scholarly journals Literature Review and Global Consensus on Management of Acute Radiation Syndrome Affecting Nonhematopoietic Organ Systems

2011 ◽  
Vol 5 (3) ◽  
pp. 183-201 ◽  
Author(s):  
Nicholas Dainiak ◽  
Robert Nicolas Gent ◽  
Zhanat Carr ◽  
Rita Schneider ◽  
Judith Bader ◽  
...  
Keyword(s):  
Randomized Controlled Trials ◽  
Acute Radiation ◽  
World Health ◽  
Controlled Trials ◽  
Strong Recommendation ◽  
Acute Radiation Syndrome ◽  
Randomized Controlled ◽  
Organ Systems ◽  
Hypothetical Scenario ◽  
Medical Countermeasures

ABSTRACTObjectives:The World Health Organization convened a panel of experts to rank the evidence for medical countermeasures for management of acute radiation syndrome (ARS) in a hypothetical scenario involving the hospitalization of 100 to 200 victims. The goal of this panel was to achieve consensus on optimal management of ARS affecting nonhematopoietic organ systems based upon evidence in the published literature.Methods:English-language articles were identified in MEDLINE and PubMed. Reference lists of retrieved articles were distributed to conferees in advance of and updated during the meeting. Published case series and case reports of ARS, publications of randomized controlled trials of relevant interventions used to treat nonirradiated individuals, reports of studies in irradiated animals, and prior recommendations of subject matter experts were selected. Studies were extracted using the Grading of Recommendations Assessment Development and Evaluation system. In cases in which data were limited or incomplete, a narrative review of the observations was made.Results:No randomized controlled trials of medical countermeasures have been completed for individuals with ARS. Reports of countermeasures were often incompletely described, making it necessary to rely on data generated in nonirradiated humans and in experimental animals. A strong recommendation is made for the administration of a serotonin-receptor antagonist prophylactically when the suspected exposure is >2 Gy and topical steroids, antibiotics, and antihistamines for radiation burns, ulcers, or blisters; excision and grafting of radiation ulcers or necrosis with intractable pain; provision of supportive care to individuals with neurovascular syndrome; and administration of electrolyte replacement therapy and sedatives to individuals with significant burns, hypovolemia, and/or shock. A strong recommendation is made against the use of systemic steroids in the absence of a specific indication. A weak recommendation is made for the use of fluoroquinolones, bowel decontamination, loperamide, and enteral nutrition, and for selective oropharyngeal/digestive decontamination, blood glucose maintenance, and stress ulcer prophylaxis in critically ill patients.Conclusions:High-quality studies of therapeutic interventions in humans exposed to nontherapeutic radiation are not available, and because of ethical concerns regarding the conduct of controlled studies in humans, such studies are unlikely to emerge in the near future.(Disaster Med Public Health Preparedness. 2011;5:183–201)

scholarly journals First Global Consensus for Evidence-Based Management of the Hematopoietic Syndrome Resulting From Exposure to Ionizing Radiation

2011 ◽  
Vol 5 (3) ◽  
pp. 202-212 ◽  
Author(s):  
Nicholas Dainiak ◽  
Robert Nicolas Gent ◽  
Zhanat Carr ◽  
Rita Schneider ◽  
Judith Bader ◽  
...  
Keyword(s):  
Randomized Controlled Trials ◽  
Narrative Review ◽  
World Health ◽  
Controlled Trials ◽  
Colony Stimulating Factor ◽  
Hematopoietic Stem ◽  
Randomized Controlled ◽  
Hypothetical Scenario ◽  
Medical Countermeasures ◽  
Stimulating Factor

ABSTRACTObjective:Hematopoietic syndrome (HS) is a clinical diagnosis assigned to people who present with ≥1 new-onset cytopenias in the setting of acute radiation exposure. The World Health Organization convened a panel of experts to evaluate the evidence and develop recommendations for medical countermeasures for the management of HS in a hypothetical scenario involving the hospitalization of 100 to 200 individuals exposed to radiation. The objective of this consultancy was to develop recommendations for treatment of the HS based upon the quality of evidence.Methods:English-language articles were identified in MEDLINE and PubMed. Reference lists of retrieved articles were distributed to panel members before the meeting and updated during the meeting. Published case series and case reports of individuals with HS, published randomized controlled trials of relevant interventions used to treat nonirradiated individuals, reports of studies in irradiated animals, and prior recommendations of subject matter experts were selected. Studies were extracted using the Grading of Recommendations Assessment Development and Evaluation (GRADE) system. In cases in which data were limited or incomplete, a narrative review of the observations was made. No randomized controlled trials of medical countermeasures have been completed for individuals with radiation-associated HS. The use of GRADE analysis of countermeasures for injury to hematopoietic tissue was restricted by the lack of comparator groups in humans. Reliance on data generated in nonirradiated humans and experimental animals was necessary.Results:Based upon GRADE analysis and narrative review, a strong recommendation was made for the administration of granulocyte colony-stimulating factor or granulocyte macrophage colony-stimulating factor and a weak recommendation was made for the use of erythropoiesis-stimulating agents or hematopoietic stem cell transplantation.Conclusions:Assessment of therapeutic interventions for HS in humans exposed to nontherapeutic radiation is difficult because of the limits of the evidence.(Disaster Med Public Health Preparedness. 2011;5:202-212)

Interventions to Reduce Alcohol Harms in Low and Middle Income Countries: a Systematic Review and Meta Analysis

2018 ◽  
Author(s):  
Joao Ricardo Nickenig Vissoci
Keyword(s):  
Systematic Review ◽  
Alcohol Use ◽  
Randomized Controlled Trials ◽  
Brain Stimulation ◽  
Meta Analysis ◽  
World Health ◽  
Controlled Trials ◽  
Middle Income ◽  
Brief Motivational Intervention ◽  
Randomized Controlled

BackgroundHarmful alcohol use leads to a large burden of disease and disability which disportionately impacts LMICs. The World Health Organization and the Lancet have issued calls for this burden to be addressed, but issues remain, primarily due to gaps in information. While a variety of interventions have been shown to be effective at reducing alcohol use in HICs, their efficacy in LMICs have yet to be assessed. This systematic review describes the current published literature on alcohol interventions in LMICs and conducts a meta analysis of clinical trials evaluating interventions to reduce alcohol use and harms in LMICs.MethodsIn accordance with PRISMA guidelines we searched the electronic databases Pubmed, EMBASE, Scopus,Web of Science, Cochrane, and Psych Info. Articles were eligible if they evaluated an intervention targeting alcohol-related harm in LMICs. After a reference and citation analysis, we conducted a quality assessment per PRISMA protocol. A meta-analysis was performed on the 39 randomized controlled trials that evaluated an alcohol-related outcome.ResultsOf the 3,801 articles from the literature search, 87 articles from 25 LMICs fit the eligibility and inclusion criteria. Of these studies, 39 randomized controlled trials were included in the meta-analysis. Nine of these studies focused specifically on medication, while the others focused on brief motivational intervention, brain stimulation, AUDIT-based brief interventions, WHO ASSIST-based interventions, group based education, basic screening and interventions, brief psychological or counseling, dyadic relapse prevention, group counseling, CBT, motivational + PTSD based interview, and health promotion/awareness. Conclusion Issues in determining feasible options specific to LMICs arise from unstandardized interventions, unequal geographic distribution of intervention implementation, and uncertain effectiveness over time. Current research shows that brain stimulation, psychotherapy, and brief motivational interviews have the potential to be effective in LMIC settings, but further feasibility testing and efforts to standardize results are necessary to accurately assess their effectiveness.

scholarly journals Randomized, double-blinded, controlled non-inferiority trials evaluating the immunogenicity and safety of fractional doses of Yellow Fever vaccines in Kenya and Uganda

2019 ◽  
Vol 4 ◽  
pp. 182 ◽  
Author(s):  
Derick Kimathi ◽  
Aitana Juan ◽  
Philip Bejon ◽  
Rebecca F. Grais ◽  
George M. Warimwe ◽  
...  
Keyword(s):  
Immune Response ◽  
Randomized Controlled Trials ◽  
Yellow Fever ◽  
Vaccine Dose ◽  
World Health ◽  
Yellow Fever Vaccine ◽  
Controlled Trials ◽  
Post Vaccination ◽  
Randomized Controlled ◽  
Link Type

Introduction: Yellow fever is endemic in specific regions of sub-Saharan Africa and the Americas, with recent epidemics occurring on both continents. The yellow fever vaccine is effective, affordable and safe, providing life-long immunity following a single dose vaccination. However, the vaccine production process is slow and cannot be readily scaled up during epidemics. This has led the World Health Organization (WHO) to recommend the use of fractional doses as a dose-sparing strategy during epidemics, but there are no randomized controlled trials of fractional yellow fever vaccine doses in Africa. Methods and analysis: We will recruit healthy adult volunteers, adults living with HIV, and children to a series of randomized controlled trials aiming to determine the immunogenicity and safety of fractional vaccine doses in comparison to the standard vaccine dose. The trials will be conducted across two sites; Kilifi, Kenya and Mbarara, Uganda. Recruited participants will be randomized to receive fractional or standard doses of yellow fever vaccine. Scheduled visits will include blood collection for serum and peripheral blood mononuclear cells (PBMCs) before vaccination and on various days – up to 2 years – post-vaccination. The primary outcome is the rate of seroconversion as measured by the plaque reduction neutralization test (PRNT50) at 28 days post-vaccination. Secondary outcomes include antibody titre changes, longevity of the immune response, safety assessment using clinical data, the nature and magnitude of the cellular immune response and post-vaccination control of viremia by vaccine dose. Ethics and dissemination: The clinical trial protocols have received approval from the relevant institutional ethics and regulatory review committees in Kenya and Uganda, and the WHO Ethics Review Committee. The research findings will be disseminated through open-access publications and presented at relevant conferences and workshops. Registration: ClinicalTrials.gov NCT02991495 (registered on 13 December 2016) and NCT04059471 (registered on 15 August 2019).

scholarly journals Effect of Ashwagandha (Withania somnifera) extract on sleep: A systematic review and meta-analysis

PLoS ONE ◽  
2021 ◽  
Vol 16 (9) ◽  
pp. e0257843
Author(s):  
Kae Ling Cheah ◽  
Mohd Noor Norhayati ◽  
Lili Husniati Yaacob ◽  
Razlina Abdul Rahman
Keyword(s):  
Quality Of Life ◽  
Randomized Controlled Trials ◽  
Meta Analysis ◽  
Safety Data ◽  
Anxiety Level ◽  
World Health ◽  
Controlled Trials ◽  
Clinical Trial Registry ◽  
Randomized Controlled

Objective To determine the effect of Ashwagandha extract on sleep. Methods A comprehensive search was conducted in CENTRAL, MEDLINE, SCOPUS, Google Scholars, World Health Organization Trials Portal, ClinicalTrials.gov, Clinical Trial Registry of India, and AYUSH Research Portal for all appropriate trials. Randomized controlled trials that examined the effect of Ashwagandha extract versus placebo on sleep in human participants 18 years old and above were considered. Two authors independently read all trials and independently extracted all relevant data. The primary outcomes were sleep quantity and sleep quality. The secondary outcomes were mental alertness on rising, anxiety level, and quality of life. Results A total of five randomized controlled trials containing 400 participants were analyzed. Ashwagandha extract exhibited a small but significant effect on overall sleep (Standardized Mean Difference -0.59; 95% Confidence Interval -0.75 to -0.42; I2 =  62%). The effects on sleep were more prominent in the subgroup of adults diagnosed with insomnia, treatment dosage ≥600 mg/day, and treatment duration ≥8 weeks. Ashwagandha extract was also found to improve mental alertness on rising and anxiety level, but no significant effect on quality of life. No serious side effects were reported. Conclusion Ashwagandha extract appears to has a beneficial effect in improving sleep in adults. However, data on the serious adverse effects of Ashwagandha extract are limited, and more safety data would be needed to assess whether it would be safe for long-term use.

scholarly journals A Review of Registered Randomized Controlled Trials for the Prevention of Obesity in Infancy

2020 ◽  
Author(s):  
Seema Mihrshahi ◽  
Danielle Jawad ◽  
Louise A. Richards ◽  
Kylie Hunter ◽  
Mahalakshmi Ekambareshwar ◽  
...  
Keyword(s):  
Randomized Controlled Trials ◽  
Overweight And Obesity ◽  
World Health ◽  
Public Health Issue ◽  
Published Data ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
Child Weight ◽  
Health Organization

Childhood overweight and obesity is a worldwide public health issue. Our objective was to describe planned, ongoing and completed randomized controlled trials (RCTs) designed for the prevention of obesity in early childhood. Two databases (World Health Organization International Clinical Trials Registry Platform, ClinicalTrials.gov) were searched to identify RCTs with the primary aim of preventing childhood obesity and at least one outcome related to child weight. Interventions needed to start in the first two years of childhood or earlier, continue for at least 6 months postnatally, include a component related to lifestyle or behaviors, and have a follow up time of at least 2 years. We identified 29 unique RCTs, implemented since 2008, with most being undertaken in high income countries. Interventions ranged from advice on diet, activity, sleep, emotion regulation and parenting education through individual home visits, clinic-based consultations or group education sessions. Eleven trials have published data on child weight related outcomes to date, though most were not sufficiently powered to detect significant effects. Many trials detected improvements in practices such as breastfeeding, screen time and physical activity in the intervention groups compared to the control groups. Further follow-up of ongoing trials is needed to assess longer-term effects.

scholarly journals A Review of Registered Randomized Controlled Trials for the Prevention of Obesity in Infancy

2021 ◽  
Vol 18 (5) ◽  
pp. 2444
Author(s):  
Seema Mihrshahi ◽  
Danielle Jawad ◽  
Louise Richards ◽  
Kylie E. Hunter ◽  
Mahalakshmi Ekambareshwar ◽  
...  
Keyword(s):  
Randomized Controlled Trials ◽  
Overweight And Obesity ◽  
World Health ◽  
Public Health Issue ◽  
Published Data ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
Child Weight ◽  
Health Organization

Childhood overweight and obesity is a worldwide public health issue. Our objective was to describe planned, ongoing and completed randomized controlled trials (RCTs) designed for the prevention of obesity in early childhood. Two databases (World Health Organization International Clinical Trials Registry Platform, ClinicalTrials.gov) were searched to identify RCTs with the primary aim of preventing childhood obesity and at least one outcome related to child weight. Interventions needed to start in the first two years of childhood or earlier, continue for at least 6 months postnatally, include a component related to lifestyle or behaviours, and have a follow up time of at least 2 years. We identified 29 unique RCTs, implemented since 2008, with most being undertaken in high income countries. Interventions ranged from advice on diet, activity, sleep, emotion regulation, and parenting education through to individual home visits, clinic-based consultations, or group education sessions. Eleven trials published data on child weight-related outcomes to date, though most were not sufficiently powered to detect significant effects. Many trials detected improvements in practices such as breastfeeding, screen time, and physical activity in the intervention groups compared to the control groups. Further follow-up of ongoing trials is needed to assess longer-term effects.

scholarly journals Reducing Salt Intake in China with “Action on Salt China” (ASC): Protocol for Campaigns and Randomized Controlled Trials (Preprint)

2019 ◽  
Author(s):  
Puhong Zhang ◽  
Feng J He ◽  
Yuan Li ◽  
Changning Li ◽  
Jing Wu ◽  
...  
Keyword(s):  
Randomized Controlled Trials ◽  
School Children ◽  
Intervention Study ◽  
Salt Intake ◽  
Mobile App ◽  
World Health ◽  
Controlled Trials ◽  
Processed Foods ◽  
Salt Reduction ◽  
Randomized Controlled

BACKGROUND Salt intake in China is over twice the maximum recommendation of the World Health Organization. Unlike most developed countries where salt intake is mainly derived from prepackaged foods, around 80% of the salt consumed in China is added during cooking. OBJECTIVE Action on Salt China (ASC), initiated in 2017, aims to develop, implement, and evaluate a comprehensive and tailored salt reduction program for national scaling-up. METHODS ASC consists of six programs working in synergy to increase salt awareness and to reduce the amount of salt used during cooking at home and in restaurants, as well as in processed foods. Since September 2018, two health campaigns on health education and processed foods have respectively started, in parallel with four open-label cluster randomized controlled trials (RCTs) in six provinces across China: (1) app-based intervention study (AIS), in which a mobile app is used to achieve and sustain salt reduction in school children and their families; (2) home cook-based intervention study (HIS), in which family cooks receive support in using less salt; (3) restaurant-based intervention study (RIS) targeting restaurant consumers, cooks, and managers; and (4) comprehensive intervention study (CIS), which is a real-world implementation and evaluation of all available interventions in the three other RCTs. To explore the barriers, facilitators, and effectiveness of delivering a comprehensive salt reduction intervention, these RCTs will last for 1 year (stage 1), followed by nationwide implementation (stage 2). In AIS, HIS, and CIS, the primary outcome of salt reduction will be evaluated by 24-hour urinary sodium excretion in 6030 participants, including 5436 adults and 594 school children around 8-9 years old. In RIS, the salt content of meals will be measured by laboratory food analysis of the 5 best-selling dishes from 192 restaurants. Secondary outcomes will include process evaluation; changes in knowledge, attitude, and practice on salt intake; and economic evaluation. RESULTS All RCTs have been approved by Queen Mary Research Ethics Committee and the Institutional Review Boards of leading institutes in China. The research started in June 2017 and is expected to be completed around March 2021. The baseline investigations of the four RCTs were completed in May 2019. CONCLUSIONS The ASC project is progressing smoothly. The intervention packages and tailored components will be promoted for salt reduction in China, and could be adopted by other countries. CLINICALTRIAL Chinese Clinical Trial Registry. AIS: ChiCTR1800017553; https://tinyurl.com/vdr8rpr. HIS: ChiCTR1800016804; https://tinyurl.com/w8c7x3w. RIS: ChiCTR1800019694; https://tinyurl.com/uqkjgfw. CIS: ChiCTR1800018119; https://tinyurl.com/s3ajldw. INTERNATIONAL REGISTERED REPORT DERR1-10.2196/15933

scholarly journals Reducing Salt Intake in China with “Action on Salt China” (ASC): Protocol for Campaigns and Randomized Controlled Trials

10.2196/15933 ◽  
2020 ◽  
Vol 9 (4) ◽  
pp. e15933 ◽  
Author(s):  
Puhong Zhang ◽  
Feng J He ◽  
Yuan Li ◽  
Changning Li ◽  
Jing Wu ◽  
...  
Keyword(s):  
Randomized Controlled Trials ◽  
School Children ◽  
Intervention Study ◽  
Salt Intake ◽  
Mobile App ◽  
World Health ◽  
Controlled Trials ◽  
Processed Foods ◽  
Salt Reduction ◽  
Randomized Controlled

Background Salt intake in China is over twice the maximum recommendation of the World Health Organization. Unlike most developed countries where salt intake is mainly derived from prepackaged foods, around 80% of the salt consumed in China is added during cooking. Objective Action on Salt China (ASC), initiated in 2017, aims to develop, implement, and evaluate a comprehensive and tailored salt reduction program for national scaling-up. Methods ASC consists of six programs working in synergy to increase salt awareness and to reduce the amount of salt used during cooking at home and in restaurants, as well as in processed foods. Since September 2018, two health campaigns on health education and processed foods have respectively started, in parallel with four open-label cluster randomized controlled trials (RCTs) in six provinces across China: (1) app-based intervention study (AIS), in which a mobile app is used to achieve and sustain salt reduction in school children and their families; (2) home cook-based intervention study (HIS), in which family cooks receive support in using less salt; (3) restaurant-based intervention study (RIS) targeting restaurant consumers, cooks, and managers; and (4) comprehensive intervention study (CIS), which is a real-world implementation and evaluation of all available interventions in the three other RCTs. To explore the barriers, facilitators, and effectiveness of delivering a comprehensive salt reduction intervention, these RCTs will last for 1 year (stage 1), followed by nationwide implementation (stage 2). In AIS, HIS, and CIS, the primary outcome of salt reduction will be evaluated by 24-hour urinary sodium excretion in 6030 participants, including 5436 adults and 594 school children around 8-9 years old. In RIS, the salt content of meals will be measured by laboratory food analysis of the 5 best-selling dishes from 192 restaurants. Secondary outcomes will include process evaluation; changes in knowledge, attitude, and practice on salt intake; and economic evaluation. Results All RCTs have been approved by Queen Mary Research Ethics Committee and the Institutional Review Boards of leading institutes in China. The research started in June 2017 and is expected to be completed around March 2021. The baseline investigations of the four RCTs were completed in May 2019. Conclusions The ASC project is progressing smoothly. The intervention packages and tailored components will be promoted for salt reduction in China, and could be adopted by other countries. Trial Registration Chinese Clinical Trial Registry. AIS: ChiCTR1800017553; https://tinyurl.com/vdr8rpr. HIS: ChiCTR1800016804; https://tinyurl.com/w8c7x3w. RIS: ChiCTR1800019694; https://tinyurl.com/uqkjgfw. CIS: ChiCTR1800018119; https://tinyurl.com/s3ajldw. International Registered Report Identifier (IRRID) DERR1-10.2196/15933

scholarly journals Therapeutic Efficacies of Normobaric Oxygen Therapy in Healthcare: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

2019 ◽  
Author(s):  
Huaping Xiao ◽  
Xu Zhao ◽  
Alexandria Brackett ◽  
Feng Dai ◽  
Lingzhong Meng
Keyword(s):  
Randomized Controlled Trials ◽  
Therapeutic Efficacy ◽  
Oxygen Therapy ◽  
World Health ◽  
Controlled Trials ◽  
Normobaric Oxygen ◽  
Randomized Controlled ◽  
Normobaric Oxygen Therapy ◽  
Bodies Of Evidence

Abstract BackgroundNormobaric oxygen therapy is one of the most commonly used treatments in healthcare; however, oxygen is not a panacea. There is currently a lack of a comprehensive review summarizing different normobaric oxygen therapies and their therapeutic efficacies based on randomized controlled trials across healthcare. MethodsWe systematically searched Ovid MEDLINE, Ovid Embase, Web of Science, and the Cochrane database from inception to April 4, 2019, for randomized controlled trials investigating the therapeutic efficacy of normobaric oxygen therapy compared to usual care. Two investigators independently extracted study data and assessed study quality.ResultsA total of 173 studies involving 81,792 patients were included in qualitative analysis, and 95 of these studies, segregated in 49 bodies of evidence according to methods of oxygen therapy used, patient populations treated, and outcomes measured, were included in meta-analyses. Normobaric oxygen therapy was guided by oxygen flow, inspired oxygen fraction (FiO2), or an oxygenation monitor. Each method had multiple different protocols. Eighteen different outcome measures were commonly used to assess the therapeutic efficacy. Ten (20%), 2 (4%) and 37 (76%) bodies of evidence suggested a beneficial, harmful, and futile effect, respectively. The quality of only two bodies of evidence (4%) was high, i.e., the significant reduction of prematurity-related mortality and necrotizing enterocolitis by 91-95% pulse oxygen saturation-guided therapy. The quality of the remaining 47 bodies of evidence was moderate (39%), low (43%), or very low (14%). Contrary to the World Health Organization recommendation, 80% FiO2-guided oxygen therapy did not affect surgical site infection in intubated surgical patients (risk ratio, 0.84; 95% confidence interval, 0.69 to 1.01; p=0.07; moderate quality).ConclusionsNormobaric oxygen therapy is widely used across healthcare; however, more than 70% of bodies of evidence suggested a futile effect and the quality of more than 50% of bodies of evidence was low or very low. How to best use normobaric oxygen therapy deserves further research.

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