No abstract

The concept of 'return to work' may be overly simplistic, and as a result, misleading. The proposed benefits previously ascribed to 'return to work' may only be achieved through consideration of the specific meaning and role of work to the individual. Interventions to address work-related issues need to be person-centred, acknowledging the work-related outcomes that are important to the individual. A conceptual and operational shift towards supporting survivors to identify and achieve their 'work-related goals' may be more appropriate.

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.

A 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.