Background: Inability to retain participants in a clinical trial poses a threat to clinical research as it can lead to a number of issues ultimately affecting generalisability, validity and reliability of the study. Patients with schizophrenia have been reported as particularly difficult to engage and retain in research and psychiatric treatment. This thesis aimed to improve the current understanding of the retention of people with schizophrenia in trials evaluating complex interventions. Methods: This thesis adopted a mixed method design. Quantitative methodology was used to identify the scale of attrition and to explore potential predictors of dropout. This included a systematic review and meta-analysis and a separate meta-analysis of individual patient data. Qualitative methodology was used in two studies to explore the perspectives of both trial staff and former trial participants on the factors important for retention and effective practices and strategies. Results: The results of the systematic review and meta-analysis demonstrated the rates of dropout from studies to be higher than from experimental interventions. Dropout from interventions significantly increased as the number of intervention sessions increased. The individual patient data meta-analysis found retention to be higher at the final follow-up assessment than at the penultimate one. The effect of arm allocation almost reached statistical significance pointing to the possibility of participants in the active arm having higher odds of completing the final follow-up than those in the control arm. Two qualitative studies identified barriers and facilitators to retention related to factors related to participant, researcher, study, and wider context. Some of the identified barriers were specific to schizophrenia. Conclusion: Attrition is a phenomenon that should be anticipated by trialists and prevented with the use of multiple strategies. The extent to which dropout can be minimised depends on a number of factors associated with the participant, researcher, study, and context.

Background Hay fever is typically poorly managed, particularly in adolescents, in whom it is responsible for considerable morbidity and impairment in educational performance. Evidence-based training of professionals has the potential to improve outcomes, but it can be expensive and so warrants formal evaluation. This trial sought to evaluate the effectiveness of a training intervention for primary care-based health care professionals on adolescent disease-specific quality of life. Methods A cluster randomised controlled trial was conducted in UK general practices. Practices were centrally randomised to a short, intensive training course on the evidence-based management of hay fever (intervention arm) or distribution of guidelines (control arm). The primary outcome measure was the change in the validated Rhinoconjunctivitis Quality of Life Questionnaire with Standardized Activities (RQLQ(S)) score in adolescents with hay fever between baseline and six weeks post-intervention (minimal clinically important difference = 0.5). Secondary outcome measures included health care professionals’ knowledge and confidence in managing hay fever, number of hay fever-related consultations, relevant treatments prescribed and symptom scores. Multi-level modelling using a random effects model was used to take account of between and within cluster variation, adjusting for strata, individual covariates and year of study. Results Thirty-eight general practices were randomised (20 in the intervention arm) and 246/341 patients (50.2% male, mean age 15 years) were included in the primary outcome analysis. Health care professionals’ self-assessed knowledge and confidence improved (prescribing/recommending treatment mean score 95% CI 1.4, 2.8), and the training was perceived to be of value. This did not however result in clinically or statistically significant improvements in RQLQ(S): -0.15, 95% CI -0.52 to +0.21. There were no differences in consultation frequency (95% CI -0.02, +0.63), treatments issued for hay fever (95% CI -0.24, +0.08) or symptom scores (95% CI - 1.03, +0.54). Conclusions Although attendance on this short, intensive hay fever training course was associated with professionals’ increased self-assessed confidence and understanding of the clinical management of hay fever, this did not translate into improvements in disease-specific quality of life or reduction in rhinitis symptoms in adolescents with hay fever.

Yes / The Pillar Integration Process was developed to facilitate integration of mixed method data, but there is limited historical application of this approach in complex intervention evaluation. To test the applicability of the technique, this paper presents two case studies examining the efficacy of a workplace intervention. The research included a pilot RCT and process evaluation. The case studies illustrate the benefits of applying the Pillar Integration Process to elicit a comprehensive understanding of intervention efficacy and to design better interventions. This paper contributes to the mixed methods research by advancing the technique through considering inherent philosophical assumptions, and evidencing the value of integrating methods within, as well as across, “qualitative” and “quantitative” categories. / Macmillan cancer support part-funded this research and were one of the participating organizations. Ergotron Inc. provided 25 sit-stand desks for use within this research. The research formed part of the lead author’s PhD study, which was funded by a School of Sport and Education, Brunel University London, PhD bursary.

Background: Having a diagnosis of schizophrenia is associated with employment difficulties, high mortality rates, substantial family burden and impoverished quality of life and it costs between 1.5 to 3 per cent of the total expenditure on national health care (Knapp et al 2004). However social functioning and participation can have a protective impact on mental health of people with a diagnosis of psychosis (Stain et al 2013). Method: A systematic and phased approach to complex intervention development was undertaken involving: (1) A systematic review of effectiveness and (2) a feasibility study, designed to explore and test the key uncertainties of an effectiveness study, was conducted in two phases. This involved the development of an occupational therapy intervention specification and a feasibility study for a pragmatic randomised controlled trial (RCT). It utilised the Developing and evaluating complex interventions guidelines (MRC 2008). A task analysis approach was applied to extrapolate occupational therapy theory, practice and outcomes for the intervention specification (Gitlin 2013). The feasibility study was carried out across two centres. It used the intervention specification and included both study and process outcomes. The primary outcome was participation in activities of everyday life and the secondary outcomes were health-related quality of life and self-reported experience of occupational performance and satisfaction with occupational performance. Service user and carer involvement was integrated into the method. Results: The systematic review highlighted that there was no evidence of effectiveness for individualised client-centred occupational therapy interventions on participation in activities of everyday life or quality of life/ health related quality of life. The methodological quality of the effectiveness studies was generally low and details provided regarding interventions made replication difficult. The feasibility study recruited less people (n=20) than planned (n=64). However the outcomes of self-reported experience of occupational performance (p=.002) and satisfaction with occupational performance (p=.001) and self-evaluated transition (SET) (p=.026) improved with occupational therapy and were found to be statistically significant (p < .05). The intervention specification captured 98% of occupational therapy provided and was shown to have good utility for research and practice purposes. Conclusion: An intervention specification that reflects practice and has utility has been developed. Methods of measuring fidelity and adherence of occupational therapy have been designed and tested. Knowledge about how occupational therapy enables participation has advanced. The essential preparatory work to address the previously key uncertainties in a pragmatic RCT has been completed and the foundations for the next stage — a larger pragmatic RCT — have been put in place.

This doctoral thesis presents the findings of a mixed methods case study of Learning Skills, a new approach to Learning to Learn that was developed and implemented at a secondary school in the south of England between 2010 and 2014, and evaluated using data collected between 2009 and 2017. Learning to Learn is a field of educational theory and practice that aims to help young people get better at learning by focusing on the processes of learning (the how as well as the what), and by enabling them to take ownership over aspects of their own learning through activities such as goal setting, self-monitoring and structured reflection. The field has developed significantly throughout the last 40 years, with a number of approaches having been implemented on a large scale in the UK. Research into metacognition and self-regulation suggests that Learning to Learn programmes should help boost academic attainment. To date however, large-scale evaluations have found mixed results, with no clear impact on academic attainment. Using an intervention design used widely in medicine and other fields, Learning Skills reconceptualises Learning to Learn as a 'complex intervention' comprised of multiple areas of evidence-informed practice. The rationale for complex interventions is that the marginal gains emerging from any individual avenue of practice stack up and interact to yield a larger effect size overall. The Learning Skills programme, which started as a year seven taught course and developed into a whole-school approach to teaching and learning, focuses centrally on three key concepts: metacognition, self-regulation and oracy. This evaluation of Learning Skills incorporates eight strands of data collection and analysis over an eight-year period, using the previous year group at the same school as a control group. These include baseline measures; attitude to learning scores; psychometric questionnaires; a language of learning evaluation; reflective learning journals; student interviews; teacher interviews; and student attainment across all subjects in years nine and 11. The primary outcome analysis - student attainment across all subject areas at three and five years - found that Learning Skills cohort one achieved significantly higher grades than the control cohort, with accelerated gains among young people from economically disadvantaged backgrounds. Secondary data analysis incorporating a range of qualitative and quantitative methods indicates a causal relationship between Learning Skills and academic attainment. As well as evaluating the impact of a new and promising approach to Learning to Learn, this study generates new knowledge about the implementation and evaluation of complex interventions in education.

Yes / Background: Experience-based co-design (EBCD) brings patients and staff together to co-design services. It is normally conducted in one organization which initiates and implements the process. We used the traditional EBCD method with a number of adaptations as part of a larger research study in the British National Health Service.Methods: The primary aim was to assess the feasibility and acceptability of conduct-ing research-initiated EBCD, to enhance intervention development prior to testing. As well as embedding the method in a research study, there were 3 further key adap-tations: (a) working across primary and secondary care sectors, (b) working on multi-ple sites and (c) incorporating theory-informed analysis.Results: We recruited four sites (covering both primary and secondary care) and, on each site, conducted the initial traditional EBCD meetings, with separate staff and patient groups—followed by a single joint patient-staff event, where four priority areas for co-design were agreed. This event was driven by theory-informed analysis, as well as the traditional trigger film of patient experiences. Each site worked on one priority area, and the four co-design groups met over 2-3 months to design prototype tools. A second joint event was held (not usually undertaken in single-site EBCD) where they shared and compared outputs. The research team combined elements of these outputs to create an intervention, now being tested in a cluster randomized controlled trial.Conclusions: EBCD can be successfully adapted for use across an entire patient pathway with multiple organizations and as part of a research process to identify an intervention for subsequent testing in a randomized trial. Our pragmatic approach used the patient experience to identify areas for improvement and co-designed an intervention which directly reflected patient priorities. / National Institute for Health Research programme ‘Improving the safety and continuity of medicines management at care transitions (ISCOMAT)’ RP‐PG‐0514‐2009.

Background: Goal setting is accepted ‘best practice’ in stroke rehabilitation however, there is no consensus about what the key components of goal setting interventions are, how they should be optimally delivered in practice and how best to involve stroke survivors in the process. This PhD by publication describes the development and initial evaluation of a theory-based goal setting and action planning framework (G-AP) to guide goal setting practice in community based stroke rehabilitation settings. Included studies: The Medical Research Council (MRC) framework for developing and evaluating complex interventions guided the development and conduct of a programme of research which included the following studies: (i) a review of the literature to identify theories of behaviour change with most potential to inform goal setting practice (Paper 1) (ii) a causal modelling exercise to map identified theoretical constructs onto a goal setting process and convening of a multi-disciplinary task group to develop the theoretical process into a Goal setting and Action Planning (G-AP) practice framework (Paper 2) (iii) a process evaluation of the G-AP framework in one community rehabilitation team (Paper 3) (iv) a United Kingdom (UK) wide survey to investigate the nature of services providing community based stroke rehabilitation across the UK and what goal setting practice is in these settings in order to understand the context into which an evaluation of the G-AP framework could be introduced (Paper 4) Main Findings: The review of the literature identified three theories of behaviour change that offered most potential to inform goal setting practice: Social Cognitive Theory, Health Action Process Approach and Goal Setting Theory. These theories contained constructs directly relevant to the goal setting practice: self-efficacy, outcome expectancies, goal attributes, action planning, coping planning and appraisal and feedback. The causal modelling and Task group exercise: (i) Informed development of the G-AP framework into a four stage, cyclical process that included (i) goal negotiation and setting (ii) planning and measuring confidence (iii) action and (iv) appraisal, feedback and decision making. (ii) Proposed mechanisms of action: successful completion of action plans resulting in incremental improvements in goal sub-skills and self-efficacy. (iii) Predicted outcomes G-AP was likely to impact on: goal attainment and improved rehabilitation outcomes. The process evaluation suggested that each stage of the G-AP framework had a distinct purpose and made a useful contribution to the overall process. Overall, G-AP was acceptable and feasible to use but implementation of novel aspects of the framework (coping planning and measuring confidence) was inconsistent and health professionals had concerns about the potential impact of unmet goals on patients’ wellbeing. Patient reports suggested that (i) the experience of goal non-attainment could facilitate adjustment to limitations resulting from stroke and (ii) feeling involved in the goal setting process can incorporate both patient-led and professional-led approaches. The survey findings highlighted the variability that exists in community based stroke rehabilitation services in the UK (e.g. the patients they see; the input they provide). Goal setting is reportedly used with all or most stroke survivors in these services; however, practice is variable and may be sub-optimal. Conclusions: G-AP is the first practice framework which has been explicitly developed to guide health professionals through a systematic, theoretically based and patient centred goal setting process in community based stroke rehabilitation. G-AP is a cyclical process that that has four key stages, proposed mechanisms of action and has shown promise as an acceptable, feasible and effective framework to guide goal setting practice. The complexity that exists within community based stroke rehabilitation services, and the variability in usual goal setting practice used within them, should be considered when designing a study to evaluate the effectiveness of G-AP in routine practice.

Yes / Heart failure affects 26 million people globally, and the optimal management of medicines is crucial for patients, particularly when their care is transferred between hospital and the community. Optimising clinical outcomes requires well-calibrated cross-organisational processes with staff and patients responding and adapting to medicines changes. The aim of this study was to assess the feasibility of implementing a complex intervention (the Medicines at Transitions Intervention; MaTI) co-designed by patients and healthcare staff. The purpose of the intervention was to optimise medicines management across the gaps between secondary and primary care when hospitals handover care. The study objectives were to (1) assess feasibility through meeting specified progression criteria to proceed to the trial, (2) assess if the intervention was acceptable to staff and patients, and (3) determine whether amendment or refinement would be needed to enhance the MaTI. The feasibility of the MaTI was tested in three healthcare areas in the North of England between July and October 2017. Feasibility was measured and assessed through four agreed progression to trial criteria: (1) patient recruitment, (2) patient receipt of a medicines toolkit, (3) transfer of discharge information to community pharmacy, and (4) offer of a community pharmacy medicines review/discussion or medicines reconciliation. From the cardiology wards at each of the three NHS Acute Trusts (sites), 10 patients (aged ≥ 18 years) were recruited and introduced to the 'My Medicines Toolkit' (MMT). Patients were asked to identify their usual community pharmacy or nominate a pharmacy. Discharge information was transferred to the community pharmacy; pharmacists were asked to reconcile medicines and invited patients for a medicines use review (MUR) or discussion. At 1 month following discharge, all patients were sent three questionnaire sets: quality-of-life, healthcare utilisation, and a patient experience survey. In a purposive sample, 20 patients were invited to participate in a semi-structured interview about their experiences of the MaTI. Staff from hospital and primary care settings involved in patients' care were invited to participate in a semi-structured interview. Patient and staff interviews were analysed using Framework Analysis. Questionnaire completion rates were recorded and data were descriptively analysed. Thirty-one patients were recruited across three sites. Eighteen staff and 18 patients took part in interviews, and 19 patients returned questionnaire sets. All four progression to trial criteria were met. We identified barriers to patient engagement with the intervention in hospital, which were compounded by patients' focus on returning home. Some patients described not engaging in discussions with staff about medicines and lacking motivation to do so because they were preoccupied with returning home. Some patients were unable or unwilling to attend a community pharmacy in person for a medicines review. Roles and responsibilities for delivering the MaTI were different in the three sites, and staff reported variations in time spent on MaTI activities. Staff reported some work pressures and staff absences that limited the time they could spend talking to patients about their medicines. Clinical teams reported that recording a target dose for heart failure medicines in patient-held documentation was difficult as they did not always know the ideal or tolerable dose. The majority of patients reported receiving the patient-held documentation. More than two-thirds reported being offered a MUR by their community pharmacists. Delivery of the Medicines at Transitions Intervention (MaTI) was feasible at all three sites, and progression to trial criteria were met. Refinements were found to be necessary to overcome identified barriers and strengthen delivery of all steps of the intervention. Necessary changes to the MaTI were identified along with amendments to the implementation plan for the subsequent trial. Future implementation needs to take into account the complexity of medicines management and adaptation to local context. / This study is funded by the National Institute for Health Research (NIHR) (Programme Grants for Applied Research (Grant Reference Number RP-PG-0514-20009)). The study is also supported by the NIHR Yorkshire and Humber Patient Safety Translational Research Centre.

Contexte – Les interventions de santé publique et plus particulièrement les interventions de promotion de la santé sont considérées comme « complexes ». Leur évaluation représente un défi tant pour les chercheurs – lorsqu’il s’agit de caractériser ce qui produit des effets – que pour les acteurs – lorsqu’il s’agit de transférer une intervention d’efficacité prouvée –, notamment en raison de la forte influence du contexte sur l’efficacité de ces interventions. Cette problématique de la complexité soulève plusieurs questions aussi bien conceptuelles qu’opérationnelles : comment les chercheurs et acteurs appréhendent-ils ces notions en vue de développer, d’implanter, de « routiniser », ou de transférer une intervention ? Quels sont alors les méthodes et les outils évaluatifs qui permettraient de mieux appréhender la complexité de ces interventions ? Objectifs – L’objectif général de cette recherche doctorale est d’explorer l’appréhension et l’utilisation de la complexité par les chercheurs et les acteurs de terrain en santé publique et plus particulièrement en promotion de la santé. Plus spécifiquement, il avait pour objectifs de : décrire et analyser les dimensions de la complexité identifiées par les chercheurs et par les acteurs de terrain, en particulier les éléments constitutifs des interventions et de leurs contextes d’implantation ; décrire et analyser comment les chercheurs et acteurs s’appropriation les concepts de la complexité et prennent en compte la complexité des interventions dans le développement, la mise en œuvre, l’évaluation et le transfert des interventions. Méthodes – Pour répondre à ces objectifs, nous avons procédé en deux étapes. La première consistait en une revue mixte de la littérature et visait notamment à identifier l’appréhension de la complexité faite par les chercheurs l’influence de celle-ci sur leurs choix méthodologiques. La seconde a été réalisée à partir d’une étude de cas afin : de proposer une description fine de la complexité du terrain à la fois par les acteurs et avec notre regard de chercheur forméà la complexité ; d’identifier la manière dont les acteurs prenaient en compte la complexité dans leurs pratiques. Résultats – Les résultats croisés de la revue de la littérature et de l’étude de cas identifient deux dimensions majeures de complexité : les caractéristiques des parties prenantes et le contexte. Si la notion de complexité est d’actualité en recherche, nos travaux montrent qu’elle reste difficile à justifier et à décrire. La complexité, fortement reconnue par les chercheurs, avait influencé la réalisation d’adaptations méthodologiques lors de l’élaboration et/ou de l’évaluation de leurs interventions notamment par l’application des recommandations du Medical Research Council. La prise en compte de la complexité par les acteurs se rencontre quant à elle essentiellement dans les adaptations qu’ils réalisent au quotidien. Discussion – Cette recherche doctorale soulève trois points de discussion et de perspectives : la définition de la complexité et ses évolutions attendues au regard de la mise en évidence de l’importance du dynamisme des interventions ; le reporting des interventions comme levier d’amélioration de développement et d’évaluation des interventions ; la plus-value des espaces partagés acteurs-chercheurs dans la production de données probantes / Context – Public health interventions and especially health promotion interventions are considered « complex ». Their evaluation represents a challenge for researchers, which aims to communicate a proven effectiveness intervention with strong contextual influence on the effectiveness of these interventions.This issue of complexity raises several conceptual as well as operational questions: how do researchers and actors understand these notions in order to develop, implement, « routine », or transfer an intervention? What are the evaluation methods and tools that would make it possible to better understand the complexity of these interventions? Objectives – The general objective of this doctoral research is to explore the apprehension and use of complexity by researchers and stakeholders in public health and more particularly in health promotion. More commonly, it aimed to: describe and analyze the dimensions of the complexity identified by researchers and stakeholders, particularly the components of interventions and their contexts; describe and analyze how researchers and stakeholders appropriate the concepts of complexity and take into account the complexity of interventions in the development, implementation, evaluation and transfer of interventions. Methods – To meet these objectives we proceeded in two stages. The first stage consisted of a mixed review of the literature and aimed particularly at identifying the apprehension of the complexity made by the researchers of the influence of thisone on their methodological choices. The second stage was realised from a case study: to propose a fine description of the complexity of the field both by the actors and the researcher trained to the complexity; to identify the way in which the actors took into account the complexity in their practice. Results – The crossed results of the review of the literature and the study of two major dimensions: the characteristics of the stakeholders and the context. If the notion of complexity is relevant in research, our work highlight that it’s still hard to justify and describe. Researcher responsiveness has been influenced by methodological adaptations in the development and / or evaluation of their interventions, including the implementation of the recommendations of the Medical Research Council. Consideration of the complexity by the actors meets in the adaptations which are imposed on a daily basis. Discussion – This doctoral study raises three points of discussion and perspectives: the definition of the complexity and its evolutions which intervene with regard to highlighting the importance of dynamic interventions; the reporting of interventions as a lever for improving the development and evaluation of interventions; the added value of shared spaces between actors and researchers in the production of evidence

Background: The transition from trainee to newly-registered (novice) practitioner is regarded as the most stressful and challenging of time of a healthcare professional's career. Community pharmacists are unusual in that they transition into roles where they commonly work as the sole pharmacist, manage a team of support staff and are accountable from day one of professional registration (without any formal support structure), yet little research exists in this area. This study aimed to identify the transition challenges faced by novice community pharmacists and to develop and feasibility test an evidence-based intervention to ease their transitions to independent practitioners. Methods: Medical Research Council guidance for developing complex interventions was used to frame this programme of work. During development, evidence from existing literature and an exploratory nominal group study identified and prioritised the challenges faced by novice community pharmacists. Findings informed the iterative design process for a peer-coaching intervention with the following components; a social media group, one-to-one coaching, a handbook, group activities and weekly clinical/practice scenarios for group discussion. Twelve novice community pharmacists were recruited purposively to participate in the draft intervention, which was evaluated using semi-structured telephone interviews. Results: Twenty-five participants took part in homogenous group discussions consisting of novice community pharmacists, early career pharmacists, pre-registration tutors and pharmacy colleagues. Similarly to challenges reported by novice doctors and nurses, nominal group discussions identified the following challenges [in order of importance]; relationship management; lack of confidence; decision-making; being in charge and accountable; and adapting to the workplace. Relationship management was attributed to novices' lack of affective skills. There were some differences however in the challenges reported by novice community pharmacists, such as power struggles (with managers or pharmacy colleagues), inverse hierarchy, professional isolation, target culture and full immediate accountability. A number of factors perpetuating these differences were perceived to increase the weight of professional accountability and augment stress; the retail community pharmacy context, the relative lack of support and isolation from peers. Hence, the draft intervention focussed on supporting the novice community pharmacist to develop cognitive and affective skills. All participants viewed the social media forum as the most valuable component because it provided a confidential space for reassurance, feedback, and sharing or discussing practice experiences. Participants also valued one-to-one discussions with the coach, which supported meaningful reflection and developing self-awareness. Outcomes reported by all participants included increased self-efficacy, increased confidence in decision-making/managing others, an increased sense of preparedness and the ability to cope during transition. Through group components, novice community pharmacists developed and reported feeling less isolated in the workplace. Conclusions: This novel programme of work revealed the challenges faced by novice community pharmacists during transition. Findings suggest that a lack of affective and cognitive skills, the demands of the job and professional isolation caused novices to experience psychosocial stress and high job strain. A group peer-coaching intervention designed to ease the transitions of novice community pharmacists was reported to be acceptable, feasible and beneficial. Study findings led to some recommendations for transition support interventions: incorporate psychosocial support with developmental activities; provide a supportive learning space for developmental discourse that is accessible facilitated and structured; and offer coaching and supported reflection from an experienced pharmacist coach.