The IC system for protocol development

1988 ◽  
Author(s):  
D. M. Cohen ◽  
T. M. Guinther
Keyword(s):  
Protocol Development

scholarly journals Bridging research integrity and global health epidemiology (BRIDGE) statement: guidelines for good epidemiological practice

2020 ◽  
Vol 5 (10) ◽  
pp. e003236
Author(s):  
Sandra Alba ◽  
Kristien Verdonck ◽  
Annick Lenglet ◽  
Susan F Rumisha ◽  
Martijn Wienia ◽  
...  
Keyword(s):  
Global Health ◽  
Health Research ◽  
Research Integrity ◽  
Epidemiological Studies ◽  
Global Health Research ◽  
Face To Face ◽  
Protocol Development ◽  
Development Data ◽  
Collection Data ◽  
Mutual Accountability

BackgroundResearch integrity and research fairness have gained considerable momentum in the past decade and have direct implications for global health epidemiology. Research integrity and research fairness principles should be equally nurtured to produce high-quality impactful research—but bridging the two can lead to practical and ethical dilemmas. In order to provide practical guidance to researchers and epidemiologist, we set out to develop good epidemiological practice guidelines specifically for global health epidemiology, targeted at stakeholders involved in the commissioning, conduct, appraisal and publication of global health research.MethodsWe developed preliminary guidelines based on targeted online searches on existing best practices for epidemiological studies and sought to align these with key elements of global health research and research fairness. We validated these guidelines through a Delphi consultation study, to reach a consensus among a wide representation of stakeholders.ResultsA total of 45 experts provided input on the first round of e-Delphi consultation and 40 in the second. Respondents covered a range of organisations (including for example academia, ministries, NGOs, research funders, technical agencies) involved in epidemiological studies from countries around the world (Europe: 19; Africa: 10; North America: 7; Asia: 5; South-America: 3 Australia: 1). A selection of eight experts were invited for a face-to-face meeting. The final guidelines consist of a set of 6 standards and 42 accompanying criteria including study preparation, protocol development, data collection, data management, data analysis, dissemination and communication.ConclusionWhile guidelines will not by themselves guard global health from questionable and unfair research practices, they are certainly part of a concerted effort to ensure not only mutual accountability between individual researchers, their institutions and their funders but most importantly their joint accountability towards the communities they study and society at large.

scholarly journals Pediatric Surgical Reentry Strategy Following the COVID-19 Pandemic: A Tiered and Balanced Approach

2021 ◽  
pp. 000313482110111
Author(s):  
Ryan C. Pickens ◽  
Angela M. Kao ◽  
Mark A. Williams ◽  
Andrew C. Herman ◽  
Jeffrey S. Kneisl
Keyword(s):  
Pediatric Surgery ◽  
Elective Surgery ◽  
Surgical Care ◽  
Children's Hospital ◽  
Protocol Development ◽  
Balanced Approach ◽  
Projective Curves ◽  
Children’S Hospital ◽  
The Impact ◽  
Emergent Surgery

Background In response to the COVID-19 pandemic, children’s hospitals across the country postponed elective surgery beginning in March 2020. As projective curves flattened, administrators and surgeons sought to develop strategies to safely resume non-emergent surgery. This article reviews challenges and solutions specific to a children’s hospital related to the resumption of elective pediatric surgeries. We present our tiered reentry approach for pediatric surgery as well as report early data for surgical volume and tracking COVID-19 cases during reentry. Methods The experience of shutdown, protocol development, and early reentry of elective pediatric surgery are reported from Levine’s Children’s Hospital (LCH), a free-leaning children’s hospital in Charlotte, North Carolina. Data reported were obtained from de-identified hospital databases. Results Pediatric surgery experienced a dramatic decrease in case volumes at LCH during the shutdown, variable by specialty. A tiered and balanced reentry strategy was implemented with steady resumption of elective surgery following strict pre-procedural screening and testing. Early outcomes showed a steady thorough fluctuating increase in elective case volumes without evidence of a surgery-associated positive spread through periprocedural tracking. Conclusion Reentry of non-emergent pediatric surgical care requires unique considerations including the impact of COVID-19 on children, each children hospital structure and resources, and preventing undue delay in intervention for age- and disease-specific pediatric conditions. A carefully balanced strategy has been critical for safe reentry following the anticipated surge. Ongoing tracking of resource utilization, operative volumes, and testing results will remain vital as community spread continues to fluctuate across the country.

scholarly journals O-GlcNAcylation in early stages of chronic lymphocytic leukemia; protocol development for flow cytometry

2021 ◽  
pp. 1-10
Author(s):  
Viktória Temesfői ◽  
Kinga Molnár ◽  
Péter Kaltenecker ◽  
Barbara Réger ◽  
Árpád Szomor ◽  
...  
Keyword(s):  
Flow Cytometry ◽  
Lymphocyte Count ◽  
Blood Parameters ◽  
Cell Number ◽  
Metabolic Changes ◽  
Protein Glycosylation ◽  
Lymphocytic Leukemia ◽  
Tween 20 ◽  
Protocol Development ◽  
Flow Cytometric

BACKGROUND: Recent studies proved that metabolic changes in malignant disorders have an impact on protein glycosylation, however, only a few attempts have been made so far to use O-GlcNAc analysis as a prognostic tool. Glucose metabolism is reported to be altered in hematological malignancies thus, we hypothesized that monitoring intracellular O-GlcNAc levels in Rai stage 0-I (Binet A) CLL patients could give deeper insights regarding subtle metabolic changes of progression which are not completely detected by the routine follow-up procedures. OBJECTIVE: In this proof of concept study we established a flow cytometric detection method for the assessment of O-GlcNAcylation as a possible prognostic marker in CLL malignancy which was supported by fluorescence microscopy. METHODS: Healthy volunteers and CLL patients were recruited for this study. Lymphocytes were isolated, fixed and permeabilised by various methods to find the optimal experimental condition for O-GlcNAc detection by flow cytometry. O-GlcNAc levels were measured and compared to lymphocyte count and various blood parameters including plasma glucose level. RESULTS: The protocol we developed includes red blood cell lysis, formalin fixation, 0.1% Tween 20 permeabilisation and employs standardized cell number per sample and unstained controls. We have found significant correlation between O-GlcNAc levels and WBC (R2= 0.8535, p< 0.0029) and lymphocyte count (R2= 0.9225, p< 0.0006) in CLL patients. Interestingly, there was no such correlation in healthy individuals (R2= 0.05664 for O-GlcNAc vs WBC and R2= 0.04379 for O-GlcNAc vs lymphocytes). CONCLUSION: Analyzing O-GlcNAc changes in malignant disorders, specifically in malignant hematologic diseases such as CLL, could be a useful tool to monitor the progression of the disease.

Protocol Development for the Carbohydrate Quantification in Black Liquor with Brix Refractometer

2012 ◽  
Vol 93 (2) ◽  
pp. 69-74 ◽  
Author(s):  
Arnab Baksi ◽  
Sirsha Putatunda ◽  
Dwaipayan Sen ◽  
Ankur Sarkar ◽  
Chiranjib Bhattacharjee
Keyword(s):  
Black Liquor ◽  
Protocol Development

scholarly journals A transdisciplinary approach to protocol development for tobacco control research: a case study

2012 ◽  
Vol 2 (4) ◽  
pp. 431-440 ◽  
Author(s):  
Melissa A. Clark ◽  
Michelle L. Rogers ◽  
Julie Boergers ◽  
Christopher W. Kahler ◽  
Susan Ramsey ◽  
...  
Keyword(s):  
Tobacco Control ◽  
Transdisciplinary Approach ◽  
Protocol Development ◽  
Control Research
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