Systematic techniques for assisting recruitment to trials (START): study protocol for embedded, randomized controlled trials

BACKGROUND: Randomized controlled trials play a central role in evidence-based practice, but recruitment of participants, and retention of them once in the trial, is challenging. Moreover, there is a dearth of evidence that research teams can use to inform the development of their recruitment and retention strategies. As with other healthcare initiatives, the fairest test of the effectiveness of a recruitment strategy is a trial comparing alternatives, which for recruitment would mean embedding a recruitment trial within an ongoing host trial. Systematic reviews indicate that such studies are rare. Embedded trials are largely delivered in an ad hoc way, with interventions almost always developed in isolation and tested in the context of a single host trial, limiting their ability to contribute to a body of evidence with regard to a single recruitment intervention and to researchers working in different contexts. METHODS/DESIGN: The Systematic Techniques for Assisting Recruitment to Trials (START) program is funded by the United Kingdom Medical Research Council (MRC) Methodology Research Programme to support the routine adoption of embedded trials to test standardized recruitment interventions across ongoing host trials. To achieve this aim, the program involves three interrelated work packages: (1) methodology - to develop guidelines for the design, analysis and reporting of embedded recruitment studies; (2) interventions - to develop effective and useful recruitment interventions; and (3) implementation - to recruit host trials and test interventions through embedded studies. DISCUSSION: Successful completion of the START program will provide a model for a platform for the wider trials community to use to evaluate recruitment interventions or, potentially, other types of intervention linked to trial conduct. It will also increase the evidence base for two types of recruitment intervention. TRIAL REGISTRATION: The START protocol covers the methodology for embedded trials. Each embedded trial is registered separately or as a substudy of the host trial

Lay perceptions of evidence-based information – a qualitative evaluation of a website for back pain sufferers

BACKGROUND: In an evidence-informed patient choice the patient has access to research-based information about the effectiveness of health care options and is encouraged to use this information in treatment decisions. This concept has seen growing popularity in recent years. However, we still know relatively little about users' attitudes to the use of research-based information, possibly because people have been unexposed to this type of information. After developing the BackInfo website where the results of Cochrane systematic reviews on the effects of low back pain were adapted and presented to lay users we evaluated how users responded to this information. METHODS: Focus group meetings were held with 18 chronic back pain sufferers, after they had been sent a link to the website before the meetings. RESULTS: The focus groups suggest that the most important challenges to the use of BackInfo's research-based information are not primarily tied to the comprehension or presentation of the information, but are mainly associated with participants' attitudes towards the credibility of research and researchers, and the applicability of research results to themselves as individuals. Possible explanations for participants' lack of trust in research and their apparent difficulties in applying this research to their own situations include aspects that may be typical for the general public including the media's presentation of research, and a lack of familiarity with and feelings of distance to research evidence. Other aspects may be typical for patient groups with chronic and unclear medical conditions, such as a lack of trust in the health care establishment in general. CONCLUSION: In order to enhance the credibility and applicability of research evidence, providers of research-based information could explore a number of possibilities including the use of including personal stories to illustrate the research outcomes

Methodological developments in qualitative longitudinal research:the advantages and challenges of regular telephone contact with participants in a qualitative longitudinal interview study

BACKGROUND: Qualitative longitudinal research is an evolving methodology, particularly within health care research. It facilitates a nuanced understanding of how phenomena change over time and is ripe for innovative approaches. However, methodological reflections which are tailored to health care research are scarce. This article provides a synthesised and practical account of the advantages and challenges of maintaining regular telephone contact between interviews with participants in a qualitative longitudinal study. METHODS: Participants with metastatic colorectal cancer were interviewed at 3 time points over the course of a year. Half the group also received monthly telephone calls to explore the added value and the feasibility of capturing change as close to when it was occurring as possible. RESULTS: The data gathered from the telephone calls added context to the participants’ overall narrative and informed subsequent interviews. The telephone calls meant we were able to capture change close to when it happened and there was a more evolved, and involved, relationship between the researcher and the participants who were called on a monthly basis. However, ethical challenges were amplified, boundaries of the participant/researcher relationship questioned, and there was the added analytical burden. CONCLUSIONS: The telephone calls facilitated a more nuanced understanding of the illness experience to emerge, when compared with the interview only group. The findings suggest that intensive telephone contact may be justified if retention is an issue, when the phenomena being studied is unpredictable and when participants feel disempowered or lack control. These are potential issues for research involving participants with long-term illness

The patient experience

The impact of improved treatments for the management of hormone-sensitive breast cancer extends beyond clinical responses. Thanks to appropriate literature and access to the internet, patient awareness of treatment options has grown and patients are now, in many cases, able to engage their oncologists in informed conversations regarding treatment and what to expect in terms of efficacy and safety. Indeed, patients realize that although there is no cure for metastatic disease, treatment can greatly reduce the risk of progression and in the adjuvant setting, where treatment is administered with a curative intent, current treatment options reduce the risk of relapse. The approval of letrozole throughout the breast cancer continuum has provided patients with many reassuring options. The improvement in outcome with letrozole is achieved without a detrimental effect on overall quality of life. Adverse events such as hot flushes, arthralgia, vaginal dryness, and potential osteoporosis are most significant from the patient’s perspective, and it is important that caregivers pay attention to patients experiencing these events, as they can impact compliance unless effectively explained and managed. The major benefits of letrozole are to improve prospects for long-term survivorship in the adjuvant setting and to delay progression and the need for chemotherapy in the metastatic setting

Expressions of loss of adulthood in the narratives of people with colorectal cancer.

The diagnosis and treatment of colorectal cancer entail detailed discussions of bodily functions, invasive procedures, and a reorientation of life around bowel habit. Furthermore, people with stomas undergo a second experience of toilet training in adulthood. For these reasons, colorectal cancer is sometimes considered an embarrassing disease. Narrative interviews with colorectal cancer patients indicate the inadequacy of the concept of embarrassment in describing the loss of dignity, privacy, independence, and sexual confidence as well as a compromised ability to work, travel, and socialize. The link between bowel control and the constitution of adult identity must be acknowledged if health professionals and carers are to offer the most appropriate forms of information and support to people affected by colorectal cancer

What do patients with prostate or breast cancer want from an Internet site? A qualitative study of information needs.

The study aimed to explore the information needs of cancer patients, to solicit their views of Internet-based health information and to consider whether the DIPEx website would have addressed specific unmet information needs of people with breast or prostate cancer. Focus groups were conducted first to identify information needs. Participants were recruited through four breast and prostate cancer support groups in the UK. Individual interviews, in which participants were shown DIPEx and asked to search for material related to concerns that had been important to them as cancer patients, were conducted after the focus groups. Respondents said their information needs had been complex and changed over time while the information they had been given was often patchy, inconsistent, contradictory and haphazard. Access to practical and experiential information from other patients was highly valued. Those with experience of using the Internet expressed a clear preference for non-commercial sites for health information. Sites attached to recognised centres of excellence such as universities or well-known medical centres were also preferred. Respondents were aware of the possible pitfalls of taking health information from the Internet and often compared information from several sources before believing it

Women's responses to nausea and vomiting in pregnancy.

OBJECTIVE: To explore women's experiences of nausea and vomiting in pregnancy. DESIGN: secondary (thematic) analysis of data collected by narrative interviews for two wider studies about antenatal screening and about pregnancy for the DIPEx website (www.dipex.org). PARTICIPANTS AND SETTING: A maximum variation sample was recruited throughout the UK. Data from the 73 women interviewed have been analysed. Interviews took place between October 2003 and December 2004, mostly in the home. FINDINGS: sickness is considered a typical and almost inevitable feature of pregnancy. Against this backdrop, a new framework for understanding women's responses to nausea and vomiting in pregnancy, and the meanings they attach to it, is suggested: nausea and vomiting as something to be expected, survived, resisted, resented, and acknowledged by others. KEY CONCLUSIONS: The concepts of loss of self and biographical disruption from the field of chronic illness seem to resonate with the women's experiences, and may perhaps be extended to transient as well as chronic health conditions. People's experiences of their bodies in health as well as illness need to be more widely studied. IMPLICATIONS FOR PRACTICE: Many women would appreciate greater acknowledgement of the distress nausea and vomiting in pregnancy causes them, information about remedies and strategies other women have found helpful, and reassurance. Expressions of empathy by health-care professionals are frequently lacking and particularly desired

Explanations of depression among Irish migrants in Britain

Irish geographical and cultural propinquity to the UK might be considered as an advantage to migrants. However, research over 40 years shows Irish migrants to have consistent high vulnerability to mental disorders. Only recently have researchers begun to explore the reasons for this morbidity. Taking a previous epidemiological study on depression and Irish migrants as a point of departure, we explored the reasons for this morbidity—we hypothesised that depression may be related to unprepared or spontaneous migration. We report on a qualitative study in order to clarify how, from the migrant's perspective, migration might be related to depression. These perspectives were obtained through in-depth interviews with Irish-born migrants aged 18 and over living in London in order to explore psychological distress through a contextualised ‘insiders’ account. The interviews were completed with men and women who experienced depression and others who had not. We found that previous theories on Irish migrant psychiatric disorder such as racial discrimination were not supported by the narratives of Irish migrant experience. For many participants, the origins of distress are located in Ireland or in difficult life events and circumstances without a direct relationship to migration. This paper examines the causal attributes to depression among Irish migrants in the UK in the context of pre- and post-migration experiences with particular focus on gender and age