Getting added value from using qualitative research with randomized controlled trials: a qualitative interview study.

BACKGROUND: Qualitative research is undertaken with randomized controlled trials of health interventions. Our aim was to explore the perceptions of researchers with experience of this endeavour to understand the added value of qualitative research to the trial in practice. METHODS: A telephone semi-structured interview study with 18 researchers with experience of undertaking the trial and/or the qualitative research. RESULTS: Interviewees described the added value of qualitative research for the trial, explaining how it solved problems at the pretrial stage, explained findings, and helped to increase the utility of the evidence generated by the trial. From the interviews, we identified three models of relationship of the qualitative research to the trial. In 'the peripheral' model, the trial was an opportunity to undertake qualitative research, with no intention that it would add value to the trial. In 'the add-on' model, the qualitative researcher understood the potential value of the qualitative research but it was viewed as a separate and complementary endeavour by the trial lead investigator and wider team. Interviewees described how this could limit the value of the qualitative research to the trial. Finally 'the integral' model played out in two ways. In 'integral-in-theory' studies, the lead investigator viewed the qualitative research as essential to the trial. However, in practice the qualitative research was under-resourced relative to the trial, potentially limiting its ability to add value to the trial. In 'integral-in-practice' studies, interviewees described how the qualitative research was planned from the beginning of the study, senior qualitative expertise was on the team from beginning to end, and staff and time were dedicated to the qualitative research. In these studies interviewees described the qualitative research adding value to the trial although this value was not necessarily visible beyond the original research team due to the challenges of publishing this research. CONCLUSIONS: Health researchers combining qualitative research and trials viewed this practice as strengthening evaluative research. Teams viewing the qualitative research as essential to the trial, and resourcing it in practice, may have a better chance of delivering its added value to the trial.

Maximising the value of combining qualitative research and randomised controlled trials in health research: the QUAlitative Research in Trials (QUART) study--a mixed methods study.

BACKGROUND: Researchers sometimes undertake qualitative research with randomised controlled trials (RCTs) of health interventions. OBJECTIVES: To systematically explore how qualitative research is being used with trials and identify ways of maximising its value to the trial aim of providing evidence of effectiveness of health interventions. DESIGN: A sequential mixed methods study with four components. METHODS: (1) Database search of peer-reviewed journals between January 2008 and September 2010 for articles reporting the qualitative research undertaken with specific trials, (2) systematic search of database of registered trials to identify studies combining qualitative research and trials, (3) survey of 200 lead investigators of trials with no apparent qualitative research and (4) semistructured telephone interviews with 18 researchers purposively sampled from the first three methods. RESULTS: Qualitative research was undertaken with at least 12% of trials. A large number of articles reporting qualitative research undertaken with trials (n=296) were published between 2008 and 2010. A total of 28% (82/296) of articles reported qualitative research undertaken at the pre-trial stage and around one-quarter concerned drugs or devices. The articles focused on 22 aspects of the trial within five broad categories. Some focused on more than one aspect of the trial, totalling 356 examples. The qualitative research focused on the intervention being trialled (71%, 254/356), the design and conduct of the trial (15%, 54/356), the outcomes of the trial (1%, 5/356), the measures used in the trial (3%, 10/356), and the health condition in the trial (9%, 33/356). The potential value of the qualitative research to the trial endeavour included improving the external validity of trials and facilitating interpretation of trial findings. This value could be maximised by using qualitative research more at the pre-trial stage and reporting findings with explicit attention to the implications for the trial endeavour. During interviews, three models of study were identified: qualitative research as peripheral to the trial, qualitative research as an 'add-on' to the trial and a study with qualitative research and trial as essential components, with the third model offering more opportunity to maximise the value of the qualitative research. Interviewees valued the use of qualitative research with trials and identified team structures and wider structural issues which gave more value to the trial than the qualitative research as barriers to maximising the value of the qualitative research. CONCLUSION: A large number of articles were published between 2008 and 2010, addressing a wide range of aspects of trials. There were examples of this research affecting the trial by facilitating interpretation of trial findings, developing and refining interventions for testing in the trial and changing the measures used in the trial. However, researchers were not necessarily maximising the value of qualitative research undertaken with trials to the endeavour of generating evidence of effectiveness of health interventions. Researchers can maximise value by promoting its use at the pre-trial stage to ensure that the intervention and trial conduct is optimised at the main trial stage, being explicit about the conclusions for the trial endeavour in peer-reviewed journal articles reporting the qualitative research and valuing the contribution of the qualitative research as much as the trial. Future recommendations for researchers include: plan the qualitative research, design and implement studies not trials, use qualitative research at the feasibility and pilot stage of trials, be explicit in publications about the impact of the qualitative research on the trial and implications for the trial endeavour, undertake in-depth qualitative research, allow qualitative research to take a challenging role and develop a learning environment around the use of qualitative research and trials. FUNDING: This project was funded by the Medical Research Council (MRC) as part of the MRC-National Institute for Health Research Methodology Research programme.

Opposite gender doctor-patient interactions in Iran.

BACKGROUND: The importance of physician gender in patient health outcomes has been recognized for some time in the West. For example, there is some evidence to show that female doctors use good interpersonal communication skills with their patients and that patients are satisfied with female doctors. There is little known, however, about the contribution of different configurations of gender identities to a variety of positive health outcomes in non-Western countries. In Iran, in particular, the attention given to "cross-gender dyads" in doctor-patient interactions is severely limited. DESCRIPTION: The findings were based on a well-designed questionnaire, validated and found to be reliable in Australia, which we administered to medical students in Iran. EVALUATION: Overall, there was no significant difference between the mean scores of students in relation to opposite-gender comfort. Results indicate that both male and female students were more comfortable conducting intimate physical examinations on patients of the same gender as themselves. Performing a testicular examination was significantly disagreeable for both genders, but particularly for female students. CONCLUSIONS: Both genders appeared to be comfortable talking to patients of the opposite gender about intimate matters, but same-gender dyads were viewed as preferable to cross-gender dyads in relation to physical examinations. Further qualitative research is needed to understand how these views are constituted and how they operate in practice. We make some recommendations, and we discuss the limitations of study.

Does NHS Direct empower patients?

NHS Direct is a 24h telephone helpline established in England and Wales, UK to offer advice and information for people about health, illness and the National Health Service (NHS) so that they are better able to care for themselves and their families. In 2001/2002 we undertook in-depth home interviews with 60 users of the service in two NHS Direct sites in England. In this paper we consider the extent to which NHS Direct facilitates patient empowerment in terms of helping people to be in control of their health and health care interactions. Our research suggests that NHS Direct facilitates patient empowerment by enabling patients to self care and to access health advice and services. It is also seen to offer the prerequisites for empowerment perceived to be lacking in the wider NHS, including time, respect, listening, support, and information. The service also functions by offering an alternative contact point for people seeking to avoid being labelled 'time wasters' by other busy health care providers. In the context of a wider health service which appears to problematise individuals' ability to make decisions about the appropriateness of seeking health care, NHS Direct legitimises help-seeking actions. Empowerment in the context of NHS Direct has been associated with self care as a way of reducing 'unnecessary' demand on health services. However, health professional and patient perspectives on what is considered necessary demand differ, and in certain contexts, patient empowerment may involve service use as well as self care. Further, our data reveal the context-dependent nature of a concept like empowerment. For example, when people are ill, in pain, or anxious about a loved one, they may value being cared for more than being empowered. Our research suggests that, in addition to its other functions, NHS Direct is also valued as contributing to a sense of being cared for.

Male callers to NHS Direct: the assertive carer, the new dad and the reluctant patient.

It has been suggested in the light of mortality and morbidity rates, and men's reluctance to seek medical help and advice, that there is a crisis in men's health. Little is known about men's experiences of using health care services, despite an emergent UK men's health movement. NHS Direct, the new telephone advice line, was designed to be more accessible, convenient and responsive to the public's needs for health care. In-depth interviews with male callers to the service, aged between 29 and 59, reveal that they sought help in their roles as fathers, partners and on their own behalf. Having used it once, they anticipated doing so again. Their learning about health matters, from both the formal structure and the informal agenda of the telephone consultation, suggests the potential of men's use of this service for 'normalizing' help seeking by men, and thereby for longer-term improvements in men's health.