New Zealand women's preference for treatment decision-making when considering hormone replacement therapy : a thesis presented in partial fulfilment of the requirements for the degree of Master of Arts in Psychology at Massey University

The menopause phase has increasingly been defined as a deficiency disease amenable to treatment. The main medical treatment for menopause is Hormone Replacement Therapy (HRT). At present very little is known about how New Zealand women make their decisions regarding HRT. What is known is that the medical information concerning HRT is uncertain and doctors are an important factor in the decision-making process. Recent research has shown that there is much dissatisfaction with the service doctors are providing New Zealand women. Much of this dissatisfaction may result from the mismatch of decision-making styles between doctors and women. Accordingly it was necessary to investigate the style preferences of New Zealand women. The aim of the present study was to test the Charles, Gafni & Whelan (1999) theoretical framework for treatment decision-making on New Zealand women considering HRT. The present study seeks to identify three distinct styles of decision-making preference and investigate whether the style preferences are maintained throughout the entire process. One hundred and forty-eight mid-aged women were surveyed about their decisional style preferences. The measure used was designed specifically for the present study and was unique with regard to incorporating stages within the decision-making process. The Charles et al. (1999) framework was found to be an appropriate model for conceptualising the decision-making context of HRT. Support was also found for the dynamic nature of treatment decision-making proposed by Charles et al. (1999) as the three main styles were also found to be amenable to change. The Charles et al. (1999) framework could be a useful educational and assessment tool for doctors and women. Future research is needed to replicate the results of the present study

Predicting the early therapeutic alliance in the treatment of drug misuse

Aims - To predict the early therapeutic alliance from a range of potentially relevant factors, including clients' social relationships, motivation and psychological resources, and counsellors' professional experience and ex-user status. Design - The study recruited 187 clients starting residential rehabilitation treatment for drug misuse in three UK services. Counsellor and client information was assessed at intake, and client and counsellor ratings of the alliance were obtained during weeks 1, 2 and 3. Measurements - The intake assessment battery included scales on psychological wellbeing, treatment motivation, coping strategies and attachment style. Client and counsellor versions of the Working Alliance Inventory (WAI-S) were used for weekly alliance measurement. Hierarchical linear models were used to examine the relationship between alliance and predictor variables. Findings - Clients who had better motivation, coping strategies, social support and a secure attachment style were more likely to develop good alliances. Findings with regard to counsellor characteristics were not clear cut: clients rated their relationships with ex-user counsellors, experienced counsellors and male counsellors as better, but more experienced counsellors rated their alliances as worse. Conclusions - The findings offer important leads as to what interventions might improve the therapeutic alliance. Further work will need to establish whether the therapeutic alliance and ultimately treatment outcomes can be enhanced by working on improving clients' motivation and psychosocial resources

An individually randomised controlled multi-centre pragmatic trial with embedded economic and process evaluations of early vocational rehabilitation compared with usual care for stroke survivors: study protocol for the RETurn to work After stroKE (RETAKE) trial

Background: Return to work (RTW) is achieved by less than 50% of stroke survivors. The rising incidence of stroke among younger people, the UK economic forecast, and clinical drivers highlight the need for stroke survivors to receive support with RTW. However, evidence for this type of support is lacking. This randomised controlled trial (RCT) will investigate whether Early Stroke Specialist Vocational Rehabilitation (ESSVR) plus usual care (UC) (i.e., usual NHS rehabilitation) is more clinically and cost effective for supporting post-stroke RTW, than UC alone. Methods: 760 stroke survivors and their carers will be recruited from approximately 20 NHS stroke services. A 5:4 allocation ratio will be employed to randomise participants to receive ESSVR plus UC, or UC alone. The individually tailored ESSVR intervention will commence within 12 weeks of stroke onset and be delivered for up to 12 months as necessary by trained RETAKE occupational therapists in the community, participants’ homes or workplaces, outpatient/inpatient therapy settings, via telephone, email or SMS text message. Outcome data will be collected via self-report questionnaires administered by post or online at 3, 6, and 12 months follow-up. The primary outcome will be self-reported RTW and job retention at 12 months (minimum 2 hours/week). Secondary outcomes will include: mood; function; participation; health-related quality of life; confidence; intervention compliance; health and social care resource use; and mortality. An embedded economic evaluation will estimate cost-effectiveness and cost-utility analyses from National Health Service (NHS) and Personal Social Services (PSS) perspectives. An embedded process evaluation will employ a mixed methods approach to explore ESSVR implementation, contextual factors linked to outcome variation, and factors affecting NHS roll-out. Discussion: This article describes the protocol for a multi-centre RCT evaluating the clinical- and cost-effectiveness of an early vocational rehabilitation intervention aimed at supporting adults to return to work following a stroke. Evidence favouring the ESSVR intervention would support its roll-out in NHS settings. Trial registration: ISRCTN, ISRCTN12464275. Registered on 26th February 2018, http://www.isrctn.com/ISRCTN12464275

RETurn to work After stroKE (RETAKE) Trial: protocol for a mixed-methods process evaluation using normalisation process theory

Objectives: This mixed-method process evaluation underpinned by normalisation process theory aims to measure fidelity to the intervention, understand the social and structural context in which the intervention is delivered and identify barriers and facilitators to intervention implementation. Setting: RETurn to work After stroKE (RETAKE) is a multicentre individual patient randomised controlled trial to determine whether Early Stroke Specialist Vocational Rehabilitation (ESSVR) plus usual care is a clinically and cost-effective therapy to facilitate return to work after stroke, compared with usual care alone. This protocol paper describes the embedded process evaluation. Participants and outcome measures: Intervention training for therapists will be observed and use of remote mentor support reviewed through documentary analysis. Fidelity will be assessed through participant questionnaires and analysis of therapy records, examining frequency, duration and content of ESSVR sessions. To understand the influence of social and structural contexts, the process evaluation will explore therapists’ attitudes towards evidence-based practice, competency to deliver the intervention and evaluate potential sources of contamination. Longitudinal case studies incorporating non-participant observations will be conducted with a proportion of intervention and usual care participants. Semistructured interviews with stroke survivors, carers, occupational therapists, mentors, service managers and employers will explore their experiences as RETAKE participants. Analysis of qualitative data will draw on thematic and framework approaches. Quantitative data analysis will include regression models and descriptive statistics. Qualitative and quantitative data will be independently analysed by process evaluation and Clinical Trials Research Unit teams, respectively. Linked data, for example, fidelity and describing usual care will be synthesised by comparing and integrating quantitative descriptive data with the qualitative findings. Ethics and dissemination: Approval obtained through the East Midlands—Nottingham 2 Research Ethics Committee (Ref: 18/EM/0019) and the National Health ServiceResearch Authority. Dissemination via journal publications, stroke conferences, social media and meetings with national Stroke clinical leads. Trial registration number: ISRCTN12464275

Levetiracetam versus phenytoin for second-line treatment of paediatric convulsive status epilepticus (EcLiPSE): a multicentre, open-label, randomised trial

Background Phenytoin is the recommended second-line intravenous anticonvulsant for treatment of paediatric convulsive status epilepticus in the UK; however, some evidence suggests that levetiracetam could be an effective and safer alternative. This trial compared the efficacy and safety of phenytoin and levetiracetam for second-line management of paediatric convulsive status epilepticus.Methods This open-label, randomised clinical trial was undertaken at 30 UK emergency departments at secondary and tertiary care centres. Participants aged 6 months to under 18 years, with convulsive status epilepticus requiring second-line treatment, were randomly assigned (1:1) using a computer-generated randomisation schedule to receive levetiracetam (40 mg/kg over 5 min) or phenytoin (20 mg/kg over at least 20 min), stratified by centre. The primary outcome was time from randomisation to cessation of convulsive status epilepticus, analysed in the modified intention-to-treat population (excluding those who did not require second-line treatment after randomisation and those who did not provide consent). This trial is registered with ISRCTN, number ISRCTN22567894.Findings Between July 17, 2015, and April 7, 2018, 1432 patients were assessed for eligibility. After exclusion of ineligible patients, 404 patients were randomly assigned. After exclusion of those who did not require second-line treatment and those who did not consent, 286 randomised participants were treated and had available data: 152 allocated to levetiracetam, and 134 to phenytoin. Convulsive status epilepticus was terminated in 106 (70%) children in the levetiracetam group and in 86 (64%) in the phenytoin group. Median time from randomisation to cessation of convulsive status epilepticus was 35 min (IQR 20 to not assessable) in the levetiracetam group and 45 min (24 to not assessable) in the phenytoin group (hazard ratio 1·20, 95% CI 0·91–1·60; p=0·20). One participant who received levetiracetam followed by phenytoin died as a result of catastrophic cerebral oedema unrelated to either treatment. One participant who received phenytoin had serious adverse reactions related to study treatment (hypotension considered to be immediately life-threatening [a serious adverse reaction] and increased focal seizures and decreased consciousness considered to be medically significant [a suspected unexpected serious adverse reaction]). Interpretation Although levetiracetam was not significantly superior to phenytoin, the results, together with previously reported safety profiles and comparative ease of administration of levetiracetam, suggest it could be an appropriate alternative to phenytoin as the first-choice, second-line anticonvulsant in the treatment of paediatric convulsive status epilepticus

Finishing the euchromatic sequence of the human genome

The sequence of the human genome encodes the genetic instructions for human physiology, as well as rich information about human evolution. In 2001, the International Human Genome Sequencing Consortium reported a draft sequence of the euchromatic portion of the human genome. Since then, the international collaboration has worked to convert this draft into a genome sequence with high accuracy and nearly complete coverage. Here, we report the result of this finishing process. The current genome sequence (Build 35) contains 2.85 billion nucleotides interrupted by only 341 gaps. It covers ∼99% of the euchromatic genome and is accurate to an error rate of ∼1 event per 100,000 bases. Many of the remaining euchromatic gaps are associated with segmental duplications and will require focused work with new methods. The near-complete sequence, the first for a vertebrate, greatly improves the precision of biological analyses of the human genome including studies of gene number, birth and death. Notably, the human enome seems to encode only 20,000-25,000 protein-coding genes. The genome sequence reported here should serve as a firm foundation for biomedical research in the decades ahead

Sensitivity to Emotion Specified in Facial Expressions and the Impact of Aging and Alzheimer's Disease

This thesis describes a program of research that investigated the sensitivity of healthy young adults, healthy older adults and individuals with Alzheimer’s disease (AD) to happiness, sadness and fear emotion specified in facial expressions. In particular, the research investigated the sensitivity of these individuals to the distinctions between spontaneous expressions of emotional experience (genuine expressions) and deliberate, simulated expressions of emotional experience (posed expressions). The specific focus was to examine whether aging and/or AD effects sensitivity to the target emotions. Emotion-categorization and priming tasks were completed by all participants. The tasks employed an original set of cologically valid facial displays generated specifically for the present research. The categorization task (Experiments 1a, 2a, 3a, 4a) required participants to judge whether targets were, or were not showing and feeling each target emotion. The results showed that all 3 groups identified a genuine expression as both showing and feeling the target emotion whilst a posed expression was identified more frequently as showing than feeling the emotion. Signal detection analysis demonstrated that all 3 groups were sensitive to the expression of emotion, reliably differentiating expressions of experienced emotion (genuine expression) from expressions unrelated to emotional experience (posed and neutral expressions). In addition, both healthy young and older adults could reliably differentiate between posed and genuine expressions of happiness and sadness, whereas, individuals with AD could not. Sensitivity to emotion specified in facial expressions was found to be emotion specific and to be independent of both the level of general cognitive functioning and of specific cognitive functions. The priming task (Experiments 1b, 2b, 3b,4b) employed the facial expressions as primes in a word valence task in order to investigate spontaneous attention to facial expression. Healthy young adults only showed an emotion-congruency priming effect for genuine expressions. Healthy older adults and individuals with AD showed no priming effects. Results are discussed in terms of the understanding of the recognition of emotional states in others and the impact of aging and AD on the recognition of emotional states. Consideration is given to how these findings might influence the care and management of individuals with AD