Equipoise across the patient population: optimising recruitment to a randomised controlled trial
Abstract Background This paper proposes a novel perspective on the value of qualitative research for improving trial design and optimising recruitment. We report findings from a qualitative study set within the OPEN trial, a surgical randomised controlled trial (RCT) comparing two interventions for...
| Main Authors: | , , , |
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| Format: | Article |
| Language: | English |
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BMC
2017-03-01
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| Series: | Trials |
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| Online Access: | http://link.springer.com/article/10.1186/s13063-016-1711-8 |
| _version_ | 1818850642563694592 |
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| author | Paul Whybrow Robert Pickard Susan Hrisos Tim Rapley |
| author_facet | Paul Whybrow Robert Pickard Susan Hrisos Tim Rapley |
| author_sort | Paul Whybrow |
| collection | DOAJ |
| description | Abstract Background This paper proposes a novel perspective on the value of qualitative research for improving trial design and optimising recruitment. We report findings from a qualitative study set within the OPEN trial, a surgical randomised controlled trial (RCT) comparing two interventions for recurrent bulbar urethral stricture, a common cause of urinary problems in men. Methods Interviews were conducted with men meeting trial eligibility criteria (n = 19) to explore reasons for accepting or declining participation and with operating urologists (n = 15) to explore trial acceptability. Results Patients expressed various preferences and understood these in the context of relative severity and tolerability of their symptoms. Accounts suggest a common trajectory of worsening symptoms with a particular window within which either treatment arm would be considered acceptable. Interviews with clinician recruiters found that uncertainty varied between general and specialist sites, which reflect clinicians’ relative exposure to different proportions of the patient population. Conclusion Recruitment post referral, at specialist sites, was challenging due to patient (and clinician) expectations. Trial design, particularly where there are fixed points for recruitment along the care pathway, can enable or constrain the possibilities for effective accrual depending on how it aligns with the optimum point of patient equipoise. Qualitative recruitment investigations, often focussed on information provision and patient engagement, may also look to better understand the target patient population in order to optimise the point at which patients are approached. Trial registration ISRCTN Registry, ISRCTN98009168 . Registered on 29 November 2012. |
| first_indexed | 2024-12-19T06:52:23Z |
| format | Article |
| id | doaj.art-703300bca94c4097b4db398dbd2098fb |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-12-19T06:52:23Z |
| publishDate | 2017-03-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-703300bca94c4097b4db398dbd2098fb2022-12-21T20:31:40ZengBMCTrials1745-62152017-03-0118111210.1186/s13063-016-1711-8Equipoise across the patient population: optimising recruitment to a randomised controlled trialPaul Whybrow0Robert Pickard1Susan Hrisos2Tim Rapley3Newcastle UniversityInstitute of Cellular Medicine, The Medical School, Newcastle UniversityNewcastle UniversityNewcastle UniversityAbstract Background This paper proposes a novel perspective on the value of qualitative research for improving trial design and optimising recruitment. We report findings from a qualitative study set within the OPEN trial, a surgical randomised controlled trial (RCT) comparing two interventions for recurrent bulbar urethral stricture, a common cause of urinary problems in men. Methods Interviews were conducted with men meeting trial eligibility criteria (n = 19) to explore reasons for accepting or declining participation and with operating urologists (n = 15) to explore trial acceptability. Results Patients expressed various preferences and understood these in the context of relative severity and tolerability of their symptoms. Accounts suggest a common trajectory of worsening symptoms with a particular window within which either treatment arm would be considered acceptable. Interviews with clinician recruiters found that uncertainty varied between general and specialist sites, which reflect clinicians’ relative exposure to different proportions of the patient population. Conclusion Recruitment post referral, at specialist sites, was challenging due to patient (and clinician) expectations. Trial design, particularly where there are fixed points for recruitment along the care pathway, can enable or constrain the possibilities for effective accrual depending on how it aligns with the optimum point of patient equipoise. Qualitative recruitment investigations, often focussed on information provision and patient engagement, may also look to better understand the target patient population in order to optimise the point at which patients are approached. Trial registration ISRCTN Registry, ISRCTN98009168 . Registered on 29 November 2012.http://link.springer.com/article/10.1186/s13063-016-1711-8TrialsRecruitmentQualitativeMulticentreTrial designSurgical trial |
| spellingShingle | Paul Whybrow Robert Pickard Susan Hrisos Tim Rapley Equipoise across the patient population: optimising recruitment to a randomised controlled trial Trials Trials Recruitment Qualitative Multicentre Trial design Surgical trial |
| title | Equipoise across the patient population: optimising recruitment to a randomised controlled trial |
| title_full | Equipoise across the patient population: optimising recruitment to a randomised controlled trial |
| title_fullStr | Equipoise across the patient population: optimising recruitment to a randomised controlled trial |
| title_full_unstemmed | Equipoise across the patient population: optimising recruitment to a randomised controlled trial |
| title_short | Equipoise across the patient population: optimising recruitment to a randomised controlled trial |
| title_sort | equipoise across the patient population optimising recruitment to a randomised controlled trial |
| topic | Trials Recruitment Qualitative Multicentre Trial design Surgical trial |
| url | http://link.springer.com/article/10.1186/s13063-016-1711-8 |
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