scholarly journals Quantifying Withdrawal of Consent, Loss to Follow-Up, Early Drug Discontinuation, and Censoring in Oncology Trials

2021 ◽  
pp. 1-8
Author(s):  
Brooke E. Wilson ◽  
Michelle B. Nadler ◽  
Alexandra Desnoyers ◽  
Eitan Amir
Keyword(s):  
Censored Data ◽  
Control Group ◽  
Drug Discontinuation ◽  
Open Label ◽  
Loss To Follow Up ◽  
Significant Difference ◽  
And Control ◽  
Experimental Group ◽  
Early Drug

Background: Censoring due to early drug discontinuation (EDD) or withdrawal of consent or loss to follow-up (WCLFU) can result in postrandomization bias. In oncology, censoring rules vary with no defined standards. In this study, we sought to describe the planned handling and transparency of censoring data in oncology trials supporting FDA approval and to compare EDD and WCLFU in experimental and control arms. Methods: We searched FDA archives to identify solid tumor drug approvals and their associated trials between 2015 and 2019, and extracted the planned handling and reporting of censored data. We compared the proportion of WCLFU and EDD between the experimental and control arms by using generalized estimating equations, and performed logistic regression to identify trial characteristics associated with WCLFU occurring more frequently in the control group. Results: Censoring rules were defined adequately in 48 (59%) of 81 included studies. Only 14 (17%) reported proportions of censored participants clearly. The proportion of WCLFU was higher in the control group than in the experimental group (mean, 3.9% vs 2.5%; β-coefficient, −2.2; 95% CI, −3.1 to −1.3; P<.001). EDD was numerically higher in the experimental arm in 61% of studies, but there was no statistically significant difference in the proportion of EDD between the experimental and control groups (mean, 21.6% vs 19.9%, respectively; β-coefficient, 0.27; 95% CI, −0.32 to 0.87; P=.37). The proportion of EDD due to adverse effects (AEs) was higher in the experimental group (mean, 13.2% vs 8.5%; β-coefficient, 1.5; 95% CI, 0.57–2.45; P=.002). WCLFU was higher in the control group in studies with an active control group (odds ratio [OR], 10.1; P<.001) and in open label studies (OR, 3.00; P=.08). Conclusions: There are significant differences in WCLFU and EDD for AEs between the experimental and control arms in oncology trials. This may introduce postrandomization bias. Trials should improve the reporting and handling of censored data so that clinicians and patients are fully informed regarding the expected benefits of a treatment.

Piano-accompanied solfège reading experiences of preservice music teachers

2020 ◽  
pp. 1321103X1987107
Author(s):  
Elif Guven
Keyword(s):  
Music Teachers ◽  
Control Group ◽  
Reading Practices ◽  
Control Groups ◽  
Plot Analysis ◽  
Experimental Implementation ◽  
Significant Difference ◽  
And Control ◽  
Experimental Group

This study examines how piano-accompanied solfège reading practices of preservice music teachers ( N = 28) affect their performance on their musical hearing, reading, and writing (MHRW) classes. A pretest–posttest design with control groups was employed. The data were analyzed by 2 × 2 split-plot analysis of variance (ANOVA) and one-way ANOVA. Consequently, a significant difference was not found between the MHRW performance scores of the experimental and control groups. An analysis of mean performance scores revealed that the scores received by the control group were higher than those of the experimental group after the practice. Follow-up interviews that were held with 14 students after the experimental implementation revealed that students believed piano-accompanied courses were more useful, and they felt more comfortable with piano accompaniment. Although MHRW performance scores indicated that piano-accompanied solfège reading practices did not have a significant effect on preservice music teachers’ MHRW performances, it helped them participate in courses more enthusiastically.

scholarly journals MENINGKATKAN ERP-EFFICACY MAHASISWA PSIKOLOGI MELALUI ODOO HUMAN CAPITAL TRAINING

2019 ◽  
Vol 3 (2) ◽  
pp. 1-13
Author(s):  
Dian Juliarti Bantam ◽  
Arief Fahmie ◽  
Emi Zulaifah
Keyword(s):  
Human Capital ◽  
Psychology Students ◽  
Control Group ◽  
A Value ◽  
Significant Difference ◽  
Quasi Experimental ◽  
Experimental Type ◽  
And Control ◽  
Experimental Group

This reserach examined the effect of Odoo Human Capital Training (OHCT) to improve ERP-Efficacy of psychology students. The reasearch is an intervention to improve efficacy about ERP softwares. This research used classroom action research (CAR) method of quasi experimental type with nonequivalent control group with pretest and posttest design. The participants were 35 students, with 18 students assigned to experimental group and 17 students to control group. The experimental group was trained for 4-5 hours each day within two days. The ERP-Efficacy was mesured by the ERP-Efficacy Questionnaire (ERPEQ) using 3 aspect from Compeau dan Higgins (1995). The aspect are ERP magnitude, ERP strength, and ERP generalizability. The data were analyzed by using anava mixed design. The result showed there was a significant difference of ERP-Efficacy between experimental and control group for pretest, posttest and follow up observations, with a value of F = 37.25 and p = 0.000 (p0.05). These hypothesis of this research that the effect of OHCT can improve the ERP-Efficacy among psychology students were accepted.

scholarly journals The Effectiveness of Marital Relationship Enrichment Training Based on Choice Theory, on Distress Tolerance of Women Recovered from Addiction

2020 ◽  
Vol 26 (4) ◽  
pp. 316-331
Author(s):  
Elham Ghajari ◽  
◽  
Hassan Toozandehjani ◽  
Hamid Nejat ◽  
◽  
...  
Keyword(s):  
Repeated Measures ◽  
Distress Tolerance ◽  
Choice Theory ◽  
Control Group ◽  
Significant Difference ◽  
Post Test ◽  
The Mean ◽  
And Control ◽  
Experimental Group

Aims: Most people in the community believe that substance abuse is masculine, while women are progressing alongside men in this area, with statistics indicating an increasing number of infected women. The purpose of this study was to determine the effectiveness of enriching couples relationships on tolerance of distressed women who were drug abusers Methods & Materials: This is a quasi-experimental study with pre-test, post-test and follow-up test with control group. Initially, 40 women were selected from the study and 20 were randomly assigned to the experimental group and 20 to the control group. Subjects were then assessed using a distress tolerance test (Simmons & Gahr, 2005). Experimental group participants participated in enrichment sessions based on Doba, Graham, Britz and Minatra (2009) choice theory and control group subjects remained on the waiting list. A follow-up test was taken after three months. Multivariate analysis of variance with repeated measures was used to analyze the data. The above analyzes were performed with SPSS V. 24 software Findings: The results indicated that there was a significant difference between the mean of pre-test, posttest and follow-up scores of distress tolerance scales in the experimental and control groups. (P<0.05). The mean distress tolerance in the experimental group increased from 34.533 to 42.80 in the pre-test phase and reached 42.533 in the follow-up phase. Also, the significant interaction between the stages with the experimental group in the mentioned variable indicates that in the post-test and follow-up stages, the mean of the experimental groups was significantly higher than the control group. Conclusion: Due to the increasing trend of addiction in women, proper education is one of the essentials. Therefore, it is recommended to take effective steps to improve couple distress tolerance training by enriching couple relationships

scholarly journals Analysis of the Effect of Scamper Education Program on five-year-old children’s creativity

2016 ◽  
Vol 13 (3) ◽  
pp. 5968
Author(s):  
Nazan Kaytez ◽  
Abide Güngör Aytar
Keyword(s):  
Education Program ◽  
Personal Information ◽  
Control Group ◽  
National Education ◽  
Creative Behavior ◽  
Significant Difference ◽  
Post Test ◽  
And Control ◽  
Experimental Group

This study is conducted with a view to examine the effect of Scamper Education Program on five-year-old children’s creativity. Study group of the research consists of a total of 40 children including an experimental group of 20 five-year-old children and a control group of 20 children attending kindergarten affiliated to Directorate of National Education in Çankırı city center. In the research, an experimental model with pretest, posttest, follow-up test control group was used. Children in the experimental group were applied with Scamper Education Program two days a week for a period of eight weeks. The children in the control group continued their own training programs. As the data collection tool in the study, “Personal Information Form” and “Creative Behavior and Personality Traits Scale were used.  Single factor covariance analysis (ANCOVA) and t test were used for data analysis. As a result of the research, it has been determined that there is a significant difference between creativity score averages of children in the experiment and control group (p<0.001), there is no significant differences between post-test and follow-up test score averages of children in the experiment group (p>0.05). This result shows that Scamper Education Program provided to the experimental group is effective in creativity of children.

scholarly journals Comparative Analysis of the Therapeutic Effect of Disinfectant and Non-disinfectant on the Separation of the Labia Minora in Infants

2021 ◽  
Vol 5 (6) ◽  
pp. 159-165
Author(s):  
Qiqi Chen ◽  
Guangyan Lin ◽  
Jun Xiong ◽  
Ping Wei
Keyword(s):  
Urinary Tract Infection ◽  
Urinary Tract ◽  
Tract Infection ◽  
Test Group ◽  
Control Group ◽  
Labia Minora ◽  
Significant Difference ◽  
And Control ◽  
Experimental Group

Objective: To compare the effects of the use and non-use of a disinfectant on the outcomes of separation of the labia minora in infants. Methods: The patients were randomly divided into an experimental group with 24 cases and a control group with 25 cases. In the control group, 1% iodophor was used to clean and disinfect the large and small labia and the surrounding skin, while normal saline was used in the experimental group. Other procedures such as the surgery and nursing method were the same in both groups. Results: There were no symptoms of urinary tract infection such as redness of the vulva, swelling, pain, and abnormal urination in the test group and control group after three days of follow-up, and no recurrence was seen at one month of follow-up. There was no statistically significant difference between the two groups (P > 0.05). Conclusion: Use or non-use of a disinfectant to clean the urethral opening before separation of the labia minora has no significant effect on the outcomes, and does not cause postoperative urinary tract infection symptoms. Moreover, non-use of a disinfectant can prevent local irritation and reduce the economic burden on the patients.

scholarly journals Effectiveness of Kangaroo Mother Care in Weight Gain among Newborn Babies in AVBRH Hospitals of Wardha

2021 ◽  
pp. 532-537
Author(s):  
Archana Maurya ◽  
B. Lakhakar ◽  
Bibin Kurian ◽  
Switi Besekar
Keyword(s):  
Weight Gain ◽  
Kangaroo Mother Care ◽  
Control Group ◽  
Breathing Patterns ◽  
Control Group Design ◽  
Significant Difference ◽  
The Mean ◽  
And Control ◽  
Experimental Group

Introduction: Kangaroo Mother Care is a simple and feasible intervention; acceptable to most mothers admitted in hospitals. There may be benefits in terms of reducing the incidence of hypothermia with no adverse effects of Kangaroo Mother Care. Kangaroo Care infants showed improvement in regular breathing patterns and virtually no periodic breathing, weight gain in low birth babies, suggesting  that Kangaroo Mother Care is safe for these infants. Materials and Methods: Randomized control trai, l  experimental and control group design was used in study this study was conducted in post natal wards of AVBR Hospital. In this study samples were newborns that were fulfilling the inclusion and exclusion criteria. 500 newborns were selected and it was equally divided into two groups as control 250 and experimental 250. Random sampling technique was used in this study. A checklist regarding the frequency and duration of KMC was prepared for the experimental group.  Results: The mean weight gain in the control group at birth is 2.71, on discharge it is 2.53 and on follow up it is 3.07. The mean weight gain in the experimental group at birth is 2.74, on discharge it is 2.67 and on follow up it is 3.31.  Conclusion: Significant difference was found in the mean weight gain between experimental and control group. Thus it is concluded that KMC is effective in increasing the weight of the newborn babies.

Role of Nutrition Counseling and Lifestyle Modification in Managing Prediabetes

2021 ◽  
pp. 037957212110254
Author(s):  
Harleen Kaur ◽  
Neerja Singla ◽  
Rohini Jain
Keyword(s):  
Hemoglobin A1c ◽  
Lifestyle Modification ◽  
Fasting Blood Glucose ◽  
Nutrition Intervention ◽  
Control Group ◽  
Population Prevalence ◽  
Significant Difference ◽  
And Control ◽  
Experimental Group

Objective: India is the second country after China having the highest population prevalence of diabetes. Several research studies investigating diabetes have been done, but not much work has been done on prediabetes. The purpose of this study was to investigate the effect of nutrition and lifestyle modification on prediabetic females. Methods: A total of 120 prediabetic females from Ludhiana city were divided into 2 matched groups: control group (n = 60) and experimental group (n = 60). Impact of nutrition intervention for dietary and lifestyle modification (for 3 months) was assessed on the anthropometric, dietary, biochemical parameters, and diabetes risk score of the experimental group and control group (no intervention). Results: All the selected 120 subjects completed the study (experimental group = 60; control group = 60). There was significant difference in the changes between the 2 groups throughout the study. The fasting blood glucose and glycated hemoglobin A1c levels of the experimental group subjects reduced significantly ( P ≤ .01). However, no change was observed among the control group subjects. The lipid profile of the experimental group showed a significant improvement ( P ≤ .01). Conclusion: Nutrition counselling of the prediabetics regarding dietary and lifestyle modification is recommended so as to improve their metabolic control, thus preventing them from being diabetics.

scholarly journals Parenting Stress and Need Assessment of Families with Disabled Children across Himachal Himalaya

2015 ◽  
Vol 3 (2) ◽  
pp. 38 ◽  
Author(s):  
Randhir S. Ranta ◽  
Vijay Kumar Sharma ◽  
Pankaj Gupta
Keyword(s):  
Parenting Stress ◽  
Assessment Scale ◽  
Control Group ◽  
Disabled Children ◽  
Normal Children ◽  
Need Assessment ◽  
Significant Difference ◽  
Group A ◽  
And Control ◽  
Experimental Group

The study pertains to the parenting stress, which is believed to be the resultant of child disability and further assesses the needs of the families across selected pockets of Himachal Himalaya. Perceived Stress Questionnaire (PSQ) and Need Assessment Scale were used for the purpose. For assessing the stress level among the parents, PQS was administered among two hundred parents having disabled children, herein called experimental group and two hundred parents with normal children, herein called control group. A three point Need assessment scale was used to measure the needs of 200 families on five different parameters. The result of t-test shows the significant difference between experimental and control groups indicating that the parents of disabled children experience more stress than their control counterpart. The study indicates that people need proper guidance and information regarding a child’s disability, nutritional requirements of a child, vocational training and child management. There is a need for proper counselling for parents suffering from stress and creating consciousness among parents of children with disabilities and in the society.

The effect of patience training on university students’ patience and life satisfaction levels

2021 ◽  
Vol 9 (3) ◽  
pp. 712-719
Author(s):  
Ayşe Eliüşük Bülbül ◽  
Keyword(s):  
Life Satisfaction ◽  
University Students ◽  
Wilcoxon Test ◽  
Control Group ◽  
Control Group Design ◽  
Satisfaction Scale ◽  
Significant Difference ◽  
Post Test ◽  
And Control ◽  
Experimental Group

The purpose of this study is to determine the effect of the "patience training program" on the patience and life satisfaction levels of university students. The study was organized as a pre-test, post-test experiment and control group design. For a total of 30 students from which were 17 in the control group and 17 in the experimental group, patience training was given for 5 weeks. The "Patient Scale" developed by Schnitker (2010) and adapted to Turkish by Eliüşük and Arslan (2016) and the "Life Satisfaction Scale" developed by Diener, Emmons, Larsen and Griffin (1985) and adapted to Turkish by Dağlı and Baysal (2016) were used as a data collection tool in the study. The "Wilcoxon" test was used for the comparison of in-group differences in the analysis of obtained data and the "Mann-Whitney U" test was used in examining the differences between the two groups. As a result of the study, it was observed that the patience and life satisfaction average scores of students in the experimental group receiving "patience training" increased significantly, while there was no significant difference in the patience and life satisfaction averages scores of the control group students.

scholarly journals The Effect of Using Group Work Technique on Developing Attitudes of non-English Major Students towards Learning English as a Foreign Language

2019 ◽  
Vol 25 (103) ◽  
pp. 1-22
Author(s):  
Asst. Instr. Hayder Abdulzahra Shalash
Keyword(s):  
Foreign Language ◽  
Group Work ◽  
Basic Education ◽  
Control Group ◽  
Significant Difference ◽  
English Major ◽  
And Control ◽  
Experimental Group ◽  
Work Technique ◽  
Learning English

       The present study aims at investigating the effect of applying group work technique on developing non-English major students' attitude towards learning English as a foreign language .Two null hypotheses have been formulated; the first hypothesis states that there is no statistically significant difference between the experimental and control group in their attitude towards learning EFL after the experiment. The second one states that there is no statistically significant difference in (pre-post questionnaire) of the experimental group students' attitude towards learning EFL. To achieve the aim of the study, and verify its hypothesis, the researcher has applied eight week experiment. A sample of 62 students has been chosen and divided into experimental and control groups. It has been chosen randomly from the second year students in the Basic Education College/ Department of History/Academic year (2017-2018).        The attitude questionnaire for both groups was applied before and after the experiment. After processing the results statistically, it was found that there is a statistically significant difference in favor of the experimental group. Having used the t-test formula, it was found that there is statistically significant development in the experimental group students' attitude towards learning EFL, which in turn indicates that the use of GWT is more effective than the traditional method.  Conclusion and recommendations were drawn.  

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