Isabel O C de Salis

Clear obstacles and hidden challenges: understanding recruiter perspectives in six pragmatic randomised controlled trials

BackgroundRecruitment of sufficient participants in an efficient manner is still widely acknowledged to be a major challenge to the mounting and completion of randomised controlled trials (RCTs). Few recruitment interventions have involved staff undertaking recruitment. This study aimed i) to understand the recruitment process from the perspective of recruiters actively recruiting RCT participants in six pragmatic RCTs, and ii) to identify opportunities for interventions to improve recruitment.MethodsInterviews were undertaken with 72 individuals (32 doctors or RCT Chief investigators (CIs); 40 nurses/other health professionals) who were actively recruiting participants in six RCTs to explore their experiences of recruitment. The RCTs varied in scale, duration, and clinical contexts. Interviews were fully transcribed and analysed using qualitative content and thematic analytic methods derived from grounded theory. For this analysis, data were systematically extracted from each RCT and synthesised across all six RCTs to produce a detailed and nuanced understanding of the recruitment process from the perspectives of the recruiters.ResultsRecruiters readily identified organisational difficulties, fewer than expected eligible patients, and patients’ treatment preferences as the key barriers to recruitment. As they described their experiences of recruitment, several previously hidden issues related to their roles as researchers and clinicians emerged, imbued with discomfort and emotion. The synthesis across the RCTs showed that doctors were uncomfortable about aspects of patient eligibility and the effectiveness of interventions, whereas nurses were anxious about approaching potential RCT participants and conflicts between the research and their clinical responsibilities. Recruiters seemed unaware that their views contributed to recruitment difficulties. Their views were not known to RCT CIs. Training and support needs were identified for both groups of staff.ConclusionsThe synthesis showed that recruitment to these RCTs was a complex and fragile process. Clear obstacles were identified but hidden challenges related to recruiters’ roles undermined recruitment, unbeknown to RCT CIs. Qualitative research can elicit and identify the hidden challenges. Training and support are then needed for recruiters to become more comfortable with the design and principles of RCTs, so that they can engage more openly with potentially eligible participants and create a more resilient recruitment process.

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.

The intellectual challenges and emotional consequences of equipoise contributed to the fragility of recruitment in six randomized controlled trials

Objective The aim of the study was to investigate how doctors considered and experienced the concept of equipoise while recruiting patients to randomized controlled trials (RCTs). Study Design and Setting In-depth interviews with 32 doctors in six publicly funded pragmatic RCTs explored their perceptions of equipoise as they undertook RCT recruitment. The RCTs varied in size, duration, type of complex intervention, and clinical specialties. Interview data were analyzed using qualitative content and thematic analytical methods derived from grounded theory and synthesized across six RCTs. Results All six RCTs suffered from poor recruitment. Doctors wanted to gather robust evidence but experienced considerable discomfort and emotion in relation to their clinical instincts and concerns about patient eligibility and safety. Although they relied on a sense of community equipoise to justify participation, most acknowledged having “hunches” about particular treatments and patients, some of which undermined recruitment. Surgeons experienced these issues most intensely. Training and support promoted greater confidence in equipoise and improved engagement and recruitment. Conclusion Recruitment to RCTs is a fragile process and difficult for doctors intellectually and emotionally. Training and support can enable most doctors to become comfortable with key RCT concepts including equipoise, uncertainty, patient eligibility, and randomization, promoting a more resilient recruitment process in partnership with patients.

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 studys 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 staffs 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.

'I'm fishing really' - inflammatory marker testing in primary care: a qualitative study

Background Inflammatory markers can be helpful as part of the diagnostic workup for specific diseases or for monitoring disease activity. A third use is as a screening and/or triage tool to differentiate between the presence or absence of disease. Most research into inflammatory markers looks at diagnosis of specific diseases and comes from secondary care. Qualitative studies to explore when and why clinicians use these tests in primary care are lacking. Aim To identify clinicians’ approaches to inflammatory marker testing in primary care. Design and setting Qualitative study with 26 GPs and nurse practitioners. Method Interviews were conducted using a semi-structured topic guide. Clinicians reviewed recent cases of inflammatory marker testing in their pathology inbox. Interviews were audiorecorded and transcribed. Qualitative analysis was conducted by two of the authors. Results Clinicians are uncertain about the appropriate use of inflammatory markers and differ in their approach to testing patients with undifferentiated symptoms. Normal or significantly elevated inflammatory markers are seen as helpful, but mildly raised inflammatory markers in the context of non-specific symptoms are difficult to interpret. Clinicians describe a tension between not wanting to ‘miss anything’ and, on the other hand, being wary of picking up borderline abnormalities that can lead to cascades of further tests. Diagnostic uncertainty is a common reason for inflammatory marker testing, with the aim to reassure; however, paradoxically, inconclusive results can generate a cycle of uncertainty and anxiety. Conclusion Further research is needed to define when inflammatory marker testing is useful in primary care and how to interpret results.

Experiencing Menopause in the UK: the interrelated Narratives of Normality, Distress and Transformation

ABSTRACT We investigated the experience and perspectives of menopause among 48 UK mothers through qualitative in-depth interviews. Interviews were analyzed thematically then explored using social science theories. Three interdependent narratives emerged: menopause as a normal, biological process, distinct from self and social transitions; menopause as struggle, an “idiom of distress” expressing upset, identity loss, shame, and social upheaval; and menopause as transformative and liberating, arising from biopsychic and relational changes. Some women followed a predictable “rite of passage” trajectory with transformation emerging from distress, but not all: Menopause arises from a complex interplay of personal predicament, somatic change, and sociocultural context.

Guidance was developed on how to write a plain language summary for diagnostic test accuracy reviews

OBJECTIVE To develop guidance for authors of diagnostic test accuracy (DTA) reviews to help them write a plain language summary of the results of their review. STUDY DESIGN AND SETTING We used a combination of focus groups, user testing, and a web-based survey. Participants included patient representatives, media representatives, and health professionals. RESULTS We present step-by-step guidance for authors of DTA reviews for writing a plain language summary. This guidance is illustrated with examples of reader-tested sentences, explanations, and a figure. CONCLUSION We hope this guidance will allow reviewers to present the findings of DTA reviews so that it is easier for readers to understand the results and conclusions. This will increase the accessibility of these reviews for various audiences.