Bayesian adaptive two-stage design for determining person-time in Phase II clinical trials with Poisson data

Adaptive clinical trial designs can often improve drug-study efficiency by utilizing data obtained during the course of the trial. We present a novel Bayesian two-stage adaptive design for Phase II clinical trials with Poisson-distributed outcomes that allows for person-observation-time adjustments for early termination due to either futility or efficacy. Our design is motivated by the adaptive trial from [9 V. Sambucini, A Bayesian predictive two-stage design for Phase II clinical trials, Stat. Med. 27 (2008), pp. 1199–1224. doi: 10.1002/sim.3021[Crossref], [PubMed], [Web of Science ®] , [Google Scholar]], which uses binomial data. Although many frequentist and Bayesian two-stage adaptive designs for count data have been proposed in the literature, many designs do not allow for person-time adjustments after the first stage. This restriction limits flexibility in the study design. However, our proposed design allows for such flexibility by basing the second-stage person-time on the first-stage observed-count data. We demonstrate the implementation of our Bayesian predictive adaptive two-stage design using a hypothetical Phase II trial of Immune Globulin (Intravenous).     

Statistical power to detect violation of the proportional hazards assumption when using the Cox regression model

The use of the Cox proportional hazards regression model is wide-spread. A key assumption of the model is that of proportional hazards. Analysts frequently test the validity of this assumption using statistical significance testing. However, the statistical power of such assessments is frequently unknown. We used Monte Carlo simulations to estimate the statistical power of two different methods for detecting violations of this assumption. When the covariate was binary, we found that a model-based method had greater power than a method based on cumulative sums of martingale residuals. Furthermore, the parametric nature of the distribution of event times had an impact on power when the covariate was binary. Statistical power to detect a strong violation of the proportional hazards assumption was low to moderate even when the number of observed events was high. In many data sets, power to detect a violation of this assumption is likely to be low to modest.     

Fighting for survival: The experiences of lesbian,gay, bisexual,transgender, and questioning students in religious colleges and universities

ABSTRACT

Little is known about the experiences of lesbian, gay, bisexual, transgender, and questioning (LGBTQ) students attending religious colleges and universities. This study used grounded theory to analyze the narratives (N = 271) of LGBTQ former and current students. The central theme described by LGBTQ students was a fight for survival with five subthemes: (a) institutionalized homo/transphobia (strict school policies, enforcement of heterosexuality and gender conformity through discipline, conversion therapy); (b) a culture of fear (fear of exposure, homophobic panic and code words, seeking cover); (c) marginalization and isolation; (d) struggle (suffering and suicide, reconciling faith and LGBTQ identity); and (e) coping and resilience (surviving through critical thinking and strategic activism). Implications for practice are provided.     

Success of University Student Volunteers in Obtaining Consent for Reviewing Private Health Information for Emergency Research

This study aimed to determine the success of university student volunteers in obtaining consent from parents to allow review of their child’s personal health information (PHI) for emergency research screening. This study also aimed to examine the variables associated with successful consent. This was a prospective cross-sectional study conducted at a pediatric emergency department (ED). University students, who functioned as delegates of the health information custodian, approached parents for consent. Of 2,506 parents, 1,852 (73.9%) provided consent to allow review of their child’s PHI for research screening. Variables associated with successful consent were high (≥12 months) versus low (<12 months) volunteer experience (OR = 2.0), research related (vs. unrelated) to the child’s chief complaint (OR = 2.0), child treated regularly by specialists at the study institution (OR = 1.7), and ED presentation mid-week vs. weekend (OR = 1.7) and morning vs. evening presentation (OR = 1.4). When approached by a university student volunteer, about 25% of parents declined to have their child’s PHI reviewed for research screening. This model of obtaining consent may put some emergency research at risk for selection bias. Variables that increase the odds of successful consent can be considered in program design to improve the effectiveness of this model.     

Debating New Zealand’s foreign relations: the role and impact of the University of Otago Foreign Policy School 1966–1976

For over half a century, the internationally recognised University of Otago Foreign Policy School has annually drawn together a mix of government officials, diplomats, academics, students and members of the general public to discuss issues of international significance. This article considers the establishment of the Foreign Policy School, and analyses its impact on the formulation and implementation of foreign policy between 1966 and 1976. Michelle Hale Williams’ conceptual model is employed to assess the School’s influence on public and political debate. It is argued the School’s influence was directly and most clearly evident at what Williams defines as the agendas and institutional levels. There was a gradual but definite shift in New Zealand’s foreign policy outlook between the mid-1960s and mid-1970s, which is reflected in questions raised and discussed by the School. Public engagement with foreign policy questions, in which the School played an enabling role, was also transformed in the course of this period. The School rapidly became an important forum for foreign policy discussions between groups that had previously had little interaction. This article shows that, while it generated few concrete results at the level of policy, the School certainly played a part in helping to foster a national world-view that was increasingly based on New Zealand values and interests, paving the way for the emergence of a more independent foreign policy.     

Relations Between Economic Well-Being,Family Support,Community Attachment,and Life Satisfaction Among LGBQ Adults

While studies with the general population indicate that one’s life satisfaction is related to economic well-being and social support, much less is known about these constructs among lesbian, gay, bisexual, and queer (LGBQ) populations. The current study examines the relationship between economic well-being and life satisfaction in a sample of 458 LGBQ individuals. Further, the direct and moderating effects of family and community support are examined. As hypothesized, perceived financial stress and proximal family support each had a significant main effect on life satisfaction. Household income (adjusted by number of individuals living in the household) had a non-linear effect on life satisfaction. Community support for LGBQ individuals was not associated with life satisfaction, and the moderating hypotheses were not supported. The findings and the implications for future research are discussed.     

Scale development for measuring publics’ emotions in organizational crises

Although publics’ emotional responses have gained increasing importance in crisis communication research, reliable scales measuring crisis emotions specific to organizational crises are lacking. As the first study developing a multiple-item scale for measuring publics’ crisis emotions, this study examines the conceptualization and operationalization of attribution-independent crisis emotions versus attribution-dependent crisis emotions by employing two survey data sets (N = 490) for scale development and testing. Results indicate that three types of emotions are likely to be felt by publics when exposed to organizational crises: (1) attribution-independent (AI) crisis emotions; (2) external-attribution-dependent (EAD) crisis emotions; and (3) internal-attribution-dependent (IAD) crisis emotions. The scale's reliability, factorial structure, and validity are further assessed. The findings confirm that the underlying processes of publics’ emotions felt in crisis situations are different from those felt in non-crisis situations. Consequently, this scale provides a valid and reliable psychometric tool for researchers and crisis managers to measure publics’ different emotions that are relevant to a crisis situation, as a result of crisis attribution appraisal.     

Family Functioning and Mental Health of Transgender and Gender-Nonconforming Youth in the Trans Teen and Family Narratives Project

Transgender and gender-nonconforming (TGN) youth are at increased risk for adverse mental health outcomes, but better family functioning may be protective. This study describes TGN youth’s mental health and associations with family functioning in a community-based sample. Participants were from 33 families (96 family members) and included 33 TGN youth, ages 13 to 17 years; 48 cisgender (non-transgender) caregivers; and 15 cisgender siblings. Participants completed a survey with measures of family functioning (family communication, family satisfaction) and mental health of TGN youth (suicidality, self-harm, depression, anxiety, self-esteem, resilience). TGN youth reported a high risk of mental health concerns: suicidality (15% to 30%), self-harm (49%), clinically significant depressive symptoms (61%); and moderate self-esteem (M = 27.55, SD = 7.15) and resiliency (M = 3.67, SD = 0.53). In adjusted models, better family functioning from the TGN youth’s perspective was associated with better mental health outcomes among TGN youth (β ranged from ?0.40 to ?0.65 for self-harm, depressive symptoms, and anxious symptoms, and 0.58 to 0.70 for self-esteem and resiliency). Findings from this study highlight the importance of considering TGN youth’s perspectives on the family to inform interventions to improve family functioning in families with TGN youth.