Designing and analyzing clinical trials for personalized medicine via Bayesian models

Patients with different characteristics (e.g., biomarkers, risk factors) may have different responses to the same medicine. Personalized medicine clinical studies that are designed to identify patient subgroup treatment efficacies can benefit patients and save medical resources. However, subgroup treatment effect identification complicates the study design in consideration of desired operating characteristics. We investigate three Bayesian adaptive models for subgroup treatment effect identification: pairwise independent, hierarchical, and cluster hierarchical achieved via Dirichlet Process (DP). The impact of interim analysis and longitudinal data modeling on the personalized medicine study design is also explored. Interim analysis is considered since they can accelerate personalized medicine studies in cases where early stopping rules for success or futility are met. We apply integrated two-component prediction method (ITP) for longitudinal data simulation, and simple linear regression for longitudinal data imputation to optimize the study design. The designs' performance in terms of power for the subgroup treatment effects and overall treatment effect, sample size, and study duration are investigated via simulation. We found the hierarchical model is an optimal approach to identifying subgroup treatment effects, and the cluster hierarchical model is an excellent alternative approach in cases where sufficient information is not available for specifying the priors. The interim analysis introduction to the study design lead to the trade-off between power and expected sample size via the adjustment of the early stopping criteria. The introduction of the longitudinal modeling slightly improves the power. These findings can be applied to future personalized medicine studies with discrete or time-to-event endpoints.     

Great Expectations: Preventive Health Concepts in Childbearing and Parenting for College Students

Abstract

The authors tested the long-term effectiveness of a cognitive-behavioral group intervention in reducing depressive symptoms, decreasing negative thinking, and enhancing self-esteem in 92 college women aged 18 to 24 years who ere at risk for clinical depression. The women were randomly assigned to either an experimental or a no-treatment control group. The experimental group participated in a 6-week cognitive-behavioral intervention that targeted identification and reduction of negative thinking, using such techniques as thought stopping and affirmations. Data on depressive symptoms, self-esteem, and negative thinking were collected before the intervention and at intervals of 1, 6, and 18 months postintervention. The women in the intervention group experienced a greater decrease in depressive symptoms and negative thinking and a greater increase in self-esteem than those in the control group. The beneficial effects continued over an 18-month follow-up period. These findings support the importance of thought stopping and affirmations as prevention interventions with at-risk college women.     

Financing Rural New England University Health Services: A Pilot Study

Abstract

Patient satisfaction in university health settings has received little research attention, and it is unclear whether the issue is being addressed in college health clinics. Because providers may make their own evaluations of patient satisfaction in the absence of other information, the authors conducted a study to determine whether healthcare providers at a university health clinic could accurately assess patient satisfaction. Ten providers completed a 10-item questionnaire immediately following the medical encounter to rate their perceptions of selected patients' levels of satisfaction. After seeing a healthcare provider, 201 patients completed a comparable questionnaire indicating how satisfied they were with the experience. Responses of providers and patients were compared, using a paired-sample t test. The results showed that providers' ratings were significantly lower than patients' ratings, indicating that providers were unable to judge patient satisfaction accurately. The results suggest that formal evaluations of patient satisfaction should be included in college health services.     

Pornography,erotica, and attitudes toward women: The effects of repeated exposure

It is a widespread belief that pornography causes negative attitudes toward women, but tests of this belief are contradictory. A large body of research has studied the effect of violent pornography on behavior, but the effects of erotica and violence have often been confounded. Thus, the relationship between pornography and attitudes toward women was assessed in two correlational studies, and the effect of (nonviolent) erotica on attitudes towards women was tested experimentally. The dependent measure was the score on a questionnaire measuring attitudes toward women and women's issues. The questionnaire possessed high reliability; factor analysis indicated a single general factor. Participants included 184 psychology students and 20 patrons at an “adult” theater. Multiple linear regressions indicated that hours of viewing pornography was not a reliable predictor of attitudes toward women in either sample. Patrons of the adult theater, who viewed more pornography, had more favorable attitudes toward women than male or female college students. In Study 3, 75 students were randomly assigned to watch four hours of erotica or four hours of psychology films over five consecutive days. Power analysis indicated a strong test. Manipulation checks showed a difference in students’ perception of the erotic nature of the videos, but attitudes toward women were not influenced by type of video.     

Long-term changes in parenting and child behavior after the Home-Start family support program

Background

The intervention Home-Start is a wide spread program in a number of countries, among which the Netherlands. In Home-Start, trained volunteers visit families with young children in need of support once or twice a week to help them to deal with problems in family life and parenting. Little is known, however, about the effects of Home-Start. This study describes short-term and long term changes in families that participated in Home-Start.

Methods

Three groups of families with young children (at the start mean age 1 1/2 years) were followed over a period of four years. One of the groups of families participated in the Home-Start family support program in the first 6.6 months of this period. The two other groups were (1) a randomly selected community sample and (2) a group of families with elevated parenting stress and a need for support. Data were collected at the beginning of the study, (after median 1.4 months), directly after the intervention (median 6.6 months) and at two follow-up occasions (respectively, median 12.5 and 49.2 months after the first measurement). At the last measurement, data were available for 33, 45 and 34 families respectively.

Results

Multilevel analysis showed more positive changes in parental wellbeing, competence and behavior (more consistent behavior and less rejection) during the intervention period in the Home-Start group than in the two other groups. At the three year follow up, the Home-Start group showed, compared to the other groups, more improvements in parenting (more responsiveness), but also diminished child externalizing and internalizing behavior problems (less oppositional defiant behavior, affective problems and anxiety problems).

Conclusions

Home-Start seems a promising family support intervention that deserves to be studied more extensively.     

Implementing Working for Families: the impact of the policy on selected Māori whānau

Abstract

This paper presents an analysis of the qualitative data collected for a study investigating the effect of the Working for Families policy on Māori families’ self-reported whānau ora (family wellbeing). Data are drawn from a discrete set of 30 qualitative interviews undertaken with Māori whānau involved in the Te Hoe Nuku Roa Longitudinal Study. Whānau perceptions about how the Working for Families policy has impacted on their lives and the contribution the policy has made towards their family's wellbeing is presented. The paper discusses how the Working for Families policy appears to have become an integral component of household income for many low-to-middle-income whānau and reflects on how this policy, conceived and designed (amongst other things) to alleviate and redress child poverty, is contributing towards supporting family wellbeing or ‘whānau ora’.     

The Nursing Home as Total Institution: A Case Study and Suggestions for the Aged Care System

A symbolic interactionist perspective is used to examine the effects of institutionalization on residents of a Sydney nursing home. The analysis suggests that much of the ‘negative’ behaviour observed among inmates results from the institutional structuring of a dependence role. Implications for long term care of the aged in both community and institutional settings are discussed.