The role of qualitative research in adding value to a randomised controlled trial: lessons from a pilot study of a guided e-learning intervention for managers to improve employee wellbeing and reduce sickness absence.

BACKGROUND: Despite the growing popularity of mixed-methods studies and considerable emphasis on the potential value of qualitative research to the trial endeavour, there remains a dearth of published studies reporting on actual contribution. This paper presents a critically reflective account of our experience of the actual value of undertaking qualitative research alongside a pilot cluster randomised controlled trial of a guided e-learning intervention for managers in an NHS Mental Health Trust to improve employee wellbeing and reduce sickness absence. For the qualitative study we undertook 36 in-depth interviews with key informants, managers and employees. We observed and took in-depth field notes of 10 meetings involving managers and employees at the Trust, and the two qualitative researchers acted as participant observers at steering committee and monthly research team meetings. We adopted a narrative methodological orientation alongside a thematic approach to data analysis, eliciting a rich account of the complexities of managing stress at work. RESULTS: We identified two key overarching roles played by the qualitative research: 'problematising' and 'contextualising'. Specifically, the qualitative data revealed and challenged assumptions embedded in the trial about the nature of the learning process, and exposed the slippery and contested nature of abstracted variables, on which a trial depends. The qualitative data challenged the trial's logic model, and provided a rich understanding of the context within which the trial and intervention took place. CONCLUSIONS: While acknowledging the ever-present tension in mixed-methods research between the requirements of quantitative research to represent the social world as abstracted variables, and the goal of qualitative research to explore and document the complexity of social phenomena, we adopted a pragmatic position that enabled us to engage with this tension in a productive and partially integrative way. Our critically reflective account of the praxis of integration illuminated opportunities and challenges for maximising the value of qualitative research to a trial. This paper sets out tangible illustrative lessons for other mixed-methods researchers endeavouring to get the most from qualitative research. TRIAL REGISTRATION: This study is registered as ISRCTN58661009 . Registration was submitted on 22 April 2013 and completed on 17 June 2013.

Pilot study of a cluster randomised trial of a guided e-learning health promotion intervention for managers based on management standards for the improvement of employee well-being and reduction of sickness absence: GEM Study.

OBJECTIVES: To investigate the feasibility of recruitment, adherence and likely effectiveness of an e-learning intervention for managers to improve employees' well-being and reduce sickness absence. METHODS: The GEM Study (guided e-learning for managers) was a mixed methods pilot cluster randomised trial. Employees were recruited from four mental health services prior to randomising three services to the intervention and one to no-intervention control. Intervention managers received a facilitated e-learning programme on work-related stress. Main outcomes were Warwick Edinburgh Mental Wellbeing Scale (WEMWBS), 12-item GHQ and sickness absence <21 days from human resources. 35 in-depth interviews were undertaken with key informants, managers and employees, and additional observational data collected. RESULTS: 424 of 649 (65%) employees approached consented, of whom 350 provided WEMWBS at baseline and 284 at follow-up; 41 managers out of 49 were recruited from the three intervention clusters and 21 adhered to the intervention. WEMWBS scores fell from 50.4-49.0 in the control (n=59) and 51.0-49.9 in the intervention (n=225), giving an intervention effect of 0.5 (95% CI -3.2 to 4.2). 120/225 intervention employees had a manager who was adherent to the intervention. HR data on sickness absence (n=393) showed no evidence of effect. There were no effects on GHQ score or work characteristics. Online quiz knowledge scores increased across the study in adherent managers. Qualitative data provided a rich picture of the context within which the intervention took place and managers' and employees' experiences of it. CONCLUSIONS: A small benefit from the intervention on well-being was explained by the mixed methods approach, implicating a low intervention uptake by managers and suggesting that education alone may be insufficient. A full trial of the guided e-learning intervention and economic evaluation is feasible. Future research should include more active encouragement of manager motivation, reflection and behaviour change. TRIAL REGISTRATION NUMBER: ISRCTN58661009.

Ethical principles and the rationing of health care: a qualitative study in general practice.

BACKGROUND: Researching sensitive topics, such as the rationing of treatments and denial of care, raises a number of ethical and methodological problems. AIM: To describe the methods and findings from a number of focus group discussions that examined how GPs apply ethical principles when allocating scarce resources. DESIGN OF STUDY: A small-scale qualitative study involving purposive sampling, semi-structured interviews and focus groups. SETTING: Twenty-four GPs from two contrasting areas of London: one relatively affluent and one relatively deprived. METHOD: Initial interviews asked GPs to identify key resource allocation issues. The interviews were transcribed and themes were identified. A number of case studies, each illustrative of an ethical issue related to rationing, were written up in the form of vignettes. In focus group discussions, GPs were given a number of these vignettes to debate. RESULTS: With respect to the ethical basis for decision making, the findings from this part of the study emphasised the role of social and psychological factors, the influence of the quality of the relationship between GPs and patients and confusion among GPs about their role in decision making. CONCLUSION: The use of vignettes developed from prior interviews with GPs creates a non-threatening environment to discuss sensitive or controversial issues. The acceptance by GPs of general moral principles does not entail clarity of coherence of the application of these principles in practice.

Is patient involvement possible when decisions involve scarce resources? A qualitative study of decision-making in primary care.

Greater patient involvement has become a key goal of health care provision. This study explored the way in which general practitioners (GPs) in the UK manage the dual responsibilities of treating individual patients and making the most equitable use of National Health Service (NHS) resources in the context of the policy of greater patient involvement in decision-making. We undertook a qualitative study incorporating a series of interviews and focus groups with a sample of 24 GPs. We analysed GP accounts of decision-making by relating these to substantive ethical principles and the key procedural principle of explicitness in decision-making. GPs saw patient involvement in positive terms but for some GPs involvement served an instrumental purpose, for instance improving patient 'compliance'. GPs identified strongly with the role of patient advocate but experienced role tensions particularly with respect to wider responsibilities for budgets, populations, and society in general. GPs had an implicit understanding of the key ethical principle of explicitness and of other substantive ethical principles but there was incongruence between these and their interpretation in practice. Limited availability of GP time played an important role in this theory/practice gap. GPs engaged in implicit categorisation of patients, legitimating this process by reference to the diversity and complexity of general practice. If patient involvement in health care decision-making is to be increased, then questions of scarcity of resources, including time, will need to be taken into account. If strategies for greater patient involvement are to be pursued then this will have significant implications for funding primary care, particularly in terms of addressing the demands made on consultation time. Good ethics and good professional practice cost money and must be budgeted for. More explicit decision-making in primary care will need to be accompanied by greater explicitness at the national level about roles and responsibilities. Increased patient involvement has consequences for GP training and ways of addressing rationing dilemmas will need to be an important part of this training. Further research is needed to understand micro-decision-making, in particular the spaces in which processes of implicit categorisation lead to distorted communication between doctor and patient.