Clear obstacles and hidden challenges: understanding recruiter perspectives in six pragmatic randomised controlled trials

Jenny L Donovan, Sangeetha Paramasivan, Isabel de Salis, Merran Toerien, Jenny L Donovan, Sangeetha Paramasivan, Isabel de Salis, Merran Toerien

Abstract

Background: Recruitment of sufficient participants in an efficient manner is still widely acknowledged to be a major challenge to the mounting and completion of randomised controlled trials (RCTs). Few recruitment interventions have involved staff undertaking recruitment. This study aimed i) to understand the recruitment process from the perspective of recruiters actively recruiting RCT participants in six pragmatic RCTs, and ii) to identify opportunities for interventions to improve recruitment.

Methods: Interviews were undertaken with 72 individuals (32 doctors or RCT Chief investigators (CIs); 40 nurses/other health professionals) who were actively recruiting participants in six RCTs to explore their experiences of recruitment. The RCTs varied in scale, duration, and clinical contexts. Interviews were fully transcribed and analysed using qualitative content and thematic analytic methods derived from grounded theory. For this analysis, data were systematically extracted from each RCT and synthesised across all six RCTs to produce a detailed and nuanced understanding of the recruitment process from the perspectives of the recruiters.

Results: Recruiters readily identified organisational difficulties, fewer than expected eligible patients, and patients' treatment preferences as the key barriers to recruitment. As they described their experiences of recruitment, several previously hidden issues related to their roles as researchers and clinicians emerged, imbued with discomfort and emotion. The synthesis across the RCTs showed that doctors were uncomfortable about aspects of patient eligibility and the effectiveness of interventions, whereas nurses were anxious about approaching potential RCT participants and conflicts between the research and their clinical responsibilities. Recruiters seemed unaware that their views contributed to recruitment difficulties. Their views were not known to RCT CIs. Training and support needs were identified for both groups of staff.

Conclusions: The synthesis showed that recruitment to these RCTs was a complex and fragile process. Clear obstacles were identified but hidden challenges related to recruiters' roles undermined recruitment, unbeknown to RCT CIs. Qualitative research can elicit and identify the hidden challenges. Training and support are then needed for recruiters to become more comfortable with the design and principles of RCTs, so that they can engage more openly with potentially eligible participants and create a more resilient recruitment process.

References

    1. McDonald AM, Knight RC, Campbell MK, Entwistle VA, Grant AM, Cook JA, Elbourne DR, Francis D, Garcia J, Roberts I, Snowdon C. What influences recruitment to randomised controlled trials? Trials. 2006;7:9. doi: 10.1186/1745-6215-7-9.
    1. Campbell MK, Snowdon C, Francis D, Elbourne D, McDonald AM, Knight R, Entwistle V, Garcia J, Roberts I, Grant A, Grant A. STEPS group. Recruitment to randomised trials: strategies for trial enrolment and participation study. The STEPS study. Health Technol Assess. 2007;11:48–105.
    1. Ross S, Grant A, Counsell C, Gillespie W, Russell I, Prescott R. Barriers to participation in randomised controlled trials: a systematic review. J Clin Epidemiol. 1999;52:1143–1156. doi: 10.1016/S0895-4356(99)00141-9.
    1. Haidich A-B, Ioannidis JPA. Patterns of patient enrollment in randomized controlled trials. J Clin Epidemiol. 2001;54:877–883. doi: 10.1016/S0895-4356(01)00353-5.
    1. Hunninghake DB, Darby CA, Probstfield JL. Recruitment experience in clinical trials: literature summary and annotated bibliography. Control Clin Trials. 1987;8:6S–30S. doi: 10.1016/0197-2456(87)90004-3.
    1. Treweek S, Mitchell E, Pitkethly M, Cook J, Kjeldstrøm M, Taskila T, Johansen M, Sullivan F, Wilson S, Jackson C, Jones R. Strategies to improve recruitment to randomised controlled trials. Cochrane Database Syst Rev. 2010;1 MR000013.
    1. McDaid C, Hodges Z, Fayter D, Stirk L, Eastwood A. Systematic review of interventions to increase participation of cancer patients in randomised controlled trials. Trials. 2006;17:16.
    1. Donovan JL, Lane JA, Peters TJ, Brindle L, Salter E, Gillatt D, Powell P, Bollina P, Neal DE, Hamdy FC. and the ProtecT study group. Development of a complex intervention improved randomisation and informed consent in a randomized controlled trial. J Clin Epidemiol. 2009;62:29–36. doi: 10.1016/j.jclinepi.2008.02.010.
    1. 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;29:663–670. doi: 10.1016/j.cct.2008.03.003.
    1. Glaser BG, Strauss AL. The Discovery of Grounded Theory. Aldine Transaction: USA; 1967.
    1. Miles MB, Huberman AM. Qualitative Data Analysis. London: Sage; 1994.
    1. Agar MH. The Professional Stranger. Emerald Group: Bingley; 2008.
    1. Howard L, de Salis I, Tomlin Z, Thornicroft G, Donovan JL. Why is recruitment to trials difficult? An investigation into recruitment difficulties in an RCT of supported employment for people with severe mental illness. Contemp Clin Trials. 2009;30:40–46. doi: 10.1016/j.cct.2008.07.007.
    1. Paramasivan S, Huddart R, Hall E, Lewis R, Birtle A, Donovan JL. Key issues in recruitment to randomized controlled trials with very different interventions: a qualitative investigation of recruitment to the SPARE trial. Trials. 2011;12:78. doi: 10.1186/1745-6215-12-78.
    1. Hamilton DW, de Salis I, Donovan JL, Birchall M. The recruitment of patients to trials in head and neck cancer: a qualitative study of the EaStER trial of treatments for early laryngeal cancer. Eur Arch Otorhinolaryngol. 2013;270:2333–2337. doi: 10.1007/s00405-013-2349-8.
    1. King M, Nazareth I, Lampe F, Bower P, Chandler M, Morou M, Sibbald B, Lai R. Ross 1999. Impact of participant and physician intervention preferences on randomized trials: a systematic review. JAMA. 2005;293:1089–1099. doi: 10.1001/jama.293.9.1089.
    1. Bower P, King M, Nazareth I, Lampe F, Sibbald B. Patient preferences in randomised controlled trials: conceptual framework and implications for research. Soc Sci Med. 2005;61:685–695. doi: 10.1016/j.socscimed.2004.12.010.
    1. Mills N, Donovan JL, Wade J, Hamdy FC, Neal DE, Lane JA. Exploring treatment preferences facilitated recruitment to randomized controlled trials. J Clin Epidemiol. 2011;64:1127–1136. doi: 10.1016/j.jclinepi.2010.12.017.
    1. Bradford Hill A. Medical ethics and controlled trials (Marc Daniels lecture) Brit Med J. 1963;1:1043–1049. doi: 10.1136/bmj.1.5337.1043.
    1. Fried C. Medical Experimentation: Personal Integrity and Social Policy. Amsterdam: North-Holland Publishing; 1974. p. 51.
    1. Freedman B. Equipoise and the ethics of clinical research. New Engl J Med. 1987;312:141–145.
    1. Miller FG, Joffe S. Equipoise and the dilemma of randomized clinical trials. N Engl J Med. 2011;364(5):476–480. doi: 10.1056/NEJMsb1011301.
    1. Miller FG. Clinical equipoise and risk-benefit assessment. Clin Trials. 2012;9(5):621–627. doi: 10.1177/1740774512450952.
    1. Garcia J, Elbourne D, Snowdon C. Equipoise: a case study of the views of clinicians involved in two neonatal trials. Clin Trials. 2004;1(2):170–178. doi: 10.1191/1740774504cn020xx.
    1. Lawton J, Jenkins N, Darbyshire J, Farmer A, Holman R, Hallowell N. Understanding the outcomes of multi-centre clinical trials: a qualitative study of health professional experiences and views. Soc Sci Med. 2012;74:574–581. doi: 10.1016/j.socscimed.2011.11.012.
    1. Spilsbury K, Petherick E, Cullum N, Nelson A, Nixon J, Mason S. The role and potential contribution of clinical research nurses to clinical trials. J Clin Nurs. 2008;17:549–557.
    1. Instone SL, Mueller MR, Gilbert TL. Therapeutic discourse among nurses and physicians in controlled clinical trials. Nurs Ethics. 2008;15:803–812. doi: 10.1177/0969733008095388.
    1. Tomlin Z, de Salis I, Toerien M, Donovan JL. Patient advocacy and patient centredness in participant recruitment to randomized-controlled trials: implications for informed consent. Health Expect. 2012. [Ahead of print]
    1. National Cancer Research Network. UK: NIHR; [ ]; [ ]
    1. Fallowfield L, Jenkins V, Farewell V, Saul J, Duffy A, Eves R. Efficacy of a Cancer Research UK communication skills training model for oncologists: a randomised controlled trial. Lancet. 2002;359:650–656. doi: 10.1016/S0140-6736(02)07810-8.
    1. Hewitt J. A critical review of the arguments debating the role of the nurse advocate. J Adv Nurs. 2002;37:439–445. doi: 10.1046/j.1365-2648.2002.02110.x.
    1. Allen D. What do you do at work? Professional building and doing nursing. Int Nurs Rev. 2007;54:41–48. doi: 10.1111/j.1466-7657.2007.00496.x.
    1. Chen DT, Miller FG, Rosenstein DL. Clinical Research and the Physician–Patient Relationship. Ann Intern Med. 2003;138:669–672. doi: 10.7326/0003-4819-138-8-200304150-00015.

Source: PubMed

Sponsors and Collaborators

Medical Conditions

Drug Interventions

3
Subscribe