Advances in technology and the increased use of home medical devices, such as blood glucose meters, blood pressure monitors and heart monitors are revolutionising the way public healthcare is administered. Homes and their associated networks in conjunction with such devices will take over many mundane healthcare tasks and manage new and enriched lifestyle choices that are at present dramatically affecting our overall quality of life. The combination of wireless and fixed networking infrastructures will form explicit links between the home and its devices and external entities such as gymnasiums, hospitals and general practitioner surgeries. Through these interconnected networks new real-time healthcare management systems will emerge that continually provide information and react to adverse or unusual medical conditions received from occupants within the home. Each home user will be empowered to influence all aspects of their health where healthcare practitioners are continually informed and only used for more specialised treatments. We can see obvious benefits such a system would bring. For example, we can make decisions about actions under consideration and influence this may have on long-term health. Whether this is through real-time monitoring or trend analysis, a better understanding of health and lifestyle choices will gain which at present is not possible. Movement towards this vision is already evident. For example, pacemaker technology is well understood and a natural progression would be to make such devices wireless, allowing easy connectivity to home, hospital and healthcare practitioner networks. This will undoubtedly lead to the development of a multitude of other similar devices designed to carry out some medical function to proactively monitor and act upon adverse factors that may threaten the health of a person. Healthcare practitioners will have direct access to these devices where they could be controlled or queried allowing data to be stored, accessed, and used in assessments. Given this use of networked devices home users could even pose questions about their health will gain to millions of networked sensors either insider or outside the body, with each sensor providing information about a particular aspect of a person's health. Much work has been

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Health-Related Quality of Life (HRQoL) measures are becoming increasingly used in clinical trials and health services research, both as primary and secondary outcome measures. Investigators are now asking statisticians for advice on how to plan (e. g. sample size) and analyse studies using HRQoI_ outcomes. HRQoL outcomes like the SF-36 are usually measured on an ordinal scale. However, most investigators assume that there exists an underlying continuous latent variable that measures HRQoL, and that the actual measured outcomes (the ordered categories), reflect contiguous intervals along this continuum. The ordinal scaling of HRQoL measures means they tend to generate data that have discrete, bounded and skewed distributions. Thus, standard methods of analysis such as the t-test and linear regression that assume Normality and constant variance may not be appropriate. For this reason, non-parametric methods are often used to analyse HRQoL data. The bootstrap is one such computer intensive non-parametric method for estimating sample sizes and analysing data. From a review of the literature, I found five methods of estimating sample sizes for two-group cross-sectional comparisons of HRQoL outcomes. All five methods (amongst other factors) require the specification of an effect size, which varies according to the method of sample size estimation. The empirical effect sizes calculated from the various datasets suggested that large differences in HRQoL (as measured by the SF-36) between groups are unlikely, particularly from the RCT comparisons. Most of the observed effect sizes were mainly in the 'small' to 'moderate' range (0.2 to 0.5) using Cohen's (1988) criteria. I compared the power of various methods of sample size estimation for two-group cross-sectional study designs via bootstrap simulation. The results showed that under the location shift alternative hypothesis, conventional methods of sample size estimation performed well, particularly Whitehead's (1993) method. Whitehead's method is recommended if the HRQoL outcome has a limited number of discrete values (< 7) and/or the expected proportion of cases at either of the bounds is high. If a pilot dataset is readily available (to estimate the shape of the distribution) then bootstrap simulation may provide a more accurate and reliable estimate, than conventional methods. Finally, I used the bootstrap for hypothesis testing and the estimation of standard errors and confidence intervals for parameters, in four datasets (which illustrate the different aspects of study design). I then compared and contrasted the bootstrap with standard methods of analysing HRQoL outcomes as described in Fayers and Machin (2000). Overall, in the datasets studied with the SF-36 outcome the use of the bootstrap for estimating sample sizes and analysing HRQoL data appears to produce results similar to conventional statistical methods. Therefore, the results of this thesis suggest that bootstrap methods are not more appropriate for analysing HRQoL outcome data than standard methods. This result requires confirmation with other HRQoL outcome measures, interventions and populations.

During the course of a span of duty the nurse in hospital has to relate to a number of different people including other occupational groups, other nurses, patients and patients' relatives. The present study has been designed to examine one of these role-relationships, that between the nurse and the patients' relatives.

This research arose from my curiosity about change, and my dissatisfaction with models and tools which do not explain my real life, messy, and sometimes disappointing, experiences of trying to instigate change. My aim, therefore, has been to explore what is it like to experience and make sense of change as it is happening in my working life as a Nurse Practitioner and Primary Care Trust Board member, in primary health care in the National Health Service. Essentially I argue that the dominant way of thinking about change assumes it is a &quot;thing&quot; to be planned and then applied. I believe the error is in thinking we can produce change as if we are in control of a system. An alternative way of thinking about change arising from my experiences is that it can only express our intention for the future but is not controllable in the way often implied. I also suggest change is experienced as movement in the present where, often with hindsight, we experience a shift in patterns of how we speak about or experience something. Early on, my search was for a way of explaining my experience of change by initially drawing on the theories of complexity, which point to emergent pattern which arises spontaneously from local interaction, without any external blueprint or plan. I then turn to the theory of complex responsive processes of human relating (Stacey et al, 2000) which views human interaction as itself inherently pattern forming and therefore ordinary everyday interaction as the source of change. I take the theory of complex responsive processes as the foundational theory for my research by asking &quot;What is it like to experience change in primary health care from a complex responsive processes perspective? &quot; My methodology, which is consistent with this perspective, focuses on my own experiences, as emergent exploration of experience (Stacey and Griffin, 2005). In other words I am reflexively exploring my own experience by using narratives, stories and analysis intertwined, to reflect as closely as possible the messy reality of the way we are continuously making sense of experience and change. My experience seeing patients in primary health care; managing a nursing team; and sitting on the Board of a Primary Care Trust highlights the emotional, fantasy laden aspects of experience which are often disregarded or viewed as common knowledge. Similarly, there are feelings of anxiety surrounding any change where my identity feels threatened and there are changes in power relating between people (Elias, 1939). I argue that tools, models and labels serve to relieve feelings of anxiety, by providing an illusion of control, but may in themselves also increase anxiety and block the potential for change. During the research, my own practice has changed by becoming more reflexive as I focus on my own participation, whilst adding further dimensions to the theory. Firstly, I argue that focusing attention in this way implies a heightened awareness of responsibility and potential for one's own actions. I cannot know the result of my actions but know that they may have some effect, large or small. Secondly, I argue that the dominant discourse may perpetuate the way change is viewed as a &quot;thing&quot; external to every day experience. Rather than focusing on control, process thinking conveys a different reality of continuous sensemaking. Lastly, I argue that focusing attention on feelings, emotions and the environment as simultaneous rather than separate aspects of experience becomes important when experiencing and making sense of change from this perspective. I argue, therefore, that a complex responsive processes perspective challenges the dominant perspective on change by providing a way of understanding which resonates with my experiences, has significant implications for my own practice, and validates paying attention to ordinary everyday experience in which change is continually emerging.

The aim of this longitudinal, in-depth, explanatory case study is to develop an integrated view of strategy as a social practice from `macro to micro' in the organisational arena circumscribed by the Welsh Assembly Government, NHS Wales, and its partner agencies. It is therefore centred upon the development of the Lifelong Learning Strategy for NHS Wales. In doing so, Archer's (1995) Morphogenetic-Morphostatic Cycle is used as a framework through which to loop together macro extra-organisational societal forces with micro intra-organisational strategic managerial activities in order to determine their linked interplay in strategising, thereby rising to Whittington's challenge to `complete the practice turn', and thus address a fundamental gap in the extant literature (2006a: 613, 617; 2006b: 1903). Firstly, the macro level paradigmatic and subordinate institutional logics underpinning the reform of the United Kingdom's health care state during the Blair decade (1997-2007) are identified, thereby highlighting the emergence of discordant logics in post-devolution Wales. Secondly, the emergence of the Project Board, tasked by the Welsh Assembly Government with the oversight of the Lifelong Learning Strategy for NHS Wales, is considered. Here, attention is primarily focused upon the positional, professional, role and organisational composition of the Project Board, drawing into consideration the discordant institutional logics, and the power disparity between its elite members. Thirdly, the structural, cultural, and agential emergent properties which manifested during the development of the Lifelong Learning Strategy for NHS Wales are identified. Finally, the macro to micro cascade of generative mechanisms which modulated the development of the Lifelong Learning Strategy for NHS Wales is retroduced, and the situational logic that fostered morphogenesis or morphostasis within the strategic arena is exposed. V

Measuring change in quality of life is increasingly central to health services and clinical research evaluation. This requires instruments that are responsive to change, and that the construct being assessed is stable. I have, therefore, addressed two methodological themes: scale responsiveness and instability of the underlying quality of life construct - response shift. Responsiveness theme: I evaluated performance characteristics of a commonly reported effect size statistic, the standardised response mean (SRM). Computer simulations modelled the impact of varying computational method and distributional characteristics upon bias of estimated effect size compared to underlying true value. The studies provide evidence and reassurance that the SRM exhibits little bias when sample size, mean underlying effect size and shape of underlying distribution are varied. However, alternate approaches to handling negative values can produce markedly different effect sizes, making comparison across studies that use different methods problematic. Furthermore, parametric SRMs calculated from lognormal data may provide a greatly inflated estimate of effect size. Response shift theme: I interviewed patients at different stages of clinical management for knee injury twice over six months. A multi-method approach incorporating the individualised SEIQoL-DW measure and a retrospective pretest-posttest using EQ-5D identified evidence of re-calibration, re-prioritisation and re-conceptualisation response shift. An empirically based typology of changes was developed drawn from existing response shift theory, but which further distinguishes subtler forms of change. The studies provide evidence that re-prioritisation and re-conceptualisation may be different levels of the same process. Furthermore, mechanisms producing response shift were identified, in particular, the interaction between level of satisfaction with quality of life domain and its perceived importance. Additional approaches to studying response shift using group level comparison of SEIQoL data were critically evaluated. The thesis extends the methods for identifying, assessing and conceptualising response shift changes whilst also exploring mechanisms which may explain these changes.

This inquiry stems from my work as a psychological counsellor working in primary care. The late 20th century has seen an increasing focus on self and emotions (e.g. McCarthy 1989) with technologies such as psychotherapy and counselling (Rose 1999) as key means through which transformation of self takes place. The demand for therapeutic services continues to rise, and NICE guidelines (2004) recommend counselling as a treatment of choice in primary care, that is, in the surgeries of General Practitioners. Referral for counselling is for those with mild to moderate mental health problems (Cocksedge 1997), and counselling is offered typically for six to eight sessions. There is much research in the NHS concerned with evidence-based practice, whereas I sought to examine the client's voice with regard to their counselling, and how counselling fits within their life-world (Schutz & Luckman 1973). My aim was to gather accounts from people who had attended for counselling at their GP surgery. Using qualitative methodology, this was achieved via individual interviews with former clients. Following ethical approval, interviewees were recruited from 16 practices in South Wales. The focus is of client perceptions of counselling, examined through the ways in which the clients present themselves, their problems, and their counselling. The research questions are concerned with how former clients describe their counselling, and how client accounts can inform debates about how to enhance the delivery and practice of counselling in primary care settings. From the analysis of client accounts it can be seen that unique client factors, the diversity in interventions appreciated by clients, and contextual factors relating to the primary care setting, suggest that counsellors working in primary care be adaptive to their environment and sufficiently responsive to offer techniques and interventions from a range of therapeutic approaches, to best meet the needs of their clients.

Regulatory authorities in both developed and developing countries share the responsibility of ensuring the access of safe and effective medicines to patients however their structures, strategies, and practices vary significantly. The aim of this study was to evaluate the Gulf Cooperation Council (GCC) regulatory systems (Bahrain, Kuwait, Oman, Qatar, Saudi Arabia, United Arab Emirates (UAE) and Yemen) in order to develop a harmonised strategy. A questionnaire was designed and completed by the seven GCC authorities to provide details of their review process and the quality measures used to improve their assessment procedures. The Kuwait Drug and Food Control (KDFC) authority was assessed to identify areas for improvement in the system. Metrics for medicines approved for the private and government sectors were collected together with their patients' access time using data obtained from the authority's archives. Another questionnaire was developed to assess and compare the strategic planning processes of the regulatory authorities in the seven Gulf States. Both questionnaires were tested for applicability and practicality in the GCC region and a pilot study was conducted with two selected authorities, after which they were distributed for completion by senior managers in each of the seven GCC authorities. The results of the Kuwaiti regulatory system showed a significant decline (p < 0.001) in the number of medicines approved for the private sector from 180 to 129 products (2006 to 2009). In contrast, there was an increase in the number of medicines approved for the government sector from 22 to 48 products over the same period, but did not reach statistical significance (p > 0.05). Further analysis showed a significant decline (p < 0.001) in the patients' access time for New Active Substances (NASs) (26 to 11 months) and Existing Active Substances (EASs) (28 to 14 months) due to the enhanced political conditions and the improved performance of the authority. Furthermore, there was a significant decline in the registration time for government health supply (GHS) medicines from 10 to 7 months (p < 0.05) and for private sector medicines from 28 to 14 months (p < 0.001) over the same period. The comparative study of the seven Gulf States showed that Kuwait and Yemen carry out a verification assessment for all applications. Bahrain and Oman conduct an abridged review while Saudi Arabia and UAE perform a full review for the majority of their applications. Furthermore, the speed of the approval process in the GCC States depends on the types of products being registered (NASs or EASs), the quality of the submitted data, the level of interaction between the sponsor and the authority and whether parts of the review process are carried out in parallel or sequentially. Several GCC authorities lack the essential measures for conducting a quality review process such as Good Review Practice, assessment templates, Standard Operating Procedures and peer reviews. Finally, comparisons of the GCC strategic planning processes showed that the seven Gulf States shared common strategic parameters that can form a harmonised strategy, namely, the guidelines, SOPs, resources and Post-Marketing Surveillance (PMS). It is hoped that the findings of this study will help the GCC authorities to improve approval time for the registration of new medicines by fully engaging in the quality review practices. Such improvements will fulfil the GCC central drug registration goals and encourage the pharmaceutical industry to use the GCC centralised system which is a step towards successful harmonisation of the regional regulatory systems.

Although small-scale initiatives have taken place attempting to address the inequality in health of Gypsies and Travellers, these have had little impact nationally, being isolated and lacking impartial evaluation. Consequently, healthcare access and health status of UK Gypsy/Travellers remains very poor. This thesis is a multi-method evaluation of a complex intervention designed to improve the healthcare of Gypsies and Travellers in Wrexham. An ethnographic method was used providing both 'insiders' and 'outsiders' perspectives. Participant observations and a series of interviews with Gypsy/Travellers and service providers were undertaken, together with a study of Gypsy/Travellers' coronary and mental health status. The combination and interaction of these studies provide an overall evaluation of the community health initiative. Gypsy/Travellers' culture, lifestyle, health beliefs and experiences of healthcare are described. Gypsy/Travellers hold a strong sense of cultural identity and their lives are governed by strict rules and cultural expectations. To break the rules risks being ostracised from the community. Family life is all important and religion is fundamental to Gypsy/Traveller lives. Also, they experience wide spread discrimination which results in defensive, mistrust of non- Gypsy/Travellers. Gypsy/Travellers' CHD and mental health status have been described. Results suggest that they engage in higher CHD risk behaviours than the general population and high levels of depression and anxiety were found. The community health initiative consisting of a full-time Project Health Worker who provides an outreach service by means of a mobile health unit is described. The aim is to increase access to healthcare and develop culturally acceptable methods to improve CHD health of this group. The strengths and weaknesses of the initiative are explored and the complex interactions between culture, health and the initiative are discussed. Finally, several key elements are identified which contribute to the success of the initiative and the continuation of the initiative is discussed.