Strategies for Increasing Recruitment to Randomised Controlled Trials: Systematic Review
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BACKGROUND: Recruitment of participants into randomised controlled trials (RCTs) is critical for successful trial conduct. Although there have been two previous systematic reviews on related topics, the results (which identified specific interventions) were inconclusive and not generalizable. The aim of our study was to evaluate the relative effectiveness of recruitment strategies for participation in RCTs. METHODS AND FINDINGS: A systematic review, using the PRISMA guideline for reporting of systematic reviews, that compared methods of recruiting individual study participants into an actual or mock RCT were included. We searched MEDLINE, Embase, The Cochrane Library, and reference lists of relevant studies. From over 16,000 titles or abstracts reviewed, 396 papers were retrieved and 37 studies were included, in which 18,812 of at least 59,354 people approached agreed to participate in a clinical RCT. Recruitment strategies were broadly divided into four groups: novel trial designs (eight studies), recruiter differences (eight studies), incentives (two studies), and provision of trial information (19 studies). Strategies that increased people's awareness of the health problem being studied (e.g., an interactive computer program [relative risk (RR) 1.48, 95% confidence interval (CI) 1.00-2.18], attendance at an education session [RR 1.14, 95% CI 1.01-1.28], addition of a health questionnaire [RR 1.37, 95% CI 1.14-1.66]), or a video about the health condition (RR 1.75, 95% CI 1.11-2.74), and also monetary incentives (RR1.39, 95% CI 1.13-1.64 to RR 1.53, 95% CI 1.28-1.84) improved recruitment. Increasing patients' understanding of the trial process, recruiter differences, and various methods of randomisation and consent design did not show a difference in recruitment. Consent rates were also higher for nonblinded trial design, but differential loss to follow up between groups may jeopardise the study findings. The study's main limitation was the necessity of modifying the search strategy with subsequent search updates because of changes in MEDLINE definitions. The abstracts of previous versions of this systematic review were published in 2002 and 2007. CONCLUSION: Recruitment strategies that focus on increasing potential participants' awareness of the health problem being studied, its potential impact on their health, and their engagement in the learning process appeared to increase recruitment to clinical studies. Further trials of recruitment strategies that target engaging participants to increase their awareness of the health problems being studied and the potential impact on their health may confirm this hypothesis. Please see later in the article for the Editors' Summary.
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Different recruitment methods can substantially affect the number and type of trial participants recruited and can incur different costs.
“Different recruitment methods can substantially affect the number and type of trial participants recruited206 309 312 313 and can incur different costs.314 315 316”
From SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials (2025) · cites this paper as [312]
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Cites
Cochrane Handbook for Systematic Reviews of Interventions: Cochrane Book Series
(2008) · doi:10.1002/9780470712184 · Cited by 25,048 · see citing works
Evidence based medicine: what it is and what it isn't
Sackett, D. L., Rosenberg, W. M. C., Gray, J. A. M., Haynes, R. B., & Richardson, W. S. (1996) · BMJ · doi:10.1136/bmj.312.7023.71 · Cited by 15,769 · see citing works
Health Belief Model and Personal Health Behavior
Becker, M. H. (1976) · Medical Entomology and Zoology · Cited by 3,065 · see citing works
The Health Belief Model and Sick Role Behavior
Becker, M. H. (1974) · Health Education Monographs · doi:10.1177/109019817400200407 · Cited by 2,327 · see citing works
Recruiting Minorities Into Clinical Trials Toward a Participant-Friendly System
Swanson, G. M., & Ward, A. J. (1995) · JNCI Journal of the National Cancer Institute · doi:10.1093/jnci/87.23.1747 · Cited by 558 · see citing works
Recruitment for controlled clinical trials: Literature summary and annotated bibliography
Lovato, L., Hill, K., Hertert, S., Hunninghake, D. B., & Probstfield, J. L. (1997) · Controlled Clinical Trials · doi:10.1016/s0197-2456(96)00236-x · Cited by 400 · see citing works
Which clinical studies provide the best evidence?
Barton, S. (2000) · BMJ · doi:10.1136/bmj.321.7256.255 · Cited by 384 · see citing works
Increasing recruitment to randomised trials: a review of randomised controlled trials
Watson, J. M., & Torgerson, D. J. (2006) · BMC Medical Research Methodology · doi:10.1186/1471-2288-6-34 · Cited by 334 · see citing works
Simes, R. J., Tattersall, M. H. N., Coates, A., Raghavan, D., Solomon, H. J., & Smartt, H. (1986) · BMJ · doi:10.1136/bmj.293.6554.1065 · Cited by 202 · see citing works
Coyne, C. A., Xu, R., Raich, P. C., Plomer, K., Dignan, M., Wenzel, L. B., Fairclough, D. L., Habermann, T. M., Schnell, L., Quella, S. K., et al. (2003) · Journal of Clinical Oncology · doi:10.1200/jco.2003.07.022 · Cited by 198 · see citing works
Strategies to improve recruitment to research studies
Mapstone, J., Elbourne, D. R., & Roberts, I. (2007) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.mr000013.pub3 · Cited by 196 · see citing works
Halpern, S. D., Karlawish, J. H., Casarett, D., Berlin, J. A., & Asch, D. A. (2004) · Archives of Internal Medicine · doi:10.1001/archinte.164.7.801 · Cited by 192 · see citing works
Parents' attitudes to children's participation in randomized controlled trials
Caldwell, P. H. Y., Butow, P. N., & Craig, J. C. (2003) · The Journal of Pediatrics · doi:10.1067/mpd.2003.192 · Cited by 187 · see citing works
Self-citationAaronson, N. K., Visser-Pol, E., Leenhouts, G., Muller, M. J., van der Schot, A. C., van Dam, F. S. A. M., Keus, R. B., Koning, C. C. E., Huinink, W. W. T. B., van Dongen, J. A., et al. (1996) · Journal of Clinical Oncology · doi:10.1200/jco.1996.14.3.984 · Cited by 184 · see citing works
Kimmick, G. G., Peterson, B. L., Kornblith, A. B., Mandelblatt, J. S., Johnson, J. L., Wheeler, J., Heinze, R., Cohen, H. J., & Muss, H. B. (2005) · Journal of Clinical Oncology · doi:10.1200/jco.2005.01.222 · Cited by 127 · see citing works
Evaluating the benefits of a patient information video during the informed consent process
Weston, J. A., Hannah, M., & Downes, J. (1997) · Patient Education and Counseling · doi:10.1016/s0738-3991(96)00968-8 · Cited by 124 · see citing works
Welton, A. J., Vickers, M. R., Cooper, J. A., Meade, T. W., & Marteau, T. M. (1999) · BMJ · doi:10.1136/bmj.318.7191.1114 · Cited by 114 · see citing works
Ford, M. E., Havstad, S. L., & Davis, S. D. (2004) · Clinical Trials · doi:10.1191/1740774504cn029oa · Cited by 91 · see citing works
Presenting clinical trial information: a comparison of methods
Llewellyn‐Thomas, H. A., Thiel, E. C., Sem, F. W. C., & Harrison-Woermke, D. (1995) · Patient Education and Counseling · doi:10.1016/0738-3991(94)00705-q · Cited by 91 · see citing works
Cooper, K. G., GRANT, A. M., & Garratt, A. (1997) · BJOG An International Journal of Obstetrics & Gynaecology · doi:10.1111/j.1471-0528.1997.tb11005.x · Cited by 90 · see citing works
Avenell, A., GRANT, A. M., McGee, M., McPherson, G. C., Campbell, M., McGee, M. A., & RECORD Trial Management Group (2004) · Clinical Trials · doi:10.1191/1740774504cn053oa · Cited by 87 · see citing works
Hutchison, C., Cowan, C., McMahon, T. J., & Paul, J. (2007) · British Journal of Cancer · doi:10.1038/sj.bjc.6603943 · Cited by 85 · see citing works
Martinson, B. C., Lazovich, D., Lando, H. A., Perry, C. L., McGovern, P. G., & Boyle, R. G. (2000) · Preventive Medicine · doi:10.1006/pmed.2000.0762 · Cited by 85 · see citing works
Easterbrook, P., & Matthews, D. R. (1992) · Journal of the Royal Society of Medicine · doi:10.1177/014107689208500206 · Cited by 82 · see citing works
Impediments to recruitment in the Canadian National Breast Screening Study: Response and resolution
Baines, C. J. (1984) · Controlled Clinical Trials · doi:10.1016/0197-2456(84)90119-3 · Cited by 80 · see citing works
Who can best recruit to randomized trials?
Donovan, J., Peters, T. J., Noble, S., Powell, P. H., Gillatt, D. A., Oliver, S. E., Lane, J. A., Neal, D. E., & Hamdy, F. C. (2003) · Journal of Clinical Epidemiology · doi:10.1016/s0895-4356(03)00083-0 · Cited by 77 · see citing works
Rogers, C. G., Tyson, J. E., Kennedy, K. A., Broyles, R. S., & Hickman, J. F. (1998) · The Journal of Pediatrics · doi:10.1016/s0022-3476(98)70347-6 · Cited by 70 · see citing works
Ellis, P., Butow, P. N., & Tattersall, M. H. N. (2002) · Annals of Oncology · doi:10.1093/annonc/mdf255 · Cited by 68 · see citing works
Informed versus randomised consent to clinical trials
Gallo, C., Perrone, F., Placido, S. D., & Giusti, C. (1995) · The Lancet · doi:10.1016/s0140-6736(95)91741-1 · Cited by 66 · see citing works
Fleissig, A., Jenkins, V. A., & Fallowfield, L. J. (2001) · European Journal of Cancer · doi:10.1016/s0959-8049(00)00415-9 · Cited by 63 · see citing works
An Educational Video to Increase Clinical Trials Enrollment among Lung Cancer Patients
Du, W., Mood, D., Gadgeel, S. M., & Simon, M. S. (2008) · Journal of Thoracic Oncology · doi:10.1097/jto.0b013e31815e8bb2 · Cited by 62 · see citing works
Recruitment of Hispanic women to the Women's Health Initiative
Larkey, L., Staten, L. K., Ritenbaugh, C., Hall, R. A., Buller, D. B., Bassford, T. L., & Altimari, B. R. (2002) · Controlled Clinical Trials · doi:10.1016/s0197-2456(02)00190-3 · Cited by 61 · see citing works
Using direct mail to recruit hispanic adults into a dietary intervention: An experimental study
Kiernan, M., Phillips, K., Fair, J. M., & King, A. C. (2000) · Annals of Behavioral Medicine · doi:10.1007/bf02895172 · Cited by 60 · see citing works
Tworoger, S. S., Yasui, Y., Ulrich, C. M., Nakamura, H., LaCroix, K., Johnston, R., & McTiernan, A. (2002) · PubMed · Cited by 57 · see citing works
Is the future for clinical trials internet-based? A cluster randomized clinical trial
Litchfield, J., Freeman, J., Schou, H., Elsley, M., Fuller, R., & Chubb, B. (2005) · Clinical Trials · doi:10.1191/1740774505cn069oa · Cited by 56 · see citing works
Liénard, J.-L., Quinaux, E., Fabre, E., Piedbois, P., Jouhaud, A., Decoster, G., & Buyse, M. E. (2006) · Clinical Trials · doi:10.1177/1740774506070807 · Cited by 49 · see citing works
Patient Recruitment: US Perspective
Walson, P. D. (1999) · PEDIATRICS · doi:10.1542/peds.104.s3.619 · Cited by 48 · see citing works
Wragg, J. A., Robinson, E. J., & Lilford, R. J. (2000) · Social Science & Medicine · doi:10.1016/s0277-9536(99)00477-3 · Cited by 47 · see citing works
Mandelblatt, J. S., KAUFMAN, E., Sheppard, V. B., Pomeroy, J., Kavanaugh, J. L., Cañar, J., PALLANDRE, L., Cullen, J. W., & Huerta, E. E. (2004) · Preventive Medicine · doi:10.1016/j.ypmed.2004.09.004 · Cited by 44 · see citing works
Mailing Strategies and Costs of Recruiting Heavy Smokers in CARET, a Large Chemoprevention Trial
VALANIS, B. G., Blank, J. D., & Glass, A. G. (1998) · Controlled Clinical Trials · doi:10.1016/s0197-2456(97)00027-5 · Cited by 44 · see citing works
Clinical Research and the Noninstitutional Elderly: A Model for Subject Recruitment
Leader, M. A., & Neuwirth, E. (1978) · Journal of the American Geriatrics Society · doi:10.1111/j.1532-5415.1978.tb01951.x · Cited by 43 · see citing works
Monaghan, H., Richens, A., Colman, S., Currie, R., Girgis, S. T., Jayne, K., Neal, B. C., & Patel, A. A. (2006) · Contemporary Clinical Trials · doi:10.1016/j.cct.2006.06.004 · Cited by 41 · see citing works
Nystuen, P., & Hagen, K. B. (2004) · Journal of Clinical Epidemiology · doi:10.1016/j.jclinepi.2003.12.015 · Cited by 41 · see citing works
A randomized controlled trial comparing quantitative informed consent formats
Simelt, D. L., & Feussner, J. R. (1991) · Journal of Clinical Epidemiology · doi:10.1016/0895-4356(91)90129-w · Cited by 41 · see citing works
Myles, P. S., Fletcher, H. E., Cairo, S., Madder, H., McRae, R., Cooper, J., Devonshire, D., Hunt, J. O., Richardson, J., Machlin, H., et al. (1999) · Anesthesiology · doi:10.1097/00000542-199910000-00016 · Cited by 37 · see citing works
Blinding decreased recruitment in a prevention trial of postmenopausal hormone therapy
Hemminki, E., Hovi, S., Veerus, P., Sevón, T., Tuimala, R. J., Rahu, M., & Hakama, M. (2004) · Journal of Clinical Epidemiology · doi:10.1016/j.jclinepi.2004.04.009 · Cited by 34 · see citing works
Kendrick, D., Watson, M., Dewey, M., & Woods, A. J. (2001) · Journal of Epidemiology & Community Health · doi:10.1136/jech.55.11.845 · Cited by 24 · see citing works
Recruitment in a primary care trial on smoking cessation.
WADLAND, W. C., Hughes, Walker, R. H. S., Bronson, D. L., & Fenwick, J. W. (1990) · PubMed · Cited by 24 · see citing works
Extending Acute Trials to Remote Populations
Leira, E. C. C., Ahmed, A., Lamb, D. L., Olalde, H. M., Callison, R. C., Torner, J. C., & Adams, H. P. (2009) · Stroke · doi:10.1161/strokeaha.108.530204 · Cited by 21 · see citing works
Miller, N. L., Markowitz, J. C., Kocsis, J. H., Leon, A. C., Brisco, S. T., & Garno, J. L. (1999) · Journal of Psychiatric Research · doi:10.1016/s0022-3956(98)00045-4 · Cited by 20 · see citing works
Berner, E. S., Partridge, E. E., & Baum, S. K. (1997) · PubMed · doi:10.1080/08858199709528466 · Cited by 18 · see citing works
Pighills, A., Torgerson, D. J., & Sheldon, T. (2009) · Journal of Clinical Epidemiology · doi:10.1016/j.jclinepi.2009.01.017 · Cited by 17 · see citing works
Flagged first, then by citations
2 of the 55 references couldn’t be matched to a known paper.
Research works printed but not linked: 5
- [8]Zifferblatt SM 1975 Recruitment in large-scale clinical trials. Weiss SM Proceedings of the National Heart and Lung Institute Working Conference on health behavior Bethesda NIH 187 195
- [11]Caldwell P Craig J Hamilton S Butow PN 2002 Strategies for recruitment to RCTs: a systematic review of controlled trials and observational studies. 2002 Oct 21; Sydney, Australia; International Clinical Trials Symposium: improving health care in the new millennium. http://www.ctc.usyd.edu.au/education/4news/Symposium2002_report/caldwell.htm
- [12]Caldwell P Craig J Hamilton S Butow PN 2007 Systematic review of strategies for enhancing recruitment of participants for randomised controlled trials. 2007 Sep 24; Sydney, Australia; International Clinical Trials Symposium
- [13]Higgins J Green S Cochrane C 2008 Cochrane handbook for systematic reviews of interventions Chichester, England Wiley-Blackwell
- [23]Quinaux E Lienard JL Slimani Z Jouhard A Piedbois P Buyse M 2003 Impact of monitoring visits on patient recruitment and data quality: case study of a phase IV trial in oncology. Control Clin Trials 24 99S [conference abstract] 17060222
Cited by
Sorted by citations
SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials
Chan, A.-W., Tetzlaff, J. M., Gotzsche, P. C., Altman, D. G., Mann, H., Berlin, J. A., Dickersin, K., Hrobjartsson, A., Schulz, K. F., Parulekar, W. R., et al. (2013) · BMJ · doi:10.1136/bmj.e7586 · Cited by 6,251 · see citing works
Bonevski, B., Randell, M., Paul, C. L., Chapman, K. L., Twyman, L., Bryant, J., Brozek, I., & Hughes, C. (2014) · BMC Medical Research Methodology · doi:10.1186/1471-2288-14-42 · Cited by 1,495 · see citing works
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 · see citing works
Strategies to improve recruitment to randomised trials
Treweek, S., Pitkethly, M., Cook, J., Fraser, C., Mitchell, E., Sullivan, F., Jackson, C., Taskila, T. K., & Gardner, H. (2018) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.mr000013.pub6 · Cited by 521 · see citing works
Joseph, P. D., Craig, J., & Caldwell, P. H. Y. (2015) · British Journal of Clinical Pharmacology · doi:10.1111/bcp.12305 · Cited by 496 · see citing works
Self-citationStrategies to improve recruitment to randomised controlled trials
Treweek, S., Mitchell, E., Pitkethly, M., Cook, J., Kjeldstrøm, M., Johansen, M., Taskila, T. K., Sullivan, F., Wilson, S., Jackson, C., et al. (2010) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.mr000013.pub5 · Cited by 378 · see citing works
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 · see citing works
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 270 · see citing works
Anguera, J. A., Jordan, J. T., Castaneda, D., Gazzaley, A., & Areán, P. A. (2016) · BMJ Innovations · doi:10.1136/bmjinnov-2015-000098 · Cited by 172 · see citing works
“12 13 However, retention issues are particularly problematic for internet studies, with one recent internet-based trial reporting a drop-out rate of over 90% in a sample of 3000 individuals.”
BackgroundSPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials
Hróbjartsson, A., Boutron, I., Hopewell, S., Moher, D., Schulz, K. F., Collins, G. S., Tunn, R., Aggarwal, R., Berkwits, M., Berlin, J. A., et al. (2025) · BMJ · doi:10.1136/bmj-2024-081660 · Cited by 171 · see citing works
Online Patient Recruitment in Clinical Trials: Systematic Review and Meta-Analysis
Brøgger‐Mikkelsen, M., Ali, Z., Zibert, J. R., Andersen, A. D., & Thomsen, S. F. (2020) · Journal of Medical Internet Research · doi:10.2196/22179 · Cited by 167 · see citing works
Practical guidance: the use of social media in oncology practice
Dizon, D. S., Graham, D., Thompson, M. A., Johnson, L. J., Johnston, C., Fisch, M. J., & Miller, R. (2012) · Journal of Oncology Practice · doi:10.1200/jop.2012.000610 · Cited by 163 · see citing works
Denicoff, A. M., McCaskill‐Stevens, W., Grubbs, S. S., Bruinooge, S. S., Comis, R. L., Devine, P., Dilts, D. M., Duff, M., Ford, J. G., Joffe, S., et al. (2013) · Journal of Oncology Practice · doi:10.1200/jop.2013.001119 · Cited by 146 · see citing works
Factors That Influence Parental Decisions to Participate in Clinical Research
Hoberman, A., Shaikh, N., Bhatnagar, S., Haralam, M. A., Kearney, D. H., Colborn, D. K., Kienholz, M. L., Wang, L., Bunker, C. H., Keren, R., et al. (2013) · Archives of Pediatrics and Adolescent Medicine · doi:10.1001/jamapediatrics.2013.1050 · Cited by 144 · see citing works
Abdelazeem, B., Abbas, K. S., Amin, M. A., El‐Shahat, N. A., Malik, B. H., Kalantary, A., & Eltobgy, M. M. (2022) · PLoS ONE · doi:10.1371/journal.pone.0267534 · Cited by 143 · see citing works
Hughes-Morley, A., Young, B., Waheed, W., Small, N., & Bower, P. (2015) · Journal of Affective Disorders · doi:10.1016/j.jad.2014.10.005 · Cited by 132 · see citing works
Blockchain protocols in clinical trials: Transparency and traceability of consent
Benchoufi, M., Porcher, R., & Ravaud, P. (2018) · F1000Research · doi:10.12688/f1000research.10531.5 · Cited by 129 · see citing works
Frampton, G. K., Shepherd, J., Pickett, K., Griffiths, G., & Wyatt, J. C. (2020) · Trials · doi:10.1186/s13063-020-04358-3 · Cited by 119 · see citing works
Ramo, D. E., Thrul, J., Chavez, K., Delucchi, K., & Prochaska, J. J. (2015) · Journal of Medical Internet Research · doi:10.2196/jmir.5209 · Cited by 119 · see citing works
Salgado, T. M., Moles, R. J., Benrimoj, S. I., & Fernández-Llimós, F. (2011) · Nephrology Dialysis Transplantation · doi:10.1093/ndt/gfr287 · Cited by 116 · see citing works
Finan, S. J., Swierzbiolek, B., Priest, N., Warren, N., & Yap, M. B. H. (2018) · PeerJ · doi:10.7717/peerj.4676 · Cited by 102 · see citing works
Jordan, S. E., Watkins, A. J., Storey, M., Allen, S. J., Brooks, C. J., Garaiová, I., Heaven, M. L., Jones, R. H., Plummer, S. F., Russell, I. T., et al. (2013) · PLoS ONE · doi:10.1371/journal.pone.0067912 · Cited by 96 · see citing works
Minority recruitment into clinical trials: Experimental findings and practical implications
Brown, S. D., Lee, K., Jake‐Schoffman, D. E., King, A. C., Crawley, L. M., & Kiernan, M. (2012) · Contemporary Clinical Trials · doi:10.1016/j.cct.2012.03.003 · Cited by 93 · see citing works
Rooshenas, L., Scott, L. J., Blazeby, J. M., Rogers, C. A., Tilling, K. M., Husbands, S., Conefrey, C., Mills, N., Stein, R. C., Metcalfe, C., et al. (2018) · Journal of Clinical Epidemiology · doi:10.1016/j.jclinepi.2018.10.004 · Cited by 91 · see citing works
Effectiveness and Ethics of Incentives for Research Participation
Halpern, S. D., Chowdhury, M., Bayes, B. A., Cooney, E. L., Hitsman, B. L., Schnoll, R. A., Lubitz, S. F., Reyes, C., Patel, M. S., Greysen, S. R., et al. (2021) · JAMA Internal Medicine · doi:10.1001/jamainternmed.2021.5450 · Cited by 91 · see citing works
Knapp, P., Raynor, D. K., Silcock, J., & Parkinson, B. (2011) · BMC Medicine · doi:10.1186/1741-7015-9-89 · Cited by 84 · see citing works
Ramo, D. E., Thrul, J., Delucchi, K., Hall, S. M., Ling, P. M., Belohlavek, A., & Prochaska, J. J. (2018) · Addiction · doi:10.1111/add.14245 · Cited by 79 · see citing works
Inclusion of special populations in clinical research: important considerations and guidelines
Winter, S. S., Page‐Reeves, J., Page, K. A., Haozous, E. A., Solares, A., Cordova, C., & Larson, R. A. (2018) · Journal of Clinical and Translational Research · doi:10.18053/jctres.04.201801.003 · Cited by 79 · see citing works
Blockchain protocols in clinical trials: Transparency and traceability of consent
Benchoufi, M., Porcher, R., & Ravaud, P. (2017) · F1000Research · doi:10.12688/f1000research.10531.1 · Cited by 78 · see citing works
Goldman, R. D., Staubli, G., Cotanda, C. P., Brown, J. C. S., Hoeffe, J., Seiler, M., Gelernter, R., Hall, J. E., Griffiths, M., Davis, A. L., et al. (2020) · Human Vaccines & Immunotherapeutics · doi:10.1080/21645515.2020.1834325 · Cited by 75 · see citing works
Developing a survey of barriers and facilitators to recruitment in randomized controlled trials
Kaur, G., Smyth, R. L., & Williamson, P. R. (2012) · Trials · doi:10.1186/1745-6215-13-218 · Cited by 74 · see citing works
Page, M. J., French, S. D., McKenzie, J. E., O’Connor, D. A., & Green, S. (2011) · BMC Medical Research Methodology · doi:10.1186/1471-2288-11-35 · Cited by 69 · see citing works
de Man, Y., Wieland-Jorna, Y., Torensma, B., de Wit, K., van Veen, E. B., Francke, A. L., Oosterveld‐Vlug, M., & Verheij, R. A. (2023) · Journal of Medical Internet Research · doi:10.2196/42131 · Cited by 66 · see citing works
Tew, G. A., Moss, J., Crank, H., Mitchell, P. A., & Nawaz, S. (2012) · Archives of Physical Medicine and Rehabilitation · doi:10.1016/j.apmr.2012.07.012 · Cited by 66 · see citing works
Ben‐Zeev, D., Chander, A., Tauscher, J. S., Buck, B., Nepal, S. K., Campbell, A. T., & Doron, G. (2021) · Journal of Medical Internet Research · doi:10.2196/29201 · Cited by 65 · see citing works
The ethical anatomy of payment for research participants
Różyńska, J. K. (2022) · Medicine Health Care and Philosophy · doi:10.1007/s11019-022-10092-1 · Cited by 65 · see citing works
Standard 1: Consent and Recruitment
Caldwell, P., Dans, L. F., de Vries, M. D., Newman, J., Sammons, H., Spriggs, M., Tambe, P., Hoff, W., Woolfall, K., Young, B., et al. (2012) · Pediatrics · doi:10.1542/peds.2012-0055d · Cited by 54 · see citing works
Self-citationGuidelines for reporting embedded recruitment trials
Forbes, G., & Madurasinghe, V. (2016) · Trials · doi:10.1186/s13063-015-1126-y · Cited by 60 · see citing works
Kearney, A., Harman, N., Rosala‐Hallas, A., Beecher, C., Blazeby, J. M., Bower, P., Clarke, M. J., Cragg, W. J., Duane, S., Gardner, H., et al. (2018) · Clinical Trials · doi:10.1177/1740774518796156 · Cited by 59 · see citing works
Designing clinical trials in paediatric inflammatory bowel diseases: a PIBDnet commentary
Turner, D., Griffiths, A. M., Wilson, D. C., Mould, D. R., Baldassano, R. N., Russell, R. K., Dubinsky, M. C., Heyman, M. B., de Ridder, L., Hyams, J. S., et al. (2019) · Gut · doi:10.1136/gutjnl-2018-317987 · Cited by 55 · see citing works
Song, L., Qan'ir, Y., Guan, T., Guo, P., Xu, S., Jung, A., Idiagbonya, E., Song, F., & Kent, E. E. (2021) · Journal of Pain and Symptom Management · doi:10.1016/j.jpainsymman.2021.04.019 · Cited by 54 · see citing works
Denhoff, E. R., Milliren, C. E., de Ferranti, S. D., Steltz, S. K., & Osganian, S. K. (2015) · PLoS ONE · doi:10.1371/journal.pone.0140768 · Cited by 52 · see citing works
Bricca, A., Swithenbank, Z., SCOTT, N. W., Treweek, S. P., Johnston, M., Black, N., Hartmann‐Boyce, J., West, R., Michie, S., & de Bruin, M. (2021) · Addiction · doi:10.1111/add.15614 · Cited by 51 · see citing works
Wilman, E., Megone, C., Oliver, S. R., Duley, L., Gyte, G. M., & Wright, J. M. (2015) · Trials · doi:10.1186/s13063-015-0957-x · Cited by 51 · see citing works
Blockchain protocols in clinical trials: Transparency and traceability of consent
Benchoufi, M., Porcher, R., & Ravaud, P. (2017) · F1000Research · doi:10.12688/f1000research.10531.4 · Cited by 51 · see citing works
Breast Cancer-Related Lymphedema
Letellier, M.-È., Towers, A., Shimony, A., & Tidhar, D. (2014) · American Journal of Physical Medicine & Rehabilitation · doi:10.1097/phm.0000000000000089 · Cited by 50 · see citing works
TRIVEDI, R. B., Szarka, J. G., Beaver, K. A., Brousseau, K., Nevins, E., Yancy, W. S., Slade, A., & Voils, C. I. (2013) · Contemporary Clinical Trials · doi:10.1016/j.cct.2013.07.009 · Cited by 50 · see citing works
Lewis, M. A., & Dicker, A. P. (2015) · Seminars in Oncology · doi:10.1053/j.seminoncol.2015.07.005 · Cited by 48 · see citing works
David, M., & Ware, R. S. (2014) · Journal of Clinical Epidemiology · doi:10.1016/j.jclinepi.2014.08.001 · Cited by 48 · see citing works
Bracken, K., Askie, L. M., KEECH, A. C., Hague, W. E., & Wittert, G. (2019) · BMJ Open · doi:10.1136/bmjopen-2018-025580 · Cited by 46 · see citing works
Lantta, T., Kontio, R., Daffern, M., Adams, C. E., & Valimaki, M. A. (2016) · Patient Preference and Adherence · doi:10.2147/ppa.s103840 · Cited by 45 · see citing works
Recruitment of Research Participants
Manohar, N., MacMillan, F., Steiner, G. Z., & Arora, A. (2018) · Springer eBooks · doi:10.1007/978-981-10-2779-6_75-1 · Cited by 41 · see citing works
Updates in Cancer Cachexia: Clinical Management and Pharmacologic Interventions
Pandey, S., Bradley, L., & Fabbro, E. D. (2024) · Cancers · doi:10.3390/cancers16091696 · Cited by 40 · see citing works
Moffat, K. R., Shi, W., Cannon, P., & Sullivan, F. (2023) · Trials · doi:10.1186/s13063-022-06865-x · Cited by 39 · see citing works
Boyd, A., Tilling, K. M., Cornish, R., Davies, A., Humphries, K., & Macleod, J. (2015) · Journal of Clinical Epidemiology · doi:10.1016/j.jclinepi.2015.03.014 · Cited by 38 · see citing works
McCaughan, E., Curran, C., Northouse, L., & Parahoo, K. (2018) · Applied Nursing Research · doi:10.1016/j.apnr.2018.01.008 · Cited by 38 · see citing works
Methods to improve patient recruitment and retention in stroke trials
Berge, E., Stapf, C., Salman, R. A., Ford, G. A., Sandercock, P. A., van der Worp, H. B., Petersson, J., Dippel, D. W. J., Krieger, D. W., & Lees, K. R. (2016) · International Journal of Stroke · doi:10.1177/1747493016641963 · Cited by 37 · see citing works
Carroll, R., Antigua, J. P., Taichman, D. B., Palevsky, H. I., Forfia, P. R., Kawut, S. M., & Halpern, S. D. (2012) · Clinical Trials · doi:10.1177/1740774512438981 · Cited by 37 · see citing works
Sanders, A., van Weeghel, I., Vogelaar, M., Verheul, W., Pieters, R., de Wit, N. J., & Bensing, J. M. (2013) · Family Practice · doi:10.1093/fampra/cmt014 · Cited by 36 · see citing works
Sekhon, M., Cartwright, M., Lawes-Wickwar, S., McBain, H. B., Ezra, D. G., Newman, S. P., & Francis, J. (2021) · Contemporary Clinical Trials Communications · doi:10.1016/j.conctc.2021.100698 · Cited by 36 · see citing works
Kasenda, B., von Elm, E. B., You, J. J., Blümle, A., Tomonaga, Y., Saccilotto, R. T., Amstutz, A., Bengough, T., Meerpohl, J. J., Stegert, M., et al. (2012) · BMC Medical Research Methodology · doi:10.1186/1471-2288-12-131 · Cited by 36 · see citing works
Dickson, S., Logan, J., Hagen, S., Stark, D., Glazener, C. M. A., McDonald, A. M., & McPherson, G. C. (2013) · Trials · doi:10.1186/1745-6215-14-389 · Cited by 34 · see citing works
Rowlands, C., Rooshenas, L., Fairhurst, K., Rees, J. R. E., Gamble, C. L., & Blazeby, J. M. (2018) · BMJ Open · doi:10.1136/bmjopen-2017-018581 · Cited by 34 · see citing works
Miller, E. G., Nowson, C. A., Dunstan, D. W., Kerr, D. A., Solah, V. A., Menzies, D., & Daly, R. M. (2016) · Trials · doi:10.1186/s13063-016-1589-5 · Cited by 33 · see citing works
Williams, C. M., Maher, C. G., Hancock, M. J., McAuley, J. H., Lin, C. C., & Latimer, J. (2013) · Journal of Clinical Epidemiology · doi:10.1016/j.jclinepi.2013.08.007 · Cited by 32 · see citing works
McCann, S. E., Edge, S. B., Hicks, D. G., Thompson, L. U., Morrison, C. D., Fetterly, G. J., Andrews, C., Clark, K., Wilton, J. H., & Kulkarni, S. (2014) · Nutrition and Cancer · doi:10.1080/01635581.2014.894097 · Cited by 32 · see citing works
The natural history of conducting and reporting clinical trials: interviews with trialists
Smyth, R. M., Jacoby, A., Altman, D. G., Gamble, C. L., & Williamson, P. R. (2015) · Trials · doi:10.1186/s13063-014-0536-6 · Cited by 32 · see citing works
Successful recruitment to trials: findings from the SCIMITAR+ Trial
collaborative, O. B. O. T. S., Peckham, E. J., Arundel, C., Bailey, D., Callen, T., Cusack, C., Crosland, S., Foster, P., Herlihy, H., James, H., et al. (2018) · Trials · doi:10.1186/s13063-018-2460-7 · Cited by 32 · see citing works
Nurse-Moderated Internet-Based Support for New Mothers: Non-Inferiority, Randomized Controlled Trial
Sawyer, M., Reece, C., Bowering, K., Jeffs, D., Sawyer, A., Mittinty, M., & Lynch, J. (2017) · Journal of Medical Internet Research · doi:10.2196/jmir.6839 · Cited by 32 · see citing works
Computer-Based Intervention to Enhance Self-Management of Calcium and Vitamin D Intake in Women
Ryan, P. A., Maierle, D., Csuka, M. E., Thomson, A., & Szabó, A. (2013) · Western Journal of Nursing Research · doi:10.1177/0193945913483369 · Cited by 31 · see citing works
Outreach to diversify clinical trial participation: A randomized recruitment study
Brown, S. D., Partee, P. N., Feng, J., Quesenberry, C. P., Hedderson, M. M., Ehrlich, S. F., Kiernan, M., & Ferrara, A. M. (2015) · Clinical Trials · doi:10.1177/1740774514568125 · Cited by 30 · see citing works
Richard, L., Piper, D. A., Weavell, W., Callander, R., Iedema, R. A. M., Furler, J., Pierce, D., Godbee, K., Gunn, J. M., & Palmer, V. J. (2017) · Trials · doi:10.1186/s13063-017-1878-7 · Cited by 30 · see citing works
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 29 · see citing works
Wong, A. D., Kirby, J. M., Guyatt, G. H., Moayyedi, P., Vora, P., & You, J. J. (2013) · Trials · doi:10.1186/1745-6215-14-40 · Cited by 29 · see citing works
Sedrak, M. S., Sun, V. C.-Y., Liu, J., George, K., Wong, A. R., Dale, W., & Dizon, D. S. (2019) · JAMA Network Open · doi:10.1001/jamanetworkopen.2019.11528 · Cited by 29 · see citing works
Sanderson, I. C., Obeid, J. S., Madathil, K. C., Gerken, K. K., Fryar, K., Rugg, D., Alstad, C. E., Alexander, R., Brady, K. T., Gramopadhye, A. K., et al. (2013) · Clinical Trials · doi:10.1177/1740774513491338 · Cited by 28 · see citing works
Recruitment of Healthcare Providers into Research Studies
Bruneau, J., Moralejo, D. G., Donovan, C., & Parsons, K. (2021) · Canadian Journal of Nursing Research · doi:10.1177/0844562120974911 · Cited by 28 · see citing works
Samsudeen, B. S., Douglas, A., & Bhopal, R. S. (2011) · Public Health · doi:10.1016/j.puhe.2011.01.013 · Cited by 28 · see citing works
Smith, O. M., McDonald, E., Zytaruk, N. L., Foster, D., Matte, A. L., Clarke, F. J., Fleury, S., Krause, K. L., McArdle, T., Skrobik, Y. K., et al. (2013) · Intensive and Critical Care Nursing · doi:10.1016/j.iccn.2013.04.006 · Cited by 28 · see citing works
Krusche, A., von Rohr, I. R., Muse, K., Duggan, D. S., Crane, C., & Williams, J. (2014) · Clinical Trials · doi:10.1177/1740774514521905 · Cited by 28 · see citing works
van Gelder, M. M. H. J., Vlenterie, R., IntHout, J., Engelen, L. J., Vrieling, A., & van de Belt, T. H. (2018) · Journal of Clinical Epidemiology · doi:10.1016/j.jclinepi.2018.02.019 · Cited by 27 · see citing works
Skinner, J. S., Fair, A. M., Holman, A. S., Boyer, A. P., & Wilkins, C. H. (2019) · Frontiers in Public Health · doi:10.3389/fpubh.2019.00104 · Cited by 26 · see citing works
Patient Empowerment and Involvement in Research
Perestelo‐Pérez, L., Rivero‐Santana, A., Sacks, A. A., Toledo‐Chávarri, A., Brito, N., Álvarez‐Pérez, Y., González, N., & Serrano‐Aguilar, P. (2017) · Advances in experimental medicine and biology · doi:10.1007/978-3-319-67144-4_15 · Cited by 26 · see citing works
Research START: A Multimethod Study of Barriers and Accelerators of Recruiting Research Participants
Stein, M. A., Shaffer, M. L., Echo‐Hawk, A., Smith, J. K., Stapleton, A. E., & Melvin, A. J. (2015) · Clinical and Translational Science · doi:10.1111/cts.12351 · Cited by 25 · see citing works
Methodological review: quality of randomized controlled trials in health literacy
Brainard, J. S., Wilsher, S. H., Salter, C., & Loke, Y. K. (2016) · BMC Health Services Research · doi:10.1186/s12913-016-1479-2 · Cited by 25 · see citing works
A screening tool for predicting gatekeeping behaviour
Snowden, A. W., & Young, J. (2017) · Nursing Open · doi:10.1002/nop2.83 · Cited by 25 · see citing works
Designing clinical trials in trauma surgery
Perry, D. C., Griffin, X. L., Parsons, N., & Costa, M. L. (2014) · Bone and Joint Research · doi:10.1302/2046-3758.34.2000283 · Cited by 24 · see citing works
Campillo‐Gimenez, B., Buscail, C., Zékri, O., Laguerre, B., Prisé, É. L., de Crevoisier, R., & Marc Cuggia, A. (2015) · Trials · doi:10.1186/s13063-014-0535-7 · Cited by 24 · see citing works
Ng, K. P., Jain, P., Gill, P. S., Heer, G., Townend, J., Freemantle, N., Greenfield, S., McManus, R. J., & Ferro, C. J. (2016) · BMJ Open · doi:10.1136/bmjopen-2015-010519 · Cited by 24 · see citing works
van Zon, S. K. R., Scholtens, S., Reijneveld, S. A., Smidt, N., & Bültmann, U. (2016) · Journal of Clinical Epidemiology · doi:10.1016/j.jclinepi.2016.03.009 · Cited by 23 · see citing works
Defining the Study Cohort: Inclusion and Exclusion Criteria
Keung, E. Z.-Y., McElroy, L. M., Ladner, D. P., & Grubbs, E. G. (2020) · Success in academic surgery · doi:10.1007/978-3-030-35488-6_5 · Cited by 23 · see citing works
Michaud, T. L., Estabrooks, P. A., You, W., Ern, J., Scoggins, D., Gonzales, K., King, K. M., Dai, H. D., & Su, D. (2022) · Preventive Medicine · doi:10.1016/j.ypmed.2022.107141 · Cited by 23 · see citing works
DeWard, S. J., Wilson, A., Bausell, H., Volz, A., & Mooney, K. (2013) · Journal of Genetic Counseling · doi:10.1007/s10897-013-9642-y · Cited by 23 · see citing works
Saag, K. G., Mohr, P. E., Esmail, L. C., Mudano, A. S., Wright, N. C., Beukelman, T., Curtis, J. R., Cutter, G., Delzell, E., Gary, L. C., et al. (2012) · Contemporary Clinical Trials · doi:10.1016/j.cct.2012.07.002 · Cited by 23 · see citing works
Lohan, M., Aventin, Á., Maguire, L. K., Curran, R., McDowell, C., Agus, A. M., Donaldson, C., Clarke, M. J., Linden, M., Kelly, C., et al. (2017) · Public Health Research · doi:10.3310/phr05010 · Cited by 23 · see citing works
Kaguelidou, F., Amiel, P., Blachier, A., Iliescu, C., Rozé, J., Tsimaratos, M., Brandt, C., Kassaï, B., Jacqz-Aigrain, É., Gaultier, C., et al. (2013) · Journal of Clinical Epidemiology · doi:10.1016/j.jclinepi.2013.04.015 · Cited by 22 · see citing works
Lim, Y., Lim, J. M., Jeong, W. J., Lee, K.-H., Keam, B., Kim, T., Kim, T. M., Han, S., Oh, D. Y., Kim, D., et al. (2017) · Cancer Research and Treatment · doi:10.4143/crt.2016.413 · Cited by 22 · see citing works
Clinical trials: Kids are not just little people.
Naka, F., Strober, B. E., & Shahriari, M. (2017) · Clinical Dermatology · doi:10.1016/j.clindermatol.2017.08.008 · Cited by 21 · see citing works
Vogel, A., Comteße, H., & Rosner, R. (2020) · Child and Adolescent Psychiatry and Mental Health · doi:10.1186/s13034-020-00320-y · Cited by 21 · see citing works
Best-Practice Guidelines for Positive Psychological Intervention Research Design
van Zyl, L. E., Efendić, E., Rothmann, S., & Shankland, R. (2019) · Springer eBooks · doi:10.1007/978-3-030-20020-6_1 · Cited by 21 · see citing works
- Authors
- Caldwell, P. H. Y., Hamilton, S., Tan, A., & Craig, J. C.
- Affiliations
- The University of Sydney (AU)
- Children's Hospital at Westmead (AU)
- Corresponding author
- Caldwell, Patrina H. Y.
- Venue
- PLoS Medicine
- Publisher
- Public Library of Science (PLoS)
- Published
- 2010-11-09
- Volume
- 7
- Issue
- 11
- Pages
- e1000368
- ISSN
- 1549-1277 (ISSN-L)
- 1549-1676
- PMC
- PMC2976724
- OpenAlex
- W2121847763
- Cited by
- 307
- References
- 55
- Citations by year
- 2026: 6 · 2025: 19 · 2024: 19 · 2023: 28 · 2022: 24 · 2021: 23 · 2020: 19 · 2019: 18 · 2018: 27 · 2017: 21 · 2016: 18 · 2015: 22 · 2014: 13 · 2013: 22 · 2012: 18
- FWCI
- 2.31
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Locations
- PLoS Medicine (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- RePEc: Research Papers in Economics (publishedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- Funders
- University of Sydney
- Topics
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Ethics in Clinical Research
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
- Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
- Keywords
- randomized controlled trials, clinical trial participation, participant awareness, financial incentives, trial design, informed consent, loss to follow-up, mock trial, health education
- MeSH terms
- Humans, Patient Education as Topic, Randomized Controlled Trials as Topic, Sample Size
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