Claims Of Safety Research Articles

Abstract 3139: Evidence Of Vascular Endothelial Dysfunction In Habitual Hookah (i.e., Waterpipe) Users: Insights For Cardiovascular Disease Risk

Introduction: Flavored hookah tobacco smoking among young adults continues to be a public health concern. While short-term exposure to flavored hookah tobacco smoking impairs vascular function, data on the long-term impact of habitual use are not clearly delineated. Research Question: Is habitual flavored hookah tobacco smoking associated with vascular endothelial dysfunction in young healthy adults? Goals: Investigate the impact of regular flavored hookah tobacco smoking on vascular endothelial function, as compared to regular cigarette smoking and never tobacco use, in young healthy adults. Methods: We assessed brachial artery flow-mediated dilation (FMD)—a well-established index of vascular endothelial function—in 22 exclusive chronic hookah smokers (25±1 years of age, 23% women; mean±SE), who reported smoking flavored hookah tobacco on average two times per week for 9±1 years, 22 exclusive cigarette smokers who reported 4±1 pack years, and 23 non-smokers. FMD and vascular endothelium-independent nitroglycerin-mediated vasodilation was assessed using high resolution ultrasound. Results: Whereas baseline brachial artery diameter was comparable between groups ( P =ns), brachial artery FMD was significantly lower in habitual hookah users and cigarette users as compared to never smokers (cigarette smokers: 5.22±0.42; hookah smokers: 6.43±0.50; non-smokers: 9.80±0.83; P <0.05). Endothelium-independent dilation of the brachial artery in response to sublingual nitroglycerin did not significantly differ between groups. Conclusions: Despite claims of safety advertised by the growing hookah tobacco industry, our findings provide evidence that, as compared to non-tobacco users, young and apparently healthy adults who regularly smoke flavored hookah tobacco exhibit reduced vascular endothelial function. These results suggest that flavored hookah tobacco smoking is not without harm and has potential harmful vascular effects, associated with increased cardiovascular disease risk.

Comparing the biological activity and composition of Cerebrolysin with other peptide preparations.

Neurological disorders, ranging from acute forms such as stroke and traumatic brain injury to neurodegenerative diseases like dementia, are the leading cause of disability-adjusted life years (DALYs) worldwide. A promising approach to address these conditions and promote nervous system regeneration is the use of the neuropeptide preparation Cerebrolysin, which has been shown to be effective in both clinical and preclinical studies. Despite claims of similar clinical efficacy and safety by several peptide preparations, concerns regarding their generic composition and efficacy have been previously raised. Based on these reports, we analyzed the peptide composition and neurotrophic activity of several peptide preparations allegedly similar to Cerebrolysin and approved in some countries for treating neurological diseases. Our results demonstrate that these preparations lack relevant biological activity and that the peptide composition is significantly different from Cerebrolysin. peptide.

Compounded Bioidentical Menopausal Hormone Therapy: ACOG Clinical Consensus No. 6.

Many compounding pharmacies use the phrase "bioidentical hormone" as a marketing term to imply that these preparations are natural and, thus, safer and more effective than U.S. Food and Drug Administration (FDA)-approved menopausal medications that use bioidentical or synthetic hormones or both. However, evidence to support marketing claims of safety and effectiveness is lacking. Compounded bioidentical menopausal hormone therapy should not be prescribed routinely when FDA-approved formulations exist. Clinicians should counsel patients that FDA-approved menopausal hormone therapies are recommended for the management of menopausal symptoms over compounded bioidentical menopausal hormone therapy. If a patient requests the use of compounded bioidentical menopausal hormone therapy, clinicians should educate them on the lack of FDA approval of these preparations and their potential risks and benefits, including the risks specific to compounding. To truly understand the benefits and harms of compounded bioidentical menopausal hormone therapy, high quality placebo-controlled randomized controlled trials with long-term follow-up comparing custom-compounded products with FDA-approved menopausal hormone therapy are needed.

Outcomes Associated With Intracranial Aneurysm Treatments Reported as Safe, Effective, or Durable

Testing new medical devices or procedures in terms of safety, effectiveness, and durability should follow the strictest methodological rigor before implementation. To review and analyze studies investigating devices and procedures used in intracranial aneurysm (IA) treatment for methods and completeness of reporting and to compare the results of studies with positive, uncertain, and negative conclusions. Embase, MEDLINE, Web of Science, and The Cochrane Central Register of Clinical Trials were searched for studies on IA treatment published between January 1, 1995, and the October 1, 2022. Grey literature was retrieved from Google Scholar. All studies making any kind of claims of safety, effectiveness, or durability in the field of IA treatment were included. Using a predefined data dictionary and analysis plan, variables ranging from patient and aneurysm characteristics to the results of treatment were extracted, as were details pertaining to study methods and completeness of reporting. Extraction was performed by 10 independent reviewers. A blinded academic neuro-linguist without involvement in IA research evaluated the conclusion of each study as either positive, uncertain, or negative. The study followed Preferring Reporting Items for Systematic Reviews and Meta-Analyses guidelines. The incidence of domain-specific outcomes between studies with positive, uncertain, or negative conclusions regarding safety, effectiveness, or durability were compared. The number of studies that provided a definition of safety, effectiveness, or durability and the incidence of incomplete reporting of domain-specific outcomes were evaluated. Overall, 12 954 studies were screened, and 1356 studies were included, comprising a total of 410 993 treated patients. There was no difference in the proportion of patients with poor outcome or in-hospital mortality between studies claiming a technique was safe, uncertain, or not safe. Similarly, there was no difference in the proportion of IAs completely occluded at last follow-up between studies claiming a technique was effective, uncertain, or noneffective. Less than 2% of studies provided any definition of safety, effectiveness, or durability, and only 1 of the 1356 studies provided a threshold under which the technique would be considered unsafe. Incomplete reporting was found in 546 reports (40%). In this systematic review and meta-analysis of IA treatment literature, studies claiming safety, effectiveness, or durability of IA treatment had methodological flaws and incomplete reporting of relevant outcomes supporting these claims.

Detection and quantification of physiologically active substances in curcumin supplements

Curcumin supplements have gained significant popularity due to their wide range of therapeutic properties, including anti-inflammatory, antimicrobial, and antioxidant effects. These supplements contain curcuminoids, which are the primary biologically active components found in turmeric, and are utilized in various applications such as food preservation, flavoring, and coloring. Additionally, curcumin is known for its beneficial effects in antitumor, antimutagenic, anticancer, and chemotherapeutic activities. Despite the claims of purity and safety, concerns have arisen regarding the vulnerability of curcumin supplements to adulteration. To address this issue, researchers collected eight commercially available curcumin supplement samples from different brands. These samples underwent a comprehensive analysis using chromatographic and spectrophotometric techniques to determine the curcuminoid content. High-Performance Liquid Chromatography (HPLC) and UV spectrophotometric methods were employed to detect and quantify the curcuminoids present in the samples. UV absorbance was measured at a specific wavelength of 425 nm, while HPLC analysis utilized a mobile phase composed of tetrahydrofuran and citric acid in water. Additionally, LC-MS/MS analysis was conducted to identify any potential presence of Sudan dyes, which could indicate adulteration. The study aimed to evaluate the curcumin content of the collected samples and compare it to the standard curcumin. The primary objectives were to identify any variations in curcuminoid concentration and to detect any potential adulteration or falsification in the commercially available curcumin supplement samples. This investigation is crucial for ensuring the authenticity and quality of curcumin supplements in the market.

Nicotine and Microvascular Responses in Skeletal Muscle from Acute Exposure to Cigarettes and Vaping.

Despite claims of safety or harm reduction for electronic cigarettes (E-cig) use (also known as vaping), emerging evidence indicates that E-cigs are not likely safe, or necessarily safer than traditional cigarettes, when considering the user's risk of developing vascular dysfunction/disease. E-cigs are different from regular cigarettes in that E-cig devices are highly customizable, and users can change the e-liquid composition (such as the base solution, flavors, and nicotine level). Since the effects of E-cigs on the microvascular responses in skeletal muscle are poorly understood, we used intravital microscopy with an acute (one-time 10 puff) exposure paradigm to evaluate the individual components of e-liquid on vascular tone and endothelial function in the arterioles of the gluteus maximus muscle of anesthetized C57Bl/6 mice. Consistent with the molecular responses seen with endothelial cells, we found that the peripheral vasoconstriction response was similar between mice exposed to E-cig aerosol or cigarette smoke (i.e., 3R4F reference cigarette); this response was not nicotine dependent, and endothelial cell-mediated vasodilation was not altered within this acute exposure paradigm. We also report that, regardless of the base solution component [i.e., vegetable glycerin (VG)-only or propylene glycol (PG)-only], the vasoconstriction responses were the same in mice with inhalation exposure to 3R4F cigarette smoke or E-cig aerosol. Key findings from this work reveal that some component other than nicotine, in inhaled smoke or aerosol, is responsible for triggering peripheral vasoconstriction in skeletal muscle, and that regardless of one's preference for an E-cig base solution composition (i.e., ratio of VG-to-PG), the acute physiological response to blood vessels appears to be the same. The data suggest that vaping is not likely to be 'safer' than smoking towards blood vessels and can be expected to produce and/or result in the same adverse vascular health outcomes associated with smoking cigarettes.

Why Do We Need Food Systems Informatics? Introduction to This Special Collection on Smart and Connected Regional Food Systems

Public interest in where food comes from and how it is produced, processed, and distributed has increased over the last few decades, with even greater focus emerging during the COVID-19 pandemic. Mounting evidence and experience point to disturbing weaknesses in our food systems’ abilities to support human livelihoods and wellbeing, and alarming long-term trends regarding both the environmental footprint of food systems and mounting vulnerabilities to shocks and stressors. How can we tackle the “wicked problems” embedded in a food system? More specifically, how can convergent research programs be designed and resulting knowledge implemented to increase inclusion, sustainability, and resilience within these complex systems, support widespread contributions to and acceptance of solutions to these challenges, and provide concrete benchmarks to measure progress and understand tradeoffs among strategies along multiple dimensions? This article introduces and defines food systems informatics (FSI) as a tool to enhance equity, sustainability, and resilience of food systems through collaborative, user-driven interaction, negotiation, experimentation, and innovation within food systems. Specific benefits we foresee in further development of FSI platforms include the creation of capacity-enabling verifiable claims of sustainability, food safety, and human health benefits relevant to particular locations and products; the creation of better incentives for the adoption of more sustainable land use practices and for the creation of more diverse agro-ecosystems; the wide-spread use of improved and verifiable metrics of sustainability, resilience, and health benefits; and improved human health through better diets.

Methodology considerations for 'Safety and effectiveness of cannabinoids to Danish patients with treatment-refractory chronic pain' by Horsted et al.

The recently published exploratory, non-controlled, study by Horsted et al. (2023) reports on the potential safety and pain-relieving effects of cannabinoids (THC, CBD), or mixed in a non-randomized order. The authors conclude that ‘oral cannabinoid therapy in general appears to be safe and effective for relief of chronic pain in some patients, including a subset of patients with cancer-related pain (9%), not responding adequately to conventional treatment regimens or experiencing intolerable adverse events’. The author's conclusion is in direct contrast to the conclusion and recommendations from the International Associations for the Study of Pain (IASP) Cannabis Task Force. Based on a thorough evaluation of current evidence, Rice et al. (2021) concluded ‘That the available clinical evidence neither supports nor refutes claims of analgesic efficacy or safety for cannabinoids, cannabis, or cannabis-based medicines’ and suggested future studies and recommendations should follow rigid rules of conclusive randomized, placebo-controlled randomized controlled trials (RCTs) to provide evidence (Haroutounian et al., 2021). The study by Horsted et al. is a retrospective study and hence is not monitored by the Danish medical agency and executed as a good clinical practice (GCP) study although investigating the effect of a new treatment modality. Furthermore, the study was not registered at ClinicalTrials.gov as this is not normally mandatory for retrospective studies submitted to the European Journal of Pain. Many RCTs have been published demonstrating no effect of cannabinoids on clinical pain or potential underlying pain mechanisms when compared to placebo (e.g. Zubcevic et al., 2022). None of such studies and only one of the 14 IASP statement's current state-of-the-art papers are referenced in the manuscript by Horsted et al. and hence not discussed in the light of the current best evidence. The study found an average decrease in clinical pain intensity of 1.8 (baseline pain approx. 7 on a 0–10 numerical rating scale), which corresponds to an effect of approx. 25%. This is in the low end of placebo effects reported in previous high-quality pain studies and what is reported in other well-controlled placebo-controlled pain studies (McQuay et al., 1996). The expectancy and placebo effects are largely (and often exclusively) found responsible for the therapeutic effects of non-pharmacological treatments such as, e.g. cannabis. The Horsted et al. study was conducted in Denmark and here cannabis has attracted much attention in the media. The positive media promotion of cannabis products will increase the placebo effects and as the study was conducted without any control or placebo groups the effect size and the placebo responses can obviously not be separated. Most recent meta-analysis likewise concluded that ‘placebo responses contribute significantly to pain reduction in cannabinoid clinical trials’ and ‘the unusually high media attention surrounding cannabinoid trials, with positive reports irrespective of scientific results, may uphold high expectations and shape placebo responses in future’. The authors state that ‘with the relatively long follow-up it is likely that the placebo effect is of less importance’. This is not empirically validated as studies have shown long-lasting (up to 5 years) placebo effects in trials. The Horsted et al. study enrolled 826 patients, yet only 214 patients were follow-up for the last visit, 243 patients were registered as ‘lost to follow-up’ and an additional 122 patients were discontinued. In addition, among the included patients, data of interest were missing (e.g. 39 (18%) of the 214 included patients with the last visit recorded had missing values regarding pain intensity measured as numeric rating scale). Only 25.9% (214/826) of the included eligible patients were included in the analysis. All these excluded patients are likely to not benefit from the study drug (no effect or severe side effects), which is not addressed in details. Thus, the excluded patients (constituting +40% of the original sample) are a likely source of a major selection bias, compromising the study's validity and conclusions. The authors do refer to the supplementary material for a description of the excluded patients, but this material is not presented in a way that allows for further analyses. The exploratory nature of this non-placebo controlled cannabis study does not provide new evidence for the use of cannabinoids for the treatment of pain. The pain alleviation reported is at its best similar to placebo responses reported in multiple randomized pain cannabis trials. The concerningly high number of patients excluded from the analysis further compromises the integrity and validity of the study. Center for Neuroplasticity and Pain (CNAP) is supported by the Danish National Research Foundation (DNRF121). The Center for Mathematical Modeling of Knee Osteoarthritis (MathKOA) is funded by the Novo Nordisk Foundation (NNF21OC0065373). The authors declare no conflict of interest.

Improving Drug Therapy for Pediatric Patients: Unfinished History of Pediatric Drug Development.

Improving Drug Therapy for Pediatric Patients: Unfinished History of Pediatric Drug Development.

Effect of E-cigarette use on lung immunity to influenza infection

Abstract Use of E-cigarettes, also called vaping, has been significantly increasing, with over 10 million adults and 3 million adolescents reported to actively vape. Of particular concern recently is the association of vaping with increased risk of respiratory infection, including influenza and COVID-19. Despite the claims of safety, lung immunological development appears to be impacted by vaping, with associated pulmonary toxicity and potential to impair immunity against respiratory infections. Immunity against respiratory pathogens, particularly viral pathogens is dependent on a robust CD4 and CD8 T cell responses responsible for viral clearance. CD4 and CD8 T cells then develop memory responses to protect against reinfection. T cell memory also provides protection against infection after vaccination. We asked whether vaping exposure affects T cell responses to influenza infection. We exposed animals for 8 weeks to base components of vape devices, including propylene glycol (PG), vegetable glycerin (VG), and a novel cutting agent, phytol, then assessed immune responses to influenza. We find that PGVG and phytol exposure alters pulmonary function, promotes proteomic changes to the lung, and modify immune cell subsets in the lung. We also find that PGVG and phytol exposure alters T cell responses to influenza infection, particularly T cell memory protection against heterologous infection. These results suggest that vaping affects immune responses to respiratory influenza infection, including T cell memory responses. Effects of vaping on T cell memory may have wide ranging consequences for T cell mediated protection against other respiratory disease including SARS-CoV-2 and protection after vaccination. Supported by NIH (P20 GM121176; P20GM130422)

Bioavailability, Efficacy, Safety, and Regulatory Status of Creatine and Related Compounds: A Critical Review.

In 2011, we published a paper providing an overview about the bioavailability, efficacy, and regulatory status of creatine monohydrate (CrM), as well as other “novel forms” of creatine that were being marketed at the time. This paper concluded that no other purported form of creatine had been shown to be a more effective source of creatine than CrM, and that CrM was recognized by international regulatory authorities as safe for use in dietary supplements. Moreover, that most purported “forms” of creatine that were being marketed at the time were either less bioavailable, less effective, more expensive, and/or not sufficiently studied in terms of safety and/or efficacy. We also provided examples of several “forms” of creatine that were being marketed that were not bioavailable sources of creatine or less effective than CrM in comparative effectiveness trials. We had hoped that this paper would encourage supplement manufacturers to use CrM in dietary supplements given the overwhelming efficacy and safety profile. Alternatively, encourage them to conduct research to show their purported “form” of creatine was a bioavailable, effective, and safe source of creatine before making unsubstantiated claims of greater efficacy and/or safety than CrM. Unfortunately, unsupported misrepresentations about the effectiveness and safety of various “forms” of creatine have continued. The purpose of this critical review is to: (1) provide an overview of the physiochemical properties, bioavailability, and safety of CrM; (2) describe the data needed to substantiate claims that a “novel form” of creatine is a bioavailable, effective, and safe source of creatine; (3) examine whether other marketed sources of creatine are more effective sources of creatine than CrM; (4) provide an update about the regulatory status of CrM and other purported sources of creatine sold as dietary supplements; and (5) provide guidance regarding the type of research needed to validate that a purported “new form” of creatine is a bioavailable, effective and safe source of creatine for dietary supplements. Based on this analysis, we categorized forms of creatine that are being sold as dietary supplements as either having strong, some, or no evidence of bioavailability and safety. As will be seen, CrM continues to be the only source of creatine that has substantial evidence to support bioavailability, efficacy, and safety. Additionally, CrM is the source of creatine recommended explicitly by professional societies and organizations and approved for use in global markets as a dietary ingredient or food additive.

Claims of Safety in Neurosurgical Literature: We Shouldn't Call Something Safe Without Strong Justification.

Many articles published in the neurosurgical literature make claims of safety regarding interventions. The strength of evidence supporting these claims has not been systematically evaluated. To evaluate the quality of evidence supporting claims of safety in the neurosurgery literature. The 14 neurosurgical journals listed in the Web of Science database with the highest impact factors for 2018 were included in the study. The titles and abstracts of all the articles published in these journals in 2018 were searched for the word "safety" and reviewed by 2 independent observers to identify those making a claim of safety and assess their evidence. The search identified 323 articles, representing 5% of the articles published in the 14 searched journals in 2018. Of these, 114 (1.8% of all articles and 35% of the identified articles) were judged to make a claim of safety of a neurosurgical intervention. A total of 98 (86%) of the 114 articles making a safety claim were retrospective cohort studies. Patient cohort sizes ranged from 1 to 1565 (median of 34), leading to wide variations in the CIs for estimated complication rates. No article made a statement of the assumptions underlying its claim of safety. Almost no articles that make claims of safety for neurosurgical interventions explicitly state the (1) patient population, (2) comparison intervention, nor (3) specific outcomes. To assure that claims of safety are supported by high-quality evidence, authors should address these elements early and systematically when designing studies.

Overstated Claims of Efficacy and Safety. Comment On: "Optimal Nutritional Status for a Well-Functioning Immune System Is an Important Factor to Protect Against Viral Infections". Nutrients 2020, 12, 1181.

Calder et al [...].

Reply to "Overstated Claims of Efficacy and Safety. Comment On: Optimal Nutritional Status for a Well-Functioning Immune System Is an Important Factor to Protect against Viral Infections. Nutrients 2020, 12, 1181".

We thank Vorland et al [...].

Ban on electronic cigarettes in Brazil: a policy in favor of human rights

Abstract This research aims to study the prohibition of electronic cigarettes' commerce in Brazil and to demonstrate its relevance in the realization of freedom and health, especially considering the impact of these devices worldwide. Also known as Electronic Nicotine Delivery Systems (Ends) and e-cigarettes it is a type of product designed to deliver nicotine, derived from tobacco leaf, in the form of an aerosol, some of which are also sold without nicotine. It is necessary to analyze, using rhetoric as method, as well as the science of statistics, the conflicting principles of freedom and life involved in the citizen's right to choose and public health, to answer the question: Is a complete ban on e-cigs the correct policy from the government? The commercialization, importation and advertising of electronic cigarettes was prohibited by the Brazilian Health Regulatory Agency (ANVISA) in 2009, thus banning, at least legally, access to the devices inside the country. Despite this prohibition, the trade in vaporizers and their fluids, which contains nicotine, is easily achieved on the internet, informally. It must be noted that, even considering the benefits of vaping for chronic smokers, there is the concern of secondhand smokers and the upsurge of young people taking on vaping to consider. The conclusion is that, although both individual freedom and health are constitutional rights, in this conflict between them, the suppression of individual freedom is needed, since health is a public concern, and it stands to reason that, even considering the lesser impact vaping has on people, compared to combustion cigarettes, there are two factors in play: First, nobody has the right to expose people to any chance of ill effects, negating the argument of reduced risks when compared to cigarettes. Secondly, there are no long-term studies to support the claims of safety in this practice. The ban, therefore, represents public health and respect regarding Human Rights. Key messages The conflict between individual freedom and health must prevent, in this situation, the possibility of affecting the health of new generations and nonsmokers. There are no long-term studies proving the safety of electronic cigarettes, therefore the law banning the product is a preventive act in the name of public health.

Cannabinoids, cannabis, and cannabis-based medicine for pain management: a systematic review of randomised controlled trials.

Cannabinoids, cannabis, and cannabis-based medicines (CBMs) are increasingly used to manage pain, with limited understanding of their efficacy and safety. We summarised efficacy and adverse events (AEs) of these types of drugs for treating pain using randomised controlled trials: in people of any age, with any type of pain, and for any treatment duration. Primary outcomes were 30% and 50% reduction in pain intensity, and AEs. We assessed risk of bias of included studies, and the overall quality of evidence using GRADE. Studies of <7 and >7 days treatment duration were analysed separately. We included 36 studies (7217 participants) delivering cannabinoids (8 studies), cannabis (6 studies), and CBM (22 studies); all had high and/or uncertain risk of bias. Evidence of benefit was found for cannabis <7 days (risk difference 0.33, 95% confidence interval 0.20-0.46; 2 trials, 231 patients, very low-quality evidence) and nabiximols >7 days (risk difference 0.06, 95% confidence interval 0.01-0.12; 6 trials, 1484 patients, very low-quality evidence). No other beneficial effects were found for other types of cannabinoids, cannabis, or CBM in our primary analyses; 81% of subgroup analyses were negative. Cannabis, nabiximols, and delta-9-tetrahydrocannabinol had more AEs than control. Studies in this field have unclear or high risk of bias, and outcomes had GRADE rating of low- or very low-quality evidence. We have little confidence in the estimates of effect. The evidence neither supports nor refutes claims of efficacy and safety for cannabinoids, cannabis, or CBM in the management of pain.

Charcoal-based mouthwashes: a literature review.

The commercial marketplace has seen a rapid increase in the number of over-the-counter charcoal-containing mouthwashes. The purpose of this systemic review was to examine the clinical and laboratory evidence supporting therapeutic claims of efficacy and safety of use of charcoal-based mouthwashes. Secondly, the product labels and information of 36 commercially marketed charcoal mouthwashes were reviewed for active ingredients. Only 8% of charcoal mouthwashes contained an active ingredient, such as cetylpyridinium chloride or chlorhexidine. There is insufficient evidence to substantiate the therapeutic and cosmetic marketing claims of charcoal-based mouthwashes, including antimicrobial activity, anti-halitosis, tooth whitening, periodontal disease control, caries reduction and tooth remineralisation, among others. Moreover, there is no available information on charcoal particulate size or abrasivity of any of these products. Dental clinicians should advise their patients to exercise caution when using over-the-counter charcoal-containing mouthwashes because of the lack of evidence supporting therapeutic or cosmetic effectiveness as well as safety.

Smoking and pregnancy: The era of electronic nicotine delivery systems.

Electronic nicotine delivery systems have been commercially available in the United States since 2007. Despite a decrease in combustible cigarette use, electronic nicotine delivery systems use has dramatically increased among both adults and adolescents. These devices have been marketed as smoking cessation aids, although data on their efficacy are scarce. Pregnant women are an especially vulnerable population susceptible to claims of safety and efficacy, and the medical community remains inadequately informed on how to counsel these women. The purpose of this article is to review known literature regarding the use of electronic nicotine delivery systems in pregnancy, to understand the differences between cigarettes and electronic nicotine delivery systems use in pregnancy, and to further guide clinicians on how to advise the pregnant woman on their use.

Devotionalism in Diversity: The Islamic Paradigm in Multiculturalism in Langsa-Aceh Indonesia

This article is the result of a study that discusses the paradigm of Langsa Aceh scholars (Islamic scholars) to overcome multiculturalism. This study also reveals the consistency of the agreement of Islamic scholars regarding exclusivity and inclusiveness; prevent the emergence of radicalism in the Islamic community, especially the urban areas of Langsa in Aceh. It discusses the phenomenon of recent recruitment by "brainwashing" in younger students because they filled with certain radicalistic ideologies. The teachings of Islamic education are more about claiming the truth of the religion itself and consider religion as the only one to achieve salvation (emphasizing claims of self-truth and safety). This research is qualitative with a descriptive-analytical application. Primary data obtained from in-depth interviews with sources of religious leaders, lecturers of Islamic Higher Education, teachers, non-Muslim students, and community elements. Reliability of piety in diversity and the paradigm of multiculturalism converted to statistical equations. Mathematical equations applied to the Cohen Kappa coefficient (a measure of authenticity) and measured between exclusivity and inclusiveness with the claims of self-righteousness and the safety paradigm of Islamic scholars. The level of agreement between the instruments assessed illustrates the reliability between assessors -IRR- the results of the informant's interview level of consensus are identified between the safety of the results of the consistency of the contract between piety and exclusivity, because self-claims show "lack" (kappa, 0.20-0.41) , while the agreement between service and safety is "very good" (kappa 0.81-0.90). With inter-assessor reliability, K = 0.89 with an extraordinary category.

Michael Hviid Jacobsen (ed) (2014) The Poetics of Crime Understanding and Researching Crime and Deviance Through Creative Sources

Neoliberalism, market policies, and competition have created challenges to security governance after 9/11 (Ferguson, 2017). The proliferating scientific republic and increasing securitisation have bolstered new knowledge claims over the idea of crime, and have given rise to different orientations and methods to craft an understanding of crime. ‘The Poetics of Crime’ can be seen as a rigorous attempt that departs from the notion of thoughtfully ‘cultivated beliefs’ and carefully ‘nurtured debated attempts’ being the outcome of postmodernity’s claims of safety, security and surveillance. Proliferating security fetishism thus promoting ‘criminological society’ produces different sets of knowledge on crime. Methodological cynicism and beliefs have whirled the existing preconditions of defining crime through logical positivism and syllogism, opening up new avenues to develop knowledge to define contemporaneous of crime. The book under review attempts to transcend and criticise conventional methods of understanding crime and find creative ways to define crime. With shifting approaches to theorising crime, and significant shifts in policing practices, there is a pressing need to adopt a more egalitarian approach to understand crime through public criminology (Loader, 2000; Loader and Sparks, 2011). The book is divided into four sections. It offers a rich critique of existing methodological issues and the influences of bureaucratic practices on criminology, while attempting to study the antecedents of crime through new approaches to understanding art forms. In their criminological perspectives, scholars highlight the significance of ‘fact in fiction’ for building an understanding of crime.