What influenced people with chronic or refractory breathlessness and advanced disease to take part and remain in a drug trial? A qualitative study

Abstract

Background: Recruitment and retention in clinical trials remains an important challenge, particularly in the context of advanced disease. It is important to understand what affects retention to improve trial quality, minimise attrition and reduce missing data. We conducted a qualitative study embedded within a randomised feasibility trial and explored what influenced people to take part and remain in the trial. Methods: We conducted a qualitative study embedded within a double-blind randomised trial (BETTER-B[Feasibility]: BETter TreatmEnts for Refractory Breathlessness) designed using a person-centred approach. Participants with cancer, chronic obstructive pulmonary disease (COPD), interstitial lung disease (ILD), or chronic heart failure (CHF), with a modified Medical Research Council dyspnoea scale grade of 3/4 were recruited from three UK sites. A convenience subsample completed qualitative interviews after the trial. Interviews were analysed using thematic analysis. Results were considered in relation to the core elements of person-centred care and our model of the person-centred trial. Results: In the feasibility trial 409 people were screened for eligibility, and 64 were randomised. No participant was lost to follow-up. Twenty-two participants took part in a qualitative interview. Eleven had a diagnosis of COPD, 8 ILD, 2 CHF and 1 lung cancer. The participants' median age was 71 years (range 56-84). Sixteen were male. Twenty had completed the trial, and two withdrew due to adverse effects. The relationship between patient and professional, potential for benefit, trial processes and the intervention all influenced the decision to participate in the trial. The relationship with the research team and continuity, perceived benefit, and aspects relating to trial processes and the intervention influenced the decision to remain in the trial. Conclusions: In this feasibility trial recruitment targets were met, attrition levels were low, and aspects of the personcentred approach were viewed positively by trial participants. Prioritisation of the relationship between the patient and professional; person-centred processes, including home visits, assistance with questionnaires, and involvement of the carer; and enabling people to participate by having processes in line with individual capabilities appear to support recruitment and retention in clinical trials in advanced disease. We recommend the integration of a person-centred approach in all clinical trials.

Integrating qualitative interviews in drug development and the use of qualitative evidence in product labelling and health technology assessments: a review

“…Interviewers were from qualitative ( n = 13), social science ( n = 2), medical ( n = 1), or local trial staff ( n = 1) backgrounds; ten studies did not specify the professional background of the interviewers. Among the studies retrieved, 11 followed a longitudinal design with entry/baseline and/or intermediate and/or exit interviews ( 12 , 22 – 26 , 29 , 30 , 33 , 36 , 37 ), seven were exit interviews only ( 13 , 16 , 21 , 28 , 31 , 34 , 35 ), two were entry interviews only ( 14 , 26 ) and seven did not specify the interview time point. The interviews were embedded in phase 2 studies ( n = 10), phase 2/3 ( n = 1), phase 3 ( n = 5), phase 4 ( n = 1), in studies where the phase was not applicable ( n = 7) or not specified ( n = 3).…”

“…Participants interviewed included the entire trial population or a subpopulation. The interviews were conducted with all study participants in three trials ( 14 , 26 , 32 ) and with a subset of the study participants (median of about 14%) in 20 trials ( 12 , 13 , 15 – 18 , 21 – 25 , 27 – 31 , 33 – 36 ).…”

The Development of the Australian National Palliative Care Clinical Studies Collaborative “Integrating Qualitative Research into Clinical Trials Framework”

“…Meanwhile, tThe MORECare Guidelines provide a conceptual approach to such a bridge by promoting mixed methods research at all phases of complex intervention development and evaluation (22). Meanwhile a number of authors have offered 'real world' examples to target different key challenges within a trial such as maximising participant recruitment and retention (23)(24)(25)(26). In developing our framework we believe we have provided a practical means of incorporating qualitative work across the landscape of clinical trial design and conduct.…”

The Impact of Optic Nerve Disorders on Sleep Wake

“…Content could be piloted and reviewed by a patient support group, with easy-to-understand language free from jargon, that is age-appropriate and addresses key concerns a participant may have about safety and their ability to attend study appointments. Recording detailed contact information such as Email addresses, telephone numbers, home address and Email and telephone details of a close friend or relative can ensure that contact can be made with participants and that they can be updated with study progress newsletters which also give details of its benefits, and feel engaged with the process (1324,1325).…”

“…Providing participants with a clear timeline of clinic visits and text message or telephone reminders prior to appointments can help participants know what to expect and feel involved with the study process (1325). Reducing the participant burden can improve retention, for example by arranging transport to clinical appointments and covering transport and childcare costs, and conducting questionnaires over the telephone or sending them via Email if participants are too unwell or unable to attend clinic appointments (1324,1326).…”