Jamie Murdoch

This data collection consists of 27 participant information sheets and 23 consent forms freely available on-line. Materials were collected following a comprehensive search for publicly available ethical materials from randomised control trials (RCTs) targeting cancer (2007-17), primarily by systematically searching key on-line databases and monograph series. These corpora, which are different, to our knowledge, than any existing collection of medical English, could further research on information provision for patients in RCTs specifically and in healthcare settings more generally, in addition to advancing the study of the language of written ethical documents. Secondary analyses of these data could be undertaken using techniques from corpus linguistics, computational linguistics, and/or discourse analysis, for example, to investigate the nature and complexity of the language used and/or broach participants’ understanding of ethical principles or preference for how different language functions are expressed.

Background: Prior to COVID-19 there had been a renewed policy focus in the National Health Service on the health and well-being of the healthcare workforce, with the ambulance sector identified as a priority area. This focus is more important than ever as the sector deals with the acute and longer-term consequences of a pandemic. Aim: To systematically identify, summarise and map the evidence regarding mental health, well-being and support interventions for United Kingdom ambulance services staff and to identify evidence gaps. Method: Evidence mapping methodology of published and grey original research published in English from 1 January 2000 to 23 May 2020 describing the health risk, mental health and/or well-being of UK ambulance services staff including retired staff, volunteers and students. MEDLINE, EMBASE, PsychINFO, CINAHL and AMED databases, plus EThOS, Zetoc, OpenGrey and Google, were searched, alongside hand-searching of grey literature and bibliographies. Information was ...

Background There is increasing evidence that the substantial global burden of disease for tuberculosis unfolds in concert with dimensions of common mental disorders. Person-centred care holds much promise to ameliorate these comorbidities in low-to-middle income countries (LMICs) and emerging economies. Towards this end, this paper aims to review 1) the nature and extent of tuberculosis and common mental disorder comorbidity and 2) person-centred tuberculosis care in low-to-middle income countries and emerging economies. Main text A scoping review of 100 articles was conducted of English-language studies published from 2000 to 2019 in peer-reviewed and grey literature, using established guidelines, for each of the study objectives. Four broad tuberculosis/mental disorder comorbidities were described in the literature, namely alcohol use and tuberculosis, depression and tuberculosis, anxiety and tuberculosis, and general mental health and tuberculosis. Rates of comorbidity varied wid...

Process evaluations typically use qualitative and quantitative methods to explain the observed effects of trial findings. However, there is potential to miss important insights about the implementation of the study and intervention because of a lack of theorising and definition of the relevant analytical context requiring investigation. In this workshop we will draw on Murdoch et al’s previous work to propose that the design of process evaluations should be framed by a consideration of four inter-related elements of context at the macro, meso and micro level: 1. Institutional, network relations, histories of relationships and interaction prior to implementing the intervention; 2. Types of activity participants are engaged in and interactional arrangements of intervention delivery; 3. Broader discourses, policies in play during trial implementation; 4. Acts and utterances involved in intervention delivery. Objectives: To enable participants to investigate the context of trial sites u...

Background: In 2008, nine towns in England received government funding to promote healthy lifestyles by increasing opportunities for residents to engage in physical activity and make healthier food choices. This qualitative research was undertaken in Thetford, a town in Norfolk with a population of about 22,000, high levels of deprivation and a large migrant community. It explores residents' perceptions of environmental and social influences on uptake of physical activity and dietary choices. Methods: Six focus group discussions and a series of semi-structured interviews were undertaken with residents of disadvantaged neighbourhoods, young people and community workers. Discussions were recorded, transcribed and analysed using elements of framework analysis. Results: Participants perceived aspects of the town's physical environment and infrastructure as limiting their ability to be active and to have a healthy diet. The geographical location of recreational facilities was cit...

Objectives To evaluate the effectiveness of using electronic registers to identify and improve management of high-risk asthma patients in primary care. Design Cluster-randomised controlled trial with stratification by high/low deprivation scores and 1-year follow-up. Participants 29 GP practices in Norfolk, UK with suitable software systems used electronic searches and clinical knowledge to identify 911 patients aged 5+ years at high risk from their asthma as defined by British asthma guidelines (severe asthma plus adverse psychosocial characteristics, including poor adherence). Intervention Intervention practices established registers of high-risk asthma patients and used an electronic alert to identify these patients at all practice encounters. This allowed reception staff to prioritise appointments and facilitate patient access to clinicians and clinical staff to review patients' asthma at all opportunities. Practice staff received a 1-h tailored training session on the use of alerts and actions to be taken from a GP (MN) and nurse (JW). Control practices continued with routine care. Outcomes A composite measure of moderate–severe exacerbations (primary outcome, see Abstract S137 Table 1 for definition), disaggregated exacerbation-related events, consultations and medications (secondary outcomes) were derived from anonymous clinical data extracted from practice-based patient records for the year before and after implementation of registers.Abstract S137 Table 1 Events per person per year Intervention (N=14 pracs, 457 patients) Control (N=15 pracs, 454 patients) Rate ratio (95% CI) p Value Median (IQR) rate of moderate–severe exacerbations (composite of below*) 1 (2) 0 (2) 1.21 (0.95 to 1.55) 0.13 No. (%) of patients hospitalised for asthma* 15 (3.3) 29 (6.4) 0.52 (0.28 to 0.98) 0.04 No. (%) of patients attending A&E for asthma* 29 (6.4) 37 (8.2) 0.73 (0.41 to 1.30) 0.28 No. (%) of patients attending out-of-hours for asthma* 26 (5.7) 32 (7.1) 0.84 (0.46 to 1.51) 0.56 No. (%) of patients prescribed courses of oral prednisolone for exacerbations* 247 (54.1) 213 (46.9) 1.24 (0.99 to 1.54) 0.06 No. (%) of patients prescribed nebulised short-acting β-agonists 36 (7.9) 63 (13.9) 0.56 (0.37 to 0.84) 0.005 Median (IQR) no. inhaled short-acting β-agonists prescribed 6 (10) 7 (12) 1.03 (0.89 to 1.19) 0.70 Median (IQR) dose of inhaled corticosteroids prescribed (μg/day) 658 (1036) 658 (1036) 1.14 (1.00 to 1.30) 0.04 Median (IQR) no. inhaled long-acting β-agonists prescribed 8 (9) 6 (9) 1.24 (1.08 to 1.42) 0.003 Median (IQR) no. primary care consultations for any reason 9 (11) 8 (11) 1.08 (0.93 to 1.25) 0.34 No. (%) of patients who ‘did not attend’ primary care consultations for any reason 81 (17.7) 102 (22.5) 0.53 (0.31 to 0.90) 0.02 Results See Abstract S137 Table 1 for results of unadjusted analyses. After adjustment for relevant covariates at baseline similar effects were observed but only the effect on nebulised β-agonists prescriptions remained significant. Conclusions Use of at-risk registers had no significant effect on the overall rate of moderate–severe exacerbations. However, they were associated with increases in prescriptions of oral steroids, inhaled steroids and long-acting β-agonists, coupled with reductions in asthma hospitalisations, prescriptions of nebulised short-acting β-agonists and in failures to attend primary care appointments. Together these are suggestive of improved asthma management in the intervention group.

In this article we describe the use of a data-sharing focus group for triangulation with face-to-face interviews. In contrast to member-checking triangulation, this focus group was undertaken to provide a different interactional context to analyze moral discourses in talk about asthma medicine taking. Using principles of discursive psychology to analyze data, participants adopted strategies to manage dilemmas of identification with research findings. Talk about medicine taking was contextualized to the demands of the interaction. Strategies included avoiding direct reference to findings; collectively aligning with medical perspectives; and using stories to carry opinions. Participants also expressed moral discourses around managing asthma in everyday life. These discursive variations strengthened assertions of the role of morality in participants' talk and highlighted advantages in engaging with participants' strategies in focus groups. Different viewpoints identified in this research create problems for member checking, suggesting that researchers need to be sensitive in considering methods of sharing data with participants.

ObjectivesTo achieve universal health coverage, health systems need to be strengthened to support the consistent delivery of high-quality, evidence-informed care at scale. The aim of the National Institute for Health Research (NIHR) Global Research Unit on HeAlth System StrEngThening in Sub-Saharan Africa (ASSET) is to address this need in a four-year programme spanning three healthcare platforms (primary health care for the integrated treatment of chronic conditions in adults, maternal and newborn, surgical care) involving eight work packages. This paper describes the pre-implementation phase research protocols that assess: (1) barriers to accessing care; (2) health system bottlenecks in care process and pathways; (3) quality of care, and; (4) people centredness. Findings from this research are used to engage stakeholders and to inform the selection of a set of health system strengthening interventions (HSSIs) and subsequent methodology for evaluation. SettingsPublicly funded healt...

BackgroundDespite progress towards meeting End TB strategy targets for reducing tuberculosis (TB) incidence and deaths by 2035, South Africa remains among the top ten high-burden tuberculosis countries globally. A large challenge lies in how policies to improve detection, diagnosis and treatment completion interact with social and structural drivers of TB. Detailed understanding and theoretical development of the contextual determinants of problems in TB care is required for developing effective interventions. This article reports findings from the pre-implementation phase of a study of TB care in South Africa, contributing to ASSET - a broader five-year research programme developing and evaluating health system strengthening interventions in sub-Saharan Africa. The study aimed to develop hypothetical propositions regarding the contextual determinants of problems in TB care to inform intervention development to reduce TB deaths and incidence whilst ensuring the delivery of quality i...

Background The needs of children in care are a government priority, yet the evidence base for effective interventions to support the emotional wellbeing of children in care is lacking. Research suggests that supporting the carer-child relationship, by promoting the carer’s reflective parenting, may be an effective approach to improving the wellbeing of these children. Methods The study comprises a definitive, superiority, two-armed, parallel, pragmatic, randomised controlled trial, with embedded process evaluation and economic evaluation, and an internal pilot, to evaluate the effectiveness, and cost-effectiveness, of the Reflective Fostering Programme. Randomisation is at the individual level using a 1:1 allocation ratio. The study is being conducted in local authority sites across England, and is targeted at foster carers (including kinship carers) looking after children aged 4 to 13. Consenting participants are randomly allocated to the Reflective Fostering Programme (interventio...

Implementation research is a multidisciplinary field that addresses the complex phenomenon of how context influences our ability to deliver evidence-informed healthcare. There is increasing realisation of the importance of applying robust implementation research to scale-up lifesaving interventions that meet health-related sustainable development goals. However, the lack of high-quality implementation research is impeding our ability to meet these targets. Within implementation research, theory refers to the proposed description of how an intervention is expected to bring about change and how this relates to inputs, outputs, and outcomes. Although there is increasing interest in applying theory to understand how and why implementation programmes work in real-world settings, global health actors still tend to favour impact evaluations conducted in controlled environments. This may, in part, be due to the relative methodological complexity of implementation research and the need to dr...

Background There is a growing need for methods that acknowledge and successfully capture the dynamic interaction between context and implementation of complex interventions. Case study research has the potential to provide such understanding, enabling in-depth investigation of the particularities of phenomena. However, there is limited guidance on how and when to best use different case study research approaches when evaluating complex interventions. This study aimed to review and synthesise the literature on case study research across relevant disciplines, and determine relevance to the study of contextual influences on complex interventions in health systems and public health research. Methods Systematic meta-narrative review of the literature comprising (i) a scoping review of seminal texts (n = 60) on case study methodology and on context, complexity and interventions, (ii) detailed review of empirical literature on case study, context and complex interventions (n = 71), and (ii...

Background A colorectal resection is standard treatment for patients with colorectal cancer (CRC). However, the procedure results in significant post-operative mortality and reduced quality of life. Maximising pre-operative cardiopulmonary fitness could improve post-surgical outcomes. PREPARE-ABC is a multi-centre, three-armed, randomised controlled trial investigating the effects of exercise interventions, with motivational support on short and longer-term recovery outcomes in CRC patients undergoing major lower-gastrointestinal surgery. The trial included an internal pilot phase with parallel process evaluation. The aim of the process evaluation was to optimise intervention implementation for the main trial. Methods Mixed methods process evaluation conducted in 14 UK hospitals between November 2016 and March 2018. Data included a site profile questionnaire and telephone scoping interview with hospital staff, 34 qualitative observations of standard care and 14 observations of inter...

Obtaining informed consent (IC) is an ethical imperative, signifying participants’ understanding of the conditions and implications of research participation. One setting where the stakes for understanding are high is randomized controlled trials (RCTs), which test the effectiveness and safety of medical interventions. However, the use of legalese and medicalese in ethical forms coupled with the need to explain RCT-related concepts (e.g. randomization) can increase patients’ cognitive load when reading text. There is a need to systematically examine the language demands of IC documents, including whether the processes intended to safeguard patients by providing clear information might do the opposite through complex, inaccessible language. Therefore, the goal of this study is to build an open-access corpus of patient information sheets (PIS) and consent forms (CF) and analyze each genre using an interdisciplinary approach to capture multidimensional measures of language quality beyo...

Background Prevalence of depression is increasing in young people, and there is a need to develop and evaluate behavioural interventions which may provide benefits equal to or greater than talking therapies or pharmacological alternatives. Exercise could be beneficial for young people living with depression, but robust, large-scale trials of effectiveness and the impact of exercise intensity are lacking. This study aims to test whether a randomised controlled trial (RCT) of an intervention targeting young people living with depression is feasible by determining whether it is possible to recruit and retain young people, develop and deliver the intervention as planned, and evaluate training and delivery. Methods The design is a three-arm cluster randomised controlled feasibility trial with embedded process evaluation. Participants will be help-seeking young people, aged 13–17 years experiencing mild to moderate low mood or depression, referred from three counties in England. The inter...

Background Depression is a common health problem during adolescence and is associated with adverse academic, social and health outcomes. To meet the demand for treatment for adolescent depression, there is a need for evidence-based interventions suitable for delivery outside of specialist Child and Adolescent Mental Health Services (CAMHS). Interpersonal Counselling for Adolescents (IPC-A) is a brief manualised intervention for adolescent depression suitable for delivery by staff who are not qualified health professionals following participation in a brief training course. While initial piloting within Local Authority services has generated promising results, the effectiveness and cost-effectiveness of IPC-A has yet to be established. This study aims to assess the feasibility of a randomised controlled trial (RCT), evaluating the effectiveness and cost-effectiveness of IPC-A delivered by staff without core professional training in comparison to current provision. Method Feasibility ...

The call for universal health coverage requires the urgent implementation and scale-up of interventions that are known to be effective, in resource-poor settings. Achieving this objective requires high-quality implementation research (IR) that evaluates the complex phenomenon of the influence of context on the ability to effectively deliver evidence-based practice. Nevertheless, IR for global health is failing to apply a robust, theoretically driven approach, leading to ethical concerns associated with research that is not methodologically sound.Inappropriate methods are often used in IR to address and report on context. This may result in a lack in understanding of how to effectively adapt the intervention to the new setting and a lack of clarity in conceptualising whether there is sufficient evidence to generalise findings from previous IR to a new setting, or if a randomised controlled trial (RCT) is needed. Some of the ethical issues arising from this shortcoming include poor-qu...

ABSTRACTBackgroundASSET (Health System Strengthening in Sub-Saharan Africa) is a health system strengthening (HSS) programme that aims to develop and evaluate effective and sustainable solutions that support high-quality care that involve eight work packages across four sub-Saharan African countries. Here we present the protocol for the implementation science (IS) theme within ASSET that aims to (1) understand what HSS interventions work, for whom and how; and (2) how implementation science methodologies can be adapted to improve the design and evaluation of HSS interventions within resource-poor contexts.MethodsPre-implementation phaseThe IS theme, jointly with ASSET work-packages, applies IS determinant frameworks to identify factors that influence the effectiveness of delivering evidence-informed care. Determinants are used to select a set of HSS interventions for further evaluation, where work packages also theorise selective mechanisms to achieve the expected outcomes.Piloting ...

Background The need for better methods for evaluation in health research has been widely recognised. The ‘complexity turn’ has drawn attention to the limitations of relying on causal inference from randomised controlled trials alone for understanding whether, and under which conditions, interventions in complex systems improve health services or the public health, and what mechanisms might link interventions and outcomes. We argue that case study research—currently denigrated as poor evidence—is an under-utilised resource for not only providing evidence about context and transferability, but also for helping strengthen causal inferences when pathways between intervention and effects are likely to be non-linear. Main body Case study research, as an overall approach, is based on in-depth explorations of complex phenomena in their natural, or real-life, settings. Empirical case studies typically enable dynamic understanding of complex challenges and provide evidence about causal mechan...

Background: Despite significant reductions in mortality, preventable and treatable conditions remain leading causes of death and illness in children in South Africa. The PACK Child intervention, comprising clinical decision support tool (guide), training strategy and health systems strengthening components, was developed to expand on WHO’s Integrated Management of Childhood Illness programme, extending care of children under 5 years to those aged 0-13 years, those with chronic conditions needing regular follow-up, integration of curative and preventive measures and routine care of the well child. In 2017-2018, PACK Child was piloted in 10 primary healthcare facilities in the Western Cape Province. Here we report findings from an investigation into the contextual features of South African primary care that shaped how clinicians delivered the PACK Child intervention within clinical consultations. Methods: Process evaluation using linguistic ethnographic methodology which provides anal...

BackgroundDespite significant reductions in mortality, preventable and treatable conditions remain the leading causes of death in children under five within South Africa. The WHO’s Integrated Management of Childhood Illness (IMCI) programme has been widely implemented to address the most common causes of mortality in children under five. Although effective, limitations in IMCI scope and adherence have emerged. The Practical Approach to Care Kit (PACK) Child guide has been developed to expand on IMCI and address these limitations. It is intended as a clinical decision support tool for health workers with additional systems strengthening components, including active implementation and training strategy to address contextual and organisational factors hindering quality of care for children. Implementation is complex, requiring comprehensive pilot and process evaluation. The PACK Child pilot and feasibility study will sample 10 primary care facilities in the Western Cape Province. Staff...

IntroductionGoal-setting is recommended for patients with multimorbidity, but there is little evidence to support its use in general practice.ObjectiveTo assess the feasibility of goal-setting for patients with multimorbidity, before undertaking a definitive trial.Design and settingCluster-randomised controlled feasibility trial of goal-setting compared with control in six general practices.ParticipantsAdults with two or more long term health conditions and at risk of unplanned hospital admission.InterventionsGeneral practitioners (GPs) underwent training and patients were asked to consider goals before an initial goal-setting consultation and a follow-up consultation 6 months later. The control group received usual care planning.Outcome measuresHealth-related quality of life (EQ-5D-5L), capability (ICEpop CAPability measure for Older people), Patient Assessment of Chronic Illness Care and healthcare use. All consultations were video-recorded or audio-recorded, and focus groups were...