Sertraline in symptomatic chronic breathlessness: a double blind, randomised trial

Maddocks³

et al. 2019

Preprint

BackgroundRecruitment 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. MethodsQualitative 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 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. ResultsIn the feasibility trial 409 people were screened for eligibility and 64 randomised. No participant was lost to follow up. 22 participants took part in a qualitative interview. 11 had a diagnosis of COPD, 8 ILD, 2 CHF, and 1 lung cancer. Median age was 71 years (56-84). 16 were male. 20 had completed the trial, 2 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. ConclusionsIn this feasibility trial recruitment targets were met, attrition levels were low, and aspects of the person-centred 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

Section: So How Can Pcc Be Applied To Clinical Trials In Practice?supporting

confidence: 79%

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

Maddocks³

et al. 2019

Preprint

“…16 of the interviews were conducted with male patients which is reflective of the main trial participants. This is similar to other trials (44) and may reflect that fact that chronic lung disease has previously been considered to be a condition predominantly affecting men (45). It has however recently been acknowledged that women remain underrepresented in chronic lung disease trials and this should be addressed in future research (46).…”

Section: Strengths and Limitationssupporting

confidence: 78%

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

Maddocks³

et al. 2019

Preprint

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 Qualitative study embedded within a double blind randomised trial 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 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 randomised. No participant was lost to follow up. 22 participants provided qualitative interviews. 11 had a diagnosis of COPD, 8 ILD, 2 CHF, and 1 lung cancer. Median age was 71 years (56-84). 16 were male. 20 had completed the trial, 2 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 person-centred approach were viewed positively by trial participants. Prioritisation of the relationship between the patient and professional, ensuring a person-centred trial design, and enabling people to participate by having processes in line with individual capabilities may support recruitment and retention in clinical trials in advanced disease. We would recommend the integration of a person-centred approach in all clinical trials.

“…Sixteen of the interviews were conducted with male patients, which is reflective of the main trial participants. This is similar to other trials [46] and may reflect the fact that chronic lung disease has previously been considered to be a condition predominantly affecting men [47]. It has recently been acknowledged, however, that women remain underrepresented in chronic lung disease trials, and this should be addressed in future research [48].…”

Section: Strengths and Limitationssupporting

confidence: 77%

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

Maddocks

et al. 2020

Trials

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.