Awareness of Publication Guidelines and the Responsible Conduct of Research

We have conducted a longitudinal survey of NIH-funded F32 postdoctoral fellows to determine if mandated instruction in the responsible conduct of research (RCR) has measurable effects on awareness of, attentiveness to, and behavioral judgments about research ethics and authorship and publication. Of 418 F32 fellows participating in the study, 50% were aware of and had referred to guidelines on authorship and publication practices while 50% were either unaware of or had not referred to guidelines. Groups were similar with regard to total number of peer-reviewed publications and total number of first author publications, years of research experience, years since completing their doctoral degree, and receipt of RCR training. The equal distribution of guideline awareness and use, and group similarities with regard to career development and achievement provided us with an opportunity to consider whether awareness of and use of guidelines is associated with broader judgments about author roles and responsibilities. The findings suggest that awareness and utilization of guidelines are, at best, only modestly associated with more ethically appropriate judgments and attitudes about author roles and responsibilities among novice F32’s.     

US college and university student health screening requirements for tuberculosis and vaccine-preventable diseases, 2012

ABSTRACT

Objective: Colleges are at risk for communicable disease outbreaks because of the high degree of person-to-person interactions and relatively crowded dormitory settings. This report describes the US college student health screening requirements among US resident and international students for tuberculosis (TB) and vaccine-preventable diseases (VPDs) as they relate to the American College Health Association (ACHA) guidelines. Methods/Participants: In April 2012, US college health administrators (N = 2,858) were sent online surveys to assess their respective school's TB screening and immunization requirements. Results: Surveys were completed by 308 (11%) schools. Most schools were aware of the ACHA immunization (78%) and TB screening (76%) guidelines. Schools reported having policies related to immunization screening (80.4%), immunization compliance (93%), TB screening (55%), and TB compliance (87%). Conclusion: Most colleges were following ACHA guidelines. However, there are opportunities for improvement to fully utilize the recommendations and prevent outbreaks of communicable diseases among students in colleges.     

‘It's against our law,never mind anyone else's’: the Disability Discrimination Act 1995 and adults with learning disabilities

This study examines Part III of the Disability Discrimination Act 1995 (the provision of goods, services and facilities) in relation to adults with learning disabilities. The study had a participatory element in that self‐advocates co‐facilitated focus groups and joined the Research Advisory Group. The paper presents views of people with learning disabilities, garnered through focus groups and interviews, about the Act and about using services. Awareness of their rights was generally low, although activists were generally better informed. While usually offered reasonable service in shops, pubs and other facilities, people were sometimes treated unfairly. This could take three forms – being treated with a lack of courtesy and respect, failure to make reasonable adjustments and outright refusal to serve. People felt a strong sense of injustice when treated in these ways but the majority were unlikely to complain, although a few had challenged unfair treatment. The paper concludes with recommendations for policy and practice.     

Coverage of the population in Census 2000: Results from Demographic Analysis

Since the 1960 Census, Demographic Analysis (DA) has been used by the Census Bureau to evaluate the coverage of the population. Administrative statistics on births, deaths, immigration and Medicare enrollments as well as estimates of legal emigration and net undocumented immigration are used to produce demographic analysis estimates of the population for the census date. These estimates are compared to the Census 2000 data to evaluate coverage in the census. The results are also compared to measures of undercount obtained from dual system estimation. The DA measures substantial reduction in net undercount in Census 2000 compared to 1990. The reductions occur among all demographic categories: all broad age groups, males and females, Blacks and Non-Blacks.     

Potential impact of COVID-19 on ongoing clinical trials: a simulation study with the neurological Yale Global Tic Severity Scale based on the CANNA-TICS study

The COVID-19 pandemic has manifold impacts on clinical trials. In response, drug regulatory agencies and public health bodies have issued guidance on how to assess potential impacts on ongoing clinical trials and stress the importance of a risk-assessment as a pre-requisite for modifications to the clinical trial conduct. This article presents a simulation study to assess the impact on the power of an ongoing clinical trial without the need to unblind trial data and compromise trial integrity. In the context of the CANNA-TICS trial, investigating the effect of nabiximols on reducing the total tic score of the Yale Global Tic Severity Scale (YGTSS-TTS) in patients with chronic tic disorders and Tourette syndrome, the impact of the two COVID-19 related intercurrent events handled by a treatment policy strategy is investigated using a multiplicative and additive data generating model. The empirical power is examined for the analysis of the YGTSS-TTS as a continuous and dichotomized endpoint using analysis techniques adjusted and unadjusted for the occurrence of the intercurrent event. In the investigated scenarios, the simulation studies showed that substantial power losses are possible, potentially making sample size increases necessary to retain sufficient power. However, we were also able to identify scenarios with only limited loss of power. By adjusting for the occurrence of the intercurrent event, the power loss could be diminished to different degrees in most scenarios. In summary, the presented risk assessment approach may support decisions on trial modifications like sample size increases, while maintaining trial integrity.     

Quaranteens: Prepandemic relationship quality and changes in adolescent internalizing problems during the COVID-19 pandemic

This preregistered longitudinal study examined changes in adolescents' depressive and anxiety symptoms before and during the COVID-19 pandemic using latent additive piece-wise growth models. It also assessed whether support from and conflict with mothers, fathers, siblings, and best friends explained heterogeneity in change patterns. One hundred and ninety-two Dutch adolescents (Mean age: 14.3 years; 68.8% female) completed online biweekly questionnaires for a year (November 2019–October 2020), consisting of a prepandemic, lockdown, and reopening phase. Depressive symptoms increased following the lockdown and decreased upon reopening. Anxiety symptoms showed an immediate decrease followed by a gradual increase in the reopening phase. Prepandemic family and best friend support and conflict did not explain heterogeneity in depressive and anxiety symptoms during the COVID-19 pandemic.