Variation in analytic transparency in recent efficacy studies of antidepressant medication

2018 ◽  
Vol 23 (5) ◽  
pp. 177-182
Author(s):  
Steven Vannoy ◽  
Madeline Brodt ◽  
Lisa Cosgrove ◽  
Allen F Shaughnessy
Keyword(s):  
Missing Data ◽  
Antidepressant Treatment ◽  
Antidepressant Medication ◽  
Drug Efficacy ◽  
Mixed Effects ◽  
Repeated Measure ◽  
Study Results ◽  
Clinical Trial Results

The validity of clinical trial results is influenced by researchers’ decisions regarding the management of missing data. Inadequate management of missing data has been identified as a significant source of bias that can result in an overestimation of drug efficacy. Transparency related to the management of missing data is essential to assess the strength of evidence reported in publications. In a subset of 17 randomised clinical trials for two new antidepressant medications, we present a case study in which we examined investigators’ decisions regarding how to handle missing data and if their chosen method took into account, possible violations of analytic requirements that could affect results. The majority of trials (76%) concluded that there was a benefit of antidepressant treatment and in 94% the methodology for handling missing data was identifiable. Of these, 50% imputed data using the last observation carried forward and half used a mixed-effects model repeated measure approach. Most reports did not provide a rationale for the method used, and no trials described analyses regarding differences between completers and dropouts. Sensitivity analysis was inconsistently reported and correction for multiple comparisons was not uniformly applied. Lack of transparency for analytic choices related to handling of missing data testing was common in this subset of RCTs. Because management of missing data can directly influence the quality of study results, it is critical that journal editors develop and enforce standards for methodological transparency.

scholarly journals Kontribusi Muhasabah dalam Mengembangkan Resiliensi Pada Orang Tua Anak Berkebutuhan Khusus

2021 ◽  
Vol 6 (2) ◽  
pp. 244-262
Author(s):  
Fatma Laili Khoirun Nida
Keyword(s):  
Special Needs ◽  
Poor Quality ◽  
Children With Special Needs ◽  
Case Study Approach ◽  
Study Approach ◽  
Study Results ◽  
Resilience Factors ◽  
Depth Interviews

The phenomenon of the poor quality of parental care for children with disabilities makes resilience one of the psychological capital that contributes to improving the quality of care. This study describes how through a muhasabah intervention in Blimbingrejo Village, Nalumsari District, Jepara Regency. The purpose of this study was to provide information for parents of children with special needs about muhasabah interventions in developing the resilience abilities of parents when carrying out their care. The urgency of this research is to reduce parenting stress experienced by parents because of the developmental barriers of their children. This research is qualitative with a case study approach through in-depth interviews and observation techniques. The study results explain that the condition of children with special needs is often a stressor for their parents. However, parents can live with complete steadfastness as a form of their resilience. The pattern of resilience formed is supported mainly by thinking about what they are trying to do. There are indications of the meaning of resilience factors in the practice of muhasabah in the form of the ability to regulate emotions, develop optimism and empathy, control impulses and causal analysis, good self-efficacy and take wisdom as an indication of aspects of the reaching out process. The results of this study are helpful information in developing the concept and practice of caring for children with special needs.

scholarly journals Economic Aspects of the Missing Data Problem – the Case of the Patient Registry

2017 ◽  
Vol 65 (5) ◽  
pp. 1779-1791
Author(s):  
Hatice Uenal ◽  
David Hampel
Keyword(s):  
Missing Data ◽  
Data Quality ◽  
Quality Analysis ◽  
Quality Of Data ◽  
Quality Costs ◽  
Missing Data Problem ◽  
Study Results ◽  
The Cost ◽  
Cost Factors

Registries are indispensable in medical studies and provide the basis for reliable study results for research questions. Depending on the purpose of use, a high quality of data is a prerequisite. However, with increasing registry quality, costs also increase accordingly. Considering these time and cost factors, this work is an attempt to estimate the cost advantages of applying statistical tools to existing registry data, including quality evaluation. Results for quality analysis showed that there are unquestionable savings of millions in study costs by reducing the time horizon and saving on average € 523,126 for every reduced year. Replacing additionally the over 25 % missing data in some variables, data quality was immensely improved. To conclude, our findings showed dearly the importance of data quality and statistical input in avoiding biased conclusions due to incomplete data.

scholarly journals Perception of Professional Engineers toward Quality of Worklife and Organizational Commitment: A Case Study

2004 ◽  
Vol 6 (3) ◽  
pp. 323 ◽  
Author(s):  
Razali Mat Zin
Keyword(s):  
Organizational Commitment ◽  
Physical Environment ◽  
Growth And Development ◽  
Empirical Investigation ◽  
Social Relevance ◽  
Quality Of Worklife ◽  
Study Results ◽  
Development Participation

This empirical investigation was aimed to determine the pattern of the  relationships between the perceived presence of quality of worklife (QWL) factors and organizational commitment using samples from professional engineers in Malaysia. Engineers in private sector were selected to participate in this study. A total of 250 sets of questionnaires were sent to the selected organizations, and 152 useable questionnaire representing a response rate of 60.8% were used for statistical analysis. A QWL measure consisting of seven factors: growth and development, participation, physical environment, supervision, pay and benefit, social relevance, and workplace integration was developed based on Walton’s (1974) conception. The three-component model and measure of organizational commitment developed by Allen and Meyer (1990) was adopted in this study. Results of regression analysis indicated that only two QWL factors, growth and development and pay and benefit, were significant in explaining organizational commitment. Implication and suggestions for further research are also discussed.

scholarly journals 98Framework for the Treatment And Reporting of Missing data in Observational Studies: The TARMOS framework

2021 ◽  
Vol 50 (Supplement_1) ◽  
Author(s):  
Rosie Cornish ◽  
Kate Tilling ◽  
Rosie Cornish ◽  
James Carpenter
Keyword(s):  
Missing Data ◽  
Observational Studies ◽  
Potential Effect ◽  
Observational Research ◽  
Analysis Model ◽  
Parents And Children ◽  
Alternative Approach ◽  
Study Results ◽  
Data Checking

Abstract Focus of presentation Missing data are ubiquitous in medical research. Although there is increasing guidance on how to handle missing data, practice is changing slowly and misapprehensions abound, particularly in observational research. We present a practical framework for handling and reporting the analysis of incomplete data in observational studies, which we illustrate using a case study from the Avon Longitudinal Study of Parents and Children. Findings The framework consists of three steps: 1) Develop an analysis plan specifying the analysis model and how missing data are going to be addressed. Important considerations are whether a complete records analysis is likely to be valid, whether multiple imputation or an alternative approach is likely to offer benefits, and whether a sensitivity analysis regarding the missingness mechanism is required. 2) Explore the data, checking the methods outlined in the analysis plan are appropriate, and conduct the pre-planned analysis. 3) Report the results, including a description of the missing data, details on how missing data were addressed, and the results from all analyses, interpreted in light of the missing data and clinical relevance. Conclusions/Implications This framework encourages researchers to think carefully about their missing data and be transparent about the potential effect on the study results. This will increase confidence in the reliability and reproducibility of results from published papers. Key messages Researchers need to develop a plan for missing data prior to conducting their analysis, and be transparent about how they handled the missing data and its potential effect when reporting their results.

scholarly journals 98Framework for the Treatment And Reporting of Missing data in Observational Studies: The TARMOS framework

2021 ◽  
Vol 50 (Supplement_1) ◽  
Author(s):  
Katherine Lee ◽  
Kate Tilling ◽  
Rosie Cornish ◽  
James Carpenter
Keyword(s):  
Missing Data ◽  
Observational Studies ◽  
Potential Effect ◽  
Observational Research ◽  
Analysis Model ◽  
Parents And Children ◽  
Alternative Approach ◽  
Study Results ◽  
Data Checking

Abstract Focus of presentation Missing data are ubiquitous in medical research. Although there is increasing guidance on how to handle missing data, practice is changing slowly and misapprehensions abound, particularly in observational research. We present a practical framework for handling and reporting the analysis of incomplete data in observational studies, which we illustrate using a case study from the Avon Longitudinal Study of Parents and Children. Findings The framework consists of three steps: 1) Develop an analysis plan specifying the analysis model and how missing data are going to be addressed. Important considerations are whether a complete records analysis is likely to be valid, whether multiple imputation or an alternative approach is likely to offer benefits, and whether a sensitivity analysis regarding the missingness mechanism is required. 2) Explore the data, checking the methods outlined in the analysis plan are appropriate, and conduct the pre-planned analysis. 3) Report the results, including a description of the missing data, details on how missing data were addressed, and the results from all analyses, interpreted in light of the missing data and clinical relevance. Conclusions/Implications This framework encourages researchers to think carefully about their missing data and be transparent about the potential effect on the study results. This will increase confidence in the reliability and reproducibility of results from published papers. Key messages Researchers need to develop a plan for missing data prior to conducting their analysis, and be transparent about how they handled the missing data and its potential effect when reporting their results.

Do sustainability practices influence university quality? A Colombian case study

2020 ◽  
Vol 21 (7) ◽  
pp. 1525-1543 ◽  
Author(s):  
Paula M. Hernandez-Diaz ◽  
Jorge-Andrés Polanco ◽  
Sandra Milena Castaño
Keyword(s):  
Quality Assurance ◽  
Latin American ◽  
Social Impact ◽  
Economic Benefits ◽  
Content Type ◽  
Study Approach ◽  
Starting Point ◽  
Study Results

Purpose This paper aims to know how university’s strategic managers, from botacademic and administrative systems, perceive the relationship between sustainability and accreditation as sustainability incorporation and the quality of their processes are amongst the actual challenges of universities. Design/methodology/approach This paper opted for an inductive, exploratory study using the case study approach, including 19 in-depth interviews to administrative and academic managers in a private, high-quality certified university in Colombia. The data were assessed using the content analysis methodology. The Colombian accreditation guidelines were the base to analyse the data as accreditation is part of the quality assurance system. Findings This paper provides empirical insights into how the implementation of sustainability in universities relates to the Colombian accreditation factors. The main links found were in the areas of the university’s social impact and organisational responsibility, which are highly relevant to graduates, external stakeholders and sustainability skills. Sustainable campus operation was associated with environmental management and improvement of the quality of the physical plant, with social and economic benefits in the long-term. Additionally, this research found a need for administrative and academic managers to understand and increase their commitment to sustainability. Research limitations/implications Because it was a case study, results are not generalisable. Consequently, further research on similar lines is required to universalise the mentioned observation and results. Practical implications The accreditation factors related to sustainability, inductively defined and exposed in this paper, provide an idea of how sustainability implementation could contribute to higher education quality assurance. Originality/value This paper contributes to filling the knowledge gap about embedding sustainability in Latin-American universities. This paper postulates a starting point considering accreditation standards and the link of the strategic manager’s perceptions of sustainability.

Effect of abiraterone acetate (AA) on patient-reported pain in metastatic castration-resistant prostate cancer (mCRPC) post-docetaxel: Results of longitudinal sensitivity analyses.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 9618-9618 ◽  
Author(s):  
Yanni Hao ◽  
Charles S. Cleeland ◽  
Dennis Gagnon ◽  
Derek Espindle ◽  
Arturo Molina ◽  
...  
Keyword(s):  
Missing Data ◽  
Pain Intensity ◽  
Short Form ◽  
Mixed Effects ◽  
Pain Interference ◽  
Sensitivity Analyses ◽  
Repeated Measure ◽  
Patient Reported ◽  
Pain Outcomes ◽  
The Impact

9618 Background: The COU-AA-301 phase 3 trial showed that AA + prednisone (P) improved overall survival in mCRPC patients (pts) post-docetaxel. Compared with P alone, AA + P also had significant benefits on patient-reported pain. Here we describe post hoc sensitivity analyses of pain data from that trial, using different methods to compensate for the potential impact of missing data. Methods: Pts with mCRPC progressing after docetaxel-based chemotherapy were randomized 2:1 to AA + P or placebo + P. Pain intensity and interference of pain with daily activities were assessed with the Brief Pain Inventory-Short Form (BPI-SF) questionnaire at baseline, Day 15 of Cycle 1, and Day 1 of each 28-day treatment cycle thereafter until treatment discontinuation. The effect of treatment on BPI-SF scores was analyzed using repeated measure mixed-effects (RMM) models, piecewise linear mixed-effects (PWLME) models, and joint mixed-effects and log time-to-dropout (JMEL) models. RMM and PWMLE models assumed missing data (due to death, study dropout, or administrative issues) to be missing at random, the JMEL model to be missing not at random. Model results were compared between treatment arms. Results: 797 pts were randomized to AA + P, and 398 to P only. RMM model estimates suggested statistically significant (p < 0.05) differences in change from baseline for pain intensity and pain interference scores in favor of AA + P at the majority of study visits through cycle 11. PWLME models yielded significantly smaller areas under the curve (AUCs) for AA + P vs P for pain intensity (p = 0.0031) and pain interference (p = 0.0006); smaller AUCs reflect better pain outcomes. Results using JMEL models were nearly identical to those with PWLME models, with AUCs for AA + P significantly smaller than for P alone for pain intensity (p = 0.0031) and pain interference (p = 0.0007). Conclusions: Using various modeling methods that assess the impact of missing data, AA + P showed superior patterns of pain outcomes over time compared with P only in mCRPC pts refractory to docetaxel. These results support the previously reported pain benefits of AA + P over P alone from the same trial. Clinical trial information: NCT00638690.

scholarly journals Technology Readiness and Customer Satisfaction with Travel Technologies: A Cross-Country Investigation

2016 ◽  
Vol 56 (5) ◽  
pp. 563-577 ◽  
Author(s):  
Ying Wang ◽  
Kevin Kam Fung So ◽  
Beverley A. Sparks
Keyword(s):  
Online Survey ◽  
Service Providers ◽  
The United States ◽  
Technology Readiness ◽  
Study Results ◽  
Cross Country ◽  
Tourism And Hospitality

Technologies have dramatically transformed tourist experience. However, research has largely focused on traveler attitudes and technology adoption rather than their experience with travel technologies. Taking a cross-country perspective, this study examines the role of technology readiness (TR) as a personality trait in shaping travelers’ satisfaction with travel technologies, using airlines as a case study. Results of an online survey of travelers in Australia, China, and the United States revealed the moderating effects of the TR dimensions of optimism and innovativeness as well as country of residence on the relationships between perceived quality of technology-enabled services (TESs), satisfaction with TESs, overall satisfaction, and future behavior. These relationships were stronger among travelers with higher TR and varied across countries. The results suggest that tourism and hospitality service providers should incorporate measures of traveler TR and TESs’ performance into their customer-experience monitoring system.

scholarly journals Preventive maintenance features specific to offset printing machines

2021 ◽  
Vol 343 ◽  
pp. 08012
Author(s):  
Emilia Bălan ◽  
Liviu Berculescu ◽  
Răzvan-George Răcheru ◽  
Dorin Vasile Piţigoi ◽  
Lucia Adăscăliţa
Keyword(s):  
Preventive Maintenance ◽  
Offset Printing ◽  
Printing Process ◽  
Machine Performance ◽  
Continuous Quality ◽  
Study Results ◽  
Maintenance Activities ◽  
Printing Processes

In the printing industry, where production never stops, it is very important to continuously maintain machine performance. If a machine breaks down, the production will stop and it will disturb the production process. Therefore, the maintenance system must be managed efficiently to solve those problems. The paper presents the study results on continuous quality improvement of offset printing using preventive maintenance features. Offset printing is a process that involves a multitude of variables, independent and interdependent factors. The offset printing process was analyzed and the factors that have a significant influence on the quality of the process and the products made were identified. The defects that may occur during the printing process and the causes thereof have also been identified and the types of non-conformities of the end products were estabilished. The experimental method was used. The case study was conducted on Manroland 508. For the planning of preventive maintenance activities, the duration of the maintenance works necessary to ensure the proper functioning of the offset printing machines was established. Finally, maintenance activities that would guarantee and continuously improve the quality of the printing processes and the printed products were issued.

scholarly journals Effects of using cannabidiol on a patient with difficult- tocontrol epilepsy

2021 ◽  
Author(s):  
Maria Eduarda Moreira ◽  
Ana Carolina Soares de Lira ◽  
Bárbara Letícia Barreto Ramos Aragão ◽  
Amuriama Suassuna ◽  
Kelly Farias
Keyword(s):  
Drug Treatment ◽  
Epileptic Seizures ◽  
Therapeutic Effects ◽  
Promising Alternative ◽  
Environmental Interaction ◽  
Study Results ◽  
History Of ◽  
Control Methodology

Introduction: Epilepsies are chronic neurological syndromes, characterized by spontaneous and recurrent crises. It is estimated that there is a worldwide prevalence of 1.0% and that around 30% of patients remain refractory to drug treatment. The active Cannabis plant has been used for medicinal purposes. Extracts with a high CBD content have been shown to be effective in reducing the frequency and severity of epileptic seizures. Objective: To expose the therapeutic effects of CBD and its consequences in a patient with crises that are difficult to control. Methodology: Case study. Results: Male patient, 18 years old, has epileptic seizures that are difficult to control since he was 7 months old. Progressively, he presented loss of motor functions, social and environmental interaction, and even with the combination of antiepileptic drugs, the crises remained uncontrolled. Magnetic resonance examinations indicate hypogenesis of the corpus callosum, volumetric reduction of the cerebellar vermis, increase of the cerebrospinal fluid space, posteriorly displaced brain stem, with volumetric loss. The diagnosis suggests Dandy-Walker and West syndrome. In 2017, it started using CBD and currently has an 85% reduction in crises. There was an increase in personal and environmental interaction, improved levels of concentration and bimanual skills, and began to express emotions and feelings more clearly. Conclusion: CBD represents a promising alternative for epileptic refractory patients to drug treatment, which can prevent the occurrence of brain damage and modify the natural history of the disease and the quality of life.

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