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Understanding and Improving Recruitment to Randomised Controlled Trials: Qualitative Research Approaches
Open accessAbstract
CONTEXT: The importance of evidence from randomised trials is now widely recognised, although recruitment is often difficult. Qualitative research has shown promise in identifying the key barriers to recruitment, and interventions have been developed to reduce organisational difficulties and support clinicians undertaking recruitment. OBJECTIVE: This article provides an introduction to qualitative research techniques and explains how this approach can be used to understand-and subsequently improve-recruitment and informed consent within a range of clinical trials. EVIDENCE ACQUISITION: A literature search was performed using Medline, Embase, and CINAHL. All studies with qualitative research methods that focused on the recruitment activity of clinicians were included in the review. EVIDENCE SYNTHESIS: The majority of studies reported that organisational difficulties and lack of time for clinical staff were key barriers to recruitment. However, a synthesis of qualitative studies highlighted the intellectual and emotional challenges that arise when combining research with clinical roles, particularly in relation to equipoise and patient eligibility. To support recruiters to become more comfortable with the design and principles of randomised controlled trials, interventions have been developed, including the QuinteT Recruitment Intervention, which comprises in-depth investigation of recruitment obstacles in real time, followed by implementation of tailored strategies to address these challenges as the trial proceeds. CONCLUSIONS: Qualitative research can provide important insights into the complexities of recruitment to trials and inform the development of interventions, and provide support and training initiatives as required. Investigators should consider implementing such methods in trials expected to be challenging or recruiting below target. PATIENT SUMMARY: Qualitative research is a term used to describe a range of methods that can be implemented to understand participants' perspectives and behaviours. Data are gathered from interviews, focus groups, or observations. In this review, we demonstrate how this approach can be used to understand-and improve-recruitment to clinical trials. Taken together, our review suggests that healthcare professionals can find recruiting to trials challenging and require support with this process.
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“Moreover, intellectual and emotional challenges arise when combining research with clinical roles, subsequently affecting recruitment, as has also been previously reported (56).”
From Total Sleep Deprivation Followed by Bright Light Therapy as Rapid Relief for Depression: A Pragmatic Randomized Controlled Trial (2021) · cites this paper as [56]
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“Participants are often concerned about being randomized to a less effective treatment [141, 142], but here the 2 treatment arms will be in true clinical equipoise [143].”
From A Sequential Multiple Assignment Randomized Trial (SMART) study of medication and CBT sequencing in the treatment of pediatric anxiety disorders (2021) · cites this paper as [143]
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Citations
Cites
Using thematic analysis in psychology
Braun, V., & Clarke, V. (2006) · Qualitative Research in Psychology · doi:10.1191/1478088706qp063oa · Cited by 194,414
Research Design: Qualitative, Quantitative, and Mixed Methods Approaches
Creswell, J. W. (1994) · Cited by 35,213
Research Design: Qualitative, Quantitative, and Mixed Methods Approaches
Sloane-Seale, A. (2009) · Canadian Journal of University Continuing Education · doi:10.21225/d54s3d · Cited by 14,328
Qualitative methods for health research
Green, J., & Thorogood, N. (2009) · Choice Reviews Online · doi:10.5860/choice.47-0901 · Cited by 4,612
10-Year Outcomes after Monitoring, Surgery, or Radiotherapy for Localized Prostate Cancer
Hamdy, F. C., Donovan, J., Lane, J. A., Mason, M. D., Metcalfe, C. D., Holding, P., Davis, M., Peters, T. J., Turner, E. L., Martin, R. M., et al. (2016) · New England Journal of Medicine · doi:10.1056/nejmoa1606220 · Cited by 2,642
Patient-Reported Outcomes after Monitoring, Surgery, or Radiotherapy for Prostate Cancer
Donovan, J., Hamdy, F. C., Lane, J. A., Mason, M. D., Metcalfe, C. D., Walsh, E. I., Blazeby, J. M., Peters, T. J., Holding, P., Bonnington, S., et al. (2016) · New England Journal of Medicine · doi:10.1056/nejmoa1606221 · Cited by 1,344
McDonald, A. M., Knight, R. C., Campbell, M. K., Entwistle, V. A., Grant, A. M., Cook, J. A., Elbourne, D. R., Francis, D., Garcia, J., Roberts, I., et al. (2006) · Trials · doi:10.1186/1745-6215-7-9 · Cited by 946
Barriers to Participation in Randomised Controlled Trials
Ross, S., Grant, A., Counsell, C., Gillespie, W., Russell, I., & Prescott, R. (1999) · Journal of Clinical Epidemiology · doi:10.1016/s0895-4356(99)00141-9 · Cited by 907
Treweek, S. P., Lockhart, P., Pitkethly, M., Cook, J. A., Kjeldstrøm, M., Johansen, M., Taskila, T. K., Sullivan, F., Wilson, S., Jackson, C. M., et al. (2013) · BMJ Open · doi:10.1136/bmjopen-2012-002360 · Cited by 625
Campbell, M., Snowdon, C., Francis, D., Elbourne, D., McDonald, A., Knight, R., Entwistle, V, Garcia, J., Roberts, I., Grant, A., et al. (2007) · Health Technology Assessment · doi:10.3310/hta11480 · Cited by 433
Fletcher, B., Gheorghe, A., Moore, D., Wilson, S., & Damery, S. L. (2012) · BMJ Open · doi:10.1136/bmjopen-2011-000496 · Cited by 374
Bower, P., Brueton, V., Gamble, C., Treweek, S., Smith, C. T., Young, B., & Williamson, P. (2014) · Trials · doi:10.1186/1745-6215-15-399 · Cited by 369
Donovan, J., Rooshenas, L., Jepson, M., Elliott, D., Wade, J., AVERY, K. N. L., Mills, N., Wilson, C., Paramasivan, S., & Blazeby, J. M. (2016) · Trials · doi:10.1186/s13063-016-1391-4 · Cited by 275
Donovan, J. L., Paramasivan, S., de Salis, I., & Toerien, M. (2014) · Trials · doi:10.1186/1745-6215-15-5 · Cited by 262
Influence of Clinical Communication on Patients' Decision Making on Participation in Clinical Trials
Albrecht, T. L., Eggly, S. S., Gleason, M. E. J., Harper, F. W. K., Foster, T. S., Peterson, A. M., Orom, H., Penner, L. A., & Ruckdeschel, J. C. (2008) · Journal of Clinical Oncology · doi:10.1200/jco.2007.14.8114 · Cited by 249
Featherstone, K., & Donovan, J. (2002) · Social Science & Medicine · doi:10.1016/s0277-9536(01)00197-6 · Cited by 231
Featherstone, K., & Donovan, J. (1998) · BMJ · doi:10.1136/bmj.317.7167.1177 · Cited by 228
Wade, J., Donovan, J., Lane, J. A., Neal, D. E., & Hamdy, F. C. (2009) · Social Science & Medicine · doi:10.1016/j.socscimed.2009.02.023 · Cited by 208
Wilt, T. J., Brawer, M. K., Barry, M. J., Jones, K. M., Kwon, Y. K., Gingrich, J. R., Aronson, W. J., Nsouli, I. S., Iyer, P., Cartagena, R., et al. (2008) · Contemporary Clinical Trials · doi:10.1016/j.cct.2008.08.002 · Cited by 170
Donovan, J., Lane, J. A., Peters, T. J., Brindle, L. A., Salter, E., Gillatt, D. A., Powell, P. H., Bollina, P. R., Neal, D. E., & Hamdy, F. C. (2008) · Journal of Clinical Epidemiology · doi:10.1016/j.jclinepi.2008.02.010 · Cited by 156
Paramasivan, S., Huddart, R. A., Hall, E., Lewis, R., Birtle, A. J., & Donovan, J. (2011) · Trials · doi:10.1186/1745-6215-12-78 · Cited by 147
Mills, N., Donovan, J. L., Smith, M., Jacoby, A., Neal, D. E., & Hamdy, F. C. (2003) · Controlled Clinical Trials · doi:10.1016/s0197-2456(03)00020-5 · Cited by 142
Rooshenas, L., Elliott, D., Wade, J., Jepson, M., Paramasivan, S., Strong, S., Wilson, C., Beard, D., Blazeby, J. M., Birtle, A., et al. (2016) · PLOS Medicine · doi:10.1371/journal.pmed.1002147 · Cited by 140
The role and potential contribution of clinical research nurses to clinical trials
Spilsbury, K., Petherick, E., Cullum, N. A., Nelson, E. A., Nixon, J., & Mason, S. M. (2007) · Journal of Clinical Nursing · doi:10.1111/j.1365-2702.2006.01872.x · Cited by 130
Exploring treatment preferences facilitated recruitment to randomized controlled trials
Mills, N., Donovan, J., Wade, J., Hamdy, F. C., Neal, D. E., & Lane, J. A. (2011) · Journal of Clinical Epidemiology · doi:10.1016/j.jclinepi.2010.12.017 · Cited by 127
Mason, V. L., Shaw, A. R. G., Wiles, N., Mulligan, J., Peters, T., Sharp, D., & Lewis, G. (2007) · Family Practice · doi:10.1093/fampra/cmm047 · Cited by 112
Cook, C. E., & Sheets, C. Z. (2011) · Journal of Manual & Manipulative Therapy · doi:10.1179/106698111x12899036752014 · Cited by 97
Ziébland, S., Featherstone, K., Snowdon, C., Barker, K. L., Frost, H., & Fairbank, J. T. (2007) · Trials · doi:10.1186/1745-6215-8-4 · Cited by 88
Griffin, D. R., Wall, P. D. H., Realpe, A. X., Adams, A., Parsons, N., Hobson, R., Achten, J., Fry, J., Costa, M. L., Petrou, S., et al. (2016) · Health Technology Assessment · doi:10.3310/hta20320 · Cited by 83
Stein, R. C., Dunn, J., Bartlett, J. M. S., Campbell, A. F., Marshall, A., Hall, P. S., Rooshenas, L., Morgan, A. A., Poole, C. J., Pinder, S. E., et al. (2016) · Health Technology Assessment · doi:10.3310/hta20100 · Cited by 82
Mills, N., Blazeby, J. M., Hamdy, F. C., Neal, D. E., Campbell, B. K., Wilson, C., Paramasivan, S., & Donovan, J. (2014) · Trials · doi:10.1186/1745-6215-15-323 · Cited by 80
Behrendt, C., Gölz, T., Roesler, C., Bertz, H., & Wünsch, A. (2010) · Journal of Medical Ethics · doi:10.1136/jme.2010.035485 · Cited by 79
Hamilton, D. W., de Salis, I. O. C., Donovan, J., & Birchall, M. (2013) · European Archives of Oto-Rhino-Laryngology · doi:10.1007/s00405-013-2349-8 · Cited by 74
Lawton, J., Snowdon, C., Morrow, S., Norman, J. E., Denison, F. C., & Hallowell, N. (2016) · Trials · doi:10.1186/s13063-016-1323-3 · Cited by 70
Djulbegović, B. (2009) · Cancer Control · doi:10.1177/107327480901600409 · Cited by 65
A systematic review of training programmes for recruiters to randomised controlled trials
Townsend, D., Mills, N., Savović, J., & Donovan, J. (2015) · Trials · doi:10.1186/s13063-015-0908-6 · Cited by 61
Newington, L. (2014) · Journal of Clinical Medicine Research · doi:10.14740/jocmr1619w · Cited by 58
de Salis, I. O. C., Tomlin, Z., Toerien, M., & Donovan, J. (2008) · Contemporary Clinical Trials · doi:10.1016/j.cct.2008.03.003 · Cited by 55
Potter, S., Mills, N., Cawthorn, S., Donovan, J., & Blazeby, J. M. (2014) · Trials · doi:10.1186/1745-6215-15-80 · Cited by 53
Levels of Evidence in the Urological Literature
Borawski, K. M., Norris, R. D., Fesperman, S. F., Vieweg, J., Preminger, G. M., & Dahm, P. (2007) · The Journal of Urology · doi:10.1016/j.juro.2007.05.150 · Cited by 53
Lawton, J., Kirkham, J., White, D. A., Rankin, D., Cooper, C. L., & Heller, S. R. (2015) · Trials · doi:10.1186/1745-6215-16-3 · Cited by 53
Patterson, S., Kramo, K., Soteriou, T., & Crawford, M. (2010) · Journal of Mental Health · doi:10.3109/09638237.2010.520367 · Cited by 51
The role and potential contribution of clinical research nurses to clinical trials
Spilsbury, Petherick, Cullum, N. A., Nelson, Nixon, & ', M. (2008) · Journal of Clinical Nursing · Cited by 48
Clinicians' Attitudes to Recruitment to Randomised Trials in Cancer Care: A Qualitative Study
Langley, C., Gray, S. F., Selley, S., Bowie, C., & Price, C. (2000) · Journal of Health Services Research & Policy · doi:10.1177/135581960000500307 · Cited by 44
French, C., & Stavropoulou, C. (2016) · BMC Medical Research Methodology · doi:10.1186/s12874-016-0204-5 · Cited by 43
Strong, S., Paramasivan, S., Mills, N., Wilson, C., Donovan, J., & Blazeby, J. M. (2016) · Trials · doi:10.1186/s13063-016-1341-1 · Cited by 42
Blazeby, J. M., Strong, S., Donovan, J., Wilson, C., Hollingworth, W., Crosby, T. D. L., Nicklin, J., Falk, S. J., Barham, C. P., Hollowood, A. D., et al. (2014) · British Journal of Cancer · doi:10.1038/bjc.2014.313 · Cited by 36
Tomlin, Z., deSalis, I., Toerien, M., & Donovan, J. (2012) · Health Expectations · doi:10.1111/j.1369-7625.2012.00792.x · Cited by 33
Horwood, J. P., Johnson, E. C., & Gooberman‐Hill, R. (2015) · International Journal of Orthopaedic and Trauma Nursing · doi:10.1016/j.ijotn.2015.05.002 · Cited by 32
Paramasivan, S., Strong, S., Wilson, C., Campbell, B. K., Blazeby, J. M., & Donovan, J. (2015) · Trials · doi:10.1186/s13063-015-0617-1 · Cited by 30
Potter, R. C., Dale, J. R., & Caramlau, I. O. (2009) · Journal of research in nursing · doi:10.1177/1744987108098228 · Cited by 27
The Future of Clinical Practice Guidelines in Urology
Dahm, P., Chapple, C. R., Konety, B. R., Joyce, A., PARSONS, K. F., Wolf, J. S., RAZVI, H. A., & N’Dow, J. (2011) · European Urology · doi:10.1016/j.eururo.2011.04.007 · Cited by 25
The Future of Randomised Controlled Trials in Urology
Dahm, P., N’Dow, J., Holmberg, L., & Hamdy, F. C. (2014) · European Urology · doi:10.1016/j.eururo.2014.01.015 · Cited by 22
Experiences of randomization: Interviews with patients and clinicians in the SPCG-IV trial
Bill‐Axelson, A., Christensson, A., Carlsson, M., Norlén, B. J., & Holmberg, L. (2008) · Scandinavian Journal of Urology and Nephrology · doi:10.1080/00365590801950253 · Cited by 17
Stuart, J., Barnes, J., Spiby, H., & Elbourne, D. R. (2015) · Midwifery · doi:10.1016/j.midw.2015.04.011 · Cited by 17
Recruitment of physician offices for an office‐based adolescent smoking cessation study
McIntosh, S. E., Ossip-Klein, D. J., Hazel-Fernandez, L. A., Spada, J., McDonald, P., & Klein, J. D. (2005) · Nicotine & Tobacco Research · doi:10.1080/14622200500125567 · Cited by 16
Lamb, K. V., Backhouse, M. R., & Adderley, U. J. (2016) · Journal of Tissue Viability · doi:10.1016/j.jtv.2016.03.004 · Cited by 15
Mann, C., Delgado, D., & Horwood, J. P. (2013) · Journal of Advanced Nursing · doi:10.1111/jan.12254 · Cited by 12
The conflicting roles of clinicians versus investigators in HIV randomised clinical trials
Hales, G., Beveridge, A., & Smith, D. (2001) · Culture Health & Sexuality · doi:10.1080/136910501750035680 · Cited by 11
Research works printed but not linked: 1
- Donovan, 2014, The intellectual challenges and emotional consequences of equipoise contributed to the fragility of recruitment in six randomised controlled trials, J Clin Epidemiol, 67912
Cited by
Sorted by citations
Catto, J. W. F., Gordon, K., Collinson, M., Poad, H., Twiddy, M., Johnson, M. I., Jain, S., Chahal, R., Simms, M. S., Dooldeniya, M., et al. (2020) · Journal of Clinical Oncology · doi:10.1200/jco.20.01665 · Cited by 123
Lim, E. K. S., Harris, R. A., McKeon, H. E., Batchelor, T. J. P., Dunning, J., Shackcloth, M. J., Anikin, V., Naidu, B. V., Belcher, E., Loubani, M., et al. (2022) · Health Technology Assessment · doi:10.3310/thbq1793 · Cited by 102
Catto, J. W. F., Khetrapal, P., Ambler, G., Sarpong, R., Khan, M. S., Tan, M., Feber, A., Dixon, S., Goodwin, L., Williams, N. R., et al. (2018) · BMJ Open · doi:10.1136/bmjopen-2017-020500 · Cited by 89
Tinkler, L., Smith, V., Yiannakou, Y., & Robinson, L. J. (2017) · Journal of Advanced Nursing · doi:10.1111/jan.13409 · Cited by 93
Hamdy, F. C., Elliott, D., le Conte, S., Davies, L. C., Burns, R., Thomson, C., Gray, R. G., Wolstenholme, J. L., Donovan, J., Fitzpatrick, R. M., et al. (2018) · Health Technology Assessment · doi:10.3310/hta22520 · Cited by 74
Metadata
- Authors
- Elliott, D., Husbands, S., Hamdy, F. C., Holmberg, L., & Donovan, J. L.
- Affiliations
- University of Bristol (GB)
- University of Oxford (GB)
- Uppsala University (SE)
- Corresponding author
- Elliott, Daisy
- Venue
- European Urology
- Publisher
- Elsevier BV
- Published
- 2017-11
- Volume
- 72
- Issue
- 5
- Pages
- 789-798
- ISSN
- 0302-2838 (ISSN-L)
- OpenAlex
- W2620883902
- Cited by
- 161
- References
- 59
- Citations by year
- 2026: 5 · 2025: 12 · 2024: 12 · 2023: 19 · 2022: 22 · 2021: 35 · 2020: 29 · 2019: 12 · 2018: 11 · 2017: 4
- FWCI
- 2.49
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- Locations
- European Urology (publishedVersion, cc-by-nc-nd)
- PubMed (publishedVersion)
- KTH Publication Database DiVA (KTH Royal Institute of Technology) (submittedVersion, other-oa)
- Research Portal (King's College London) (submittedVersion, cc-by-nc-nd)
- Bristol Research (University of Bristol) (submittedVersion, cc-by-nc-nd)
- Funders
- University Hospitals Bristol NHS Foundation Trust
- National Institute for Health and Care Research (NF-SI-0513-10121)
- Royal College of Surgeons of England
- Medical Research Council (MR/K025643/1)
- Topics
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Ethics in Clinical Research
- Health Sciences › Health Professions › General Health Professions › Health Policy Implementation Science
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
- Keywords
- clinical trial recruitment, recruitment barriers, informed consent, organizational barriers, equipoise, patient eligibility, qualitative research
- MeSH terms
- Attitude of Health Personnel, Emotions, Humans, Health Knowledge, Attitudes, Practice, Research Personnel, Randomized Controlled Trials as Topic, Workload, Sample Size, Patient Selection, Qualitative Research, Workflow
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