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https://www.readbyqxmd.com/read/28923007/patients-beliefs-regarding-informed-consent-for-low-risk-pragmatic-trials
#1
Rafael Dal-Ré, Antonio J Carcas, Xavier Carné, David Wendler
BACKGROUND: The requirement to obtain written informed consent may undermine the potential of pragmatic randomized clinical trials (pRCTs) to improve evidence-based care. This requirement could compromise trials statistical power or even force it to close them down prematurely. However, recent data from the U.S. and Spain suggest that a majority of the public endorses written consent for low-risk pRCTs. The present manuscript assesses whether this view is shared by patients. METHODS: This was a cross-sectional, probability-based survey, with a 2 × 2 factorial design, assessing support for written informed consent versus verbal consent or general notification for two low-risk pRCTs in hypertension, one comparing 2 drugs with similar risk/benefit profiles and the other comparing the same drug being taken in the morning or at night...
September 18, 2017: BMC Medical Research Methodology
https://www.readbyqxmd.com/read/28812978/cioms-2016
#2
EDITORIAL
Sunita Vs Bandewar
No abstract text is available yet for this article.
July 2017: Indian Journal of Medical Ethics
https://www.readbyqxmd.com/read/28661402/cioms-guidelines-remain-conservative-about-vulnerability-and-social-justice
#3
Calvin Wai-Loon Ho
This paper begins by considering how the revised CIOMS guidelines have progressed beyond a mere labelling approach in the handling of vulnerability.. However, progress is limited as the guidelines remain fixated on voluntariness and harm reduction or prevention. Although these are important considerations, vulnerability could also serve as a robust analytic for the evaluation of situational and pathogenic (or structural) contributions to susceptibilities to harm. They could also provide better guidance on how to differentiate among varying types and degrees of harm, rather than merely noting their presence...
July 2017: Indian Journal of Medical Ethics
https://www.readbyqxmd.com/read/28648545/application-of-the-revised-who-causality-assessment-protocol-for-adverse-events-following-immunization-in-india
#4
Awnish Kumar Singh, Abram L Wagner, Jyoti Joshi, Bradley F Carlson, Satinder Aneja, Matthew L Boulton
BACKGROUND: In 2013, the World Health Organization (WHO) and CIOMS introduced a revised Causality Assessment Protocol (CAP) for Adverse Events following Immunization (AEFI). India is one of the first countries to adopt the revised CAP. This study describes the application of the revised CAP in India. METHODS: We describe use of CAP by India's AEFI surveillance program to assess reported AEFIs. Using publicly available results of causality assessment for reported AEFIs, we describe the results by demographic characteristics and review the trends for the results of the causality assessment...
June 22, 2017: Vaccine
https://www.readbyqxmd.com/read/28645716/guide-to-active-vaccine-safety-surveillance-report-of-cioms-working-group-on-vaccine-safety-executive-summary
#5
U Heininger, K Holm, I Caplanusi, S R Bailey
In 2013, the Council for International Organizations of Medical Sciences (CIOMS) created a Working Group on Vaccine Safety (WG) to address unmet needs in the area of vaccine pharmacovigilance. Generating reliable data about specific vaccine safety concerns is becoming a priority due to recent progress in the development and deployment of new vaccines of global importance, as well as novel vaccines targeting diseases specifically endemic to many resource-limited countries (RLCs), e.g. malaria, dengue. The WG created a Guide to Active Vaccine Safety Surveillance (AVSS) to assist national regulatory authorities and national immunization program officers in RLCs in determining the best course of action with regards to non-routine pharmacovigilance activities, when confronted with a launch of a new vaccine or a vaccine that is new to their country...
July 13, 2017: Vaccine
https://www.readbyqxmd.com/read/28525526/critical-analysis-of-the-council-for-international-organizations-of-medical-sciences-2016-international-guidelines-for-health-related-research-involving-humans
#6
REVIEW
Miguel Hugo Kottow Lang
This paper presents a preliminary discussion of the Council for International Organizations of Medical Sciences (CIOMS), recently issued “International Ethical Guidelines for Health-related Research Involving Humans” (2016) that acknowledges the document’s declared concern of the protection of human subjects and awareness of their needs and interests in “low-resource settings”. Nevertheless, guideline recommendations present exceptional situations –vulnerability, mental incompetence- wherein voluntary and consented participation may be reduced or omitted under three concurrent conditions: compelling scientific value, the need to include persons that will not benefit directly from participation, exposure to minimal or slight risks...
May 15, 2017: Medwave
https://www.readbyqxmd.com/read/28433963/schuklenk-s-critique-of-the-cioms-guidelines-all-procedure-no-substance
#7
Ruth Macklin
No abstract text is available yet for this article.
July 2017: Indian Journal of Medical Ethics
https://www.readbyqxmd.com/read/28285263/research-ethics-for-a-globalised-world-the-revised-cioms-international-guidelines
#8
Hans-Jöerg Ehni, Urban Wiesing
On December 6, 2016, the Council of International Organisations of Medical Sciences published a new version of its guidelines with the title "International Ethical Guidelines for Health-related Research Involving Humans." In this article we briefly describe the revision process and the structure and content of these guidelines. We outline some of its main guidelines such as the ones on social value, post-trial access, and risk-benefit ratio. In our overall evaluation we come to the conclusion that the CIOMS guidelines manage to strike a balance between the protection of human participants in health-related research and the promotion of such research activities in an exemplary way...
March 7, 2017: Indian Journal of Medical Ethics
https://www.readbyqxmd.com/read/28285262/revised-cioms-research-ethics-guidance-on-the-importance-of-process-for-credibility
#9
Udo Schuklenk
This paper reviews the 2016 CIOMS International Ethical Guidelines for Health-related Research Involving Humans. I argue that these new guidelines constitute a significant improvement over the guidelines they replace. However, the procedures put in place by CIOMS resulted in an authoring group consisting of a majority of authors and advisors hailing from the global North, while the guidelines squarely aim at influencing policies in the global South. I question CIOMS' strategy to produce a consensus based document, and raise concerns about frequent appeals to authority designed to establish the credibility of these guidelines and the processes that led to them...
March 7, 2017: Indian Journal of Medical Ethics
https://www.readbyqxmd.com/read/28093797/adverse-reactions-to-dietary-supplements-containing-red-yeast-rice-assessment-of-cases-from-the-italian-surveillance-system
#10
Gabriela Mazzanti, Paola Angela Moro, Emanuel Raschi, Roberto Da Cas, Francesca Menniti-Ippolito
AIMS: Red yeast rice (RYR) is contained in dietary supplements for patients with dyslipidemia. RYR supplements contain monacolin K, which is chemically identical to lovastatin, a licensed drug with a well-known risk profile. We aim to describe the safety profile of RYR by analysing spontaneous reports of suspected adverse reactions (ARs). METHODS: Within the Italian Surveillance System of Natural Health Products, suspected ARs were collected and evaluated by a multidisciplinary group of experts to assess causality using the WHO-UMC system or the CIOMS/RUCAM score, for hepatic reactions...
April 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28025733/antibiotic-induced-liver-injury-in-paediatric-outpatients-a-case-control-study-in-primary-care-databases
#11
Carmen Ferrajolo, Katia M C Verhamme, Gianluca Trifirò, Geert W 't Jong, Gino Picelli, Carlo Giaquinto, Giampiero Mazzaglia, Bruno H Stricker, Francesco Rossi, Annalisa Capuano, Miriam C J M Sturkenboom
INTRODUCTION: Antibiotics are the most commonly prescribed drug class in children. Real-world data mining on the paediatric population showed potential associations between antibiotic use and acute liver injury. OBJECTIVE: We assessed risk estimates of liver injury associated with antibiotic use in children and adolescent outpatients. METHODS: A large, multi-database, population-based, case-control study was performed in people <18 years of age from two European countries (Italy and The Netherlands) during the period 2000-2008...
April 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/27923072/revised-cioms-international-ethical-guidelines-for-health-related-research-involving-humans
#12
Johannes J M van Delden, Rieke van der Graaf
No abstract text is available yet for this article.
January 10, 2017: JAMA: the Journal of the American Medical Association
https://www.readbyqxmd.com/read/27818430/how-should-we-treat-the-vulnerable-qualitative-study-of-authoritative-ethics-documents
#13
Ivana Zagorac
The aim of this study is to explore what actual guidance is provided by authoritative ethics documents regarding the recognition and protection of the vulnerable. The documents included in this analysis are the Belmont Report, the Declaration of Helsinki, The Council for International Organizations of Medical Sciences (CIOMS) Guidelines, and the UNESCO Universal Declaration on Bioethics and Human Rights, including its supplementary report on vulnerability. A qualitative analysis of these documents was conducted in light of three questions: what is vulnerability, who are the vulnerable, and how should the vulnerable be protected? The results show significant differences among the documents regarding the first two questions...
2016: Journal of Health Care for the Poor and Underserved
https://www.readbyqxmd.com/read/27272353/quality-control-and-complication-screening-programme-of-chinese-medicinal-drugs-at-the-first-german-hospital-of-traditional-chinese-medicine-a-retrospective-analysis
#14
Dieter Melchart, Stefan Hager, Jingzhang Dai, Wolfgang Weidenhammer
BACKGROUND: The use of drugs derived from plants is a cornerstone of Traditional Chinese Medicine (TCM). Yet, too little is known about risk and safety of Chinese medicinal drugs (CMD). Therefore, the TCM hospital Bad Kötzting has developed a quality control and complication screening programme in order to ensure a safe administration of TCM drugs to their patients. METHODS: All Chinese medicinal drugs delivered to the hospital between September 1, 2012 and December 31, 2013 entered the quality control program and were screened for microbial contamination, aflatoxin, pesticides and heavy metals...
2016: Forschende Komplementärmedizin, Research in Complementary Medicine
https://www.readbyqxmd.com/read/26712744/rucam-in-drug-and-herb-induced-liver-injury-the-update
#15
REVIEW
Gaby Danan, Rolf Teschke
RUCAM (Roussel Uclaf Causality Assessment Method) or its previous synonym CIOMS (Council for International Organizations of Medical Sciences) is a well established tool in common use to quantitatively assess causality in cases of suspected drug induced liver injury (DILI) and herb induced liver injury (HILI). Historical background and the original work confirm the use of RUCAM as single term for future cases, dismissing now the term CIOMS for reasons of simplicity and clarity. RUCAM represents a structured, standardized, validated, and hepatotoxicity specific diagnostic approach that attributes scores to individual key items, providing final quantitative gradings of causality for each suspect drug/herb in a case report...
December 24, 2015: International Journal of Molecular Sciences
https://www.readbyqxmd.com/read/26626645/the-mystery-of-the-hawaii-liver-disease-cluster-in-summer-2013-a-pragmatic-and-clinical-approach-to-solve-the-problem
#16
Rolf Teschke, Alexander Schwarzenboeck, Christian Frenzel, Johannes Schulze, Axel Eickhoff, Albrecht Wolff
BACKGROUND AND AIM: In the fall of 2013, the US Centers for Disease Control and Prevention (CDC) published a preliminary report on a cluster of liver disease cases that emerged in Hawaii in the summer 2013. This report claimed a temporal association as sufficient evidence that OxyELITE Pro (OEP), a dietary supplement (DS) mainly for weight loss, was the cause of this mysterious cluster. However, the presented data were inconsistent and required a thorough reanalysis. MATERIAL AND METHODS: To further investigate the cause(s) of this cluster, we critically evaluated redacted raw clinical data of the cluster patients, as the CDC report received tremendous publicity in local and nationwide newspapers and television...
January 2016: Annals of Hepatology
https://www.readbyqxmd.com/read/26598920/drug-induced-liver-injury-a-2-year-retrospective-study-of-1169-hospitalized-patients-in-a-single-medical-center
#17
Hong Jung Woo, Ha Yeon Kim, Eun Sol Choi, Young-Hwan Cho, Youngchul Kim, Jang-Hoon Lee, Eungyeong Jang
BACKGROUND: Although herbal medicines (HMs) are widely used in Asian and Western countries, medicinal information concerning their hepatic toxicity or interaction with conventional medicines (CMs) is sparse. PURPOSE: The aim of our study was to estimate the prevalence of drug-induced liver injury (DILI) among total inpatients prescribed HMs or CMs. Furthermore, we noted all medications suspected to be associated with hepatotoxicity in the liver injury group during the period of hospitalization...
December 1, 2015: Phytomedicine: International Journal of Phytotherapy and Phytopharmacology
https://www.readbyqxmd.com/read/26357619/traditional-chinese-medicine-induced-liver-injury
#18
REVIEW
Rolf Teschke
Traditional Chinese Medicine (TCM) is popular around the world and encompasses many different practices with particular emphasis on herbal TCM. Using the PubMed database, a literature search was undertaken to assess the extent herbal TCM products exert rare hepatotoxicity. Analysis of reported cases revealed numerous specified herbal TCM products with potential hepatotoxicity. Among these were An Shu Ling, Bai Fang, Bai Xian Pi, Ban Tu Wan, Bo He, Bo Ye Qing Niu Dan, Bofu Tsu Sho San, Boh Gol Zhee, Cang Er Zi, Chai Hu, Chaso, Chi R Yun, Chuan Lian Zi, Ci Wu Jia, Da Chai Hu Tang, Da Huang, Du Huo, Gan Cao, Ge Gen, Ho Shou Wu, Hu Bohe You, Hu Zhang, Huang Qin, Huang Yao Zi, Hwang Geun Cho, Ji Gu Cao, Ji Ji, Ji Xue Cao, Jiguja, Jin Bu Huan, Jue Ming Zi, Kamishoyosan, Kudzu, Lei Gong Teng, Long Dan Xie Gan Tang, Lu Cha, Ma Huang, Mao Guo Tian Jie Cai, Onshido, Polygonum multiflorum, Qian Li Guang, Ren Shen, Sairei To, Shan Chi, Shen Min, Shi Can, Shi Liu Pi, Shou Wu Pian, Tian Hua Fen, White flood, Wu Bei Zi, Xi Shu, Xiao Chai Hu Tang, Yin Chen Hao, Zexie, Zhen Chu Cao, and various unclassified Chinese herbal mixtures...
June 2014: Journal of Clinical and Translational Hepatology
https://www.readbyqxmd.com/read/26357608/drug-and-herb-induced-liver-injury-in-clinical-and-translational-hepatology-causality-assessment-methods-quo-vadis
#19
REVIEW
Rolf Teschke, Axel Eickhoff, Johannes Schulze
Drug-induced liver injury (DILI) and herb-induced liver injury (HILI) are typical diseases of clinical and translational hepatology. Their diagnosis is complex and requires an experienced clinician to translate basic science into clinical judgment and identify a valid causality algorithm. To prospectively assess causality starting on the day DILI or HILI is suspected, the best approach for physicians is to use the Council for International Organizations of Medical Sciences (CIOMS) scale in its original or preferably its updated version...
September 2013: Journal of Clinical and Translational Hepatology
https://www.readbyqxmd.com/read/26291593/acute-cholestatic-liver-injury-from-hydralazine-intake
#20
Hadi Harati, Maziar Rahmani, Sassan Taghizadeh
Hydralazine is a commonly used oral antihypertensive agent. We report a rare case of hydralazine-induced hepatotoxicity in the form of subacute hepatic necrosis. A 75-year-old African American woman presented with jaundice of 7-day duration. She was started on hydralazine 100 mg 3 times a day 10 weeks before presentation. On physical examination, scleral icterus was noted. Workup revealed elevated liver transaminases, alkaline phosphatase, and conjugated bilirubin. She had no history of liver disease, and liver function tests had been normal before starting hydralazine...
September 2016: American Journal of Therapeutics
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