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Open Access 01-12-2015 | Research

A systematic review of training programmes for recruiters to randomised controlled trials

Authors: Daisy Townsend, Nicola Mills, Jelena Savović, Jenny L. Donovan

Published in: Trials | Issue 1/2015

Abstract

Background

Recruitment to randomised controlled trials (RCTs) is often difficult. Clinician related factors have been implicated as important reasons for low rates of recruitment. Clinicians (doctors and other health professionals) can experience discomfort with some underlying principles of RCTs and experience difficulties in conveying them positively to potential trial participants. Recruiter training has been suggested to address identified problems but a synthesis of this research is lacking. The aim of our study was to systematically review the available evidence on training interventions for recruiters to randomised trials.

Methods

Studies that evaluated training programmes for trial recruiters were included. Those that provided only general communication training not linked to RCT recruitment were excluded. Data extraction and quality assessment were completed by two reviewers independently, with a third author where necessary.

Results

Seventeen studies of 9615 potentially eligible titles and abstracts were included in the review: three randomised controlled studies, two non-randomised controlled studies, nine uncontrolled pre-test/post-test studies, two qualitative studies, and a post-training questionnaire survey. Most studies were of moderate or weak quality. Training programmes were mostly set within cancer trials, and usually consisted of workshops with a mix of health professionals over one or two consecutive days covering generic and trial specific issues. Recruiter training programmes were well received and some increased recruiters’ self-confidence in communicating key RCT concepts to patients. There was, however, little evidence that this training increased actual recruitment rates or patient understanding, satisfaction, or levels of informed consent.

Conclusions

There is a need to develop recruiter training programmes that can lead to improved recruitment and informed consent in randomised trials.

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Farrell B, Kenyon S, Shakur H. Managing clinical trials. Trials. 2010;11:78. doi:10.1186/1745-6215-11-78.CrossRefPubMedPubMedCentral

McDonald AM, Knight RC, Campbell MK, Entwistle VA, Grant AM, Cook JA, et al. What influences recruitment to randomised controlled trials? A review of trials funded by two UK funding agencies. Trials. 2006;7:9. doi:10.1186/1745-6215-7-9.CrossRefPubMedPubMedCentral

Longbottom ME, Roberts JN, Tom M, Hughes SE, Howard VJ, Sheffet AJ, et al. Interventions to increase enrolment in a large multicenter phase 3 trial of carotid stenting vs. endarterectomy. Int J Stroke. 2012;7:447–543. doi:10.1111/j.1747-4949.2012.00833.x.PubMedPubMedCentral

Donovan JL, de Salis I, Toerien M, Paramasivan S, Hamdy FC, Blazeby J. The intellectual challenges and emotional consequences of equipoise contributed to the fragility of recruitment in six randomized controlled trials. J Clin Epidemiol. 2014;67:912–20. doi:10.1016/j.jclinepi.2014.03.010.CrossRefPubMedPubMedCentral

International Conference on Harmonisation. Guideline for good clinical practice E6. 1996. Available at: http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E6/E6_R1_Guideline.pdf [Accessed 16 September 2015].

Wade J, Donovan JL, Lane JA, Neal DE, Hamdy FC. It’s not just what you say, it’s also how you say it: opening the ‘black box’ of informed consent appointments in randomised controlled trials. Soc Sci Med. 2009;68:2018–28. doi:10.1016/j.socscimed.2009.02.023.CrossRefPubMed

Jenkins V, Fallowfield L. Reasons for accepting or declining to participate in randomized clinical trials for cancer therapy. Br J Cancer. 2000;82:1783–8. doi:10.1054/bjoc.2000.1142.CrossRefPubMedPubMedCentral

Albrecht TL, Eggly SS, Gleason ME, Harper FW, Foster TS, Peterson AM, et al. Influence of clinical communication on patients’ decision making on participation in clinical trials. J Clin Oncol. 2008;26:2666–73. doi:10.1200/JCO.2007.14.8114.CrossRefPubMed

Donovan JL, Paramasivan S, de Salis I, Toerien M. Clear obstacles and hidden challenges: understanding recruiter perspectives in six pragmatic randomised controlled trials. Trials. 2014;15:5. doi:10.1186/1745-6215-15-5.CrossRefPubMedPubMedCentral

10.

Fletcher B, Gheorghe A, Moore D, Wilson S, Damery S. Improving the recruitment activity of clinicians in randomised controlled trials: a systematic review. BMJ Open. 2012;2:496. doi:10.1136/bmjopen-2011-000496.CrossRef

11.

Bower B, Brueton V, Gamble C, Treweek S, Tudur Smith C, Young B, et al. Interventions to improve recruitment and retention in clinical trials: a survey and workshop to assess current practice and future priorities. Trials. 2014;15:399. doi:10.1186/1745-6215-15-399.CrossRefPubMedPubMedCentral

12.

Treweek S, Lockhart P, Pitkethly M, Cook J, Kjeldstrøm M, Johansen M, et al. Methods to improve recruitment to randomised controlled trials: Cochrane systematic review and meta-analysis. BMJ Open. 2013;3:e002360. doi:10.1136/bmjopen-2012-002360.CrossRefPubMedPubMedCentral

13.

Larkey LK, Staten LK, Ritenbaugh C, Hall RA, Buller DB, Bassford T, et al. Recruitment of Hispanic women to the Women’s Health Initiative: the case of Embajadoras in Arizona. Control Clin Trials. 2002;23:289–98. doi:10.1016/s0197-2456(02)00190-3.CrossRefPubMed

14.

Kimmick CG, Peterson BL, Kornblith AB, Mandelblatt J, Johnson JL, Wheeler J, et al. Improving accrual of older persons to cancer treatment trials: A randomized trial comparing an educational intervention with standard information: CALGB 360001. J Clin Oncol. 2005;23:2201–7. doi:10.1200/JCO.2005.01.222.CrossRefPubMed

15.

Donovan JL, Lane JA, Peters TJ, Brindle L, Salter E, Gillatt D, et al. for the ProtecT Study Group: Development of a complex intervention to improve randomisation and informed consent in randomised controlled trials. J Clin Epidemiol. 2009;62:29–36. doi:10.1016/j.jclinepi.2008.02.010.CrossRefPubMed

16.

Kenyon S, Rhodes A, Taylor D. A recipe for successful recruitment to a randomised controlled trial. MIDIRS Midwifery Digest. 2005;15:16–9.

17.

Higgins JPT, Green S, editors. Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0 [updated March 2011]. The Cochrane Collaboration. 2011. Available from www.cochrane-handbook.org.

18.

Effective Public Health Practice Project. Quality assessment tool for quantitative studies. http://www.ephpp.ca/PDF/Quality%20Assessment%20Tool_2010_2.pdf [Accessed 16 September 2015]

19.

Critical Appraisal Skills Programme. 10 questions to help you make sense of qualitative research. http://www.civilservice.gov.uk/wp-content/uploads/2011/09/Qualitative-Appraisal-Tool_tcm6-7385.pdf [Accessed 16 September 2015]

20.

Fallowfield LJ, Solis-Trapala I, Jenkins VA. Evaluation of an educational program to improve communication with patients in early-phase trial participation. Oncologist. 2012;17:377–83. doi:10.1634/theoncologist.2011-0271.CrossRefPubMedPubMedCentral

21.

Fisher L, Hessler D, Naranjo D, Polonsky W. AASAP: A program to increase recruitment and retention in clinical trials. Patient Educ Couns. 2012;86:372–7. doi:10.1016/j.pec.2011.07.002.CrossRefPubMed

22.

Jenkins V, Fallowfield L, Solis-Trapala I, Langridge C, Farewell V. Discussing randomised clinical trials of cancer therapy: evaluation of a Cancer Research UK training programme. BMJ. 2005;330:400–6. http://dx.doi.org/10.1136/bmj.38366.562685.8F.CrossRefPubMedPubMedCentral

23.

Brown RF, Butow PN, Boyle F, Tattersall MHN. Seeking informed consent to cancer clinical trials: evaluating the efficacy of doctor communication skills training. Psych Onc. 2007;16:507–16. doi:10.1002/pon.1095.CrossRef

24.

Jenkins VA, Farewell D, Farewell V, Batt L, Wagstaff J, Langridge C, et al. Teams Talking Trials: results of an RCT to improve the communication of cancer teams about treatment trials. Contemp Clin Trials. 2013;31(1):43–51. doi:10.1016/j.cct.2013.02.003.CrossRef

25.

Fallowfield L, Langridge C, Jenkins V. Communication skills training for breast cancer teams talking about trials. Breast. 2014;23:193–7.CrossRefPubMed

26.

Blazeby JM, Strong S, Donovan JL, Wilson C, Hollingworth W, Crosby T, et al. Feasibility RCT of definitive chemoradiotherapy or chemotherapy and surgery for oesophageal squamous cell cancer. Br J Cancer. 2014;111:234–40.CrossRefPubMedPubMedCentral

27.

Bernhard J, Butow P, Aldridge J, Juraskova I, Ribi K, Brown R. Communication about standard treatment options and clinical trials: can we teach doctors new skills to improve patient outcomes? Psycho-Oncology. 2012;12:1593–601. doi:10.1002/pon.2044.

28.

Hietanen P, Aro A, Holli KA, Schreck M, Peura A, Joensuu HT. A short communication course for physicians improves the quality of patient information in a clinical trial. Acta Oncol. 2007;46:42–8. doi:10.1080/02841860600849067.CrossRefPubMed

29.

Yap TY, Yamokoski A, Noll R, Drotar D, Zyzanski S, et al. A physician-directed intervention: teaching and measuring better informed consent. Acad Med. 2009;84:1036–42. doi:10.1097/ACM.0b013e3181acfbcd.CrossRefPubMed

30.

Kendall B, Städeli R, Schegg B, Olbrich M, Chen E, Harmelin-Kadouri R, et al. Clinical trial educator program – a novel approach to accelerate enrolment in a phase III International Acute Coronary Syndrome Trial. Clinical Trials. 2012;9(3):358–66. doi:10.1177/1740774512440760.CrossRefPubMed

31.

Mann C, Delgado D, Horwood J. Evaluation of internal peer‐review to train nurses recruiting to a randomized controlled trial–Internal Peer‐review for Recruitment Training in Trials (InterPReTiT). J Adv Nurs. 2014;70(4):777–90. doi:10.1111/jan.12254.CrossRefPubMed

32.

Paramasivan S, Huddart R, Hall E, Lewis R, Birtle A, Donovan JL. Key issues in recruitment to randomised controlled trials with very different interventions: a qualitative investigation of recruitment to the SPARE trial (CRUK/07/011). Trials. 2011;12:78. doi:10.1186/1745-6215-12-78.CrossRefPubMedPubMedCentral

33.

Wuensch A, Goelz T, Bertz H, Wirsching M, Fritzsche K. Disclosing information about randomised controlled trials in oncology: training concept and evaluation of an individualised communication skills training for physicians COM-ON-rct. Eur J Cancer Care. 2011;20:570–6. doi:10.1111/j.1365-2354.2010.01233.x.CrossRef

34.

Brown RF, Butow PN, Ellis P, Boyle F, Tattersall MHN. Seeking informed consent to cancer clinical trials: Describing current practice. Soc Sci Med. 2004;58:2445–57. doi:10.1016/j.socscimed.2003.09.007.CrossRefPubMed

35.

Barth J, Lannen P. Efficacy of communication skills training courses in oncology: a systematic review and meta-analysis. Ann Oncol. 2011;22:1030–40. doi:10.1093/annonc/mdq441.CrossRefPubMed

36.

De Salis I, Tomlin Z, Toerien M, Donovan J. Qualitative research to improve RCT recruitment: issues arising in establishing research collaborations. Contemp Clin Trials. 2008;29:663–70. doi:10.1016/j.cct.2008.03.003.CrossRefPubMed

37.

Moher D, Liberati A, Tetzlaff J, Altman DG. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. J Clin Epidemiol. 2009;62:1006–12. doi:10.1016/j.jclinepi.2009.06.005.CrossRefPubMed

38.

Mc Daid C, Hodges Z, Fayter D, Stirk L, Eastwood A. Increasing participation of cancer patients in randomised controlled trials: a systematic review. Trials. 2006;7:16. doi:10.1186/1745-6215-7-16.CrossRefPubMedPubMedCentral

39.

Bokken L, Rethans JJ, Jöbsis Q, Duvivier R, Scherpbier A, van der Vleuten C. Instructiveness of real patients and simulated patients in undergraduate medical education: a randomized experiment. Acad Med. 2010;85:148–54. doi:10.1097/ACM.0b013e3181c48130.CrossRefPubMed

40.

Fallowfield L, Jenkins V, Farewell V. Enduring impact of a communication skills training programme: Results of a 12-month follow-up. Brit J Cancer. 2003;89:1445–9. doi:10.1038/sj.bjc.6601309.CrossRefPubMedPubMedCentral

Title: A systematic review of training programmes for recruiters to randomised controlled trials
Authors: Daisy Townsend
Nicola Mills
Jelena Savović
Jenny L. Donovan
Publication date: 01-12-2015
Publisher: BioMed Central
Published in: Trials / Issue 1/2015
Electronic ISSN: 1745-6215
DOI: https://doi.org/10.1186/s13063-015-0908-6

At a glance: The STEP trials

Springer Medicine

A systematic review of training programmes for recruiters to randomised controlled trials

Abstract

Background

Methods

Results

Conclusions

At a glance: The STEP trials

Springer Medicine

Abstract

Background

Methods

Results

Conclusions

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