40% of residents living in care homes in the United Kingdom have significant depressive symptoms, compared with 9% living in the community. Care homes can appear to be depressing places, but whether the physical environment of homes directly affects depression in care home residents is unknown. The overall aim of the thesis was to establish whether the physical environment or specific features of the physical environment predict depressive symptoms in older people living in care homes. A mixed methods approach was used: 1. A systematic review was conducted to identify and evaluate instruments designed to measure the physical environment of healthcare settings and informed the choice of instrument used to measure the physical environment of care homes in an observational study. 2. Semi-structured interviews with 15 participants living in four care homes identified features of care home design that were considered important to investigate in the observational study and assisted with interpretation of the results. 3. An observational study explored the longitudinal relationship between the physical environment and depressive symptoms using data from an interventional trial among older people living in care homes. The physical environments of 50 care homes were assessed using The Sheffield Care Environment Assessment Matrix (SCEAM). Depressive symptoms were measured using the Geriatric Depression Scale (GDS-15) for 510 residents living in the care homes at baseline, six and twelve months. Multi-level modelling was used to analyse the data. Interviews revealed residents valued environments that increased opportunity for social interaction, maximised physical function, and allowed access to outdoor space. In the observational study the overall physical environment of care homes (overall SCEAM score) did not predict depressive symptoms. Care homes that scored highly on the SCEAM domain community weakly predicted lower depressive symptoms. Controlling for dependency (Barthel Index), social engagement (Index of Social Engagement) and home type (nursing/residential) ‘access to outdoor space’ predicted greater depressive symptoms. This finding initially appeared counterintuitive; however evidence from the interview study suggested access to outdoor space was restricted for residents in many different ways: locked doors, lack of paths, inadequate seating, steep steps, and needing permission or assistance of staff to go outside. Residents may have ‘free access to outdoor space’ but are prevented from using the outdoors for reasons that negatively affect their decisional autonomy and consequently their mood. The research provides evidence to support care home design that encourages social interaction and allows unrestricted access to outdoor spaces in order to positively influence mood in care home residents.

This thesis explores how men with mild to moderate learning disabilities perceive and experience how disability, relative poverty and gender impact on their health. Its theoretical framework grounded in analysis of these social divisions, and informed by the men’s own accounts - previously neglected in research, reveals complex challenges affecting their health on a daily basis. Consistent with the thesis’ overarching perspective, key elements of a participatory approach were adopted in the fieldwork to ensure men with learning disabilities’ active research involvement. They comprised the steering group, and twenty men participated in qualitative interviews facilitated by accessible materials and detailed preliminary preparations. The findings showed the men were aware of health issues, but were grappling with the adverse health effects of impairment, including disabilist health care and victimisation. Low income associated with limited employment confined most men to relative poverty with negative effects on health. The findings demonstrated a sharp appreciation of masculinity. Marginalised by other men, they experienced health threatening abuse, but their resistance to conventional male disregard for health care, had positive implications for their health. The thesis provides a more informed, nuanced understanding of the adverse impact of different dimensions of social disadvantage on the health of men with mild to moderate learning disabilities. In doing so, it demonstrates the value of developing knowledge grounded in their perspectives and experience.

There is evidence that sedentary behaviour and breaks in sedentary time, independent of physical activity levels, influence human health. In order to explore this relationship, accurate and validated measurement instruments are required. Such tools are also required for exploring the effects of factors such as the differences in sedentary behaviour between groups, e.g. overweight/obese vs. healthy weight children. One promising instrument for making such measurements is the activPAL™ monitor. This is an event-based accelerometer with inbuilt inclinometer, and it may be more accurate for the measurement of sitting time and breaks in sitting than earlier instruments. An important setting in the monitor depends on the time required to define a new posture – the minimum sitting/upright period (MSUP). At present, the optimum activPAL™ MSUP setting is not known, particularly for children, who are likely to change posture faster than adults. This thesis includes four studies: Study 1 (Chapter 3): Using the activPAL™, we investigated the effect of variations in MSUP on total sitting time and breaks in sitting. Methods: Study 1a: In this in vitro experiment, the activPAL™ monitor was turned from a horizontal position to a vertical position manually (by hand) to simulate 5 sitting bouts. The length of the sitting time was varied from 1s to 10s. The number of the true events (i.e. 50) and the data from the activPAL™ (the number of sitting bouts for each bout length) was compared and represented in a graph. Study 1b: in data collected from children in a free-living environment (23 children (mean (SD) age 4.5yrs (0.7)) who wore the activPAL™ (24 hr/d) for 5-7d), we varied the setting of the MSUP. For each child, we calculated the following measures of sitting behaviour: volume (total time in sit/lie postures); number of breaks (number of sit/lie to stand transitions); number of sitting bouts (number of discrete periods spent sitting/lying); and pattern of accumulation of sitting (represented by accumulation curves and fragmentation index). We first studied the activPAL™ using the default setting of 10s MSUP, and then reduced this to 5s, 2s, and 1s. Results: Study 1a: the analysis software did not count sitting bouts of a shorter duration than the user defined MSUP in the new posture. For example, the sitting bouts with a period less than 10s were not counted when we used the activPAL™ setting of 10s MSUP. Study 1b: Comparing settings of 10, 5, 2, and 1s, there were no significant differences in total sitting time (6.2 hr (1.0), 6.3 hr (1.0), 6.4 hr (1.0), and 6.3 hr (1.6), respectively) between settings, but there were significant increases in: the apparent number of breaks - 8(3), 14(2), 21(4), and 28 (6)/hr) total number of bouts (118(18) vs 382 (80)); and Fragmentation Index (19.3 (3.7) vs 61.6 (16.4)), with a reduction in 50% bout length from 80s (14.7) to 42s (7.7) at 10s and 1s setting, respectively. Conclusion: With the activPAL™, breaks in sitting, but not total sitting time, are highly sensitive to the setting of the MSUP. Additional studies will be required to confirm these findings and to define the most appropriate MSUP for different age groups. Simple measures can characterise sitting behaviour in young children using the activPAL™. Study 2 (Chapter 4): Posture transitions are likely to be much more rapid in young children than in adults. We investigated the optimum activPAL™ setting of MSUP to define a change in posture for measurement of sitting time and breaks in sitting (not previously known). We evaluated the validity of different minimum event duration settings against direct observation as the criterion method. Methods: In a convenience sample of 30 pre-school children (mean age 4.1yrs (SD 0.5)), we validated the activPAL™ measures of sitting time and breaks in sitting at different MSUP settings against direct observation. Results: In comparison with direct observation, a 2s setting had the smallest error relative to direct observation (95% limits of agreement: -14 to +17 sitting bouts/hr, mean difference 1.83, p = 0.2). Conclusion: For pre-school children, 2s appears to be an appropriate MSUP to define breaks in sitting using the activPAL™. Study 3 (Chapter 5): The identification of risk factors for obesity is considered key to obesity prevention. Differences in time sitting compared to standing have been observed in obese and non-obese adults. Whether such differences are present between obese and non-obese children has not yet been examined. In a pilot study, we investigated differences in sitting behaviour between overweight/obese and healthy weight children. Methods: Overweight/obese children were recruited from weight management and dietetic clinics, the Active Children Eating Smart programme, and from three primary schools, while healthy weight children were recruited from schools. The participants wore the activPAL™ (24 hr/d) for 5-7d. During waking time, the time spent sitting, number of sitting bouts, the 50% and 90% sitting bouts length, and the Fragmentation Index were measured in both groups using the activPAL™ with a 2s MSUP setting. Results were available for 26 healthy weight children (mean age 6.4yrs (SD 0.9), median BMI Z-score 0.04 (range -3.24 - 0.66)) and 13 overweight/obese children (mean age 6.4 yrs (SD 0.9), median BMI Z-score of 1.38 (range 1.14 - 3.10). Results: In healthy weight children during the waking hours, the mean (SD) percentage of waking time spent sitting was 53.0 % (6.4) representing 6.8 hrs (0.9) per day; mean (SD) total number of sitting bouts per day was 280 (65). The median (range) of 50% and 90% of sitting bouts were ≤50.0s (40.0-50.0) and ≤3.5 min (2.0-6.0), respectively. The mean (SD) Fragmentation Index was 42.1(12.7). In the 13 overweight/obese children, the mean (SD) percentage of waking time spent sitting was 52.4% (5.2), representing 6.9 hrs per day (SD 0.8). The total number of sitting bouts was 284 per day (66). The median (range) of 50% and 90% of sitting bouts length were ≤50.0s (40.0-50.0) and ≤3.5 min (3.0-6.0), respectively. The mean (SD) Fragmentation Index was 41.5 (9.6). Conclusion: Both healthy weight children and overweight/obese children in this study spent the majority of their waking time sitting. Furthermore, there were no significant difference in the sitting time, number, or duration of sitting bouts and the Fragmentation Index between the two groups in this study. Study 4 (Chapter 6): Previous studies have shown differences in the total sedentary time between boys and girls using accelerometers where sedentary behaviour was defined as low movement or low energy expenditure. In the present study, we examined whether there were also differences in breaks in sitting time. Methods: A convenience sample of 62 (32 girls: 30 boys) free-living healthy children (mean age 5.8yrs (SD1.3)) was recruited from nurseries and schools in Glasgow and Edinburgh, Scotland, who each wore the activPAL™ monitor continuously for 5–7 days. For each child, the components of sedentary behaviour were measured. Results: The percentage of waking time spent sitting was significantly higher in girls, the mean (SD) (54.4% (5.6)) compared to boys (50.9 (5.6)), (2-sample t-test, p-value <0.02). The total sitting time in girls vs. boys respectively per day was 6.9 (0.8) vs. (6.5) (0.9), (p-value <0.08). There were no significant differences in the number of sitting bouts, Fragmentation Index, or in 50% and 90% sitting bout length between girls and boys. Conclusion: This study suggested that girls spend more time in sitting than boys. However, there were no significant gender differences in the number or duration of sitting bouts. Summary Conclusion: These studies have validated the activPAL™ as an instrument for measuring breaks in sedentary time in young children, and have established appropriate settings for making accurate measurements in this age group. Using these monitors to explore differences between obese and non-obese children, and between boys and girls, we found that, while there were differences between boys and girls in the total sitting time, there were no differences in the number of breaks between girls and boys, or between obese and non-obese children. These studies suggest that the activPAL™ may be useful to identify between group differences in sitting time and sitting fragmentation in future studies.

Antimicrobial resistance is an international public health problem and is associated with increased morbidity, mortality, and healthcare costs. Antibiotic consumption, particularly indiscriminate use of these agents, is recognised as a major cause of resistance. Clinical guidelines recommend that in otherwise healthy individuals, antibiotics should not be used in the management of acute dental conditions, in the absence of spreading infection and systemic upset. Instead, a surgical intervention should be the first-line treatment for such problems. This thesis describes the use of antibiotics for acute dental conditions in primary care in the UK, and explores factors that influence prescribing for dental problems using a mixed methods approach.

Globally malaria still remains the most important parasitic disease of public health interest. In the recent past, most endemic countries have deployed and scaled up both preventive and curative interventions to reduce malaria transmission and, ideally, eliminate it. This has lead to global reductions in both mortality and incidence of malaria. These declines have been attributed to the reinvigoration of the global malaria control agenda by the explicit ambition of achieving elimination, which has lead to an increase in funding for national control programmes to increase coverage of preventive interventions, field compatible diagnostic tools for confirming parasite infection, and increased access to effective treatment. As a result of declines in malaria transmission, the focal nature of malaria transmission has become much more evident and has lead to consideration of surveillance as a key intervention for malaria control/elimination in its own right. Surveillance systems have been well established in most formal health facilities but the incorporation of these systems at community level and operationalised by community health workers (CHWs) still remains limited. Additionally, these few examples of CHW-implemented surveillance systems have been typically only reporting indicators of malaria infection burden, without capturing indicators of intervention availability, deployment, coverage and utilisation, thus representing a missed opportunity for routine monitoring and evaluation of impact of interventions in “real time” to inform program planning and implementation. The study was established as part of a multi-country study under the Malaria Transmission Consortium Project whose primary objective was to develop and evaluate new or improved methods for measuring malaria transmission. Thus the overall goal of this study was to demonstrate how malaria transmission, and impact of interventions, could be routinely measured through a novel longitudinal community based surveillance system (CBSS) operationalised by modestly paid CHWs. The CBSS included both passive and active surveillance activities using field – compatible test kits for in situ parasitological detection of malaria infections, based on which confirmed cases were treated with anti-malarial drugs, coupled with a detailed questionnaire on access and use of malaria control interventions and population characteristics. Passive surveillance was achieved conventionally whenever community members self-reported to the CHWs and active surveillance was achieved through monthly active visits to all households in their catchment populations to offer testing and treatment. In addition to recording detailed details of each patient contact in a paper patient register, weekly summaries of selected data elements were submitted by the CHWs using a mobile phone platform via short messaging system (SMS). The detailed reference data recorded in the patient register was then used to monitor malaria infection dynamics in the study population, evaluate the impact of preventative measures, such as indoor residual spraying (IRS) and long-lasting insecticidal nets (LLINs) and validate the electronic summaries submitted via SMS. Overall, the CBSS did not routinely capture all malaria infections in the study population and was insufficient to eliminate the human parasite reservoir. This was primarily due to limited study participant participation with the monthly active testing and treatment offered by the CHWs. However, the CBSS clearly demonstrated the incremental and residual impact to supplementation of pyrethroid-treated LLINs with non - pyrethroid insecticides applied by IRS in areas where the dominant malaria vector is highly resistant to pyrethroids. The adequacy of the SMS reports submitted by the CHWs confirms the great potential of mobile phone technology for facilitating and improving the effectiveness of community based reporting. Despite its limitations, the CBSS successfully provided programmatically relevant information regarding malaria infection dynamics across the large study area at a very affordable cost. The CHWs demonstrated their ability to not only provide treatment services but also adequately report their findings both electronically and on paper. CHWs are primarily tasked with providing routine health services at community level but clearly also have a valuable auxiliary role to play in “real time” surveillance of malaria, and most probably a range of other diseases. If the full potential of CHWs as agents of health surveillance can be realized, control programme progress can be measured through spatial and temporal mapping of transmission with greater sensitivity and at finer scales than is possible with health facilities alone, to enable improved, better-informed program planning, resource allocation and implementation.

The idea of cross-boundary clinical decision support has the potential to transform the design of future work environments for e-health through a connected healthcare system that allows for harnessing of information and peer opinion across geographical boundaries for better decision-making. The trouble, however, is that the use of healthcare information in decision-making usually occurs within the context of a complex structure of clinical work practices that is often shaped by a wide range of factors, including organisational culture, local work contexts, socially constructed traditions of actions, experiences and patients’ circumstances. They vary across geographical boundaries, and have remained largely unaccounted for in the design of current e-health systems. As a result, achieving the visions of e-health, particularly in relation to cross-boundary clinical decision support, requires a rethinking of key clinical and organisational processes in a manner that accommodates work practice as a fundamental part of how clinicians work and make decisions in the real-world. This thesis investigates the concept of work practice as a design requirement for cross-boundary clinical decision support systems in e-health. It is argued that the task of enabling informed decision support across geographical boundaries in e-health can be enhanced through an understanding, and a formal characterisation, of work practices in various healthcare work contexts, and a specification of how practice can be used, managed and transformed to suit various clinical problem situations and patients’ needs. This research takes a clinical practice-centred approach to inform e-health system design, and draws on the concept of work practice and cultural-historical theory in social science as well as situation awareness in order to describe the local traditions of actions that guide clinicians’ work in the real world. It contributes a coherent conceptual architecture comprising a practice-centred awareness model for cross-boundary awareness, a frame-based technique, named PracticeFrame, for formalising and representing work practice for system design, and ContextMorph, for adaptively transforming a suggestion across work boundaries to suit a user’s local work context and practices. An in-depth user-informed requirements capture was used to gain an understanding of clinical work practices for designing e-health system for cross-boundary decision support. A proof of concept prototype, named CaDHealth, which is based on the Brahms work practice modelling tool and includes a work practice visualisation model, named the practice display, was developed and used to conduct user-based evaluation. The evaluation revealed that incorporating practice-centred awareness enhances usefulness, acceptance and user adoption of e-health systems for cross-boundary clinical decision support.

Introduction In this thesis, analytical approaches for the design and evaluation of cluster randomised trials are presented and reviewed. In particular, statistical power/sample size issues relating to the design of cluster randomised trials for which only a limited number of clusters are available are assessed using a series of simulation studies. The use of computer simulation methods made it possible to investigate how well cluster randomised trials with limited numbers of clusters available can be optimised both in terms of statistical power and also the accuracy of parameter estimates. The study design conditions performing best in the simulation studies were then applied to a community intervention study involving informal healthcare providers: the 'Triage Plus integrated tuberculosis (TB) and human immuno-deficiency virus (HIV) community intervention project in Lilongwe rural, Malawi'. Aims and objectives The general aims of this dissertation were to: 1. investigate if it is possible to improve the analytical approach to the evaluation of cluster-randomised trials where the complexity of the intervention demands a small number of clusters and in which the primary outcome measure is a count of events occurring in a specified time interval; 2. investigate the effectiveness of engaging informal healthcare providers in integrated TB and HIV community intervention in treatment initiation rates and testing access rates, a cluster randomised trial was conducted in Malawi for which only a limited number of clusters were available to the researchers. The specific objectives were: 1. to review cluster randomised trials and the statistical methods used in the assessment of the effectiveness of the intervention in this type of trial when the primary outcome measure is a count of events occurring in a specified time interval; 2. to assess the statistical efficiencies of different design conditions in terms of statistical power and the accuracy of parameter estimates when determining the effectiveness of complex interventions with a limited number of clusters in this situation; iii 3. to identify the circumstances under which each of the statistical methods would be most robust in detecting significant intervention effects or providing accurate estimates of intervention effects; 4. to apply these statistical approaches to the data collected in the cluster randomised clinical trial of community based interventions for TB and HIV (the 'Triage Plus' study); 5. to assess the effect of involving non-paid informal healthcare providers in integrated TB and HIV community interventions aimed at improving testing and treatment initiation rates for these two diseases. Methods Two research approaches were used in this dissertation: 1. Simulation studies were used to investigate statistical efficiencies in terms of statistical power and accuracy in parameter estimation under different study design conditions for cluster randomised trials in which the primary outcome measure is a count of the number of events occurring during a specified period of time. 2. These statistical approaches were then applied to obtain robust estimates of the effect of the test intervention using the data collected during the “Triage Plus” study. The Triage Plus intervention, implemented in rural areas of Lilongwe, involved informal healthcare providers in an integrated TB and HIV community intervention. This intervention specifically involved empowering the informal healthcare providers in disease recognition, sputum specimen collection, referral of presumptive TB cases, and conducting community TB and HIV awareness meetings. Results The simulation studies showed that statistical efficiency and power both varied considerably under the different design conditions investigated. Non-coverage rates within the nominal value of 5% and negligible biases in the estimated fixed effects parameters (regression coefficients) were observed for all scenarios investigated including the (minimal) 3 cluster per arm design. However, it was discovered that, in order to achieve adequate power in low incidence disease conditions such as TB treatment initiation rates, more repeated measurement times were required to achieve adequate power of 80% with a true effect size of 20% or lower (for example, 12 measurement times were needed to achieve adequate power in this situation in a 3 cluster per arm design when the ICC was 0.00154). With an ICC of 0.081 iv at least 9 clusters were needed to achieve adequate statistical power of ≥80% with an effect size of 20% with 6 and 12 measurement time points respectively for high and low incidence disease conditions. For an effect size of 40%, at least 3 clusters per arm were needed to achieve adequate power with 4 repeated measurement times in low incidence diseases and 3 measurement times for high incidence diseases. For ICCs of 0.321 and above, no adequate statistical power was achieved with an effect size of ≤40% in both high and low disease incidence conditions. In the analysis of the TB services access data from the Triage plus study, the intervention significantly increased the number of presumptive TB cases accessing testing sites by 15.2% (p=0.003) in the first 12 months of the intervention; however, this was followed by a statistically non-significant reduction of 18.3% (p=0.224) when the intervention was rolled-out into the control clusters. Overall, the intervention was associated with a non-significant increase in TB treatment initiation rates of 18% (p=0.112). In the analysis of HIV services access rates, antiretroviral therapy (ART) initiation rates increased significantly by 34.7% (p=0.048) in the intervention clusters in the first 12 months of intervention, and the ART initiation rates were similar after rolling-out the intervention to the control clusters. Overall, the intervention was associated with a 61% increase in HIV testing uptake rates (p<0.001). Conclusion: To achieve adequate statistical power and improved precision in parameter estimation in cluster randomised trials with a count outcome measure, with the ICC of 0.00154 the simulation results suggested that a minimum of 3 clusters per arm is required with at least 12 measurement times for the estimation of an effect size of 20% (or higher) in low incidence disease situations. However, for high incidence outcomes, a minimum of 3 clusters per arm with 3 or more measurement times may be adequate to achieve a statistical power of at least 80%. For an ICC of 0.081, at least 3 clusters per arm were needed to achieve adequate power if the effect size was 40% after 4 repeated measurement times in low incidence diseases and 3 measurement times for high incidence diseases. With ICCs of 0.321 and above, no adequate statistical power was achieved with an effect size of ≤40% in both high and low disease incidence conditions. For the TB and HIV interventions in the “Triage Plus” study, engaging informal health care providers was clearly effective in improving TB and HIV testing uptake as well as ART v initiation. This reinforces the need for community participation in integrated TB and HIV interventions to combat the two diseases. However, for these providers to be effective in promoting TB treatment initiation, the number of sites offering TB testing and treatment initiation in rural areas should be increased to make them more accessible to the population.

Introduction: Speech and language therapy (SLT) is purported to be a scientifically-based discipline. A commitment to scientific practice is currently best represented by practicing in an evidenced-based way, specifically by the use of research evidence, yet studies examining the use of research evidence both within the profession and across disciplines, consistently suggest that research is less than influential in guiding practice decisions. This suggests practice may not be scientific. Furthermore, unscientific practice may be represented by the use of pseudoscientific and / or non-scientific therapies. Aim: The aim of this research was to explore professional knowledge and decision-making scaffolds in SLT clinical practice with special attention paid to scientific underpinnings. The intention was to gain an authentic understanding of the role of science in practice and thus, a deeper appreciation of the nature of SLT practice. Methodology and Methods: A mixed-methodology approach was undertaken targeting SLTs working in Ireland. The initial quantitative phase consisted of an electronic survey (n=271) focussing on therapy choices in disability and dysphagia, reasons for use and non-use of these therapies, and factors influencing decision-making. The subsequent qualitative phase utilised three focus groups (n = 48). Group one consisted of SLTs working in a disability setting, group two of SLTs working in an acute hospital setting and group three of SLTs working in a community setting. Data were analysed using a variety of techniques including descriptive statistics and inferential statistics for the survey data, and thematic analysis for the focus group data. Results: The therapies SLTs always-use in both areas of practice represent limited approaches to intervention. In disability, practice is effectively represented by seven high-use predominantly augmentative and alternative communication therapies; in dysphagia the three high-use therapies are mainly bolus modification techniques. A limited range of reasons explained use. Across all areas of practice and all therapies and techniques, client suitability and clinical experience dominated as the main reasons interventions were always used. The principal reasons for not using therapies were lack of training, lack of knowledge and lack of suitability. A clinical lifespan is suggested with early-years clinicians being most dependent on external sources, specifically colleagues, to inform decision-making. Clinicians in the middle years of their careers appear more autonomous while those in the later years appear to branch out to external sources again, most specifically research evidence. Disability and dysphagia clinicians are significantly different in their use of all reasons for use and non-use with the exception of clinical experience. Scientific reasons are not well represented in either area of practice. Moreover, there is an apparent disconnect between attitudes and practice. For example, respondents demonstrate clear research values generally but not when therapy-specific reasoning is explicated. Three main themes were identified from focus group data: practice imperfect; practice as grounded and growing, and; critical practice. Practice as defined by clinicians is grey-zoned, eclectic, experimental, developmental and pragmatic, being primarily pivoted upon a clinician’s tool bag and experimental practice. This tool bag is composed predominantly of population-specific experience and facilitates the clinician to construct individualised interventions. Clinicians demonstrate scientific thinking but do not automatically reference scientific scaffolds unless explicated. Conclusion: Clinical practice is narrowly defined being predominantly scaffolded upon a limited range of therapies and case evidence and practical evidence. Practice is also constructed by SLTs as experimental and flexible. Scientific practice as characterised by research evidence is not evident in this study, however clinicians may operate scientifically through the use of scientific behaviours including experimentation, trial and error and on-going learning. This understanding of practice has implications for the dominant model of evidence-based practice.

Background: Problems with acceptability of healthcare interventions can undermine the validity of randomised evaluation studies. Hence, assessing acceptability is an important methodological issue. However, the research literature provides little guidance on how to define and assess acceptability. Acceptability of a healthcare intervention could be different, depending on the perspective taken: patients and healthcare professionals may have different views. Perceptions of acceptability may also change according to when acceptability is assessed, in relation to a person’s engagement with the intervention. A person can have perceptions about prospective acceptability (i.e. prior to taking part in the intervention); concurrent acceptability (i.e. whilst taking part in the intervention) and retrospective acceptability (after participating in the intervention). Objectives: The overall aim of this programme of research was to define acceptability in the context of healthcare interventions and to develop a Theoretical Framework of Acceptability (TFA) that can be applied to assess acceptability from two stakeholder perspectives: healthcare professionals and patients. The specific objectives were to: 1) Identify, from the published literature, how the acceptability of healthcare interventions has been defined, operationalised and theorised; 2) Theorise the concept of acceptability and develop a theoretical framework of acceptability (TFA) to guide assessment and develop preliminary assessment tools; 3) Use the tools to apply the TFA to assess intervention acceptability qualitatively, and 4) Apply pre-validation methods to develop preliminary versions of two TFA-based questionnaires. Methods: Six studies were conducted: 1. A systematic overview of reviews of published studies to investigate how the acceptability of healthcare interventions has been defined, theorised and assessed. The results of this study formed the basis for study 2. 2. Inductive and deductive methods of reasoning were applied to theorise acceptability and to develop the Theoretical Framework of Acceptability (TFA). 3. Semi-structured interviews with eligible participants who declined to participate in a Randomised Controlled Trial (RCT) comparing a new patient-led model of care with standard care, for managing blepharospasm and hemifacial spasm. The TFA was applied to identify whether participants’ reasons for refusal were associated with prospective acceptability of the intervention or with other factors. 4. Application of the TFA to analyse semi-structured interviews to assess healthcare professionals’ retrospective acceptability of two feedback interventions delivered in a research programme aimed at developing and evaluating audit and feedback interventions to increase evidence-based transfusion practice. 5. An extension of Study 3: semi-structured interviews with patients who agreed to participate in the RCT, at three-month follow-up, to assess patients’ concurrent acceptability of the standard model of care and the patient led model of care for managing blepharospasm and hemifacial spasm. 6. Pre-validation methods were applied to develop two TFA-based questionnaires applicable to the RCTs described in Studies 3, 4 and 5. Results: Study 1: acceptability had not been theorised and there was no standard definition used in the literature. Operational definitions of acceptability were often reported and often reflected measures of observed behaviour. Study 2: proposed definition: Acceptability is a multi-faceted construct that reflects the extent to which people delivering or receiving a healthcare intervention consider it to be appropriate, based on anticipated or experienced cognitive and emotional responses to the intervention. The TFA was proposed as a multi-component framework that can be applied to assess intervention acceptability across three temporal perspectives: prospective, concurrent and retrospective. The TFA consists of seven component constructs: Affective attitude, Burden, Ethicality, Intervention Coherence, Opportunity Costs, Perceived Effectiveness and Self-efficacy. Studies 3-5: It was feasible to apply the TFA in these empirical studies. Study 6: Two acceptability questionnaires were developed; the TFA informed the development of items reflecting the seven component constructs of the TFA. Conclusion: Despite frequent claims that the acceptability of healthcare interventions has been assessed, acceptability research could be more robust. Investigating acceptability as a multi-component construct resulted in richer information about the acceptability of each intervention, and suggestions for enhancing intervention acceptability across three temporal perspectives. The TFA offers the research community a systematic and theoretical approach to advance the science and practice of acceptability assessment for healthcare interventions.

There is a paucity of research into the effect of stress on the dietary behaviour of undergraduate students in non-western societies, particularly middle-eastern countries. This is in spite of the seeming importance of culture and ethnicity as potential moderating factors of the stress- diet relationship. Consequently, there is limited knowledge and understanding of the factors that influence the stress-diet relationship in these societies. The aim of this study was to investigate the effect of academic stress on the dietary behaviour of female undergraduate students in King Abdul-Aziz University in Saudi Arabia and how it is influenced by the lifestyle choices and coping strategies adopted by students. A longitudinal survey of a convenient sample of undergraduate students was carried out using several instruments. These included a self-completed questionnaire (to collect data on socio-demographics, lifestyle choices), Perceived Stress Scale (PSS14), Brief COPE instrument, and 24hour recall interviews. Data were collected when no examinations were scheduled (T1), and again during examinations (T2). The participants were drawn from the female undergraduate student population in six different faculties at the university with a median age of 21.6 years. 491 participants were recruited to the study (T1), of whom 322 completed the follow-up study (T2) during the examination period. The results showed that students reported significantly higher levels of stress during examinations (p < 0.001) and that age and smoking were the two discriminating factors of students’ perception of stress. The analysis of food data revealed that there wasn’t a significant difference in the nutrient intake of students during (T1) and (T2). Nonetheless, results showed that during examinations the frequency of food intake was significantly lower (t(320) = 6.195; p=0.001), as with fast food intake (t(320) = -3.439; p=0.001). Whereas the intake of healthy food by students who reported significantly higher levels of stress decreased significantly. The study results also indicated that students reported significantly higher emotion focused coping scores (t (321) = 4.559; p < 0.001) during examinations. The findings from this study corroborate existing evidence linking changes in eating behaviour with the increased use of emotional coping strategies. The research equally identified concerns about body image and weight gain as other possible moderators of changes in the frequency of food intake by students during examinations. The key indicators of these concerns include students stated desire to lose weight, actively taking actions to lose weight, skipping meals and self-reported ideal BMIs less than their current BMI. Future work would be usefully directed towards investigating further the paradox between observed increase in emotional coping and reduced frequency in food intake. The influence the food environment (both availability and cultural values) and its impact on dietary behaviour during high stress periods should be explored further.