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

Trials

Volumn 16, Issue 1, 2015, Pages

  Townsend, Daisy ^a   Mills, Nicola ^a   Savović, Jelena ^a   Donovan, Jenny L ^a  

^a UNIVERSITY OF BRISTOL   (United Kingdom)

Author keywords

Communication; Equipoise; Randomisation; Recruitment; Training; Trials

Indexed keywords

ARTICLE; CANCER RESEARCH; COMPARATIVE STUDY; DATA EXTRACTION; EDUCATION PROGRAM; EVIDENCE BASED MEDICINE; HEALTH PRACTITIONER; HEALTH SURVEY; HUMAN; INFORMED CONSENT; INTERPERSONAL COMMUNICATION; MEDICAL RESEARCH; PARAMEDICAL EDUCATION; PRETEST POSTTEST DESIGN; PROGRAM DEVELOPMENT; QUALITATIVE RESEARCH; QUALITY CONTROL; QUESTIONNAIRE; RANDOMIZED CONTROLLED TRIAL (TOPIC); RESEARCH SUBJECT; SATISFACTION; SELF CONCEPT; SYSTEMATIC REVIEW; ATTITUDE TO HEALTH; COMPREHENSION; EDUCATION; HEALTH PERSONNEL ATTITUDE; HUMAN RELATION; IN SERVICE TRAINING; PATIENT EDUCATION; PATIENT SELECTION; PERSONNEL; PROCEDURES; PROGRAM EVALUATION; PSYCHOLOGY; SAMPLE SIZE;

ATTITUDE OF HEALTH PERSONNEL; COMMUNICATION; COMPREHENSION; HEALTH KNOWLEDGE, ATTITUDES, PRACTICE; HUMANS; INFORMED CONSENT; INSERVICE TRAINING; PATIENT EDUCATION AS TOPIC; PATIENT SELECTION; PROFESSIONAL-PATIENT RELATIONS; PROGRAM DEVELOPMENT; PROGRAM EVALUATION; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RESEARCH PERSONNEL; RESEARCH SUBJECTS; SAMPLE SIZE;

EID: 84942516175     PISSN: None     EISSN: 17456215     Source Type: Journal    
DOI: 10.1186/s13063-015-0908-6     Document Type: Article

References (40)

1. Farrell B, Kenyon S, Shakur H. Managing clinical trials. Trials. 2010;11:78. doi: 10.1186/1745-6215-11-78 .
2. 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 .
3. 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 .
4. 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 .
5. 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].
6. 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 .
7. 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 .
8. 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 .
9. 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 .
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 .
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 .
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 .
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 .
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 .
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 .
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 .
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 .
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 .
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 .
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 .
25. Fallowfield L, Langridge C, Jenkins V. Communication skills training for breast cancer teams talking about trials. Breast. 2014;23:193-7.
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.
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 .
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 .
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 .
31. Mann C, Delgado D, Horwood J. Evaluation of internal peerreview to train nurses recruiting to a randomized controlled trial-Internal Peerreview for Recruitment Training in Trials (InterPReTiT). J Adv Nurs. 2014;70(4):777-90. doi: 10.1111/jan.12254 .
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 .
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 .
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 .
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 .
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 .
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 .
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 .
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 .
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 .