Bayesian designs with frequentist and Bayesian error rate considerations

So far, most Phase II trials have been designed and analysed under a frequentist framework. Under this framework, a trial is designed so that the overall Type I and Type II errors of the trial are controlled at some desired levels. Recently, a number of articles have advocated the use of Bavesian designs in practice. Under a Bayesian framework, a trial is designed so that the trial stops when the posterior probability of treatment is within certain prespecified thresholds. In this article, we argue that trials under a Bayesian framework can also be designed to control frequentist error rates. We introduce a Bayesian version of Simon's well-known two-stage design to achieve this goal. We also consider two other errors, which are called Bayesian errors in this article because of their similarities to posterior probabilities. We show that our method can also control these Bayesian-type errors. We compare our method with other recent Bayesian designs in a numerical study and discuss implications of different designs on error rates. An example of a clinical trial for patients with nasopharyngeal carcinoma is used to illustrate differences of the different designs.

Designs for phase I clinical trials with multiple courses of subjects at different doses

The goal of this article is to provide a new design framework and its corresponding estimation for phase I trials. Existing phase I designs assign each subject to one dose level based on responses from previous subjects. Yet it is possible that subjects with neither toxicity nor efficacy responses can be treated at higher dose levels, and their subsequent responses to higher doses will provide more information. In addition, for some trials, it might be possible to obtain multiple responses (repeated measures) from a subject at different dose levels. In this article, a nonparametric estimation method is developed for such studies. We also explore how the designs of multiple doses per subject can be implemented to improve design efficiency. The gain of efficiency from "single dose per subject" to "multiple doses per subject" is evaluated for several scenarios. Our numerical study shows that using "multiple doses per subject" and the proposed estimation method together increases the efficiency substantially.

Decision-theoretic designs for dose-finding clinical trials with multiple outcomes

A decision-theoretic framework is proposed for designing sequential dose-finding trials with multiple outcomes. The optimal strategy is solvable theoretically via backward induction. However, for dose-finding studies involving k doses, the computational complexity is the same as the bandit problem with k-dependent arms, which is computationally prohibitive. We therefore provide two computationally compromised strategies, which is of practical interest as the computational complexity is greatly reduced: one is closely related to the continual reassessment method (CRM), and the other improves CRM and approximates to the optimal strategy better. In particular, we present the framework for phase I/II trials with multiple outcomes. Applications to a pediatric HIV trial and a cancer chemotherapy trial are given to illustrate the proposed approach. Simulation results for the two trials show that the computationally compromised strategy can perform well and appear to be ethical for allocating patients. The proposed framework can provide better approximation to the optimal strategy if more extensive computing is available.

Optimal designs for evaluating a series of treatments

Several articles in this journal have studied optimal designs for testing a series of treatments to identify promising ones for further study. These designs formulate testing as an ongoing process until a promising treatment is identified. This formulation is considered to be more realistic but substantially increases the computational complexity. In this article, we show that these new designs, which control the error rates for a series of treatments, can be reformulated as conventional designs that control the error rates for each individual treatment. This reformulation leads to a more meaningful interpretation of the error rates and hence easier specification of the error rates in practice. The reformulation also allows us to use conventional designs from published tables or standard computer programs to design trials for a series of treatments. We illustrate these using a study in soft tissue sarcoma.

Isotonic designs for phase I trials

The purpose of a phase I trial in cancer is to determine the level (dose) of the treatment under study that has an acceptable level of adverse effects. Although substantial progress has recently been made in this area using parametric approaches, the method that is widely used is based on treating small cohorts of patients at escalating doses until the frequency of toxicities seen at a dose exceeds a predefined tolerable toxicity rate. This method is popular because of its simplicity and freedom from parametric assumptions. In this payer, we consider cases in which it is undesirable to assume a parametric dose-toxicity relationship. We propose a simple model-free approach by modifying the method that is in common use. The approach assumes toxicity is nondecreasing with dose and fits an isotonic regression to accumulated data. At any point in a trial, the dose given is that with estimated toxicity deemed closest to the maximum tolerable toxicity. Simulations indicate that this approach performs substantially better than the commonly used method and it compares favorably with other phase I designs.

Low PAPR Square STBCs from Complex Partial-Orthogonal Designs (CPODs)

Space-time codes from complex orthogonal designs (CODs) with no zero entries offer low Peak to Average Power Ratio (PAPR) and avoid the problem of switching off antennas. But square CODs for 2(a) antennas with a + 1. complex variables, with no zero entries were discovered only for a <= 3 and if a + 1 = 2(k), for k >= 4. In this paper, a method of obtaining no zero entry (NZE) square designs, called Complex Partial-Orthogonal Designs (CPODs), for 2(a+1) antennas whenever a certain type of NZE code exists for 2(a) antennas is presented. Then, starting from a so constructed NZE CPOD for n = 2(a+1) antennas, a construction procedure is given to obtain NZE CPODs for 2n antennas, successively. Compared to the CODs, CPODs have slightly more ML decoding complexity for rectangular QAM constellations and the same ML decoding complexity for other complex constellations. Using the recently constructed NZE CODs for 8 antennas our method leads to NZE CPODs for 16 antennas. The class of CPODs do not offer full-diversity for all complex constellations. For the NZE CPODs presented in the paper, conditions on the signal sets which will guarantee full-diversity are identified. Simulation results show that bit error performance of our codes is same as that of the CODs under average power constraint and superior to CODs under peak power constraint.

Nés sous de bons auspices? Etude qualitative de facteurs contribuant à l'acquisition du bilinguisme par les enfants d'un couple mixte

Pro gradu- tutkielmassani tarkastelen suomi-ranska kaksikielisyyden kehittymistä perheissä, joissa vanhemmilla on eri äidinkieli. Työni tavoitteena on ollut tutkia kuinka eri ympäristötekijät vaikuttavat kaksikielisyyden omaksumiseen ja miten perheiden erilainen panostus vähemmistökielen, ts. kielen joka ei esiinny ympäristössä, oppimiseen näkyy saavutetuissa tuloksissa. Tutkimukseeni osallistui 13 perhettä, joilla on 10-12 vuotiaita, ranskaa ja suomea päivittäin käyttäviä lapsia. Lapsia oli yhteensä 18. Voidakseni tarkastella myös kieliympäristön vaikutusta oppimiseen valittiin perheistä kuusi Suomesta ja seitsemän Ranskasta sekä Sveitsin ranskankieliseltä alueelta. Tutkimusmenetelmiini kuului vanhempien haastattelu perheen sosiolingvististen tekijöiden selville saamiseksi ja lasten kanssa keskustelu suullisen kielitaidon arvioimiseksi. Pääpaino kielitaidon arvioinnissa oli kuitenkin kirjallisella tekstillä, jonka lapset tuottivat molemmilla kielillä tekstittömän kirjan kuvien perusteella. Teksteistä suoritettiin virheanalyysit, joissa eri virheet jaettiin ortografisiin, semanttisiin ja kieliopillisiin virheisiin. Jokaiselle lapselle lasketiin myös keskiarvo, joka osoitti kuinka monta sanaa tekstissä oli jokaista virhettä kohti. Näiden keskiarvojen pohjalta tutkittiin yhteneväisyyksiä virhemäärien sekä perheiden sosiolingvististen tekijöiden kesken. Yhteenvedossa verrattiin myös tuloksia teoriaosassa esitettyihin kielitieteilijöiden tarjoamiin periaatteisiin. Tutkielman perusteella voidaan todeta, että ympäristön vaikutus näytetään usein aliarvioitaneen kaksikielisyyttä koskevissa teoksissa. Hyvään kielitaitoon vähemmistökielessä tarvitaan enemmän kuin yksi kieli - yksi henkilö menetelmä, jossa vanhemmat puhuvat lapselle omaa äidinkieltään. Hyviksi vahvistuskeinoiksi havaittiin varsinkin kaksikielinen koulu sekä useat vierailut toisen vanhemman kotimaahan. Varsinkin perheen nuorimpien lasten vähemmistökielen oppimiseen tulisi panostaa sillä näillä on syntymästään asti mahdollisuus käyttää enemmistökieltä myös vanhempien sisarusten kanssa. Kieliympäristön vaikutuksesta havaittiin, että Suomessa asuvat lapset hallitsivat yleisesti ottaen paremmin vähemmistökielensä kuin Ranskassa asuvat. Tähän pidettiin syynä ranskalais-suomalaisen koulun positiivista vaikutusta kielen oppimiselle sekä ranskankielen arvostettua asemaa Suomessa. Avainsanat: Kaksikielisyys, kieltenoppiminen, bilinguisme, acquisition des langues, couple mixte

‘They rush you and push you too much … and you can't really get any good response off them’: A qualitative examination of family involvement in care of people with dementia in acute care

Aim: To explore the role and needs of the family carer across different acute care contexts and their level of involvement in the care of their relative with dementia in this setting. Method: A pragmatic, exploratory-descriptive qualitative approach. A convenience sample of 30 family carers across three sites completed semi-structured interviews. Results: Family carers wanted to be involved in the acute care of their family member with dementia. They acknowledged the importance of a central source of information, educated staff, guidelines on roles and processes, and positive communication, as well as respect from staff for the carer’s knowledge of the older person and their needs. They also highlighted the need for medical staff to discuss with them the family member’s treatment and care. Conclusion: There is a need for family-focused interventions to improve communication and involvement of family in the care of family members with dementia in the acute setting.

Healthcare users’ experiences of communicating with healthcare professionals about children who have life-limiting conditions: A qualitative systematic review protocol

REVIEW QUESTION / OBJECTIVE The objective of this review is to identify and synthesize the best international qualitative evidence on healthcare users’ experiences of communication with healthcare professionals about children who have life-limiting conditions. For the purposes of this review, “healthcare users” will be taken to include children who have life-limiting conditions and their families. The question to be addressed is: - What are healthcare users’ experiences of communicating with healthcare professionals about children who have life-limiting conditions? INCLUSION CRITERIA - Types of participants: This review will consider all qualitative studies that focus on users of healthcare services for children who have life-limiting conditions. These users are anticipated to include children who have a life-limiting condition and their family members. In instances where children are not under the legal care of one or both parents, service users may also include other types of legal guardians. - Phenomena of interest: This review will consider experiences of communicating with healthcare professionals about children who have life-limiting conditions. - Context: This review will consider studies relating to communication with healthcare professionals about children who have a life-limiting condition, irrespective of whether the healthcare service is based in a hospital, hospice, or community setting. There is no restriction on the country in which a study was conducted.

Soliciting additional concerns in the primary care consultation and the utility of a brief communication intervention to aid solicitation: A qualitative study

Objective To investigate the perspectives of general practitioners (GPs) on the practice of soliciting additional concerns (ACs) and the acceptability and utility of two brief interventions (prompts) designed to aid the solicitation. Methods Eighteen GPs participating in a feasibility randomised controlled trial were interviewed. Interviews were semi-structured and audio-recorded. Data were analysed using a Framework Approach. Results Participants perceived eliciting ACs as important for: reducing the need for multiple visits, identifying serious illness early, and increasing patient and GP satisfaction. GPs found the prompts easy to use and some continued their use after the study had ended to aid time management. Others noted similarities between the intervention and their usual practice. Nevertheless, soliciting ACs in every consultation was not unanimously supported. Conclusion The prompts were acceptable to GPs within a trial context, but there was disagreement as to whether ACs should be solicited routinely. Some GPs considered the intervention to aid their prioritisation efficiency within consultations. Practice implications Some GPs will find prompts which encourage ACs to be solicited early in the consultation enable them to better organise priorities and manage time-limited consultations more effectively.

Developing a best practice pathway to support improvements in Indigenous Australians' mental health and well-being: A qualitative study

Objective: There is a need to adapt pathways to care to promote access to mental health services for Indigenous people in Australia. This study explored Indigenous community and service provider perspectives of well-being and ways to promote access to care for Indigenous people at risk of depressive illness. Design: A participatory action research framework was used to inform the development of an agreed early intervention pathway; thematic analysis Setting: 2 remote communities in the Northern Territory. Participants: Using snowball and purposive sampling, 27 service providers and community members with knowledge of the local context and the diverse needs of those at risk of depression were interviewed. 30% of participants were Indigenous. The proposed pathway to care was adapted in response to participant feedback. Results: The study found that Indigenous mental health and well-being is perceived as multifaceted and strongly linked to cultural identity. It also confirms that there is broad support for promotion of a clear pathway to early intervention. Key identified components of this pathway were the health centre, visiting and community-based services, and local community resources including elders, cultural activities and families. Enablers to early intervention were reported. Significant barriers to the detection and treatment of those at risk of depression were identified, including insufficient resources, negative attitudes and stigma, and limited awareness of support options. Conclusions: Successful early intervention for wellbeing concerns requires improved understanding of Indigenous well-being perspectives and a systematic change in service delivery that promotes integration, flexibility and collaboration between services and the community, and recognises the importance of social determinants in health promotion and the healing process. Such changes require policy support, targeted training and education, and ongoing promotion.

A qualitative exploration of Internet-based treatment for comorbid depression and alcohol misuse

Background Many Internet-based treatments for depression and for alcohol misuse have a positive impact, yet little is known about how these treatments work. Most research on web-based interventions involves efficacy trials which, while important, offer little explanation about how people perceive and use online programs. Objective This study aimed to undertake a qualitative exploration of participants' experience, perceived impact and use of an integrated web-based program for comorbid depression and alcohol misuse. Specifically, it explored users' perspectives on the intensity of their treatment and the level of support they received. Methods Interviewees were drawn from participants in a randomised controlled trial of the OnTrack web-based treatment for depression and alcohol misuse, which compared Brief Self-Guided, Comprehensive Self-Guided and Comprehensive Therapist-Assisted versions of the program. Twenty-nine people (9–11 from each condition) completed semi-structured telephone interviews asking about their impressions and experiences with the program. Interview transcriptions were subject to a 6-step thematic analysis, employing a conceptual matrix to identify thematic differences across groups. Results Positive experiences and outcomes were more pronounced among participants receiving the comprehensive treatments than the brief one, but other responses were relatively consistent across conditions. A major theme was a wish for more individualisation and human contact, even in participants receiving emailed assistance. Some confused follow-up research assessments with therapist support. There was little correspondence between the perceived impact of the program and the amount reportedly completed, and some participants said they used strategies offline or completed exercises mentally. Conclusions This study highlighted discrepancies between how web-based treatments are intended to be used and how people actually engage with them. A challenge for the next wave of these interventions is the provision of individualised responses and coaching that retains an emphasis on self-management and constrains cost.

Systematic literature review: Research on Supported Playgroups

Overview This review of research conducted with supported playgroups was prepared for the Queensland Department of Education, Training and Employment (DETE). The report provides a synthesis of the research on the effectiveness of supported playgroups to improve child, parent, and community outcomes and to identify key features of supported playgroups that support effective outcomes. Supported playgroups are community-based services that provide a low intensity parenting intervention, through regular group sessions for parent-child dyads. Supported playgroups target vulnerable families who may benefit from parenting support. Supported playgroups have common goals to enhance children’s early learning and parental wellbeing. Method A search strategy was devised to identify research studies, nationally and internationally, that involved parent-child group programs for families with young children, delivered under the leadership of an employed facilitator. Academic databases and other data sources were explored for studies conducted in the period from 2004 to 2014. Summary descriptions of the research studies were developed; assessment of research methodologies was made; research evidence on the effectiveness of supported playgroups to improve child, parent, and community outcomes was identified; and comparative analyses of the implementation features of supported playgroups were completed. Findings The search strategy identified 34 research publications, reporting on 29 different programs. Twenty-six of the studies report on research conducted in Australia and eight reported on research conducted in other countries, including the United Kingdom, Canada, and the United States. Three clusters of playgroups were identified: Category 1 - Standard supported playgroups; Category 2 - Mobile playgroups; Category 3 – Supported playgroups with specific interventions. The research studies identified encompassed experimental and non-experimental research designs. The studies of standard supported playgroups and mobile playgroups were most often qualitative studies and modest in scale, in terms of the number of research participants. Experimental and quasi-experimental research designs characterised the studies identified in the category of supported playgroups with specific interventions. Overall, the research studies that were categorised as supported playgroups with specific interventions provided stronger evidence for effectiveness to improve parental behaviour in ways that are known to support children’s early developmental competence. Qualitative studies, including case studies and ethnographic research, documented important features of program delivery, such as the importance of facilitators’ interpersonal skills to positive experiences for families in the playgroups; as well as the important opportunities that the playgroups afforded to vulnerable families to reduce social isolation. Conclusions The potential for supported playgroups to improve a broad range of learning and psychosocial outcomes for children and parents was suggested by many of the research studies. However, the nature of the research designs employed means that it is not possible to conclude that there is strong evidence of the impact of supported playgroups on child, parent, and community outcomes. The qualitative studies did provide rich descriptions about the implementation processes of playgroups and also captured the variability in the delivery of the playgroups in terms of who participated, local contextual factors that impacted on the playgroup experiences, and the nature of the experiences of parents within the playgroups. Research methodologies need to be employed that address the limitations of the studies to date. This would provide more defensible evidence that supported playgroups have an impact over time on outcomes for children, families, and communities. Overall, this area of research remains relatively under-evaluated in terms of rigorous research designs. The identified research studies point to some promising research directions but do not yet enable strong claims to be made about the effectiveness of the standard playgroup or mobile playgroup models to impact on parenting outcomes. Data collected from interview and survey methodologies clearly identifies that supported playgroups are highly acceptable to families. Given the popularity of supported playgroups to engage families across diverse communities, and the reported high levels of satisfaction and benefits identified within many of the research studies, it is clear that the provision of supported playgroups is fulfilling an important community need by providing support to parents with young children. However, there is a need to strengthen the evidence base that supported playgroups are an effective early parenting intervention that improves outcomes for children, parents, and communities.

Neulemallien muodikkuus : Näkyvätkö kansainväliset muotitrendit suomalaisten käsityölehtien neulemalleissa?

The aim of this work was to study, whether international fashion trends show in knit designs in Finnish craft magazines and how trends are modified. Women s knitted clothes and accessories in autumn winter season 2005 2006 were analyzed. Future research, trends, fashion, designing and knitting provides theoretical basis for this study. The trend material of this study came from Carlin Women s knitwear winter 2005 2006, which is fashion forecast for Women s knitwear. In addition to the trend book, I selected two international fashion magazines to reinforce this study. Fashion magazines were L´Officiel, 1000 models, Milan New York winter 05/06, No 52, April 2005 and Collezioni Donna, Prêt-à-porter autumn-winter 2005 2006, No 107. Finnish craft magazines in this study were MODA s issues 4/2005, 5/2005, 6/2005 and Novita s issues autumn 2005, winter 2005 and Suuri Käsityölehti s issues 8/2005, 9/2005, 10/2005. For the base of the analyze I took themes from the trend book. From fashion magazines I searched knitwear designs and these designs were sorted out by themes of trend book. To this trend and fashion material I compared knit designs from craft magazines. I analyzed how fashion trends show in knit designs and how they are modified. I also studied what features of trends were shown and which did not appear in knit designs of the craft magazines. For analyzing trend pictures and knit designs in craft magazines I applied qualitative content analysis and image analysis. According to the results of this research, effects of trend can be recognized in knit designs of craft maga-zines, although the fashion trends have been applied very discreetly. Knit designs were very similar re-gardless of magazine. The craft magazine data included approximately as many designs from Novita and MODA. In Suuri Käsityölehti provided only fifth of the designs data. There were also designs in MODA and Suuri Käsityölehti, which were made of Novita s yarns. This research material includes yarns of 15 different yarn manufacturers. Although half of all knit designs were knitted from Novita s yarn. There were 10 different yarns from Novita. Nevertheless Novita s yarn called Aino was the most popular. Finnish craft magazines have not respond to popularity of knitting. Magazines do not provide any novelty designs for knitters. Knit designs in Finnish craft magazines are usually practical basic designs without any innovativeness.