Rose Wiles

Development and evaluation of complex interventions in health services research: case study of the Southampton heart integrated care project (SHIP)

Interventions are often defined pragmatically and lack any clear theoretical basis, which limits generalisability. Implementation is rarely described, which limits understanding of why an intervention is or is not locally successful. Integration of qualitative methods within pilot trials can help interpret the quantitative result by clarifying process and testing theory. This approach defines three levels of understanding: the evidence and theory which inform the intervention, the tasks and processes involved in applying the theoretical principles, and people with whom, and context within which, the intervention is operationalised. A case study shows how this novel method of programme development and evaluation can be applied.

Continuity, transition and participation: preparing clients for life in the community post-stroke.

Aims. To examine issues of continuity and transition facing clients as they return to life in the community following stroke and the role of rehabilitation in this process. Key findings and implications. The sudden onset of disability following a stroke represents a major disruption to the continuity of a persons life experience. Rehabilitation has an important role in the transition from the non-disabled to the disabled state however current rehabilitation services and outcomes post-stroke focus on functional recovery rather than on a return to meaningful roles and activities and pay little attention to the transition from the non-disabled to the disabled self. Although some current rehabilitation models address the importance of involvement in a life situation, they do not adequately address issues of the role of the environment, the nature of community, the importance of meaning and choice when thinking about life situations, and change in abilities across the life course. Conclusions. Models of rehabilitation service delivery need to move to a chronic disease management model that incorporates outcomes that are meaningful to clients, and not the assumed needs or outcomes as defined by rehabilitation professionals.

The Management of Confidentiality and Anonymity in Social Research

This article explores the ways in which social researchers manage issues of confidentiality and the contexts in which deliberate and accidental disclosures occur. The data are drawn from a qualitative study of social researchers’ practices in relation to informed consent. It comprised 31 individual interviews and six focus groups as well as invited email responses with researchers working with vulnerable groups or with an interest in research ethics. Researchers reported feeling compelled to break confidentiality when participants were perceived as being at risk of harm but not in cases of involvement in illegal activity. Situations in which accidental disclosures occurred were also identified. Researchers reported varying ways in which they protected the confidentiality of their participants in the dissemination of their research, including omitting data and changing key characteristics of participants. The implications of researchers’ practices on data integrity and relationships with participants are discussed.

Researching researchers: Lessons for research ethics

There is widespread debate about ethical practice in social research with most social researchers arguing that situational relativist approaches are appropriate for resolving the ethical issues that emerge. In this article, we draw on research conducted on an ESRC-funded study of informed consent in social research to explore the ethical issues that are raised when conducting research with one’s peers. The study involved conducting focus groups and telephone interviews with academic and non-academic researchers. The ethical issues emerging from the study related to consent, data ownership and the management of confidentiality and anonymity. Participants’ responses to these issues and the ways that we managed them are discussed. We conclude by exploring the implications of this study for research more generally and argue that the increased regulation of research needs to enable researchers to attend reflexively to the social context in which consent takes place.

Informed Consent, Gatekeepers and Go-Betweens: Negotiating Consent in Child- and Youth-Orientated Institutions.

Gaining informed consent from research participants is widely regarded as central to ethical research practice. This article reports on research which sought to identify contemporary practice in this area amongst researchers working in fields where research participants are often constructed as vulnerable within the research process, and where their potential involvement tends to be mediated by institutional gatekeepers. Drawing on telephone interview and focus group data, the article focuses specifically on the experiences of researchers working with children and young people. It highlights the tensions experienced by many researchers between a personal commitment to an ethical framework which seeks to prioritise the agency and competency of children and young people, and the conditions imposed upon them by working within institutional settings where these principles may be undermined. This research suggests that the consent practices of child- and youth-orientated institutions, however much frowned upon, tend to go largely unchallenged by researchers, to the detriment of the rights of children and young people to opt in and out of research on their own behalf.

Patients' expectations of recovery following stroke: a qualitative study

Purpose : Patients and carers frequently express disappointment with the extent of recovery achieved at the point of discharge from physiotherapy. Research has suggested that high expectations of recovery may be encouraged by physiotherapists. This study examined the information exchanged between physiotherapists and patients in relation to recovery following stroke in order to explore this issue. Methods : The study comprised in-depth longitudinal case studies of 16 patients with a first incident stroke. Qualitative interviews were conducted with patients and their physiotherapists to explore their understandings and expectations of recovery and of physiotherapy at three time points. Patients were assessed for deficits of movement, function and mood at the same three stages and observations of out-patient sessions were also conducted. Qualitative data were analysed using thematic analysis. The assessment data were analysed using descriptive and comparative statistics. Results : Data indicated deficits of movement improved significantly between the first and third assessments. The qualitative data showed that physiotherapists did not encourage over-optimistic expectations of recovery through the verbal information they provided to patients. Nevertheless patients did maintain high expectations of recovery throughout the three-month post-stroke period. Conclusion : Improved communication strategies, informed by an evidence base of recovery, should be used to encourage realistic expectations of physiotherapy without destroying the process of active participation and skill acquisition.

Innovation in qualitative research methods: a narrative review

This article reviews claims for methodological innovation in qualitative research. It comprises a review of 57 papers published between 2000–9 in which claims to innovation in qualitative methods have been made. These papers encompass creative methods, narrative methods, mixed methods, online/e-research methods, focus groups and software tools. The majority of claims of innovation are made for new methods or designs, with the remainder claiming adaptations or adoption of existing methodological innovations. However, the evidence provided of wholly new methodologies or designs was limited, and in several papers such claims turned out to relate either to adaptations to existing methods, or to the transfer and adaptation of methods from other disciplines, primarily from arts and humanities. We argue that over-claiming innovation in the sense of the development of a wholly new methodology or design has a number of important implications that are potentially detrimental to qualitative social science.

Research Ethics and Data Quality: The Implications of Informed Consent

Patterns of research governance are changing rapidly in the field of social research. In current debates about these changes one issue of particular concern is the impact that new patterns of research governance will have on the quality of the data collected. The ‘optimistic’ scenario on this issue is that more ethical research practice will lead to better‐quality data, but a more ‘pessimistic’ scenario exists in which the unintended outcome is poorer‐quality data. Drawing on material from a study of researchers’ experiences of dealing with the process of gaining informed consent from research participants, this article identifies the various ways in which the researchers position themselves in relation to the competing ‘optimistic’ and ‘pessimistic’ scenarios. It concludes by seeking to develop a synthesis of the two positions in which ethical research practice is treated neither as an automatic guarantee of, nor as an inevitable obstacle to, the collection of good‐quality data.

Randomised controlled trial of self management leaflets and booklets for minor illness provided by post

Abstract Objective: To assess the effectiveness of providing information by post about managing minor illnesses. Design: Randomised controlled trial. Setting: Six general practices. Participants: Random sample of 4002 patients from the practice registers. Intervention: Patients were randomised to receive one of three kinds of leaflet or booklet endorsed by their general practitioner: control (surgery access times), booklet, or summary card. Main outcome measures: Attendance with the 42 minor illnesses listed in the booklet. Perceived usefulness of leaflets or booklets, confidence in managing illness, and willingness to wait before seeing the doctor. Results: 238 (6%) patients did not receive the intervention as allocated. Of the remaining 3764 patients, 2965 (79%) had notes available for review after one year. Compared with the control group, fewer patients attended commonly with the minor illnesses in the booklet group (≥2 consultations a year: odds ratio 0.81, 95% confidence interval 0.67 to 0.99) and the summary card group (0.83; 0.72 to 0.96). Among patients who had attended with respiratory tract infections in the past year there was a reduction in those attending in the booklet group (0.81; 0.62 to 1.07) and summary card group (0.67; 0.51 to 0.89) compared with the control group. The incidence of contacts with minor illness fell slightly compared with the previous year in the booklet (incidence ratio 0.97; 0.84 to 1.13) and summary card groups (0.93; 0.80 to 1.07). More patients in the intervention groups felt greater confidence in managing illness (booklet 32%, card 34%, control 12%, P<0.001), but there was no difference in willingness to wait score (all groups mean=32, P=0.67). Conclusion: Most patients find information about minor illness provided by post useful, and it helps their confidence in managing illness. Information may reduce the number attending commonly with minor illness, but the effect on overall contacts is likely to be modest. These data suggest that posting detailed information booklets about minor illness to the general population would have a limited effect. What is already known on this topic Increasing attendance for minor illness in primary care is a threat to consultation time and quality of care Few recent studies have examined the effect of providing patients with information on self management of minor illness What this study adds Most patients find information about minor illness provided by post useful, and it helps their confidence in managing illness Information booklets and leaflets reduced the number attending frequently with minor illness, but the effect on overall contacts was not significant Information booklets on minor illness provided by post may have a limited role in the NHS

Informed Consent and the Research Process: Following Rules or Striking Balances?

Gaining informed consent from people being researched is central to ethical research practice. There are, however, several factors that make the issue of informed consent problematic, especially in research involving members of groups that are commonly characterised as ‘vulnerable’ such as children and people with learning disabilities. This paper reports on a project funded by the UK Economic and Social Research Council (ESRC) which was concerned to identify and disseminate best practice in relation to informed consent in research with six such groups. The context for the study is the increased attention that is being paid to the issue of informed consent in research, not least because of the broad changes taking place in research governance and regulation in the UK. The project involved the analysis of researchers’ views and experiences of informed consent. The paper focuses on two particular difficulties inherent in the processes of gaining and maintaining informed consent. The first of these is that there is no consensus amongst researchers concerning what comprises ‘informed consent’. The second is that there is no consensus about whether the same sets of principles and procedures are equally applicable to research among different groups and to research conducted within different methodological frameworks. In exploring both these difficulties we draw on our findings to highlight the nature of these issues and some of our participants’ responses to them. These issues have relevance to wider debates about the role of guidelines and regulation for ethical practice. We found that study participants were generally less in favour of guidelines that regulate the way research is conducted and more in favour of guidelines that help researchers to strike balances between the conflicting pressures that inevitably occur in research.