Children who experience well-being are engaging more confidently and positively with their caregiver and peers, which helps them to profit more from available learning opportunities and support current and later life outcomes. The goodness-of-fit theory suggests that children’s well-being might be a result of the interplay between their temperament and the environment. However, there is a lack of studies that examined the association between children’s temperament and well-being in early childhood education and care, and whether this association is affected by (...) ECEC process quality. Using a multilevel random coefficient approach, this study examines the association between toddlers’ temperament and well-being in Norwegian ECEC and investigates whether process quality moderates this association. Results reveal an association between temperament and well-being. Staff-child conflict moderates the association between shyness and well-being, and between activity and well-being. Moreover, high emotional behavioral support moderates the association between activity and well-being. Extra attention should be paid by the staff to these children’s needs. (shrink)

Promotion of prescription drugs may appear to be severely limited in some jurisdictions due to restrictions on direct-to-consumer advertising. However, in most jurisdictions, strategies exist to raise consumer awareness about prescription drugs, notably through the deployment of direct-to-consumer information campaigns that encourage patients to seek help for particular medical conditions. In Canada, DTCI is presented by industry and regulated by Health Canada as being purely informational activities, but their design and integration in broader promotional campaigns raise very similar ethical concerns (...) as those associated with DTCA. Specifically, DTCI can be an effective means of familiarizing the public with the scope and benefits of a particular prescription drug and so, like DTCA, can promote increased patient-consumer demand and thus a problematic rise in the prescribing and use of medications that may be neither the most appropriate nor the most cost-effective. Yet, with DTCI the industry is playing within the existing rules and regulations set by health regulators. To respond appropriately to this regulatory incoherence, we argue that DTCI should be regulated as a type of direct-to-consumer indirect advertising. Even if the case and specific regulations presented here are Canadian, the implications extend to every country that has a partial or total prohibition on DTCA. (shrink)

Undergraduates (total N = 185) were asked about performance-affecting drugs. Some drugs supposedly affected athletic performance, others memory, and others attention. Some improved performance for anyone who took them, others for the top 10% of performers, others for the bottom 10%, and finally, yet other drugs worked only on the bottom 10% who also showed physical abnormalities. Participants were asked about the fairness of allowing the drug to be used, about banning it, and about whether predictions of future (...) performance based on testing with or without the drug were better. The study found that participants appreciated the "interaction effect", that they felt it was less unfair to allow the drug if it affected the bottom 10% than if it affected everyone, and they were more eager to have the drug banned if it affected everyone. Participants were least tolerant of drugs that affected athletic performance and most tolerant of those that affected attention. (shrink)

Background: In this study, we aimed to investigate the effects of a mindfulness program including Mindfulness-Based Stress Reduction on the mental health of student teachers when offered at their educational institution in a real-life context.Methods: A parallel randomized controlled trial was conducted among self-selected student teachers at a Danish undergraduate program for teacher education in the autumns of 2019 and 2020. Participation was not recommended in case of clinical depression or a diagnosis of psychosis or schizophrenia, abuse of alcohol, drugs, (...) and/or medicine. Randomization was performed by a Statistician who was blinded to the identity of the students. Data was collected using self-reported questionnaires. The primary outcome was a change in perceived stress 3 months from baseline. Secondary outcome measures were symptoms of anxiety and depression, well-being, resilience, mindfulness, and thoughts and feelings during rest. The effects were analyzed according to the intention-to-treat principle using mixed-effect linear regression models. Mediating effects of mindfulness skills on the mental health outcomes were explored using structural equation modeling.Results: The study group included 67 student teachers with 34 allocated to the intervention group ; and 33 students allocated to a waiting list control group. At baseline, mean Perceived Stress Scale scores were 18.88 in the intervention group and 17.91 in the waiting list control group. A total of 56 students completed the questionnaire at a 3-month follow-up. Statistically significant effects of the intervention were found on perceived stress, symptoms of anxiety and depression, well-being, and on three of seven resting-state dimensions. No effects were found on resilience or mindfulness. Statistically significant mediated effects via resting-state dimensions were found.Conclusion The findings suggested that offering a mindfulness program at an undergraduate program for teacher education could significantly improve the mental health among self-selected students within 3 months. Results of mediation analysis supported the hypothesis that some of the effects might be explained by reduced distracting thoughts.Clinical Trial Registration: [www.ClinicalTrials.gov], identifier [NCT04558099]. (shrink)

Studies have reported high rates of childhood maltreatment among individuals with drug addiction problems; however, investigation about the potentially protective factors to mitigate the effects of maltreatment experiences on motivation to engage in addiction treatment has received less attention. This study aims at exploring the mediating effects of forgiveness and self-efficacy on the association between childhood maltreatment and treatment motivation among drug addicts. A total of 360 male drug addicts were recruited from three mandatory inpatient rehabilitation (...) centers in Malaysia. Participants completed a package of self-report questionnaires including measures of childhood maltreatment experiences, forgiveness, self-efficacy, and motivation for treatment. The analysis conducted using the structural equation model revealed that childhood maltreatment significantly predicted lower treatment motivation, while forgiveness and self-efficacy played a fully mediating role regarding the effect of childhood maltreatment on treatment motivation. In conclusion, these findings suggest that combining the element of forgiveness and self-efficacy in treatment programs appears to benefit the drug addicts with childhood maltreatment history. (shrink)

BackgroundThe US Food and Drug Administration (FDA) regulates goods accounting for 20% of US consumers’ total expenditure. The agency’s potential susceptibility to corporate lobbying and political influence may adversely affect the its abilities to fulfill its duties as a vital federal agency. This study assesses whether the FDA’s product recall classifications in recall scenarios are influenced by firms’ lobbying activities.MethodsThe universe of all FDA recalls between 2012 and 2019 is obtained from the FDA’s website. Firm names are matched (...) to federal-level lobbying data obtained from the Center for Responsive Politics – a non-profit and nonpartisan organization that tracks lobbying expenditures and campaign contributions. Analyses are conducted using ordinary-least-squares regressions, in which the dependent variable is recall classification and independent variables are three different measures of firms’ lobbying activities in the one year prior to the recall.ResultsFirms that engage in lobbying appear more likely to receive favourable classifications from the FDA. When examining the above results by product type, we find that classification of food recalls seems to be subject to lobbying influence, but the same does not appear to be true for drug and device recalls. Evidence is consistent with the conjecture that the distinction between medical and food firms may be a result of medical firms targeting lobbying efforts at FDA approvals, rather than recalls.ConclusionsBetween 2012 and 2019, the FDA’s product recall classifications seem to be significantly influenced by firms’ lobbying activities. Lobbying firms appear to have received more favorable (i.e., less severe) recall classifications compared to non-lobbying firms. (shrink)

The aim of this article is to examine some of the consequences of the recent advances in neurobiology in terms of the ability of drugs to manipulate the mind. Most laymen are totally ignorant of the general mechanism underlying the brain-mind relationship and therefore of the action of mind-altering drugs. Professor Grahame-Smith considers that one of the intrinsic evils of man's neurobiological make up is that a prime motive of the brain seems to be to bring comfort, security and pleasure (...) for itself. Therefore it is not surprising that drugs - notably the barbiturates and more recently the benzodiazepines (tranquilizers) - have been prescribed to give to the brain that peace of mind that it seeks. However, it can be argued that such drugs cannot replace anxiety with peace of mind or unhappiness or depression with happiness. The action of such drugs upon the molecules of the brain is negative - a placebo effect. (shrink)

ObjectiveThis study aimed to analyze the hearing improvement and prognosis factors of idiopathic sudden sensorineural hearing loss in different ages with initial total hearing loss.MethodsWe reviewed the medical records of 5,711 hospitalized patients with ISSNHL from 2016 to 2021 in our center. All of the patients had been treated with uniform combination drug therapy. After excluding the patients with initial partial hearing loss and those diagnosed with clear etiology, 188 patients were enrolled in this study and divided into (...) six age groups. In all groups, decreases in pure-tone average 1 month posttreatment, effective rate, and clinical characteristics were analyzed.ResultsAmong the 188 enrolled patients, 86% had vertigo. Complete recovery was seen in 0.5% of patients, and marked recovery was seen in 43% of patients. The mean 1 month posttreatment PTAs were as follows: 18–30 years: 80 ± 7.5 dB; 31–40 years: 100 ± 9.0 dB; 41–50 years: 99 ± 8.3 dB; 51–60 years: 101 ± 8.6 dB; 61–70 years: 96 ± 9.6 dB; and ≥ 71 years: 88 ± 13.0 dB. Compared with the other groups, the 18–30- years group showed better recovery of hearing threshold in five frequencies, and the recovery of hearing threshold at 0.25 and 0.5 Hz was better than the recovery at 1, 2, and 4 kHz. According to the results of the chi-square test statistical analysis, vertigo and comorbidities were associated with a poor prognosis of ISSNHL.ConclusionIn summary, the treatment outcomes of patients with ISSNHL with initial total hearing loss were poor. There was a significant age-related difference with respect to marked recovery 1 month posttreatment, and the 18–30- years group showed better recovery than the other age groups. (shrink)

"Cluster randomized trials," in which groups of patients are randomly assigned to different therapeutic interventions, provide a powerful way of evaluating drugs. CRTs have not been widely used, in good part because of concerns about whether patients must give informed consent to participate in them. A better understanding of how CRTs fit into clinical practice resolves the concerns.

Background: Dementia is one the major problems of aging societies, and, novel and effective non-drug therapies are required as interventions in the oldest-old to prevent cognitive decline.Objective: This study aims to examine the efficacy and safety of reminiscence using immersive virtual reality focusing on anxiety that often appears with cognitive decline. The secondary objective is to reveal the preference for VR image types for reminiscence: live-action or computer graphics.Methods: This was a pilot, open-label, and randomized crossover study which was (...) conducted on January 2020 at a single nursing home. The subjects were randomly divided into two groups in equal numbers, and they alternately viewed two types of VR images themed on the mid- to late Showa era in Japan. In group A, the CG images were viewed first, and then the LA images were viewed. In group B, the images were viewed in the opposite order. Before VR viewing, subjects responded to Mini-Mental State Examination Japanese version and State-Trait Anxiety Inventory Japanese version. After viewing the first and second VR, subjects responded to STAI and the numerical rating scale for satisfaction and side effects.Results: Ten subjects participated in this study. The values of analyses are presented in the mean. The age was 87.1 years, and the MMSE was 28.5. The total STAI score before VR viewing was 36.1, but it significantly decreased to 26.8 after the first VR viewing, and further decreased to 23.4 after the second VR viewing. The NRS score for satisfaction tended to be higher after viewing LA in group A vs. 8.6, P = 0.0993), while in group B, the score after CG was slightly lower than that after LA. There were no serious side effects.Conclusions: This study suggests that iVR reminiscence can reduce anxiety in the oldest-old without causing serious side effects. Furthermore, the impacts might be better with LA images. (shrink)

This paper attempts to define the concept of placebo as it is used in the clinical context The author claims that X is a placebo if and only if X has such a property dp, that whenever in a therapeutic situation T a stimulus S appears, then in attending conditions A, it will cause a beneficial reaction R in the patient. Formally, the same structure may be used to define any pharmacologically active drug. The main difference between the (...) class='Hi'>drug and a placebo is in the range of possible substitutions for X and the property d. For the active drug there is only one possible substitution for X and property d and it can be scientifically explained why, and how the drug works. In the case of a placebo a set of possible substitutions for X and d is open, and so far it is impossible to offer any scientifically valid explanation of the action mechanism of placebo. (shrink)

Placebos are often used by clinicians, usually deceptively and with little rationale or evidence of benefit, making their use ethically problematic. In contrast with their typical current use, a provocative line of research suggests that placebos can be intentionally exploited to extend analgesic therapeutic effects. Is it possible to extend the effects of drug treatments by interspersing placebos? We reviewed a database of placebo studies, searching for studies that indicate that placebos given after repeated administration of active treatments acquire (...) medication-like effects. We found a total of 22studies in both animals and humans hinting of evidence that placebos may work as a sort of dose extender of active painkillers. Wherever effective in relieving clinical pain, such placebo use would offer several advantages. First, extending the effects of a painkiller through the use of placebos may reduce total drug intake and side effects. Second, dose-extending placebos may decrease patient dependence. Third, using placebos along with active medication, for part of the course of treatment, should limit dose escalation and lower costs. Importantly, provided that nondisclosure is pre-authorized in the informed consent process and that robust evidence indicates therapeutic benefit comparable to that of standard full-dose therapeutic regimens, introducing dose-extending placebos into the clinical arsenal should be considered. This novel prospect of placebo use has the potential to change our general thinking about painkiller treatments, the typical regimens of painkiller applications, and the ways in which treatments are evaluated. (shrink)

Each of the antiretroviral drugs that are currently used to stop the progression of HIV infection causes its own specific side effects. Despite the expansion, multiplication, and simplification of treatment options over the past decade, side effects continue to affect people living with HIV. Yet, we see a clear disconnect between the way side effects are normalized, routinized, and framed in clinical practice and the way they are experienced by people living with HIV. This paper builds on the premise that (...) new approaches are needed to understand side effects in a manner that is more reflective of the subjective accounts of people living with HIV. Drawing on the work of Deleuze and Guattari, it offers an original application of the theory of ‘assemblage’. This theory offers a new way of theorizing side effects, and ultimately the relationship between the body and antiretroviral drugs (as technologies). Combining theory with examples derived from empirical data, we examine the multiple ways in which the body connects not only to the drugs but also to people, things, and systems. Our objective is to illustrate how this theory dares us to think differently about side effects and allows us to originally (re)think the experience of taking antiretroviral drugs. (shrink)

In a recent contribution to this journal, Patrick Tully criticizes my view that the doctrine of double effect does not prohibit a pharmaceutical company from selling a drug that has potentially fatal side-effects and that does not treat a life-threatening condition. Tully alleges my account is too permissive and makes the doctrine irrelevant to decisions about selling harmful products. In the following paper, I respond to Tully’s objections and show that he misinterprets my position and misstates some elements (...) of the doctrine of double effect. I also show how the doctrine constrains some decisions about marketing drugs with potentially fatal side-effects. (shrink)

Drug recalls and lawsuits against pharmaceutical manufacturers are accompanied by announcements emphasizing harmful drug side-effects. Those with elevated health anxiety may be more reactive to such announcements. We evaluated whether health anxiety and financial incentives affect subjective symptom endorsement, and objective outcomes of cognitive and physiological functioning during a mock drug recall. Hundred and sixty-one participants reported use of over-the-counter pain medications and presented with a fictitious medication recall via a mock Food and Drug Administration website. (...) The opportunity to join a class-action lawsuit was manipulated. We assessed health anxiety, recalled drug usage, blood pressure, heart rate, and performance on a computerized Trail Making Test. Symptom endorsement was strongly predicted by health anxiety. When combined, three health anxiety measures explained 28.5% variance. These effects remain strong after controlling for depression and anxiety. Litigation condition did not predict symptom endorsement. Blood pressure and heart rate were modestly predicted by health anxiety, but not by litigation condition. TMT performance was consistently predicted by health anxiety, with higher scores associated with poorer performance. Although there were no main effects for litigation, interactions consistently emerged for the TMT, with generally poorer performance for those with higher health anxiety in the non-litigation condition; whereas health anxiety was unrelated to performance for the litigation condition. All but one participant joined the litigation when given the opportunity, despite a healthy sample and minimal use of pain medication. Subsequent data from 67 individuals with no mention of the FDA scenario or litigation showed that health anxiety still significantly predicts symptom endorsement, but the explained variance is less than half that obtained in the FDA scenario. The findings suggest that health anxiety plays a significant role in adverse symptom reporting, beyond anxiety or depression, and this effect is independent of the presence of the FDA recall. The lack of differences for health anxiety and symptom endorsement between litigation and non-litigation conditions rules out malingering. Although it is general practice in drug recalls to list potential adverse side effects caused by medications, this may elicit unintended symptom experiences and health anxious individuals may be more susceptible. (shrink)

Grunbaum claims that the remedial failure of atreatment's characteristic factors is thegeneric, objective property of a placebo. Hestipulates that a treatment is placebic if thisremedial failure exacerbates the targetdisorder. This stipulation can subsume asplacebic effects that might be solelypharmacological, e.g., paradoxical reactions tocertain psychiatric drugs. If that exacerbationcan be explained pharmacologically, then wemight question whether Grunbaum's definitionalscheme captures the core identity of what weusually intend by the placebo concept. Ipropose that this core identity is bestcaptured by a symbolic meaning hypothesis (...) inwhich psychological factors exert thedeterminative influence. (shrink)

Aim Genetic research representative of the population is crucial to understanding the underlying causes of many diseases. In a prospective evaluation of informed consent we assessed the willingness of individuals of different ethnicities, gender and drug dependence history to participate in genetic studies in which their genetic sample could be shared with a repository at the National Institutes of Health. Methods Potential subjects were recruited from the general population through the use of flyers and referrals from previous participants and (...) clinicians with knowledge of our study. They could consent to 11 separate choices so that they could specify how and with whom their genetic sample could be shared. Rates of affirmative consent were then analysed by gender, ethnicity and drug dependence history. Results Of 1416 volunteers enrolled, 99.7% gave affirmative informed consent for studies of addiction conducted in our laboratory. No significant difference was found for participation in genetic studies conducted in our laboratory by gender, ethnicity or drug dependence history. Over all 11 questions, individuals with a history of drug use were more likely to agree to consent to participate in our study than were healthy volunteers. Conclusion A high percentage of each category of gender, ethnicity and drug history, gave affirmative consent at all levels. The level of detail in and the amount of time spent reviewing the informed consent, and a relationship of trust with the clinical investigator may contribute to this outcome. (shrink)

Background: Mental fatigue can impact physical demands and tactical behavior in sport-related contexts. Small-sided games are often used to develop a specific sport-related context. However, the effects of mental fatigue on physical demands and tactical behaviors during soccer SSGs have not been aggregated for systematical assessment.Objective: This systematic review was conducted to compare the effects of mental fatigue vs. control conditions in terms of the total running distance and tactical behavior of soccer players during SSGs.Methods: The data sources utilized (...) were PubMed, PsycINFO, Scielo, Scopus, SPORTDiscus, and Web of Science. The study eligibility criteria were established based on PICOS: Population: healthy youth and young adult men soccer players with regular training practice and belonging to teams with regular competitions; Intervention: exposed to mental fatigue-induced protocols only before SSGs; Comparator: control conditions before SSGs; Outcomes: physical demands and tactical behavior ; Study design: counterbalanced cross-over design; and only full-text and original articles written in English.Results: The database search initially identified 111 titles. From those, six articles were eligible for the systematic review and meta-analysis. Results showed no significant effect of fatigue on total running distance and tactical behavior.Conclusions: A non-significant effect of mental fatigue on total running distance and tactical behaviors performed by soccer players during SSGs was found in this systematic review. (shrink)

George Will, the well-known pundit, once observed: “A society's recreation is charged with moral significance. Sport—and a society that takes it seriously—would be debased if it did not strictly forbid things that blur the distinction between the triumph of character and the triumph of chemistry.” In opposition, Dan Duchaine, the highly publicized “steroid guru” and counter-culture columnist, declared: “There comes a time for many in competitive athletics where winning is more important than those initial goals of health, recreation, and relaxation.” (...) The parallels of these two philosophies to life in general are patent simply by substituting “sports” and “winning” for “career” and “success,” respectively.This paper will review the basis for banning anabolic steroids in athletics, and consider especially the recent medical findings that support this prohibition. This survey leads into a discussion of the available deterrents, and the secondary, but essential, role of random drug testing as a final safeguard. (shrink)

George Will, the well-known pundit, once observed: “A society's recreation is charged with moral significance. Sport—and a society that takes it seriously—would be debased if it did not strictly forbid things that blur the distinction between the triumph of character and the triumph of chemistry.” In opposition, Dan Duchaine, the highly publicized “steroid guru” and counter-culture columnist, declared: “There comes a time for many in competitive athletics where winning is more important than those initial goals of health, recreation, and relaxation.” (...) The parallels of these two philosophies to life in general are patent simply by substituting “sports” and “winning” for “career” and “success,” respectively.This paper will review the basis for banning anabolic steroids in athletics, and consider especially the recent medical findings that support this prohibition. This survey leads into a discussion of the available deterrents, and the secondary, but essential, role of random drug testing as a final safeguard. (shrink)

Effectiveness is a key criterion in assessing the justification of antibiotic resistance interventions. Depending on an intervention’s effectiveness, burdens and costs will be more or less justified, which is especially important for large scale population-level interventions with high running costs and pronounced risks to individuals in terms of wellbeing, integrity and autonomy. In this paper, we assess the case of routine hospital screening for multi-drug-resistant Gram-negative bacteria (MDRGN) from this perspective. Utilizing a comparison to screening programs for Methicillin-Resistant Staphylococcus (...) aureus (MRSA) we argue that current screening programmes for MDRGN in low endemic settings should be reconsidered, as its effectiveness is in doubt, while general downsides to screening programs remain. To accomplish justifiable antibiotic stewardship, MDRGN screening should not be viewed as a separate measure, but rather as part of a comprehensive approach. The program should be redesigned to focus on those at risk of developing symptomatic infections with MDRGN rather than merely detecting those colonised. (shrink)

The aim of this research is to analyze the effects of innovation strategies, Total Quality Management dimensions, and internationalization strategies that Higher Education Institutions might adopt, and their effects on their organizational performance. Due to globalization and the constant changes and demands that have taken place today, HEIs are forced to seek new quality assurance instruments in higher education, to ensure greater competitiveness in the markets and their survival. To examine the association between the independent variables, namely, TQM dimensions, (...) innovation strategies, and internationalization strategies with the dependent variable, that is organizational performance of HEIs, we have chosen to use multiple linear regression analysis. A nine-predictor multiple linear regression model was proposed. The nine predictor variables are Communication, Involvement/teacher empowerment, Development/Teacher training, Continuous improvement, Leadership/Administration’s Commitment, Data analysis/Measurement of results, Focus on students, Innovation Strategies, and Internationalization strategy. We conclude that some TQM variables have a significant association with the organizational performance of HEIs, namely, Involvement/teacher empowerment, and Development/teacher training. On the other hand, also the Innovation strategies and Internationalization strategy have a significant association with the organizational performance of HEIs. This research is of enormous importance for the study of HEIs, considering their role in the development of any country and its impact on society as creators of knowledge and science. Since these institutions increasingly must deal with extremely competitive market environments, knowledge of the factors that can assist in increasing the organizational performance of HEIs is of great relevance. (shrink)

Manuel Velasquez and F. Neil Brady apply the doctrine of double effect to business ethics and conclude that the doctrine allows a pharmaceutical company to sell a drug with potentially fatal side effects only if it also has the good effect of saving lives. This forbidsthe sale of many common products, such as automobiles and alcohol. My account preserves the virtues of the doctrine of double effectwithout making it too restrictive. I apply the doctrine to a pharmaceutical (...) company’s decision to market a drug with dangerous side effects and argue that free markets often offer the best way to compare the good and bad effects of business decisions. I conclude that the doctrine does allow a business to sell a potentially fatal product that does not save lives, provided that it warns consumers about the danger. (shrink)