scholarly journals Streamlining and Cycle Time Reduction of the Start-up Phase of Clinical Trials

2019 ◽  
Author(s):  
Amani Abu-Shaheen ◽  
Ahmad Al Badr ◽  
Isamme AlFayyad ◽  
Adel Al Qutub ◽  
Eissa Ali Faqeih ◽  
...  
Keyword(s):  
Cycle Time ◽  
Clinical Laboratory ◽  
Vital Role ◽  
Investigational Drug ◽  
Initial Contact ◽  
Start Up ◽  
Confidentiality Agreement ◽  
Intervention Protocol ◽  
Review Protocol ◽  
The Impact

AbstractObjectiveThe start-up phase of a clinical trial (CT) plays a vital role in execution of novel drug development. Hence, this study aims to identify the factors responsible for delaying the CT start-up phase. Further, it focuses on streamlining and reducing the cycle time of the start-up phase of newly sponsored CTs.MethodologyThirteen sponsored CTs conducted (between 2016 and 2017) in clinical research department at King Fahad Medical City, Riyadh were analyzed to identify the data specific start-up metrics usingFind an improvement area-Organize a team-Clarify current practices-Understand source of variation/problem-Select a Strategy-Plan-Do-Check-Act (FOCUS-PDCA) cycle. Five measures incorporated in the metrics were: date of initial contact with site to the signing of confidentiality agreement; date of receiving questionnaire from sponsor to date of its completion; time taken to review protocol and approve investigational drug service (IDS) form; time taken to review protocol and approve pharmacy and pathology and clinical laboratory medicine (PCLM) form and date of receipt of institutional review board (IRB) submission package to final IRB approval.Fishbone analysis was used to understand the potential causes of process variation. Mean time was calculated for each metrics prior to and post implementation of the intervention protocol to analyze and compare percentage reduction in the mean cycle time of CTs.ResultsOf the various potential factors of delay identified through Fishbone analysis, the two major ones were lack of well-defined timeline for approval and review of the study protocol; and inconsistent IRB meetings. Post introduction of the new intervention protocol, the entire CT lifecycle was reduced by 45.6% (24.8 weeks' vs 13 weeks, before and after intervention, respectively).ConclusionVaried factors are responsible for delay of the start-up phase of CTs and understanding the impact of each factor allows for optimization and faster execution of the start-up phase of CTs.

Research Participation Experiences of Informants of Suicide and Control Cases

Crisis ◽  
2010 ◽  
Vol 31 (5) ◽  
pp. 238-246 ◽  
Author(s):  
Paul W. C. Wong ◽  
Wincy S. C. Chan ◽  
Philip S. L. Beh ◽  
Fiona W. S. Yau ◽  
Paul S. F. Yip ◽  
...  
Keyword(s):  
Ethical Issues ◽  
Research Participation ◽  
Self Report ◽  
Initial Contact ◽  
Psychological Autopsy ◽  
Autopsy Study ◽  
The People ◽  
And Control ◽  
The Impact

Background: Ethical issues have been raised about using the psychological autopsy approach in the study of suicide. The impact on informants of control cases who participated in case-control psychological autopsy studies has not been investigated. Aims: (1) To investigate whether informants of suicide cases recruited by two approaches (coroners’ court and public mortuaries) respond differently to the initial contact by the research team. (2) To explore the reactions, reasons for participation, and comments of both the informants of suicide and control cases to psychological autopsy interviews. (3) To investigate the impact of the interviews on informants of suicide cases about a month after the interviews. Methods: A self-report questionnaire was used for the informants of both suicide and control cases. Telephone follow-up interviews were conducted with the informants of suicide cases. Results: The majority of the informants of suicide cases, regardless of the initial route of contact, as well as the control cases were positive about being approached to take part in the study. A minority of informants of suicide and control cases found the experience of talking about their family member to be more upsetting than expected. The telephone follow-up interviews showed that none of the informants of suicide cases reported being distressed by the psychological autopsy interviews. Limitations: The acceptance rate for our original psychological autopsy study was modest. Conclusions: The findings of this study are useful for future participants and researchers in measuring the potential benefits and risks of participating in similar sensitive research. Psychological autopsy interviews may be utilized as an active engagement approach to reach out to the people bereaved by suicide, especially in places where the postvention work is underdeveloped.

Design of spline surface vacuum gripper for pick and place robotic arms

2020 ◽  
Vol 4 (2) ◽  
pp. 48-55
Author(s):  
A. S. Jamaludin ◽  
M. N. M. Razali ◽  
N. Jasman ◽  
A. N. A. Ghafar ◽  
M. A. Hadi
Keyword(s):  
Cycle Time ◽  
Industrial Robot ◽  
Annealing Process ◽  
Vacuum Suction ◽  
Robotic Arms ◽  
Custom Made ◽  
Pick And Place ◽  
Manufacturing Procedure ◽  
Production Flexibility ◽  
The Impact

The gripper is the most important part in an industrial robot. It is related with the environment around the robot. Today, the industrial robot grippers have to be tuned and custom made for each application by engineers, by searching to get the desired repeatability and behaviour. Vacuum suction is one of the grippers in Watch Case Press Production (WCPP) and a mechanism to improve the efficiency of the manufacturing procedure. Pick and place are the important process for the annealing process. Thus, by implementing vacuum suction gripper, the process of pick and place can be improved. The purpose of vacuum gripper other than design vacuum suction mechanism is to compare the effectiveness of vacuum suction gripper with the conventional pick and place gripper. Vacuum suction gripper is a mechanism to transport part and which later sequencing, eliminating and reducing the activities required to complete the process. Throughout this study, the process pick and place became more effective, the impact on the production of annealing process is faster. The vacuum suction gripper can pick all part at the production which will lower the loss of the productivity. In conclusion, vacuum suction gripper reduces the cycle time about 20%. Vacuum suction gripper can help lower the cycle time of a machine and allow more frequent process in order to increase the production flexibility.

The Impact Of Emotional Intelligence On Leadership Excellence Of Executive Empoloyees In Public Sector Organizationin Ampara District Of Sri Lanka

2019 ◽  
Vol 118 (9) ◽  
pp. 52-60
Author(s):  
Dr.S. Gunapalan ◽  
Dr.K. Maran
Keyword(s):  
Emotional Intelligence ◽  
Public Sector ◽  
Vital Role ◽  
Public Organization ◽  
Self Awareness ◽  
Public Sector Organization ◽  
Expression Of Emotion ◽  
Asking Questions ◽  
Private Sector Organizations ◽  
The Impact

Emotional Intelligence is play a vital role to decide  leadership excellence. So this paper to study the  impact of emotional intelligence on leadership excellence of executive employee in public sector organization.Hence the objective of this  research   is to identify the  impact of emotional intelligence on leadership excellence of executive employee in Public Sector Organization in Ampara districtof Sri Lanka.emotional intelligence includes the verbal and non-verbal appraisal and expression of emotion, the regulation of emotion in the self and others, and the utilization of emotional content in problem solving. Cook (2006)[1]. Emotional intelligence is one of the  essential skill for leaders to manage their subordinate. Accordingly although there is some research done under “Emotional intelligence on leadership excellence of the executive employee in the public organization in Ampara district so this study full filed the gap. Based on the analysis, Self-awareness, Self-management, Social-awareness and Relationship management are the positively affect to the Leadership excellence. So, executive employees should consider about the Emotions of their subordinators when they completing their targets. leaders should pay the attention for recognize the situation, hove to impact their feelings for the performance & recognized their own feelings. Leaders should consider and see their own emotions when they work with others by listening carefully, understand the person by asking questions, identifying non-verbal expressions and solving problems without helming someone’s. Leadersshould consider their subordinators emotions when they find a common idea, government should give to moderate freedom to executive employees in public organization to take the decision with competing the private sector organizations.

Optimal Inventory Policies for Price and Time Sensitive Demand under Advertisement

2020 ◽  
Vol 13 ◽  
Author(s):  
Nita Shah ◽  
Ekta Patel ◽  
Kavita Rabari
Keyword(s):  
Cycle Time ◽  
Quadratic Function ◽  
Solution Procedure ◽  
Vital Role ◽  
Optimal Number ◽  
Deteriorating Items ◽  
Marginal Effect ◽  
Selling Price ◽  
Total Profit ◽  
Back Order

Aims: This article analyzes an inventory system for deteriorating items. The demand is quadratic function of time and is dependent on time, price and advertisement. Shortages are allowed and partially backlogged. Background: Demand and pricing are the two most crucial factors in inventory policy for any business to be successful. In today’s era of competitive circumstances, any product is promoted through advertisement, which plays a vital role in changing the demand pattern among the community. The marketing and demonstration of an item by time-to-time with fashionable advertisements through well-known media such as TV, radio, newspaper, magazine, etc. However, this idea is not always true for some goods like wheat, vegetables, fruits, food grains, medicines and other perishable goods due to their deteriorating nature and this in turn decreases demand for such goods. Deterioration may define as decay, damage, spoilage, evaporation, obsolescence, pilferage. Hence, deterioration effect is a major part in inventory control theory. So in this article demand rate is considered to be a function of selling price, time and occurrence of advertisement instantaneously. Objective: A solution procedure is obtained to find optimal number of price changes and optimal selling price to maximize the total profit. Method: Classical Optimization. Result: From the sensitivity analysis table, it can be seen that the optimal profit is highly sensible to advertisement coefficient and purchase cost. With an increment in rate of deterioration, selling price decreases. Scale demand has reasonable effect on cycle time and selling price. When the value of increase, the cycle length and profit goes on decreasing. Growth in profit is observed if we increase parameter b, higher will be the profit. Price elasticity is sensible parameter with respect to selling price. If backlogging rate increases, the profit will decreases. The inventory parameters holding cost, back order cost and lost sale cost have marginal effect on total profit. Conclusion: In this article, an inventory model is proposed for deteriorating items with variable demand depends upon the advertisement, selling price of the item and time. Shortages are allowed and partially backlogged and backlogging rate depends on the waiting time for the next replenishment. From this article, we can conclude that the parameters are insensible with respect to optimal profit, cycle time and selling price and rest of the parameters have practical output on total profit.

Clients' Expectations on Audit Judgments: A Note

2004 ◽  
Vol 16 (1) ◽  
pp. 63-74 ◽  
Author(s):  
Venkataraman M. Iyer ◽  
Dasaratha V. Rama
Keyword(s):  
Audit Quality ◽  
Financial Statements ◽  
Early Years ◽  
Relative Power ◽  
Client Perceptions ◽  
Audit Firm ◽  
Auditor Tenure ◽  
Start Up ◽  
Nonaudit Services ◽  
The Impact

Audited financial statements can be viewed as the product of negotiations between a company's management and its auditor. Relative power of these two parties is a major factor that determines the outcome of the negotiation. This study examines the impact of auditor tenure, importance of a client to an audit partner, nonaudit purchases, and prior audit firm experience of client personnel on client perceptions about their ability to persuade the auditor in the context of an accounting disagreement. We obtained responses to a survey from 124 CPAs in industry who are employed as CEOs, CFOs, controllers, or treasurers. Our results indicate that respondents from companies with short auditor tenures were somewhat more likely to indicate that they could persuade the auditor to accept their (client's) position in case of a disagreement. This finding is consistent with the argument that auditors are susceptible to influence in the early years as they are still in the process of recouping start-up costs, but is not consistent with concerns expressed by legislators and others that long auditor tenures will adversely affect audit quality. Respondents who believed their business was more important for the audit partner were also more likely to believe that they could persuade the auditor. However, the purchase of nonaudit services and prior audit experience were not related to client's perceptions about their ability to persuade the auditor.

scholarly journals Relative Frequency and Risk Factors of COVID-19 Related Headache in a Sample of Egyptian Population: A Hospital-Based Study

Pain Medicine ◽  
2021 ◽  
Author(s):  
Mona Hussein ◽  
Wael Fathy ◽  
Ragaey A Eid ◽  
Hoda M Abdel-Hamid ◽  
Ahmed Yehia ◽  
...  
Keyword(s):  
Multivariate Analysis ◽  
Platelet Count ◽  
Relative Frequency ◽  
Clinical Laboratory ◽  
Primary Headache ◽  
Female Gender ◽  
Imaging Data ◽  
Laboratory Findings ◽  
Neutrophil Lymphocyte Ratio ◽  
The Impact

Abstract Objectives Headache is considered one of the most frequent neurological manifestations of coronavirus disease 2019 (COVID-19). This work aimed to identify the relative frequency of COVID-19-related headache and to clarify the impact of clinical, laboratory findings of COVID-19 infection on headache occurrence and its response to analgesics. Design Cross-sectional study. Setting Recovered COVID-19 patients. Subjects In total, 782 patients with a confirmed diagnosis of COVID-19 infection. Methods Clinical, laboratory, and imaging data were obtained from the hospital medical records. Regarding patients who developed COVID-19 related headache, a trained neurologist performed an analysis of headache and its response to analgesics. Results The relative frequency of COVID-19 related headache among our sample was 55.1% with 95% confidence interval (CI) (.516–.586) for the estimated population prevalence. Female gender, malignancy, primary headache, fever, dehydration, lower levels of hemoglobin and platelets and higher levels of neutrophil/lymphocyte ratio (NLR) and CRP were significantly associated with COVID-19 related headache. Multivariate analysis revealed that female gender, fever, dehydration, primary headache, high NLR, and decreased platelet count were independent predictors of headache occurrence. By evaluating headache response to analgesics, old age, diabetes, hypertension, primary headache, severe COVID-19, steroid intake, higher CRP and ferritin and lower hemoglobin levels were associated with poor response to analgesics. Multivariate analysis revealed that primary headache, steroids intake, moderate and severe COVID-19 were independent predictors of non-response to analgesics. Discussion Headache occurs in 55.1% of patients with COVID-19. Female gender, fever, dehydration, primary headache, high NLR, and decreased platelet count are considered independent predictors of COVID-19 related headache.

scholarly journals High Expression of KLF10 Is Associated with Favorable Survival in Patients with Oral Squamous Cell Carcinoma

Medicina ◽  
2020 ◽  
Vol 57 (1) ◽  
pp. 17
Author(s):  
Chung-Min Yeh ◽  
Yi-Ju Lee ◽  
Po-Yun Ko ◽  
Yueh-Min Lin ◽  
Wen-Wei Sung
Keyword(s):  
Survival Rate ◽  
Oral Cancer ◽  
Cancer Patients ◽  
Protective Factor ◽  
Female Gender ◽  
Vital Role ◽  
Cancer Stage ◽  
Independent Prognostic Marker ◽  
Oral Cancer Patients ◽  
The Impact

Background and objectives: Krüppel-like transcription factor 10 (KLF10) plays a vital role in regulating cell proliferation, including the anti-proliferative process, activation of apoptosis, and differentiation control. KLF10 may also act as a protective factor against oral cancer. We studied the impact of KLF10 expression on the clinical outcomes of oral cancer patients to identify its role as a prognostic factor in oral cancer. Materials and Methods: KLF10 immunoreactivity was analyzed by immunohistochemical (IHC) stain analysis in 286 cancer specimens from primary oral cancer patients. The prognostic value of KLF10 on overall survival was determined by Kaplan–Meier analysis and the Cox proportional hazard model. Results: High KLF10 expression was significantly associated with male gender and betel quid chewing. The 5-year survival rate was greater for patients with high KLF10 expression than for those with low KLF10 expression (62.5% vs. 51.3%, respectively; p = 0.005), and multivariate analyses showed that high KLF10 expression was the only independent factor correlated with greater overall patient survival. The significant correlation between high KLF10 expression and a higher 5-year survival rate was observed in certain subgroups of clinical parameters, including female gender, non-smokers, cancer stage T1, and cancer stage N0. Conclusions: KLF10 expression, detected by IHC staining, could be an independent prognostic marker for oral cancer patients.

The underrepresentation of female participants in studies assessing the impact of high-dose exercise on cardiovascular outcomes: a scoping review

2021 ◽  
Vol 28 (Supplement_1) ◽  
Author(s):  
S Pallikadavath ◽  
R Patel ◽  
CL Kemp ◽  
M Hafejee ◽  
N Peckham ◽  
...  
Keyword(s):  
Scoping Review ◽  
High Volume ◽  
Cardiovascular Outcomes ◽  
High Dose ◽  
Funding Sources ◽  
Review Protocol ◽  
The Mean ◽  
The Impact ◽  
Over Time ◽  
Funding Acknowledgements

Abstract Funding Acknowledgements Type of funding sources: None. Introduction Cardiovascular adaptations as a result of exercise conducted at high-intensity and high-volume are often termed the ‘Athlete’s heart’. Studies have shown that these cardiovascular adaptations vary between sexes. It is important that both sexes are well represented in this literature. However, many studies assessing the impact of high-dose exercise on cardiovascular outcomes under-recruit female participants. Purpose This scoping review aimed to evaluate the representation of females in studies assessing the impact of high-dose exercise on cardiovascular outcomes and demonstrate how this has changed over time. Methods The scoping review protocol as outlined by Arksey and O’Malley was used. OVID and EMBASE databases were searched and studies independently reviewed by two reviewers. Studies must have investigated the effects of high-dose exercise on cardiovascular outcomes. To assess how the recruitment of females has changed over time, two methods were used. One, the median study date was used to categorise studies into two groups. Two, studies were divided into deciles to form ten equal groups over the study period. Mean percentage of female recruitment and percentage of studies that failed to include females were calculated. Results Overall, 250 studies were included. Over half the studies (50.8%, n = 127) did not include female participants. Only 3.2% (n = 8) did not include male participants. Overall, mean percentage recruitment was 18.2%. The mean percentage of recruitment was 14.5% before 2011 and 21.8% after 2011. The most recent decile of studies demonstrated the highest mean percentage of female recruitment (29.3%) and lowest number of studies that did not include female participants (26.9%). Conclusion Female participants are significantly underrepresented in studies assessing cardiovascular outcomes caused by high-dose exercise. The most recent studies show that female recruitment may be improving, however, this still falls significantly short for equal representation. Risk factors, progression and management of cardiovascular diseases vary between sexes, hence, translating findings from male dominated data is not appropriate. Future investigators should aim to establish barriers and strategies to optimise fair recruitment. Mean percentage females recruited per study (%) Percentage studies that do not include women (%) Overall (n = 250) 18.2 50.8 (n = 127) Studies before 2011 (n = 121) 14.5 59.5 (n = 72) Studies after 2011 (n = 129) 21.8 42.6 (n = 55) Table 1: Female recruitment characteristics. The year 2011 (median study year) was chosen as this divides all included studies into two equal groups.

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