Bayesian design and conduct of phase II single-arm clinical trials with binary outcomes: a tutorial

The aim of phase II single-arm clinical trials of a new drug is to determine whether it has sufficient promising activity to warrant its further development. For the last several years Bayesian statistical methods have been proposed and used. Bayesian approaches are ideal for earlier phase trials as they take into account information that accrues during a trial. Predictive probabilities are then updated and so become more accurate as the trial progresses. Suitable priors can act as pseudo samples, which make small sample clinical trials more informative. Thus patients have better chances to receive better treatments. The goal of this paper is to provide a tutorial for statisticians who use Bayesian methods for the first time or investigators who have some statistical background. In addition, real data from three clinical trials are presented as examples to illustrate how to conduct a Bayesian approach for phase II single-arm clinical trials with binary outcomes.

The effect of colored lenses on the visual evoked response in children with visual stress

Purpose. Some children with visual stress and/or headaches have fewer symptoms when wearing colored lenses. Although subjective reports of improved perception exist, few objective correlates of these effects have been established. Methods. In a pilot study, 10 children who wore Intuitive Colorimeter lenses, and claimed benefit, and two asymptomatic children were tested. Steady-state potentials were measured in response to low contrast patterns modulating at a frequency of 12 Hz. Four viewing conditions were compared: 1) no lens; 2) Colorimeter lens; 3) lens of complementary color; and 4) spectrally neutral lens with similar photopic transmission. Results. The asymptomatic children showed little or no difference between the lens and no lens conditions. When all the symptomatic children were tested together, a similar result was found. However, when the symptomatic children were divided into two groups depending on their symptoms, an interaction emerged. Children with visual stress but no headaches showed the largest amplitude visual evoked potential response in the no lens condition, whereas those children whose symptoms included severe headaches or migraine showed the largest amplitude visual evoked potential response when wearing their prescribed lens. Conclusions. The results suggest that it is possible to measure objective correlates of the beneficial subjective perceptual effects of colored lenses, at least in some children who have a history of migraine or severe headaches.

Can a computerised training paradigm assist people with intellectual disabilities to learn cognitive mediation skills? A randomised experiment

Aims: The aim was to examine whether specific skills required for cognitive behavioural therapy (CBT) could be taught using a computerised training paradigm with people who have intellectual disabilities (IDs). Training aimed to improve: a) ability to link pairs of situations and mediating beliefs to emotions, and b) ability to link pairs of situations and emotions to mediating beliefs. Method: Using a single-blind mixed experimental design, sixty-five participants with IDs were randomised to receive either computerised training or an attention-control condition. Cognitive mediation skills were assessed before and after training. Results: Participants who received training were significantly better at selecting appropriate emotions within situation beliefs pairs, controlling for baseline scores and IQ. Despite significant improvements in the ability of those who received training to correctly select intermediating beliefs for situation-feelings pairings, no between-group differences were observed at post-test. Conclusions: The findings indicated that computerised training led to a significant improvement in some aspects of cognitive mediation for people with IDs, but whether this has a positive effect upon outcome from therapy is yet to be established. (C) 2015 Elsevier Ltd. All rights reserved.

Cognitive Therapy Abilities in People with Learning Disabilities

Background  There is a need to develop and adapt therapies for use with people with learning disabilities who have mental health problems. Aims  To examine the performance of people with learning disabilities on two cognitive therapy tasks (emotion recognition and discrimination among thoughts, feelings and behaviours). We hypothesized that cognitive therapy task performance would be significantly correlated with IQ and receptive vocabulary, and that providing a visual cue would improve performance. Method  Fifty-nine people with learning disabilities were assessed on the Wechsler Abbreviated Scale of Intelligence (WASI), the British Picture Vocabulary Scale-II (BPVS-II), a test of emotion recognition and a task requiring participants to discriminate among thoughts, feelings and behaviours. In the discrimination task, participants were randomly assigned to a visual cue condition or a no-cue condition. Results  There was considerable variability in performance. Emotion recognition was significantly associated with receptive vocabulary, and discriminating among thoughts, feelings and behaviours was significantly associated with vocabulary and IQ. There was no effect of the cue on the discrimination task. Conclusion  People with learning disabilities with higher IQs and good receptive vocabulary were more likely to be able to identify different emotions and to discriminate among thoughts, feelings and behaviours. This implies that they may more easily understand the cognitive model. Structured ways of simplifying the concepts used in cognitive therapy and methods of socialization and education in the cognitive model are required to aid participation of people with learning disabilities.

Problems with accessibility to health services by persons with disabilities in Sao Paulo, Brazil

Purpose. To describe the occurrence of self-reported problems of accessibility to health services used by persons with disabilities in terms of social and health services variables. Methods. We performed a cross-sectional household survey designed to assess problems with accessibility to health services faced by persons with disabilities. We interviewed 333 persons in Sao Paulo city, in 2007. Variables related to the presence of accessibility problems, disabilities, gender, age, family head income, ethnicity, use of health services and others were analysed using frequencies, percentages, chi(2)-test, ANOVA and Poisson regression models. Results. 15.92% of the interviewed persons reported problems with accessibility to health services. Persons having multiple (prevalence ratios; PR = 2.91) or mobility disability (PR = 6.46) had more problems with accessibility than persons with hearing disability. Persons younger than 78 years old had more problems with accessibility; those who needed help to go to the health service (PR = 3.01) also. Conclusions. Persons with multiple or mobility disability, younger than 78 years, and those who needed help of others to go to the health service were more likely to have problems with accessibility to health services. This information could be one of the first steps to the management and/or planning of appropriate health services for persons with disabilities.

Demographic characteristics and prevalence of serologic markers among blood donors who use confidential unit exclusion (CUE) in Sao Paulo, Brazil: implications for modification of CUE polices in Brazil

BACKGROUND: This study evaluated demographic profiles and prevalence of serologic markers among donors who used confidential unit exclusion (CUE) to assess the effectiveness of CUE and guide public policies regarding the use of CUE for enhancing safety versus jeopardizing the blood supply by dropping CUE. STUDY DESIGN AND METHODS: We conducted a cross-sectional analysis of whole blood donations at a large public blood center in Sao Paulo from July 2007 through June 2009, compared demographic data, and confirmed serologic results among donors who used and who have never used CUE (CUE never). RESULTS: There were 265,550 whole blood units collected from 181,418 donors from July 2007 through June 2009. A total of 9658 (3.6%) units were discarded, 2973 (1.1%) because CUE was used at the current donation (CUE now) and 6685 (2.5%) because CUE was used in the past (CUE past). The CUE rate was highest among donors with less than 8 years of education (odds ratio [OR], 2.78; 95% confidence interval [CI], 2.51-3.08). CUE now donations were associated with higher positive infectious disease marker rates than CUE never donations (OR, 1.41; CI, 1.13-1.77), whereas CUE past donations were not (OR, 1.04; CI, 0.75-1.45). CONCLUSION: The CUE process results in a high rate of unit discard. CUE use on an individual donation appears predictive of a high-risk marker-positive donation and, thus, appears to contribute modestly to blood safety. The policy of discarding units from donors who have previously CUE-positive donations does not improve safety and should be discontinued.

Teachers’ Views on ICT as a Tool in English Teaching for Students with Dyslexia : An interview study with English teachers in grades 7-9

Information and communications technology (ICT) is a broad concept, which is often discussed in relation to the development of education. More specially, ICT can be seen as a tool to help teachers individualize students’ education. Students who have literacy difficulties, such as dyslexia, are in constant need of new techniques to help them learn and new tools to make their educational development easier. The aim of this thesis is to show what views teachers have regarding using ICT in English teaching at a sample of schools in the south of Sweden. A secondary part of the aim is to see what ICT tools, or other non ICT related methods, these teachers use to improve literacy skills for students with dyslexia.This empirical study is based on interviews with six participants. Previous research within the area is presented and different aspects of ICT within the National Agency for Education in Sweden, and the English syllabus, are also discussed. The results of this thesis show that ICT is seen as a helpful tool to make education easier for both students and teachers. Tools such as ViTal, Spell Right and Legimus are being used and the participants of the study also use iPads and Chromebooks in their teaching. According to the interviews, ICT can tribute to a fun way of learning and a more individualized education. Other non ICT related methods are also used to help students with dyslexia and these are often in terms of pictures in connection to words. These findings are based on a limited number of participants in a small area of south of Sweden. Therefore, further research is needed to see if the findings can be verified with more participants, in different parts of the country.

Unfulfilled rehabilitation needs and dissatisfaction with care 12 months after a stroke : an explorative observational study

BACKGROUND: People who have suffered a stroke commonly report unfulfilled need for rehabilitation. Using a model of patient satisfaction, we examined characteristics in individuals that at 3 months after stroke predicted, or at 12 months were associated with unmet need for rehabilitation or dissatisfaction with health care services at 12 months after stroke. METHODS: The participants (n = 175) received care at the stroke units at the Karolinska University Hospital, Sweden. The dependent variables "unfulfilled needs for rehabilitation" and "dissatisfaction with care" were collected using a questionnaire. Stroke severity, domains of the Stroke Impact Scale (SIS), the Sense of Coherence scale (SOC) and socio demographic factors were used as independent variables in four logistic regression analyses. RESULTS: Unfulfilled needs for rehabilitation at 12 months were predicted by strength (SIS) (odds ratio (OR) 7.05) at three months, and associated with hand function (SIS) (OR 4.38) and poor self-rated recovery (SIS) (OR 2.46) at 12 months. Dissatisfaction with care was predicted by SOC (OR 4.18) and participation (SIS) (OR 3.78), and associated with SOC (OR 3.63) and strength (SIS) (OR 3.08). CONCLUSIONS: Thirty-three percent of the participants reported unmet needs for rehabilitation and fourteen percent were dissatisfied with the care received. In order to attend to rehabilitation needs when they arise, rehabilitation services may need to be more flexible in terms of when rehabilitation is provided. Long term services with scheduled re-assessments and with more emphasis on understanding the experiences of both the patients and their social networks might better be able to provide services that attend to patients' needs and aid peoples' reorientation; this would apply particularly to those with poor coping capacity.

Health status and participation in a range of activities in an Australian community

Introduction: The aim of the research was to determine the relationship between levels of participation in a community and self-assessed health status of people in a rural and regional setting.
Method: A cross-sectional design, using a mailed, self-administered questionnaire was used. Questionnaires were mailed to a random sample of people aged 18 years and over who were registered on the electoral roll of a regional city and rural area, the Barwon and Otway regions of Victoria, Australia. The sample consisted of 1752 participants: 990 females (57%), 739 males (42%) and 23 sex undisclosed (1%). The range of participants was 18-98 years, and the mean age was 50.53 years (SD = 17.19).
Results: Self-assessed physical and mental health were measured using the SF-12 scale. Participants with low incomes, and those with low self-assessed physical and mental health scores, were significantly more likely than other participants to agree with one or more of the social isolation items, indicating that they experienced some social isolation. Low levels of participation in social, sports, leisure or support activities were associated with low self-assessed physical and mental health. Disengagement with the local community was associated with low levels of self-assessed mental health. While younger people were more likely than older people to participate in social, sports, leisure or support activities, they were less involved as members of their community. Females were more likely than males to have been involved in five or more sports, leisure or support activities. Participation in civic activities was associated with high income. Levels of participation in the four different types of activities were combined (social activities, sport, leisure or support activities, community and group activities, and civic activities). Participants classified as low participators were more likely to be older participants, to have a low income and to have low scores for both physical and mental health.
Conclusions: An association was found between health and community participation in a range of activities, and between health and engagement with the community in this rural and regional population. These findings are consistent with those reported from similar research with a metropolitan population sample. The current research suggests that the groups of people of most concern in terms of low participation rates, are people who have low incomes, people aged over 65 years, people who may be defined as possessing poor physical health and people who may be defined as possessing poor mental health. The relationship between age, community participation and health is complex and needs further exploration because it is not known whether poor health reduces community participation or whether reduced community participation results in poor health. However, current research suggests that developing and implementing strategies to promote people's engagement with and involvement in their local community is one important way of promoting the health of the community as a whole.

Twisting the knife: discrimination in the law

Of the many different variations that can occur in human sexual formation, transsexualism no doubt remains the least understood by the wider Australian community. As a consequence, the process of attaining human rights to legal status, privacy, dignity and freedom from discrimination for those who experience this unusual condition has been a slow and sometimes frustrating one. The article seeks to introduce the reader to some of the more recent developments in the international jurisprudence of transsexualism and the underlying medical evidence that has supported them. It also offers criticism of the belated attempt by the State of Victoria,  with the Births, Deaths & Marriages Registration (Amendment) Act 2004, to establish certain statutory rights in this regard. While the legislation was enacted with the stated and very laudable purpose of providing for the  correction of birth records on the Register of Births of those people with transsexualism who have altered their phenotypic sex by hormonal  medication and surgery, the article argues it has also served to remove other equally important rights already won and proposes that a final remedy will only be found, as on previous occasions, in the courts.

Employer satisfaction, job-match and future hiring intentions for employees with a disability

This paper is based on survey responses from 656 employers who used disability employment services to employ someone with a disability. Relationships between employer satisfaction and employer perceptions of job-match and future hiring intentions toward people who have a disability are outlined and discussed. Employers' perceptions of the job-match process were found to be an important determinant of their perceptions of work performance and employer satisfaction. Comparative ratings on employer satisfaction for employees with and without a disability were seen as an important indicator of future hiring intentions toward people with a disability. Findings reported in this paper provide important information on which to base strategies for improving future employment outcomes for people who have a disability.

Economic deprivation and its effects on subjective wellbeing in families of people with multiple sclerosis

Background: There has been limited research on the role of financial strain on the adjustment of people with multiple sclerosis.

Aims: This study examined the financial costs of MS and the impact of financial strain on the quality of life and adjustment of people with MS and their families.

Methods: Interviews were conducted with 16 health professionals, 26 people with MS and 11 family members of people who have MS.

Results: Economic deprivation impacted on the subjective well being of many families living with MS. Concerns included adjustment to a lower income if the person with MS reduced or ceased work, and meeting the costs of home alterations, mobility equipment, and special transport. The additional cost of living with MS is a stress factor, especially for people dependent on disability support pensions.

Conclusions: It is anticipated that the findings from this study will raise the awareness of health professionals and politicians regarding the potential impact of financial stress on people with MS and their families.

Family structure and children's television viewing and physical activity

Objectives: This study aimed to examine how physical activity (PA) and television (TV) viewing time of children varied according to family structure.

Methods: In 2001, 5- to 6-yr-old (N = 296) and 10- to 12-yr-old (N = 919) children and their parents were recruited from 19 state elementary schools in Melbourne, Australia. Children's PA was objectively assessed using accelerometers worn for 8 d. Sociodemographic and family structure information and time spent watching TV was collected via questionnaire completed by parents.

Results: ANCOVA revealed that, after controlling for socioeconomic status and age of child, boys without any siblings spent more minutes per day watching TV (153.2 +/- 71.3) compared with those who have siblings (129.0 +/- 64.4, P < 0.05). There were also significant differences in TV viewing time between boys with one sibling (125.5 +/- 59.9), two siblings (141.9 +/- 70.1), or three or more siblings (111.6 +/- 62.6, P < 0.001). Girls from single-parent families (145.7 +/- 85.1) spent significantly more minutes per day watching TV compared with girls from two-parent families (125.1 +/- 67.7, P < 0.05). Girls with siblings spent more minutes per day in PA (148.3 +/- 67.7) compared with those who were an only child (131.0 +/- 58.9, P < 0.05). There were significant interactions between parental status and having a sibling, with PA, and also with TV viewing for girls and between parental status and having a brother with PA for boys. There were also significant interactions between having an older sibling and child's sex with PA and between number of siblings and sex with TV viewing.

Conclusions: Family structure may be an important source of influence on children's PA and TV viewing time. Aspects of family structure interact differently with PA and TV viewing, suggesting interventions may need to be tailored with consideration of the family structure of children.

Not the same : a comparison of female and male clients seeking treatment from problem gambling counselling services

Previous studies of problem gamblers portray this group as being almost exclusively male. However, this study demonstrates that females comprised 46% of the population (n = 1,520) of persons who sought assistance due to concerns about their gambling from the publicly-funded BreakEven counselling services in the state of Victoria, Australia, in one 12-month period. This suggests that the model of service delivery which is community based counselling on a non-residential basis may be better able to attract female clients than treatment centres where males predominate such as veterans centres. A comparative analysis of the social and demographic characteristics of female and male gamblers within the study population was undertaken. As with previous studies, we have found significant differences between males and females who have sought help for problems associated with their gambling. Gender differences revealed in this study include females being far more likely to use electronic gaming machines (91.1% vs. 61.4%), older (39.6 years vs. 36.1 years), more likely to be born in Australia (79.4% vs. 74.7%), to be married (42.8% vs. 30.2%), living with family (78.9% vs. 61.5%) and to have dependent children (48.4% vs. 35.7%), than males who present at these services. Female gamblers (A$7,342) reported average gambling debts of less than half of that owed by males (A$19,091). These gender differences have implications for the development and conduct of problem gambling counselling services as it cannot be assumed that models of service which have demonstrated effectiveness with males will be similarly effective with females.

Further examination of relationships between events and psychiatric symptoms in adults with intellectual disability

Background: It has been proposed that people with intellectual disability (ID) might be similar to the general population in the way they respond to significant life events. Some preliminary findings have demonstrated that adults with ID who have experienced recent life events have an increased probability of having psychiatric problems. The aims of the present study were to determine whether previous findings can be replicated, and to examine the influence of additional diagnoses associated with ID on the strength of relationships between life event frequency and psychiatric problems.

Methods: Adults with ID (n = 624), living either in staffed community accommodation or in family or foster homes, were assessed on the Developmental Behaviour Checklist for Adults (DBC-A) and a 37-item life events checklist. Carers who knew the person well acted as proxy informants.

Results: People living in staffed accommodation experienced more life events than people living with natural or foster families. Life event frequency predicted DBC-A total score, five of six sub-scale scores, and caseness status, after significant demographic factors were taken into account. However, the strength of correlations between life event frequency and DBC-A total score varied among sub-groups identified by type of developmental disability and level of ID.

Conclusions: Weak but significant associations between emotional and behavioural problems and life events experienced by adults with ID were demonstrated, but it was also shown that the strength of such associations varies among sub-groups of this heterogeneous population. Future research needs to take account of the circumstances surrounding the life changes, the period of time over which changes might have taken place, and the meaning that the person might attach to the changes. Research into the causal relationship between exposure to life events and the onset of psychiatric problems is also warranted.