Joanne Coyle

Intervention description is not enough: evidence from an in-depth multiple case study on the untold role and impact of context in randomised controlled trials of seven complex interventions

BackgroundA number of single case reports have suggested that the context within which intervention studies take place may challenge the assumptions that underpin randomised controlled trials (RCTs). However, the diverse ways in which context may challenge the central tenets of the RCT, and the degree to which this information is known to researchers or subsequently reported, has received much less attention. In this paper, we explore these issues by focusing on seven RCTs of interventions varying in type and degree of complexity, and across diverse contexts.MethodsThis in-depth multiple case study using interviews, focus groups and documentary analysis was conducted in two phases. In phase one, a RCT of a nurse-led intervention provided a single exploratory case and informed the design, sampling and data collection within the main study. Phase two consisted of a multiple explanatory case study covering a spectrum of trials of different types of complex intervention. A total of eighty-four data sources across the seven trials were accessed.ResultsWe present consistent empirical evidence across all trials to indicate that four key elements of context (personal, organisational, trial and problem context) are crucial to understanding how a complex intervention works and to enable both assessments of internal validity and likely generalisability to other settings. The ways in which context challenged trial operation was often complex, idiosyncratic, and subtle; often falling outside of current trial reporting formats. However, information on such issues appeared to be available via first hand ‘insider accounts’ of each trial suggesting that improved reporting on the role of context is possible.ConclusionsSufficient detail about context needs to be understood and reported in RCTs of complex interventions, in order for the transferability of complex interventions to be assessed. Improved reporting formats that require and encourage the clarification of both general and project-specific threats to the likely internal and external validity need to be developed. In addition, a cultural change is required in which the open and honest reporting of such issues is seen as an indicator of study strength and researcher integrity, rather than a symbol of a poor quality study or investigator ability.

Supporting 'work-related goals' rather than 'return to work' after cancer? A systematic review and meta-synthesis of 25 qualitative studies

This study aimed to systematically review and synthesise qualitative studies of employment and cancer.

Lifestyle issues for colorectal cancer survivors--perceived needs, beliefs and opportunities.

PurposeAs survival rates for patients treated with colorectal cancer (CRC) increase, it is important to consider the short- and long-term self-management needs. The current work aimed to explore perceived patient needs for advice on diet, activity and beliefs about the role of lifestyle for reducing disease recurrence.MethodsForty colorectal cancer survivors, aged between 27 and 84, participated in six focus groups in community locations in the UK.ResultsThe findings suggest that CRC survivors would welcome guidance on diet in the immediate posttreatment period to alleviate symptoms and fears about food choices. Many participants actively sought lifestyle advice but experienced confusion, mixed messages, culturally inappropriate guidance and uncertainty about evidence of benefit. There was scepticism over the role of diet and physical activity as causes of cancer, in part because people believed their lifestyles had been healthy and could not see how reinstating healthy behaviours would reduce future disease risk. The sense of changing lifestyle to ‘stack the odds in their favour’ (against recurrence) appeared a more meaningful concept than prevention per se. Those people who had made or maintained dietary changes highlighted the importance of these to contributing to wellbeing and a sense of control in their life.ConclusionsA dogmatic approach to lifestyle change may lead to perceptions of victim blaming and stigmatisation. Personalised, evidence informed, guidance on lifestyle choices does appear to be a much needed part of care planning and should be built in to survivorship programmes.

“I’ve Never Not Had it So I Don’t Really Know What it’s Like Not to”: Nondifference and Biographical Disruption Among Children and Young People With Cystic Fibrosis

The relevance of biographical disruption and loss of self for children and young people is unclear, particularly in cases of congenital illness such as cystic fibrosis, where no prior period of wellness, stability, or perceived normality might exist. We explored the meaning, importance, and forms of maintenance of ideas of normality among 32 children and young people with cystic fibrosis. We examine the ways in which normalcy is produced, maintained, and threatened, and discuss the implications for the applicability and relevance of these traditional sociological concepts. Analysis of children’s and young people’s accounts resulted in a conceptualization of four forms of normalcy based on personal and social definitions and audiences. Biographical disruption appeared relevant but in a more nuanced form than its usual conceptualization when applied to adult populations. Maintaining normality within the family resulted in continual biographical revision in anticipation of future illness trajectory and life course.

Problems and solutions: Accounts by parents and children of adhering to chest physiotherapy for cystic fibrosis

Purpose. Although chest physiotherapy is central to the management of cystic fibrosis (CF), adherence among children is problematic. This study explores accounts by parents and children of the difficulties of adhering to chest physiotherapy for cystic fibrosis, and identifies strategies used by families to overcome these. Methods. A qualitative study based on in-depth interviews with 32 children with a diagnosis of cystic fibrosis aged 7 – 17 years, and with 31 parents. Results. Physiotherapy was frequently described as restrictive, threatening to identity and boring, giving rise to feelings of unfairness, inequality, ‘difference’, and social stigma. Motivation to adhere was influenced by perceptions of effectiveness that depended on external signs evident during or after the physiotherapy. Motivation was enhanced where parents and children visualized the accumulation of mucus. Some parents had developed distraction techniques that improved the experience of chest physiotherapy but had few opportunities to share these with other parents. Conclusion. The experience of physiotherapy is problematic to some parents and children. Furthermore, motivation to overcome these problems may be undermined by perceptions of ineffectiveness. Distraction techniques that change the value that the child places on the time spent doing physiotherapy and that reduces their perception of its duration may improve experience and adherence. The potential of visualization techniques to promote adherence should be investigated further.

The importance of ‘morality’ in the social construction of suicide in Scottish newspapers

Abstract Suicide stories in newspapers have been identified as an important risk factor for individual suicide because they provide real-life models for vulnerable individuals. The link between suicide ‘stories’ and suicide rates, however, is not clearly understood. One problem is the lack of detailed analysis of how suicide stories are constructed. Yet this is important because it would enable researchers to comprehend more fully how newspaper reports shape and structure ‘reality’. It is argued that the suicide story is a way of mapping out reality and that by de-constructing we can learn how this shapes and constrains our understanding of suicide and the actions adopted in response to it. The aim of this study, therefore, is to explore the social construction of suicide stories in Scottish newspapers. Two broad sheet and two tabloid newspapers were scanned for suicide stories for the year 1999. One hundred and ninety-one articles reporting suicide were identified and analysed using grounded theory. This generated a set of conceptual categories, which formed the basis of a framework. The study found that visualising, locating, social impacting and causal searching were key concepts in the construction of a suicide story, and that these were connected through the core explanatory category of ‘morality’. The study also showed how suicide was rendered explicable through the concepts of deviancy, dysfunction and moral weakness.

Finding your feet: The development of a podiatry intervention to reduce falls in care home residents

People who live in care homes often fall. Foot and ankle muscle weakness, sub-optimal footwear, and common foot problems such as corns and hallux valgus are known and potentially modifiable contributory factors to falls in older people. Conducting a randomised controlled trial in a care home setting to address these issues is challenging and presents a number of uncertainties that need to be addressed prior to undertaking a phase III trial. Therefore, this study used a qualitative approach to assess the feasibility and acceptability of a podiatry falls intervention to care home residents and staff. The data acquired during this qualitative preparatory phase will inform the conduct of a subsequent exploratory randomised controlled trial of a podiatry intervention to reduce falls in care homes.