scholarly journals Data Management

Author(s):  
Fazal Hussain ◽  
Riad El Fakih ◽  
Mahmoud Aljurf

AbstractEffective data management is critical for quality research in any hematopoietic stem cell transplantation (HSCT) center for accuracy, reliability, and validity of the data. HSCT research is a dynamic and multi-domain process encompassing innovative therapeutic modalities, techniques, and interventions to change the existing standard of care and optimize survival outcomes and patients’ quality of life. Research has evolved as one of the core competencies for the standardization, accreditation, and academic standing of the transplant center. The Data Unit is the center of gravity and the hub of research (databases, registries, translational research, and randomized control trials) in a quality cancer care facility. HSCT data collection, collation, and interpretation have become an integral part of the treatment rather than an option. Quality assurance (QA) and continuous quality improvement (CQI) in data management are pivotal for credibility, measurable/quantifiable outcomes, clinically significant impact, and setting benchmarks. Quality assurance, ethical conduct, and monitoring of HSCT data are the hallmarks of a center of excellence in galvanizing the therapeutic interventions and optimizing the outcomes.

2021 ◽  
pp. 157-165
Author(s):  
Fazal Hussain ◽  
Saud Alhayli ◽  
Mahmoud Aljurf

AbstractResearch is the only way to challenge the existing standards of care; a dynamic and multidimensional process encompassing innovative therapeutic modalities, techniques, and interventions to optimize outcomes and quality of life of cancer patients. Cancer research has emerged as one of the core competencies for the standardization, accreditation, and academic standing of any comprehensive cancer center. Data unit is the center of gravity and the hub of research and development (databases, registries, translational research, randomized control trials) in a quality cancer care facility. Quality assurance, ethical conduct, and monitoring of research are the hallmarks of a center of excellence in galvanizing the research efforts and optimizing the quality outcomes.


2021 ◽  
Author(s):  
Qi Zhang ◽  
Ke Zhang ◽  
Miao Li ◽  
Jiaxin Gu ◽  
Xintong Li ◽  
...  

Abstract Objectives To examine the validity and reliability of the Mandarin version of the Treatment Burden Questionnaire (TBQ) among stroke patients. Background Stroke patients need long-term management of symptoms and life situation, and treatment burden has recently emerged as a new concept that can influence the health outcomes during the rehabilitation process. Methods The convenience sampling method was used to recruit 187 cases of stroke patients in a tertiary grade hospital in Tianjin for a formal investigation. Item analysis, reliability and validity tests were carried out. The reliability test included internal consistency and test–retest reliability. And as well as content, structure and convergent validity were performed for the validity test. Results Of the 187 completed questionnaires, only 180 (96.3%) were suitable for analysis. According to the experts’ evaluation, the I-CVI of each item was from 0.833 to 1.000, and the S-CVI was 0.967. The exploratory factor analysis yielded three-factor components with a cumulative variation of 53.054%. Convergent validity was demonstrated using measures of Morisky’s Medication Adherence Scale 8 (r = –0.450, P < 0.01). All correlations between items and global scores ranged from 0.403 to 0.638. Internal consistency reliability and test–retest reliability were found to be acceptable, as indicated by a Cronbach’s α of 0.824 and an intraclass correlation coefficient of 0.846, respectively. Conclusions The Mandarin TBQ had acceptable validity and reliability. The use of TBQ in the assessment of treatment burden of stroke survivor may benefit health resources allocation and provide tailor therapeutic interventions to construct minimally disruptive care.


CNS Spectrums ◽  
2007 ◽  
Vol 12 (S1) ◽  
pp. 11-14
Author(s):  
Jeffrey L. Cummings

AbstractWe appear to be on the brink of a new epoch of treatment for Alzheimer's disease. Compelling evidence suggests that Aβ42 secretion is the triggering event in the pathogenesis of Alzheimer's disease, and that tau aggregation may be an important secondary event linked to neurodegeneration. Prophylactic administration of anti-amyloid agents designed to prevent Aβ accumulation in persons with subclinical disease is likely to be more effective than therapeutic interventions in established Alzheimer's disease. Drug development programs in Alzheimer's disease focus primarily on agents with anti-amyloid disease-modifying properties, and many different pharmacologic approaches to reducing amyloid pathology and tauopathy are being studied. Classes of therapeutic modalities currently in advanced-stage clinical trial testing include forms of immunotherapy (active β -amyloid immunoconjugate and human intravenous immunoglobulin), a γ-secretase inhibitor, the selective Aβ42-lowering agent R-flurbiprofen, and the anti-aggregation agent tramiprosate. Non-traditional dementia therapies such as the HMG-CoA reductase inhibitors (statins), valproate, and lithium are now being assessed for clinical benefit as anti-amyloid disease-modifying treatments. Positive findings of efficacy and safety from clinical studies are necessary but not sufficient to demonstrate that a drug has disease-modifying properties. Definitive proof of disease-modification requires evidence from validated animal models of Alzheimer's disease; rigorously controlled clinical trials showing a significantly improved, stabilized, or slowed rate of decline in cognitive and global function compared to placebo; and prospectively obtained evidence from surrogate biomarkers that the treatment resulted in measurable biological changes associated with the underlying disease process.


2020 ◽  
Vol 13 (8) ◽  
pp. 188 ◽  
Author(s):  
Shipra Malik ◽  
Anisha Gupta ◽  
Xiaobo Zhong ◽  
Theodore P. Rasmussen ◽  
Jose E. Manautou ◽  
...  

The novel SARS-CoV-2 virus has quickly spread worldwide, bringing the whole world as well as the economy to a standstill. As the world is struggling to minimize the transmission of this devastating disease, several strategies are being actively deployed to develop therapeutic interventions. Pharmaceutical companies and academic researchers are relentlessly working to investigate experimental, repurposed or FDA-approved drugs on a compassionate basis and novel biologics for SARS-CoV-2 prophylaxis and treatment. Presently, a tremendous surge of COVID-19 clinical trials are advancing through different stages. Among currently registered clinical efforts, ~86% are centered on testing small molecules or antibodies either alone or in combination with immunomodulators. The rest ~14% of clinical efforts are aimed at evaluating vaccines and convalescent plasma-based therapies to mitigate the disease's symptoms. This review provides a comprehensive overview of current therapeutic modalities being evaluated against SARS-CoV-2 virus in clinical trials.


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