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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.
Keywords
qualitative, randomised controlled trial, palliative care, breathlessness, recruitment, retention, person centred care
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Peer Review Timeline
CURRENT STATUS: Published
View the published article at Trials.
No community comments so far
Review #1 received
Received 07 Jan, 2020
Reviewers invited
Invitations sent on 12 Dec, 2019
Reviewer #1 agreed
On 12 Dec, 2019
Editor assigned
On 09 Dec, 2019
Submission checks complete
On 08 Dec, 2019
Version 2
Posted 06 Nov, 2019
No comments provided
Editorial decision: Minor revision
On 19 Nov, 2019
Review #1 received
Received 17 Nov, 2019
Reviewer #1 agreed
On 05 Nov, 2019
Editor assigned
On 01 Nov, 2019
Reviewers invited
Invitations sent on 01 Nov, 2019
Submission checks complete
On 31 Oct, 2019
No comments provided
Editorial decision: Major revision
On 16 Sep, 2019
Review #2 received
Received 30 Aug, 2019
Reviewer #2 agreed
On 08 Aug, 2019
Review #1 received
Received 15 Jul, 2019
Editor assigned
On 26 Jun, 2019
Reviewers invited
Invitations sent on 26 Jun, 2019
Reviewer #1 agreed
On 26 Jun, 2019
Submission checks complete
On 25 Jun, 2019
First submitted
On 20 May, 2019
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
Subject Areas
Hospital Medicine
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A new preprint design is coming!
We have improved readability, clarity, accessibility, and opportunities for engagement.
See the published version of this preprint at Trials.
This is a preprint, a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
Learn more about In Review
Research
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
Peer Review Timeline
CURRENT STATUS: Published
View the published article at Trials.
No community comments so far
Review #1 received
Received 07 Jan, 2020
Reviewers invited
Invitations sent on 12 Dec, 2019
Reviewer #1 agreed
On 12 Dec, 2019
Editor assigned
On 09 Dec, 2019
Submission checks complete
On 08 Dec, 2019
Version 2
Posted 06 Nov, 2019
No comments provided
Editorial decision: Minor revision
On 19 Nov, 2019
Review #1 received
Received 17 Nov, 2019
Reviewer #1 agreed
On 05 Nov, 2019
Editor assigned
On 01 Nov, 2019
Reviewers invited
Invitations sent on 01 Nov, 2019
Submission checks complete
On 31 Oct, 2019
No comments provided
Editorial decision: Major revision
On 16 Sep, 2019
Review #2 received
Received 30 Aug, 2019
Reviewer #2 agreed
On 08 Aug, 2019
Review #1 received
Received 15 Jul, 2019
Editor assigned
On 26 Jun, 2019
Reviewers invited
Invitations sent on 26 Jun, 2019
Reviewer #1 agreed
On 26 Jun, 2019
Submission checks complete
On 25 Jun, 2019
First submitted
On 20 May, 2019
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
Subject Areas
Hospital Medicine
License:
This work is licensed under a CC BY 4.0 License. Read Full License
View the published article at 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
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.
Figure 1
Figure 2
This is a list of supplementary files associated with this preprint. Click to download.
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