Safety of Thimerosal-Containing Vaccines: A Two-Phased Study of Computerized Health Maintenance Organization Databases

PEDIATRICS ◽  
2003 ◽  
Vol 112 (5) ◽  
pp. 1039-1048 ◽  
Author(s):  
Thomas Verstraeten ◽  
Robert L. Davis ◽  
Frank DeStefano ◽  
Tracy A. Lieu ◽  
Philip H. Rhodes ◽  
...  
Keyword(s):  
Phase I ◽  
Phase Ii ◽  
Attention Deficit Disorder ◽  
Neurodevelopmental Disorders ◽  
Health Maintenance Organization ◽  
Positive Association ◽  
Cumulative Exposure ◽  
Neurodevelopmental Outcomes ◽  
Significant Positive Association ◽  
Health Maintenance

Objective. To assess the possible toxicity of thimerosal-containing vaccines (TCVs) among infants. Methods. A 2-phased retrospective cohort study was conducted using computerized health maintenance organization (HMO) databases. Phase I screened for associations between neurodevelopmental disorders and thimerosal exposure among 124 170 infants who were born during 1992 to 1999 at 2 HMOs (A and B). In phase II, the most common disorders associated with exposure in phase I were reevaluated among 16 717 children who were born during 1991 to 1997 in another HMO (C). Relative risks for neurodevelopmental disorders were calculated per increase of 12.5 μg of estimated cumulative mercury exposure from TCVs in the first, third, and seventh months of life. Results. In phase I at HMO A, cumulative exposure at 3 months resulted in a significant positive association with tics (relative risk [RR]: 1.89; 95% confidence interval [CI]: 1.05–3.38). At HMO B, increased risks of language delay were found for cumulative exposure at 3 months (RR: 1.13; 95% CI: 1.01–1.27) and 7 months (RR: 1.07; 95% CI: 1.01–1.13). In phase II at HMO C, no significant associations were found. In no analyses were significant increased risks found for autism or attention-deficit disorder. Conclusions. No consistent significant associations were found between TCVs and neurodevelopmental outcomes. Conflicting results were found at different HMOs for certain outcomes. For resolving the conflicting findings, studies with uniform neurodevelopmental assessments of children with a range of cumulative thimerosal exposures are needed.

scholarly journals Interstitial Lung Abnormalities Detected by CT in Asbestos-Exposed Subjects Are More Likely Associated to Age

2021 ◽  
Vol 10 (14) ◽  
pp. 3130
Author(s):  
François Laurent ◽  
Ilyes Benlala ◽  
Gael Dournes ◽  
Celine Gramond ◽  
Isabelle Thaon ◽  
...  
Keyword(s):  
Smoking Status ◽  
Asbestos Exposure ◽  
Positive Association ◽  
Chest Ct ◽  
Cumulative Exposure ◽  
Exposure Index ◽  
Significant Positive Association ◽  
Logistic Regression Models ◽  
Lung Abnormalities ◽  
Occupationally Exposed

Objective: the aim of this study was to evaluate the association between interstitial lung abnormalities, asbestos exposure and age in a population of retired workers previously occupationally exposed to asbestos. Methods: previously occupationally exposed former workers to asbestos eligible for a survey conducted between 2003 and 2005 in four regions of France, underwent chest CT examinations and pulmonary function testing. Industrial hygienists evaluated asbestos exposure and calculated for each subject a cumulative exposure index (CEI) to asbestos. Smoking status information was also collected in this second round of screening. Expert radiologists performed blinded independent double reading of chest CT-scans and classified interstitial lung abnormalities into: no abnormality, minor interstitial findings, interstitial findings inconsistent with UIP, possible or definite UIP. In addition, emphysema was assessed visually (none, minor: emphysema <25%, moderate: between 25 and 50% and severe: >50% of the lung). Logistic regression models adjusted for age and smoking were used to assess the relationship between interstitial lung abnormalities and occupational asbestos exposure. Results: the study population consisted of 2157 male subjects. Interstitial lung abnormalities were present in 365 (16.7%) and emphysema in 444 (20.4%). Significant positive association was found between definite or possible UIP pattern and age (OR adjusted =1.08 (95% CI: 1.02–1.13)). No association was found between interstitial abnormalities and CEI or the level of asbestos exposure. Conclusion: presence of interstitial abnormalities at HRCT was associated to aging but not to cumulative exposure index in this cohort of former workers previously occupationally exposed to asbestos.

scholarly journals Long-term melatonin treatment for the sleep problems and aberrant behaviors of children with neurodevelopmental disorders

2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Kotaro Yuge ◽  
Shinichiro Nagamitsu ◽  
Yuko Ishikawa ◽  
Izumi Hamada ◽  
Hiroyuki Takahashi ◽  
...  
Keyword(s):  
Phase I ◽  
Phase Ii ◽  
Neurodevelopmental Disorders ◽  
Sleep Problems ◽  
Sleep Hygiene ◽  
Melatonin Treatment ◽  
Link Type ◽  
Aberrant Behaviors

Abstract Background Clinical evidence is required about the long-term efficacy and safety of melatonin treatment for sleep problems in children with neurodevelopmental disorders (NDDs) who underwent adequate sleep hygiene interventions. Methods We conducted a 26-week, multicenter, collaborative, uncontrolled, open-label, phase III clinical trial of melatonin granules in children 6 to 15 years of age who had NDDs and sleep problems. The study consisted of the 2-week screening phase, the 26-week medication phases I and II, and the 2-week follow-up phase. Children received 1, 2, or 4 mg melatonin granules orally in the medication phases. Variables of sleep status including sleep onset latency (SOL), aberrant behaviors listed on the Aberrant Behavior Check List-Japanese version (ABC-J), and safety were examined. The primary endpoint was SOL in the medication phase I. Results Between June 2016 and July 2018, 99 children (80 males and 19 females, 10.4 years in mean age) were enrolled at 17 medical institutions in Japan—74, 60, 22, 9, 6, and 1 of whom had autism spectrum disorder, attention-deficit/hyperactivity disorder, intellectual disabilities, motor disorders, specific learning disorder, and communication disorders, respectively, at baseline. Fifteen children received the maximal dose of 4 mg among the prespecified dose levels. SOL recorded with the electronic sleep diary shortened significantly (mean ± standard deviation [SD], − 36.7 ± 46.1 min; 95% confidence interval [CI], − 45.9 to − 27.5; P <  0.0001) in the medication phase I from baseline, and the SOL-shortening effect of melatonin persisted in the medication phase II and the follow-up phase. Temper upon wakening and sleepiness after awakening improved significantly (P <  0.0001 each) in the medication phase I from baseline and persisted in the follow-up phase. The following subscales of the ABC-J improved significantly: stereotypic behavior (P = 0.0322) in the medication phase I; and irritability, hyperactivity, and inappropriate speech (P <  0.0001) in the medication phase II. Treatment-emergent adverse events did not occur subsequent to week 16 after medication onset, and NDDs did not deteriorate in the follow-up phase. Conclusions Long-term melatonin treatment in combination with adequate sleep hygiene interventions may afford clinical benefits to children with NDDs and potentially elevates their well-being. Trial registration ClinicalTrils.gov, NCT02757066. Registered April 27, 2016.

scholarly journals Preconception and Prenatal Nutrition and Neurodevelopmental Disorders: A Systematic Review and Meta-Analysis

Nutrients ◽  
2019 ◽  
Vol 11 (7) ◽  
pp. 1628 ◽  
Author(s):  
Mengying Li ◽  
Ellen Francis ◽  
Stefanie N. Hinkle ◽  
Aparna S. Ajjarapu ◽  
Cuilin Zhang
Keyword(s):  
Attention Deficit Disorder ◽  
Neurodevelopmental Disorders ◽  
Meta Analysis ◽  
Fetal Brain ◽  
Autism Spectrum ◽  
Dietary Factors ◽  
Inverse Association ◽  
Neurodevelopmental Outcomes ◽  
Multivitamin Supplementation ◽  
Prenatal Nutrition

Preconception and prenatal nutrition is critical for fetal brain development. However, its associations with offspring neurodevelopmental disorders are not well understood. This study aims to systematically review the associations of preconception and prenatal nutrition with offspring risk of neurodevelopmental disorders. We searched the PubMed and Embase for articles published through March 2019. Nutritional exposures included nutrient intake or status, food intake, or dietary patterns. Neurodevelopmental outcomes included autism spectrum disorders (ASD), attention deficit disorder-hyperactivity (ADHD) and intellectual disabilities. A total of 2169 articles were screened, and 20 articles on ASD and 17 on ADHD were eventually reviewed. We found an overall inverse association between maternal folic acid or multivitamin supplementation and children’s risk of ASD; a meta-analysis including six prospective cohort studies estimated an RR of ASD of 0.64 (95% CI: 0.46, 0.90). Data on associations of other dietary factors and ASD, ADHD and related outcomes were inconclusive and warrant future investigation. Future studies should integrate comprehensive and more objective methods to quantify the nutritional exposures and explore alternative study design such as Mendelian randomization to evaluate potential causal effects.

Bewegungstherapie und körperliche Aktivität bei Patienten mit Herzinsuffizienz

Praxis ◽  
2018 ◽  
Vol 107 (17-18) ◽  
pp. 951-958 ◽  
Author(s):  
Matthias Wilhelm
Keyword(s):  
Phase I ◽  
Phase Ii ◽  
Körperliche Aktivität ◽  
Phase Iii

Zusammenfassung. Herzinsuffizienz ist ein klinisches Syndrom mit unterschiedlichen Ätiologien und Phänotypen. Die überwachte Bewegungstherapie und individuelle körperliche Aktivität ist bei allen Formen eine Klasse-IA-Empfehlung in aktuellen Leitlinien. Eine Bewegungstherapie kann unmittelbar nach Stabilisierung einer akuten Herzinsuffizienz im Spital begonnen werden (Phase I). Sie kann nach Entlassung in einem stationären oder ambulanten Präventions- und Rehabilitationsprogramm fortgesetzt werden (Phase II). Typische Elemente sind Ausdauer-, Kraft- und Atemtraining. Die Kosten werden von der Krankenversicherung für drei bis sechs Monate übernommen. In erfahrenen Zentren können auch Patienten mit implantierten Defibrillatoren oder linksventrikulären Unterstützungssystemen trainieren. Wichtiges Ziel der Phase II ist neben muskulärer Rekonditionierung auch die Steigerung der Gesundheitskompetenz, um die Langzeit-Adhärenz bezüglich körperlicher Aktivität zu verbessern. In Phase III bieten Herzgruppen Unterstützung.

Perceived Overprotection and Its Association With Quality of Life in Dementia

GeroPsych ◽  
2019 ◽  
Vol 32 (3) ◽  
pp. 125-134
Author(s):  
Mechthild Niemann-Mirmehdi ◽  
Andreas Häusler ◽  
Paul Gellert ◽  
Johanna Nordheim
Keyword(s):  
Quality Of Life ◽  
Patient Autonomy ◽  
Positive Association ◽  
Well Being ◽  
Negative Association ◽  
Significant Positive Association ◽  
Cross Sectional ◽  
People With Dementia ◽  
Mental Well Being

Abstract. To date, few studies have focused on perceived overprotection from the perspective of people with dementia (PwD). In the present examination, the association of perceived overprotection in PwD is examined as an autonomy-restricting factor and thus negative for their mental well-being. Cross-sectional data from the prospective DYADEM study of 82 patient/partner dyads (mean age = 74.26) were used to investigate the association between overprotection, perceived stress, depression, and quality of life (QoL). The analyses show that an overprotective contact style with PwD has a significant positive association with stress and depression, and has a negative association with QoL. The results emphasize the importance of avoiding an overprotective care style and supporting patient autonomy.

Development and Validation of an Immunization Tracking System in a Large Health Maintenance Organization

1993 ◽  
Vol 9 (2) ◽  
pp. 96-100 ◽  
Author(s):  
Thomas Payne ◽  
Susan Kanvik ◽  
Richard Seward ◽  
Doug Beeman ◽  
Angela Salazar ◽  
...  
Keyword(s):  
Tracking System ◽  
Health Maintenance Organization ◽  
Health Maintenance ◽  
Development And Validation

The Nexus Between Urbanisation and Human Empowerment: Income Group Based Findings of Bidirectional Causality

2019 ◽  
Vol 64 (1) ◽  
pp. 5-15
Author(s):  
Christos Kollias ◽  
Panayiotis Tzeremes
Keyword(s):  
Human Rights ◽  
Positive Association ◽  
Income Group ◽  
Academic Discourse ◽  
Access To Education ◽  
Democratic Institutions ◽  
Significant Positive Association ◽  
Public Action ◽  
Income Groups ◽  
Democratic Rule

Abstract The economic and social drivers of democratisation and the emergence and establishment of democratic institutions are longstanding themes of academic discourse. Within this broad body of literature, it has been argued that the process of urbanisation is also conducive to the emergence and consolidation of democracy through a number of different channels. Cities offer better access to education and facilitate organised public action and the demand for more democratic rule and respect of human rights. The nexus between urbanisation and human rights is the theme that is taken up in the present paper. Using a sample of 123 countries for the period 1981–2011, the paper examines empirically the association between urbanisation and human empowerment using the Cingranelli-Richards Index. In broad terms, the findings reported herein do not point to a strong nexus across all income groups. Nevertheless, there is evidence suggesting the presence of such a statistically significant positive association in specific cases.

How to Make COVID-19 Contact Tracing Apps work: Insights from Behavioral Economics (Preprint)

2021 ◽  
Author(s):  
Ian Ayres ◽  
Alessandro Romano ◽  
Chiara Sotis
Keyword(s):  
Phase I ◽  
Phase Ii ◽  
Network Effects ◽  
Risky Behaviors ◽  
Contact Tracing ◽  
Risk Compensation ◽  
Main Function ◽  
Double Blind ◽  
Compensation Theory ◽  
Pros And Cons

BACKGROUND Due to network effects, Contact Tracing Apps (CTAs) are only effective if many people download them. However, the response to CTAs has been tepid. For example, in France less than 2 million people (roughly 3% of the population) downloaded the CTA. Consequently, CTAs need to be fundamentally rethought to increase their effectiveness. OBJECTIVE This study aimed to show that CTAs can still play a key role in containing the pandemic, provided that they take into account insights from behavioral sciences. Moreover, we study whether emphasizing the virtues of CTA to induce people to download them makes app users engage in more risky behaviors (risk compensation theory) and whether feedback on a user’s behavior affects future behaviors. METHODS We perform a double-blind online experiment (n=1500) divided in two phases. In Phase I respondents are randomly assigned to one of three different groups: Pros of the app, Pros and Cons of the app and Control I. Respondents in the Pros group were shown information on the advantages of CTAs. Participants in the Pros and Cons group were shown information on both the advantages and the problems that characterize CTAs. Last, respondents in the Control I group were not given any information on CTAs. All participants are then asked how worried they are about the pandemic, how likely they are to download the app, and on how they intend to behave (e.g. attend small and large gathering, wear a mask, etc.). A week later we carried out Phase II. Participants in Phase II were randomly assigned to different in-app notifications in which they were informed on how much risk they were taking compared to the average user. We then ask participants their intentions for future behaviors to investigate whether these notifications were effective in making respondents more prudent. RESULTS All 1500 participants completed phase I of the experiment, whereas 1303 (86.9%) completed also phase 2. The main findings are: i) informing people on the pros of the app make them less worried about the pandemic (p=.004), ii) informing people about both the pros and the cons of the app makes them more likely to download the app (p=.07); iii) carefully devised in-app notification induce people to state that they will: attend less large gatherings (p= .05) and less small gatherings (p= .001), see less people at risk (p=.004), that they stay more at home (p=.006) and wear more often the mask (p=.09). We do not find support for the risk-compensation theory. CONCLUSIONS we suggest that CTAs should be re-framed as Behavioral Feedback Apps (BFAs). The main function of BFAs would be providing users with information on how to minimize the risk of contracting COVID-19, e.g. to provide information on how crowded a store is likely to be at a given time of the day. Moreover, the BFA could have a rating system that allows users to flag stores that do not respect safety norms, such as mandating customers to wear a mask or not respecting social distancing. These functions can inform the behavior of app users, thus playing a key role in containing the spread of the virus even if a small percentage of people download the BFA. While effective contact tracing is impossible when only 3% of the population downloads the app, less risk taking by small portions of the population can produce large benefits. BFAs can be programmed so that users can also activate a tracing function akin to the one currently carried out by CTAs. Making contact tracing an ancillary, opt-in function might facilitate a wider acceptance of BFAs.

Empirical analysis on corporate environmental performance and environmental disclosure in an emerging market context

2020 ◽  
Vol 15 (6) ◽  
pp. 1061-1082 ◽  
Author(s):  
Merve Acar ◽  
Hüseyin Temiz
Keyword(s):  
Environmental Performance ◽  
Emerging Market ◽  
Positive Association ◽  
Corporate Environmental Performance ◽  
Tobit Regression ◽  
Environmental Reporting ◽  
Environmental Disclosure ◽  
Significant Positive Association ◽  
Content Type ◽  
Environmental Disclosures

PurposeThe purpose of this study is to investigate the association between environmental performance of firms and the level of voluntary environmental disclosure in emerging markets.Design/methodology/approachWe used tobit regression OLS and t-test methods to reveal the association between environmental performance and the level of voluntary environmental disclosure.FindingsWe find a significant positive association between the level of discretionary environmental disclosures and corporate environmental performance. The result is in line with the arguments of economics disclosure theory that argues environmentally good performers disclose more.Practical implicationsMany of the environmentally good firms in Turkey are also listed in the “BIST Sustainability Index,” and this situation can be the result of the relative power of external regulations. Accordingly, it can be suggested to increase the community and governmental pressures for environmental reporting but also gives importance to increase intrinsic motivations for companies to engage in disclosure practices.Originality/valueThis study shed light on relation between environmental performance and environmental disclosure in an emerging market context. Also, it is revisited that the relation between environmental performance and the level of environmental disclosure by testing two different predictions on the level of environmental disclosures.

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