Patient advocacy and patient centredness in participant recruitment to randomized-controlled trials: implications for informed consent.

CONTEXT: With the routinization of evidence-based medicine and of the randomized-controlled trial (RCT), more patients are becoming 'sites of evidence production' yet, little is known about how they are recruited as participants; there is some evidence that 'substantively valid consent' is difficult to achieve. OBJECTIVE: To explore the views and experiences of nurses recruiting patients to randomized-controlled trials and to examine the extent to which their recruitment practices were patient-centred and patient empowering. DESIGN: Semi-structured in-depth interviews; audio recording of recruitment appointments; thematic interactional analysis (drawing on discourse and conversation analysis). SETTING AND PARTICIPANTS: Nurses recruiting patients to five publicly funded RCTs and patients consenting to the recording of their recruitment sessions. MAIN OUTCOME MEASURES: The views of recruiting nurses about their recruitment role; the extent to which nurse-patient interactions were patient-centred; the nature of the nurses' interactional strategies and the nature and extent of patient participation in the discussion. RESULTS: The nurses had a keen sense of themselves as clinicians and patient advocates and their perceptions of the trial and its interventions were inextricably linked to those of the patients. However, many of their recruitment practices made it difficult for patients to play an active and informed part in the discussion about trial participation, raising questions over the quality of consent decisions. CONCLUSION: Nurses working in patient recruitment to RCTs need to reconcile two different worlds with different demands and ethics. Evidence production, a central task in evidence-based medicine, poses a challenge to patient-centred practice and more research and relevant training are needed.

Using qualitative research methods to improve recruitment to randomized controlled trials: the Quartet study.

OBJECTIVE: Randomized controlled trials (RCTs) are considered the optimum method for evaluating health care interventions, yet many fail to recruit sufficient participants in a timely manner. The ProtecT (Prostate testing for cancer and Treatment) study employed qualitative research methods as part of a complex intervention to improve recruitment to the RCT. The Quartet (Qualitative research to improve recruitment to trials) study was set up to evalute whether the ProtecT study's success in increasing randomization rates could be replicated in other trials experiencing recruitment difficulties. This paper reports on the issues that emerged from the attempts to apply qualitative research methods to improve recruitment rates in RCTs collaborating with the Quartet team. METHODS: The methods used were: investigation of RCT documents; semi-structured interviews and focus groups with RCT staff; audio-recording of recruitment appointments; and individual and group feedback sessions for RCT staff. Data were analysed using content and thematic analysis. RESULTS: Barriers arose when we attempted to establish collaborations with RCTs. Difficulties were encountered in securing the commitment of all relevant staff because of poor communication between lead investigators and other staff as well as RCT staff's concerns about having recruitment appointments audio-recorded. Recruitment processes were often more complex than anticipated. Governance procedures took considerable time and resources, limiting the time available for data collection and implementation of the intervention before recruitment closure. CONCLUSION: Straightforward replication of the ProtecT complex intervention was more complicated than expected. However, the study has increased understanding of RCT recruitment and identified ways to overcome barriers to collaboration. Such research is more easily undertaken in the feasibility stage of an RCT, and greater success will be achieved if the research is integrated into the everyday conduct of RCTs.

General practitioners with special interests: evolution and evaluation.

General practitioners with special interests (GPSIs) have emerged in the UK as a government initiative aimed at improving access in specialities that traditionally have long waiting times for investigations and treatment. This represents, to some extent, a formalisation of existing working practices of general practitioners who had obtained specialist experience during hospital training. GPSIs are working in a wide range of clinical areas including coronary heart disease, drug abuse, echocardiography and sexual health. Similar changes at the primary-secondary care interface are taking place in other European health systems. Key issues in the development of these services include the assurance of high-quality health care, clinical governance and risk management, cost-effectiveness and impact on outpatient care, and the work and role of specialists. It is possible that these new opportunities for general practitioners and other health care professions will aid recruitment and retention of staff in primary care, enhance education and encourage commissioners of services to look carefully at unmet needs in their health economies. Further challenges include the need to train a cadre of practitioners and to provide the research evidence on which to base continued investment in this promising initiative.

Why is recruitment to trials difficult? An investigation into recruitment difficulties in an RCT of supported employment in patients with severe mental illness.

BACKGROUND: Under-recruitment to randomised controlled trials (RCTs) is often problematic and there may be particular difficulties in recruiting patients with severe mental illness. AIM: To evaluate reasons for under-recruitment in an RCT of patients with severe mental illness METHODS: Qualitative study during the recruitment phase of an RCT of supported employment. Trial staff and recruiting clinicians were interviewed. Data were analyzed thematically using constant comparative techniques. RESULTS: Recruitment rates were low. Five main reasons for recruitment difficulties were found. These included: (i) misconceptions about trials, (ii) lack of equipoise, (iii) misunderstanding of the trial arms, (iv) variable interpretations of eligibility criteria, (v) paternalism. CONCLUSION: Reasons for recruitment difficulties in trials involving patients with severe mental illness include issues that occur in trials in general, but others are more specific to these patients. Clinician and patient involvement in the study design may improve recruitment in future similar trials.

A review of reporting of participant recruitment and retention in RCTs in six major journals.

BACKGROUND: Poor recruitment and retention of participants in randomised controlled trials (RCTs) is problematic but common. Clear and detailed reporting of participant flow is essential to assess the generalisability and comparability of RCTs. Despite improved reporting since the implementation of the CONSORT statement, important problems remain. This paper aims: (i) to update and extend previous reviews evaluating reporting of participant recruitment and retention in RCTs; (ii) to quantify the level of participation throughout RCTs. METHODS: We reviewed all reports of RCTs of health care interventions and/or processes with individual randomisation, published July-December 2004 in six major journals. Short, secondary or interim reports, and Phase I/II trials were excluded. Data recorded were: general RCT details; inclusion of flow diagram; participant flow throughout trial; reasons for non-participation/withdrawal; target sample sizes. RESULTS: 133 reports were reviewed. Overall, 79% included a flow diagram, but over a third were incomplete. The majority reported the flow of participants at each stage of the trial after randomisation. However, 40% failed to report the numbers assessed for eligibility. Percentages of participants retained at each stage were high: for example, 90% of eligible individuals were randomised, and 93% of those randomised were outcome assessed. On average, trials met their sample size targets. However, there were some substantial shortfalls: for example 21% of trials reporting a sample size calculation failed to achieve adequate numbers at randomisation, and 48% at outcome assessment. Reporting of losses to follow up was variable and difficult to interpret. CONCLUSION: The majority of RCTs reported the flow of participants well after randomisation, although only two-thirds included a complete flow chart and there was great variability over the definition of "lost to follow up". Reporting of participant eligibility was poor, making assessments of recruitment practice and external validity difficult. Reporting of participant flow throughout RCTs could be improved by small changes to the CONSORT chart.

Qualitative research to improve RCT recruitment: issues arising in establishing research collaborations.

INTRODUCTION: Strategies to improve recruitment to RCTs (randomised controlled trials) are limited. The ProtecT (Prostate testing for cancer and Treatment) study successfully developed a complex intervention based on qualitative research methods to increase recruitment rates. The Quartet study (Qualitative Research to Improve Recruitment to RCTs) was established to evaluate whether the ProtecT qualitative methods could be transferred into other RCTs. This paper reports on the barriers and facilitators in setting up these collaborations. METHODS: The Quartet study collaborated with five RCTs. Qualitative methods used were: interviews and focus groups with RCT staff; audio-recording recruitment interactions; and feedback sessions for RCT staff based on qualitative findings. Data were audio-recorded, transcribed and analysed using content and thematic analyses. Issues arising during establishment of collaborations were recorded and analysed. RESULTS: Establishing collaborations proved challenging and not always surmountable. Difficulties were encountered in gaining agreement of RCT staff to participate because of central RCT staff's lack of authority over recruitment staff, poor communication within RCTs and recruiters' reluctance to have their practice scrutinised. The complexity of the recruitment process also hindered translation of ProtecT methods. Although Quartet enabled significant recruitment issues to surface, the bureaucratic tasks involved in securing governance approval delayed onset of collaborations, reducing the time to address issues and evaluate Quartet's impact. DISCUSSION: The Quartet study established collaborations with a range of RCTs and gained valuable insights for future collaborations between qualitative researchers and RCTs. Qualitative research methods need to be included at the feasibility stage of a RCT or fully integrated into the RCT, as in the ProtecT study, with routine audio-recording for monitoring and training purposes. Quartet-like collaborations could then be established without delay, and recruitment processes of RCTs could become transparent, monitored and improved.