotherapy. Results Twenty patients (mean age: 46 years, 50% female, 80% WHO grade IV and caregivers (mean age: 50 years, 70% female, 50% spouses) participated in the trial. A priori feasibility criteria were met regarding consent (70%), adherence (88%), and retention (95%) rates. Controlling for relevant covariates, change score analyses revealed clinically significant improvements for patients in the DY compared with the WLC group for overall cancer symptom severity (d = 0.96) and symptom interference (d = 0.74), depressive symptoms (d = 0.71), and mental QOL (d = 0.69). Caregivers in the DY group reported clinically significant improvements in depressive symptoms (d = 1.12), fatigue (d = 0.89), and mental QOL (d = 0.49) relative to those in the WLC group. Conclusion A DY intervention appears to be a feasible and beneficial symptom and QOL management strategy for glioma patients undergoing radiotherapy and their caregivers. An efficacy trial with a more stringent control group is warranted. Clinical Trial Number NCT02481349
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Puduvalli, Vinay K., Jing Wu, Ying Yuan, Terri S. Armstrong, Elizabeth Vera, Jimin Wu, Jihong Xu, et al. "A Bayesian adaptive randomized phase II multicenter trial of bevacizumab with or without vorinostat in adults with recurrent glioblastoma." Neuro-Oncology 22, no. 10 (March 13, 2020): 1505–15. http://dx.doi.org/10.1093/neuonc/noaa062.
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Abstract Background Bevacizumab has promising activity against recurrent glioblastoma (GBM). However, acquired resistance to this agent results in tumor recurrence. We hypothesized that vorinostat, a histone deacetylase (HDAC) inhibitor with anti-angiogenic effects, would prevent acquired resistance to bevacizumab. Methods This multicenter phase II trial used a Bayesian adaptive design to randomize patients with recurrent GBM to bevacizumab alone or bevacizumab plus vorinostat with the primary endpoint of progression-free survival (PFS) and secondary endpoints of overall survival (OS) and clinical outcomes assessment (MD Anderson Symptom Inventory Brain Tumor module [MDASI-BT]). Eligible patients were adults (≥18 y) with histologically confirmed GBM recurrent after prior radiation therapy, with adequate organ function, KPS ≥60, and no prior bevacizumab or HDAC inhibitors. Results Ninety patients (bevacizumab + vorinostat: 49, bevacizumab: 41) were enrolled, of whom 74 were evaluable for PFS (bevacizumab + vorinostat: 44, bevacizumab: 30). Median PFS (3.7 vs 3.9 mo, P = 0.94, hazard ratio [HR] 0.63 [95% CI: 0.38, 1.06, P = 0.08]), median OS (7.8 vs 9.3 mo, P = 0.64, HR 0.93 [95% CI: 0.5, 1.6, P = 0.79]) and clinical benefit were similar between the 2 arms. Toxicity (grade ≥3) in 85 evaluable patients included hypertension (n = 37), neurological changes (n = 2), anorexia (n = 2), infections (n = 9), wound dehiscence (n = 2), deep vein thrombosis/pulmonary embolism (n = 2), and colonic perforation (n = 1). Conclusions Bevacizumab combined with vorinostat did not yield improvement in PFS or OS or clinical benefit compared with bevacizumab alone or a clinical benefit in adults with recurrent GBM. This trial is the first to test a Bayesian adaptive design with adaptive randomization and Bayesian continuous monitoring in patients with primary brain tumor and demonstrates the feasibility of using complex Bayesian adaptive design in a multicenter setting.
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Taphoorn, Martin J. B., Martin J. van den Bent, Murielle E. L. Mauer, Corneel Coens, Jean-Yves Delattre, Alba A. Brandes, Peter A. E. Sillevis Smitt, et al. "Health-Related Quality of Life in Patients Treated for Anaplastic Oligodendroglioma With Adjuvant Chemotherapy: Results of a European Organisation for Research and Treatment of Cancer Randomized Clinical Trial." Journal of Clinical Oncology 25, no. 36 (December 20, 2007): 5723–30. http://dx.doi.org/10.1200/jco.2007.12.7514.
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Purpose Little is known about the health-related quality of life (HRQOL) of patients treated for anaplastic oligodendrogliomas. The impact of combined procarbazine, CCNU (lomustine), and vincristine (PCV) chemotherapy after radiotherapy (RT) compared with RT alone on HRQOL in the randomized European Organisation for Research and Treatment of Cancer (EORTC) 26951 trial was studied. Patients and Methods Adult patients with anaplastic oligodendrogliomas received RT alone or RT plus PCV chemotherapy. HRQOL was assessed with the EORTC Quality of Life Questionnaire C30 and Brain Cancer Module. Seven prespecified HRQOL end points were selected. We hypothesized that chemotherapy would impair HRQOL during treatment but that there would be a similar HRQOL between treatment arms once off treatment. Assessments were performed at randomization, at the end of RT, and then every 3 to 6 months until progression. Results A total of 368 patients were randomly assigned to one of the two arms; overall, 58% were male, and the median age was 49 years. Compliance with HRQOL was 78% at baseline and dropped to 55% to 72% up to 2.5 years post-RT. Baseline scores demonstrated considerable impairments in HRQOL for both treatment groups. The longitudinal analysis showed a significant increase in nausea/vomiting in the RT plus PCV chemotherapy arm during and shortly after chemotherapy. Because of a difference in baseline scores for fatigue and physical functioning, the differences between treatment arms during PCV did not reach significance. The nonselected scales of appetite loss and drowsiness demonstrated significant differences between treatment arms during chemotherapy in favor of the RT arm. The long-term results showed no difference between arms. Conclusion The major impact of PCV on HRQOL is on nausea/vomiting, loss of appetite, and drowsiness during and shortly after treatment. There are no long-term effects of PCV chemotherapy.
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Gerber, Bernd, Angrit Stachs, Kristina Veselinovic, Silke Polata, Thomas Müller, Thorsten Kühn, Jörg Heil, et al. "Abstract GS4-03: Patient-reported outcomes (PROs) for the intergroup sentinel mamma study (INSEMA, GBG75, ABCSG43): Persistent impact of axillary surgery on arm and breast symptoms in early breast cancer." Cancer Research 82, no. 4_Supplement (February 15, 2022): GS4–03—GS4–03. http://dx.doi.org/10.1158/1538-7445.sabcs21-gs4-03.
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Abstract Background: Despite increasing evidence disfavoring axillary lymph node dissection (ALND) for locoregional control, it remains part of guidelines for breast cancer (BC) treatment. In an attempt to re-evaluate standard local therapy, the INSEMA trial was designed to assess non-inferiority of avoiding sentinel lymph node biopsy (SLNB) or completion ALND (cALND) in early-stage clinically node-negative BC patients. Here we present PROs from the INSEMA trial. Methods: INSEMA (NCT02466737) investigates non-inferiority of invasive disease-free survival (iDFS) after no axillary surgical staging versus SLNB (first randomization 1:4) in patients with clinically node-negative BC (tumor size ≤5 cm) and primary breast-conserving surgery (BCS). In case of pN1a(sn) in the SLNB arm, patients underwent a second randomization to either SLNB alone or cALND (1:1). PROs were assessed at baseline (pre-surgery) and at 1, 3, 6, 12, and 18 months after final axillary surgery using the European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire (EORTC QLQ-C30) and its breast cancer (BR23) module. Higher scores of C30 and BR23 (range 0-100) indicate better functioning and global health status (GHS)/quality of life (QoL) or worse symptom severity, respectively. The QoL scores were compared using the Mann-Whitney U test based on the safety set. Results: Between September 2015 and April 2019, 5,502 patients were recruited for the 1st randomization and 5,173 of them were included in the intent-to-treat set (4,138 SLNB vs 1,035 no SLNB). Patient and tumor characteristics were well-balanced between treatment arms. Median age at diagnosis was 62.0 years (range 24.0 - 89.0). Overall, recruited patients presented with low-risk BC marked by 85.6% clinically stage T1, 98.5% hormone-receptor positivity, 2.4% HER2-positivity, and 3.7% G3 tumors. The majority (73.5%) had an invasive carcinoma of no special type (72.8% in SLNB vs 76.0% in no SLNB arm) and 87.0% had Ki-67 ≤ 20%. Questionnaire completion response remained high throughout the trial: n=3,915 (75.7%) returned questionnaires at 1 month after final axillary surgery, n=3,938 (76.1%) at 3 months, n=4,024 (77.8%) at 6 months, n=3,907 (75.5%) at 12 months, and n=3,637 (70.3%) at 18 months. All QoL baseline parameters regarding GHS, functional scales, and symptom scales/items were well-balanced between arms (total 4,117 SLNB vs 1,056 no SLNB as treated; 270 of 4,117 received cALND). There were significant differences for the BRBS (breast symptoms) and BRAS (arm symptoms) scores favoring the no SLNB group in all post-baseline assessments Patients in the SLNB group showed persistent higher scores for BRAS (differences in mean values ≥5.0 points at all times of assessment) including pain, arm swelling, and impaired mobility in all postoperative visits with the highest difference at 1 month after final surgery (mean scores, 23.6 vs. 12.8, p<0.001). Differences between treatment arms regarding BRBS including pain, breast swelling, hypersensitivity, and other skin problems showed a smaller range, but still a continuous trend for improved QoL in the no SLNB arm. Scoring of the QLQ-C30 questionnaire revealed no relevant differences between the treatment groups postoperatively. Conclusions: This is one of the first randomized trials investigating the omission of SLNB in clinically node-negative patients and the first to report QoL data. Patients with no SLNB benefitted regarding arm symptoms/functioning while no relevant differences in other QoL scales were seen. Data for the primary outcome of the study (iDFS) are expected for the end of 2024. Citation Format: Bernd Gerber, Angrit Stachs, Kristina Veselinovic, Silke Polata, Thomas Müller, Thorsten Kühn, Jörg Heil, Beyhan Ataseven, Roland Reitsamer, Guido Hildebrandt, Michael Knauer, Michael Golatta, Andrea Stefek, Dirk-Michael Zahm, Marc Thill, Valentina Nekljudova, David Krug, Fenja Seither, Sibylle Loibl, Toralf Reimer. Patient-reported outcomes (PROs) for the intergroup sentinel mamma study (INSEMA, GBG75, ABCSG43): Persistent impact of axillary surgery on arm and breast symptoms in early breast cancer [abstract]. In: Proceedings of the 2021 San Antonio Breast Cancer Symposium; 2021 Dec 7-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2022;82(4 Suppl):Abstract nr GS4-03.
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Samchuk, P. M., A. I. Ishchenko, and E. L. Azoeva. "Effect of maternal reproductive factors on prenatal screening rates in the first trimester." Sechenov Medical Journal 11, no. 3 (January 31, 2021): 37–46. http://dx.doi.org/10.47093/2218-7332.2020.11.3.37-46.
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Effect of maternal factors on indicators of increased risk of chromosomal abnormalities (CA), pre-eclampsia (PE), Small-forGestational-Age Fetus (SGA fetus) and preterm labour and birth (PB) during prenatal screening has not been sufficiently studied. Aim. To study the effect of maternal reproductive factors on the risk indicators of CA, PE, SGA fetus and PB, assessed during prenatal screening using the Astraia Obstetrics module. Materials and methods. Of the 11,841 pregnant women who were prenatal screened, 18.53% of the patients had at high risk of the outcomes studied (frequency 1: 100 and above). The subgroup of isolated high risk for CA included 69, PE — 66, SGA fetus — 48, PB — 52 patients. From the group of patients with low risk, 208 patients were selected for the control group by the method of stratified randomization by age. Results. Among extragenital diseases, the most common in all high-risk subgroups were: hypertension (AH) I and II degree — 31–47% versus 4.8% of the control group (p < 0.05), varicose veins of the lower extremities (VVLE) — 17–30% vs. 5.3% in the control group (p < 0.05), a history of ovarian tumor — 12–33% vs. 3% in the control group (p < 0.05). In the high-risk subgroups for the development of CA, PE and SGA fetus, fibroids uterus and iron deficiency anaemia (IDA) were more common compared to control: 10–41% vs. 1% (p < 0.05) and 10–17% vs. 3% (p < 0.05), respectively (p < 0.05). Primiparas with a history of pregnancy were more common in subgroups with a high risk of CA (33%) and PR (35%) versus 17% in controls. Conclusion. An association has been established between high risk for all the outcomes studied and AC, VVLE, history of ovarian tumor. High-risk subgroups for CA, PE and SGA fetus have a higher incidence of uterine fibroids and IDA compared to control.
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Poulin Herron, Alex, Titilayo Tatiana Agbadje, Melissa Cote, Codjo Djignefa Djade, Geneviève Roch, Francois Rousseau, and France Légaré. "Web-Based Training for Nurses on Shared Decision Making and Prenatal Screening for Down Syndrome: Protocol for a Randomized Controlled Trial." JMIR Research Protocols 9, no. 10 (October 29, 2020): e17878. http://dx.doi.org/10.2196/17878.
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Background Pregnant women often find it difficult to choose from among the wide variety of available prenatal screening options. To help pregnant women and their partners make informed decisions based on their values, needs, and preferences, a decision aid and a web-based shared decision making (SDM) training program for health professionals have been developed. In Canada, nurses provide maternity care and thus can train as decision coaches for prenatal screening. However, there is a knowledge gap about the effectiveness of SDM interventions in maternity care in nursing practice. Objective This study aims to assess the impact of an SDM training program on nurses’ intentions to use a decision aid for prenatal screening and on their knowledge and to assess their overall impressions of the training. Methods This is a 2-arm parallel randomized trial. French-speaking nurses working with pregnant women in the province of Quebec were recruited online by a private survey firm. They were randomly allocated (1:1 ratio) to either an experimental group, which completed a web-based SDM training program that included prenatal screening, or a control group, which completed a web-based training program focusing on prenatal screening alone. The experimental intervention consisted of a 3-hour web-based training hosted on the Université Laval platform with 4 modules: (1) SDM; (2) Down syndrome prenatal screening; (3) decision aids; and (4) communication between health care professionals and the patient. For the control group, the topic of SDM in Module 1 was replaced with “Context and history of prenatal screening,” and the topic of decision aids in Module 3 was replaced with “Consent in prenatal screening.” Participants completed a self-administered sociodemographic questionnaire with close-ended questions. We also assessed the participants' (1) intention to use a decision aid in prenatal screening clinical practice, (2) knowledge, (3) satisfaction with the training, (4) acceptability, and (5) perceived usefulness of the training. The randomization was done using a predetermined sequence and included 40 nurses. Participants and researchers were blinded. Intention to use a decision aid will be assessed by a t test. Bivariate and multivariate analysis will be performed to assess knowledge and overall impressions of the training. Results This study was funded in 2017 and approved by Genome Canada. Data were collected from September 2019 to late January 2020. This paper was initially submitted before data analysis began. Results are expected to be published in winter 2020. Conclusions Study results will inform us on the impact of an SDM training program on nurses’ intention to use and knowledge of decision aids for prenatal screening and their overall impressions of the training. Participant feedback will also inform an upgrade of the program, if needed. Trial Registration ClinicalTrials.gov NCT04162288; https://clinicaltrials.gov/ct2/show/NCT04162288 International Registered Report Identifier (IRRID) DERR1-10.2196/17878
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Iivanainen, Sanna, Anne-Marie Baird, Bogdana Balas, Alberto Bustillos, Yovanna Castro, Manuela Eicher, Sophie Golding, et al. "An interventional study of the impact of digital patient monitoring (DPM) on health outcomes, healthcare resource utilization, and feasibility of a combination with at-home treatment (tx) for delivery of systemic anticancer tx in clinical practice." Journal of Clinical Oncology 41, no. 16_suppl (June 1, 2023): TPS1617. http://dx.doi.org/10.1200/jco.2023.41.16_suppl.tps1617.
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TPS1617 Background: Disease- and tx-related symptoms negatively affect quality of life and may become life-threatening. There is a need for improved understanding, prevention, reduction and mitigation of symptoms, and tools to facilitate remote tracking of pt-reported outcomes (PROs) and support self-management of symptoms. As anticancer txs are increasingly given outside of the clinical settings, DPM tools are becoming more important to support remote symptom management. DPM can improve clinical care and pt outcomes; however, broad adoption requires proven usability and demonstration of real-world clinical utility/impact. ORIGAMA (NCT05694013) is an interventional, open-label, multi-country platform study investigating the clinical utility of DPM tools with specific txs. ORIGAMA will assess atezolizumab (atezo)-specific Roche DPM Modules (F. Hoffmann-La Roche Ltd, Basel, Switzerland; hosted on Kaiku Health DPM platform [Helsinki, Finland]) in two cohorts, to study the impact of DPM on clinical outcomes and healthcare resource utilization, and its feasibility to support at-home tx administration. Methods: Adult pts with ECOG PS of 0–2, an email address, and access to an internet-capable device and internet connection are eligible. In Cohort A, systemic tx-naive pts with metastatic non-small cell lung cancer (NSCLC), extensive-stage SCLC, or Child–Pugh A unresectable hepatocellular carcinoma, with a life expectancy of ≥ 12 weeks (wks) will be randomized 1:1 to a locally approved anticancer regimen of intravenous atezo and local standard-of-care (SoC) support with/without access to the Roche DPM Module. Pts will receive tx until progressive disease or per local SoC. Cohort B will assess the Roche DPM Module in pts receiving 3 cycles of subcutaneous atezo in a hospital setting, followed by 13 cycles of at-home administration by a healthcare professional. Eligible pts have programmed-death ligand 1-positive (expression on ≥ 1% of tumor cells), NSCLC (Stages IIB, IIIA, IIIB [T3–N2]), have completed adjuvant chemotherapy 4–12 wks prior to randomization, and must have a complete resection. Future cohorts may be added to investigate digital health solutions in other tx settings. The primary endpoints are the mean difference in change of the pt-reported Total Symptom Interference Score at Wk 12 from baseline (Cohort A), and flexible care adoption rate at Cycle 6 (Cohort B). The primary analysis for Cohort A will occur when all randomized pts have been followed for ≥ 12 wks and for Cohort B when all pts have completed 16 cycles of tx. Other endpoints include safety and PROs. An exploratory analysis of overall survival will be performed. ~400 pts in Cohort A and 40 pts in Cohort B will be enrolled. Recruitment has started; the first pt to be enrolled in February 2023. Clinical trial information: NCT05694013 .
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Hirsh, Vera, Fiona Helen Blackhall, Dong-Wan Kim, Benjamin Besse, Hiroshi Nokihara, Ji-Youn Han, Vanessa Roberts Tassell, Arlene Reisman, Shrividya Iyer, and Alice Tsang Shaw. "Impact of crizotinib on patient-reported symptoms and quality of life (QOL) compared with single-agent chemotherapy in a phase III study of advanced ALK+ non-small cell lung cancer (NSCLC)." Journal of Clinical Oncology 31, no. 15_suppl (May 20, 2013): 8108. http://dx.doi.org/10.1200/jco.2013.31.15_suppl.8108.
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8108 Background: PROFILE 1007 compared the efficacy and safety of the ALK inhibitor crizotinib (N=172) with that of standard-of-care chemotherapy (pemetrexed [PEM; N=99] or docetaxel [DOC; N=72]) in patients with advanced ALK+ NSCLC. The primary endpoint was progression-free survival. The main objective of our present post-hoc analyses was to compare patient-reported outcomes in the crizotinib arm with those of the DOC and PEM subgroups in the chemotherapy arm. Methods: Patient-reported outcomes were assessed at baseline, on day 1 of each cycle, and at the end of treatment using EORTC QLQ-C30 and lung cancer module QLQ-LC13. Higher scores (range 0−100) indicate higher symptom severity or better functioning/QOL. Time to deterioration (TTD) was defined as time from randomization to the earliest time with a ≥10-point increase from baseline for pain in chest, dyspnea, or cough and was compared between groups using an unstratified log-rank test. Repeated measures mixed-effects analyses were performed to compare change from baseline scores, with no adjustment for multiple comparisons. Results: Completion rates at baseline were ≥90% in each group and scores were well balanced. Crizotinib treatment was associated with a significantly longer TTD compared with PEM (median, 5.6 vs. 1.9 mo; HR, 0.66; 95% CI, 0.48−0.92; P=0.013) or DOC (median, 5.6 vs. 0.9 mo; HR, 0.37; 95% CI, 0.26−0.54; P<0.0001). A significantly greater improvement from baseline was observed with crizotinib compared with either the PEM or DOC subgroups for global QOL (P<0.01), cough (P<0.001), dyspnea (P<0.0001), pain in arm or shoulder (P<0.0001), pain in chest (P<0.0001), pain in other parts (P<0.01), fatigue (P<0.05), insomnia (P<0.05), and pain (P<0.0001). A significantly greater improvement was also observed with crizotinib compared with DOC for functioning (P<0.05), alopecia (P<0.0001), and hemoptysis (P<0.0001). Conclusions: Crizotinib treatment showed a significantly greater improvement from baseline in key patient-reported lung cancer symptoms and global QOL compared with DOC and PEM, in addition to improved efficacy previously reported. Clinical trial information: NCT00932893.
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Mouchati, Christian, Noah Andrews, James Bena, Shannon Morrison, and Nancy Foldvary-Schaefer. "0389 A Computerized Cognitive Behavioral Therapy Randomized, Controlled, Pilot Trial for Insomnia in Epilepsy." SLEEP 47, Supplement_1 (April 20, 2024): A167. http://dx.doi.org/10.1093/sleep/zsae067.0389.
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Abstract Introduction Insomnia is the most common sleep-wake complaint in adults with epilepsy (AWE), impacting quality of life and potentially seizure control. Cognitive behavioral therapy for insomnia (CBTI) is the first-line treatment, although often costly and inaccessible. We conducted a Pilot Trial using web-based CBTI for Insomnia in AWE. Methods This randomized controlled trial was conducted at Cleveland Clinic comparing the efficacy of web-based CBTI Go to Sleep (GTS) to controls who received an informational sheet on sleep hygiene. The primary outcome was a change in the Insomnia Severity Index (ISI). Fatigue Severity Scale (FSS), Epworth Sleepiness Scale (ESS), Patient Health Questionnaire-9 (PHQ-9), and self-reported total sleep time (TST) were also evaluated. GTS adherence was measured by % of modules (total of 6) completed. Change in survey scores was assessed using ANOVA tests with Pearson’s correlations between baseline and 8 weeks post-randomization. Results A total of 35 subjects (GTS: N=18; control: N=17) were included; mean age 40.9±10.9, 77.1% female, ISI 21.6±3.4, FSS 46.3±9.5, ESS 9.6±5.9, PHQ-9 12.8±5.2, TST 6.1±1.8 hr. At baseline, all patients had ISI of 15+. At follow-up, 33.3% of GTS and 47.1% of controls had scores of 15+(p=0.88). ISI change was greater in GTS than in controls (-9.0 (-11.3,-6.6) vs. -5.8 (-8.4,-3.3); p=0.079). Changes in other patient-reported outcomes (PROs) and TST between groups were not significant. However, decreases in ISI were associated with decreases in ESS, p=0.004 and PHQ-9, p< 0.001, but not FSS or TST. Eleven (61.1%) of GTS patients completed the 6-module program. 75% reported satisfaction with the audio components and content of the program and found GTS very easy to use. Completion of lessons was associated with a decrease in FSS, p=0.031. Conclusion Comparable improvement in insomnia symptoms and other PROs were observed in AWE engaging in web-based CBTI and sleep hygiene education. Program adherence was good. Despite sample size limitations, these findings support the role of non-pharmacological insomnia treatment in AWE. Support (if any)
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Burda, Kristen, Nicole Gumport, Isabelle Tully, Norah Simpson, and Rachel Manber. "0443 Change in Sleep-Cognitions After Digital or Therapist-Led Cognitive Behavioral Therapy for Insomnia in Older Adults." SLEEP 47, Supplement_1 (April 20, 2024): A190. http://dx.doi.org/10.1093/sleep/zsae067.0443.
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Abstract Introduction Traditional therapist-led cognitive behavioral therapy for insomnia (CBTI) is associated with a shift to more adaptive cognitions about sleep, as measured by the Dysfunctional Beliefs and Attitudes about Sleep Scale (DBAS). To address unhelpful beliefs about sleep, CBTI uses cognitive therapy strategies. This study sought to assess the degree to which changes in DBAS differ between patients receiving digital CBTI (dCBTI) and those receiving therapist-led CBTI after two months of treatment access. Methods The RCT of the Effectiveness of Stepped-Care Sleep Therapy in General Practice (RESTING) study evaluated a triaged stepped-care framework for delivering dCBTI and therapist-led CBTI. Based on a study-developed checklist, 137 (M age=63.26 years [SD=7.79], 69% female) participants were identified as candidates who would likely benefit from higher intensity CBTI. However, these candidates were randomly assigned to one of two study arms: online only (n=68) or stepped care (n=69). Those in the online only arm received dCBTI, and those in the stepped care arm received therapist-led CBTI. Both arms included the same CBTI components, but therapist-led CBTI additionally included a module on supporting reduction in sleep medications. Participants completed the 16-item DBAS at baseline and two months post randomization. Multilevel modeling was used to examine changes in DBAS scores and subscale scores, including Expectations, Worry/Helplessness, Consequences, and Medication subscales. Results There were no significant differences in DBAS scores between participants receiving dCBTI and those receiving therapist-led CBTI (Beta=-0.05, SE=0.21, p=.82). At the level of subscale scores, compared to dCBTI, therapist-led CBTI was associated with greater reduction in dysfunctional beliefs in the 3-item Medication subscale (Beta=-1.10, SE=0.34, p=.001). Conclusion Whereas there was no differential impact of delivery mode on overall DBAS scores, therapist-led treatment resulted in greater change in DBAS Medication subscale scores for participants pre-identified as those who would benefit from higher intensity treatment. Specifically, therapist-led interventions might be especially effective for changing beliefs that insomnia has a biochemical etiology and that sleep medications are necessary for better sleep. Changing such beliefs may be an important element in supporting sustained improvement and potentially reducing sleep medication use. Support (if any) R01AG057500
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Van Gorp, Toon, Mansoor Raza Mirza, Alain Lortholary, David Cibula, Axel Walther, Antonella Savarese, Maria Pilar Barretina-Ginesta, et al. "ENGOT-en11/GOG-3053/KEYNOTE-B21: Phase 3 study of pembrolizumab or placebo in combination with adjuvant chemotherapy with/without radiotherapy in patients with newly diagnosed high-risk endometrial cancer." Journal of Clinical Oncology 39, no. 15_suppl (May 20, 2021): TPS5608. http://dx.doi.org/10.1200/jco.2021.39.15_suppl.tps5608.
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TPS5608 Background: Pembrolizumab, a selective humanized anti–PD-1 monoclonal antibody, has demonstrated activity in patients with previously treated mismatch repair (MMR) deficient (dMMR; 57.1% ORR as monotherapy and 63.6% ORR as combination therapy with lenvatinib) and MMR proficient (pMMR; 36.2% ORR as combination therapy with lenvatinib) endometrial cancer (EC). ENGOT-en11/GOG-3053/KEYNOTE-B21 is a phase 3, randomized, double-blind study of pembrolizumab or placebo in combination with adjuvant chemotherapy with/without radiotherapy in patients with EC. Methods: Eligible patients are ≥18 years old with newly diagnosed, histologically confirmed high-risk (stage I/II non-endometrioid, stage III/IVa, p53 abnormality) EC (carcinoma or carcinosarcoma) following surgery with curative intent with no evidence of disease post-operatively or on imaging, and without prior systemic therapy/radiotherapy. In total, ̃990 patients are randomized to receive pembrolizumab 200 mg or placebo Q3W for 6 cycles + chemotherapy (carboplatin area under the curve [AUC] 5 or 6 + paclitaxel 175 mg/m2 Q3W or carboplatin AUC 2 or 2.7 + paclitaxel 60 mg/m2 QW) in stage 1. Patients receive pembrolizumab 400 mg or placebo Q6W for 6 cycles in stage 2 per their treatment assignment. At the investigator’s discretion, radiotherapy (external beam radiotherapy [EBRT] and/or brachytherapy) ± radiosensitizing cisplatin 50 mg/m2 (days 1 and 29) may be administered after completion of chemotherapy. Randomization is stratified by MMR status (pMMR vs dMMR) and, within pMMR, by planned radiation therapy (cisplatin-EBRT vs EBRT vs no EBRT), histology (endometrioid vs non-endometrioid), and International Federation of Gynecology and Obstetrics (FIGO) surgical stage (I/II vs III/IVA). Dual primary endpoints are disease-free survival (DFS; per investigator assessment) and overall survival (OS), both estimated by the Kaplan-Meier method, with a stratified log-rank test to assess treatment differences and a Cox proportional hazard model with Efron’s method of tie handling to assess the magnitude of treatment differences. Secondary endpoints include DFS (per blinded independent central review), DFS (per investigator assessment) and OS by biomarker status (PD-L1 and tumor mutational burden), safety (per National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0) and quality of life (per European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 [EORTC QLQ-C30] and Endometrial Cancer Module [EORTC QLQ-EN24]). The study began enrollment in December 2020. Clinical trial information: NCT04634877.
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Naughton, M. J., L. Gu, X. F. Wang, A. D. Seidman, E. Winer, and A. B. Kornblith. "Quality of life (QOL) companion to CALGB 9840: A phase III study of paclitaxel (P) via weekly 1 hour (hr) versus standard 3 hour infusion every 3 weeks with trastuzumab in the treatment of patients with/without HER-2/neu-overexpressing metastatic breast cancer." Journal of Clinical Oncology 24, no. 18_suppl (June 20, 2006): 674. http://dx.doi.org/10.1200/jco.2006.24.18_suppl.674.
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674 Background: This study determined if adding trastuzumab (Herceptin, T) to P modified the QOL of HER-2 non-overexpressors and examined QOL differences between patients treated with weekly versus standard P. Methods: Of the 585 patients treated in CALGB 9840, 394 provided QOL data. Eligibility criteria and main trial results were reported, indicating greater efficacy in weekly versus standard P, but no greater efficacy with T in HER-2 negatives (Seidman AD et al., Proc ASCO 2004, Vol. 22, No 14S, abstract 512). HER-2 non-overexpressors were randomized to 1 of 4 groups: 1) P 175 mg/m2 over 3 hrs every 3 wks; 2) P 80 mg/m2 over 1 hr weekly; 3) P 175 mg/m2 over 3 hrs every 3 wks + T 4 mg/kg load, then 2 mg/kg weekly; and 4) P l 80 mg/m2 over 1 hr weekly + T 4 mg/kg load, then 2 mg/kg weekly, all IV. All HER-2 overexpressors received T and were randomized to group 3 or 4. Patients completed QOL interviews prior to randomization, and at 3, 6, and 9 months. Main outcome measures were the EORTC-C30 with the Breast Module (QLQ-BR23). Data were analyzed using general linear models for repeated measures, with the following covariates: treatment arm, assessment point, patient age, race, education, marital status, performance status, prior chemotherapy, and prior radiation therapy. Results: HER-2 negative patients receiving weekly P with/without T as compared to standard P with/without T reported better global QOL (p=.022) and fewer cancer symptoms (p=.036). No QOL differences were observed among the HER-2 overexpressors. The use of T in the HER-2 negatives, regardless of P schedule, resulted in better role (p=.002) and emotional functioning (p=.039), and fewer arm (p=.045) and breast (p=.033) symptoms than HER-2 negative patients not receiving T. No differences in physical, social, and cognitive functioning were observed across any of these treatment groups. Conclusions: Both weekly P and T improved the QOL of HER-2 negative patients. There were no QOL differences by P schedule among the HER-2 overexpressors. The higher QOL in HER-2 negatives receiving T was unexpected, inconsistent with clinical data, and needs further exploration in the dataset. [Table: see text]
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Shen, X., X. Guo, X. Gao, J. Zhang, X. Hou, and Z. Feng. "AB0441 JANUS KINASES INHIBITORS THERAPY FOR THE TREATMENT OF RHEUMATOID ARTHRITIS: AN OVERVIEW OF SYSTEMATIC REVIEWS AND META-ANALYSES." Annals of the Rheumatic Diseases 82, Suppl 1 (May 30, 2023): 1409.1–1409. http://dx.doi.org/10.1136/annrheumdis-2023-eular.2496.
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BackgroundJanus kinases (JAK) inhibitors are a family of intracellular tyrosine kinases that act as hubs in the signaling process of many cytokine receptors, mediating inflammation and autoimmune diseases. It was reported that JAK inhibitors played an important role in inhibiting bone destruction by inhibiting the phosphorylation of proteins. In recent years, JAK inhibitors have been widely used to treat Rheumatoid Arthritis(RA).and proved to have an obvious curative effect. However, the efficacy and safety of the clinical use of JAK inhibitors need to be further verified.ObjectivesTo access the methodological, reporting and evidence quality of systematic reviews and meta-analyses of JAK inhibitors for RA.MethodsWe comprehensively searched the literature in CNKI, Wanfang Data, VIP, PubMed, Web of Science databases from inception to November 2022. A Measurement Tool to Assess systematic Reviews (AMSTAR-2) tool and the Preferred Reporting Items for Systematic reviews and Meta-analyses (PRISMA) were used to access the methodological and reporting quality. The level of evidence quality was evaluated by employing the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) scale.ResultsThe AMSTAR-2 tool showed that half of the included literature had low quality, and the other 6 literatures had a very low quality. The study process lacked certain normativity, which had a certain impact on the implementation of the study and the evaluation of outcomes. The PRISMA statement showed that there were numerous vulnerabilities in the methodology module of each document, which was mainly manifested in the scheme and registration. The GRADE analyses showed that the quality of the evidence for the outcome measures was moderate to low. The results showed that JAK inhibitors had certain advantages in the proportion of patients with ACR20, 50 and 70 after treatment for 3 months or 6 months. In addition, this study found that JAK inhibitors could alleviate adverse reactions. Furthermore, all the included literature had certain deficiencies in randomization, blinding, allocation, etc. There was a risk of bias, which directly reduced the evidence level of RCT trials and showed that the included studies had defects in the design of trial protocols.ConclusionThe effectiveness of JAK inhibitors for RA has certain advantages compared with placebo, and more studies need to be demonstrated than other drugs. However, the safety is uncertain and need further explored.Keywords:JAK inhibitors Rheumatoid arthritis; AMSTAR-2; PRISMA; GRADE.Disclosure of InterestsNone Declared.Funding：This project was supported by grants from National Natural Science Foundation of China (No. 81703783 and 81503415);Disclosure of InterestsNone Declared.
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Kyalwazi, Beverly, Christina Yau, Olufunmilayo Olopade, A. Jo Chien, Anne Wallace, Andres Forero-Torres, Lajos Pusztai, et al. "Abstract GS4-02: Analysis of clinical outcomes and expression-based immune signatures by race in the I-SPY 2 trial." Cancer Research 82, no. 4_Supplement (February 15, 2022): GS4–02—GS4–02. http://dx.doi.org/10.1158/1538-7445.sabcs21-gs4-02.
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Abstract Background Transcriptomic immune-related gene signatures have been associated with achievement of pathologic complete response (pCR) and prognosis in the neoadjuvant setting. I-SPY 2 is a multicenter, phase 2 platform trial using response-adaptive randomization within subtypes defined by receptor status (HR/HER2) and MammaPrint (MP) risk to evaluate novel agents as neoadjuvant therapy for women with high-risk breast cancer. Given racial disparities in mortality from breast cancer and the paucity of racial demographic data from clinical trials, we aimed to evaluate the association between racial groups and baseline characteristics, including expression-based subtypes and immune signatures, treatment response, and prognosis of patients enrolled in the I-SPY 2 TRIAL. Methods Our study population included 990 I-SPY 2 patients. 15 patients identified as part of a racial group with <10 patients enrolled in the trial and were excluded from analysis. Pre-treatment expression data was available for 971 patients. Follow-up data was available for 907 patients; median follow-up time of 4.4 yrs. Chi-square test was used to assess associations between racial groups and pre-treatment SBR grade, HR/HER2 defined subtypes, intrinsic subtype (defined by BluePrint 80-gene molecular subtyping) and residual cancer burden (RCB) class. Logistic regression was used to evaluate race association with pCR. Cox proportional hazard modeling was used to assess the association between racial groups and event free survival (EFS) in a univariate setting, adjusting for pCR status. Association between racial groups and 28 expression signatures related to immune, proliferation, ER and HER2 pathway was analyzed using ANOVA with post-hoc Tukey test in the overall population and in each receptor subtype. Results Of 975 patients included in our analysis, 787 (81%) were White, 68 (7%) were Asian, and 120 (12%) were Black or African American. No significant associations between race and pre-treatment SBR grade (p=0.49), HR/HER2 defined subtypes (p=0.09), or expression-based subtypes (p=0.25) were observed. pCR rates do not significantly differ by racial groups (Odds ratio of pCR relative to White: 1.00 for Asian and 0.89 for Black or African American); and no significant differences in RCB class distribution by race was observed (p=0.88). Event free survival was not associated with patient racial group in a univariate Cox model (Hazard ratio relative to White: 1.10, p=0.73 for Asian and 1.37, p=0.13 for Black or African American). Among the 28 expression signatures evaluated, four were differentially expressed among racial groups within the overall population (F-test p<0.05): IFN module, B cell signature, Dendritic cell signature, and Mitotic score. Pairwise comparisons between racial groups with post-hoc Tukey test identified significant differences in IFN module expression between Black or African American vs. White (p=0.019) and Dendritic cell signature expression between Asian vs White (p=0.047). Among patients in the TNBC subtype, three signatures (dendritic cell signature, macrophage signature and ERBB2 module) were differentially expressed between Black or African American and White patients (p=0.002, 0.016 and 0.007). Conclusion Our analysis demonstrates that among women with high risk breast cancer, race does not affect subtype specific response rates nor event free survival. Distribution of subtypes previously shown to be associated with pCR in the I-SPY2 trial did not significantly differ among racial groups indicating race is less likely than tumor biology to predict response. The decreased expression of immune signatures observed in Black or African American women with TNBC suggests possible differential sensitivity to immunotherapy plus combination chemotherapy. Tumor immune multiplex studies are underway to further investigate. Citation Format: Beverly Kyalwazi, Christina Yau, Olufunmilayo Olopade, A. Jo Chien, Anne Wallace, Andres Forero-Torres, Lajos Pusztai, Erin Ellis, Kathy Albain, Anne Blaes, Barbara Haley, Judy Boughey, Anthony Elias, Amy Clark, Claudine Isaacs, Rita Nanda, Hyo Han, Rachel Yung, Debu Tripathy, Kristen Edmiston, Rebecca Viscusi, Donald Northfelt, Qamar Khan, Ashish Sanil, Scott Berry, Smita Asare, Amy Wilson, Gillian Hirst, Nola Hylton, Michelle Melisko, Jane Perlmutter, Hope Rugo, Fraser Symmans, Laura van ‘t Veer, Donald Berry, Laura Esserman. Analysis of clinical outcomes and expression-based immune signatures by race in the I-SPY 2 trial [abstract]. In: Proceedings of the 2021 San Antonio Breast Cancer Symposium; 2021 Dec 7-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2022;82(4 Suppl):Abstract nr GS4-02.
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Garon, Edward B., Byoung Chul Cho, Niels Reinmuth, Ki Hyeong Lee, Alexander Luft, Myung-Ju Ahn, Gilles Robinet, et al. "Patient-reported outcomes (PROs) with first-line durvalumab (D) ± tremelimumab (T) versus chemotherapy (CT) in metastatic NSCLC: Results from MYSTIC." Journal of Clinical Oncology 37, no. 15_suppl (May 20, 2019): 9048. http://dx.doi.org/10.1200/jco.2019.37.15_suppl.9048.
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9048 Background: MYSTIC, an open-label, Phase 3 trial of first-line D (anti-PD-L1) ± T (anti-CTLA-4) vs platinum CT in mNSCLC, showed an improvement in overall survival (OS) with D vs CT in pts with tumor cell PD-L1 expression ≥25% (TC ≥25% [primary analysis population]; D vs CT, HR 0.76 [97.54% CI 0.56–1.02], p = 0.036; D+T vs CT, HR 0.85 [98.77% CI 0.61–1.17], p = 0.202). Here we summarize PROs from MYSTIC. Methods: Immunotherapy/CT-naïve mNSCLC pts were randomized (1:1:1) to D, D+T, or CT. Symptoms, function, and global health status/quality of life (QoL) were assessed using the EORTC QLQ-C30 v3 questionnaire and its lung cancer module, QLQ-LC13. A change in score from baseline ≥10 points was predefined as clinically meaningful (CM). Mean changes from baseline (over 12 mos) for prespecified symptoms were analyzed using a mixed model for repeated measures (MMRM). Time from randomization to the first CM deterioration (TTD) was analyzed. Results: Among pts with PD-L1 TC ≥25% (n = 488), there were no differences between arms in symptoms, function, or global health status/QoL at baseline. Compliance with completing the questionnaires was ≥60% to wk 120 in the D±T arms, and to wk 40 (C30) and wk 44 (LC13) in the CT arm. MMRM analysis showed significant between-arm differences in changes from baseline in favor of D for fatigue (difference vs CT −9.5) and appetite loss (−11.9; CM), and D+T for fatigue (−11.7; CM). Significantly longer TTD (median, mos) was seen with D and D+T vs CT for appetite loss (12.8 and 5.6 vs 4.5), constipation (14.6 and 9.0 vs 5.5), nausea/vomiting (16.7 and 9.7 vs 4.5), and dyspnea (10.6 and 7.4 vs 5.6); D vs CT for diarrhea (16.3 vs 9.0), insomnia (9.3 vs 6.2), and hemoptysis (not reached vs 10.3); and D+T vs CT for fatigue (5.6 vs 2.0). Significantly longer TTD (median, mos) was also seen with D and D+T vs CT for function (cognitive [9.1 and 6.6 vs 5.2], physical [9.0 and 7.4 vs 4.2], role [D vs CT only; 7.3 vs 3.7], social [12.9 and 5.4 vs 5.2]), and global health status/QoL (5.9 and 6.8 vs 5.5). Conclusions: Pts with PD-L1 TC ≥25% treated with D±T had a reduced symptom burden over time and longer TTD for symptoms, function, and global health status/QoL compared to pts receiving CT. Clinical trial information: NCT02453282.