Skip to main content

Advertisement

Table 8 Evidence checking

From: Identifying trial recruitment uncertainties using a James Lind Alliance Priority Setting Partnership – the PRioRiTy (Prioritising Recruitment in Randomised Trials) study

Uncertainty as research question Evidence reviewed (878 screened, 76 full text, 34 extracted)
1. How can randomised trials become part of routine care and best utilise current clinical care pathways? • No evidence available
2. What information should trialists communicate to members of the public who are being invited to take part in a randomised trial in order to improve recruitment to the trial? • No evidence available
3. Does patient/public involvement in planning a randomised trial improve recruitment? • No evidence available
4. What are the best approaches for designing and delivering information to members of the public who are invited to take part in a randomised trial? • Bonevski, B.; Randell, M.; Paul, C.; Chapman, K.; Twyman, L.; Bryant, J.; Brozek, I.; Hughes, C. Reaching the hard-to-reach: a systematic review of strategies for improving health and medical research with socially disadvantaged groups. BMC Medical Research Methodology 2014; 14:42. • Synnot, A.; Ryan, R.; Prictor, M.; Fetherstonhaugh, D.; Parker, B.Audio-visual presentation of information for informed consent for participation in clinical trials. Cochrane Database of Systematic Reviews 2014;9(5):CD003717. • Treweek, S.; Lockhart, P.; Pitkethly, M.; Cook, J. A.; Kjeldstrom, M.; Johansen, M.; Taskila, T. K.; Sullivan, F. M.; Wilson, S.; Jackson, C.; Jones, R.; Mitchell, E. D. Methods to improve recruitment to randomised controlled trials: Cochrane systematic review and meta-analysis. BMJ Open 2013;3(2):
5. What are the barriers and enablers for clinicians/healthcare professionals in helping conduct randomised trials? • Newington, L.; Metcalfe, A. Researchers’ and clinicians’ perceptions of recruiting participants to clinical research: a thematic meta-synthesis. Journal of Clinical Medicine Research 2014;6(3):162-72
6. What are the key motivators influencing members of the public’s decisions to take part in a randomised trial? • Limkakeng Limkakeng, A.; Phadtare, A.; Shah, J.; Vaghasia, M.; Wei, D. Y.; Shah, A.; Pietrobon, R.Willingness to participate in clinical trials among patients of Chinese heritage: a meta-synthesis. PLoS ONE [Electronic Resource] 2013; 8(1):e51328. • Nalubega, S.; Evans, C. Participant views and experiences of participating in HIV research in sub-Saharan Africa: a qualitative systematic review. JBI Database Of Systematic Reviews And Implementation Reports 2015;13(5):330-420 • Rivers, D.; August, E. M.; Sehovic, I.; Lee Green, B.; Quinn, G. P. A systematic review of the factors influencing African Americans’ participation in cancer clinical trials. Contemporary Clinical Trials 2013;35(2):13-32 • Wilman, E.; Megone, C.; Oliver, S.; Duley, L.; Gyte, G.; Wright, J. M.The ethical issues regarding consent to clinical trials with pre-term or sick neonates: a systematic review (framework synthesis) of the empirical research.Trials [Electronic Resource] 2015;16:502
7. What are the best approaches to ensure inclusion and participation of under-represented or vulnerable groups in randomised trials? • Bellera, C.; Praud, D.; Petit-Moneger, A.; McKelvie-Sebileau, P.; Soubeyran, P.; Mathoulin-Pelissier, S. Barriers to inclusion of older adults in randomised controlled clinical trials on non-Hodgkin’s lymphoma: a systematic review. Cancer Treatment Reviews 2013;39(7):812-817 • Cooper, C.; Ketley, D.; Livingston, G. Systematic review and meta-analysis to estimate potential recruitment to dementia intervention studies.International Journal of Geriatric Psychiatry 2014;29(5):515-25 • Nicholson, L. M.; Schwirian, P. M.; Groner, J. A. Recruitment and retention strategies in clinical studies with low-income and minority populations: progress from 2004 to 2014. Contemporary Clinical Trials 2015;45(Pt A):34-40
8. What are the best ways to predict recruitment rates to a randomised trial and what impact do such predictions have on recruitment? • Cooper, C. L.; Hind, D.; Duncan, R.; Walters, S.; Lartey, A.; Lee, E.; Bradburn, M.A rapid review indicated higher recruitment rates in treatment trials than in prevention trials. Journal of Clinical Epidemiology 2015;68(3):347-54
9. What are the best approaches to optimise the informed consent process when recruiting participants to randomised trials? • Farrell, E. H.; Phillips, K.; Morgan, B.; Savage, K.; Lewis, V.; Whistance, R. N.; Kelly, M.; Mann, M.; Blazeby, J. M.; Kinnersley, K.; Edwards, A. G. K. Audio-visual aids for informed consent for invasive healthcare procedures: A systematic review. British Journal of Surgery 2013;100:60 • Gillies, K.; Cotton, S. C.; Brehaut, J. C.; Politi, M. C.; Skea, Z. Decision aids for people considering taking part in clinical trials. Cochrane Database of Systematic Reviews 2015;11:CD009736 • Halkoaho, A.; Pietila, A. M.; Ebbesen, M.; Karki, S.; Kangasniemi, M. Cultural aspects related to informed consent in health research: A systematic review. Nursing Ethics 2015;23(6):698-712 • Eltorki, M.; Uleryk, E.; Freedman, S. B. Waiver of informed consent in pediatric resuscitation research: a systematic review. Academic Emergency Medicine 2013;20(8):822-34 • Boland, J.; Currow, D. C.; Wilcock, A.; Tieman, J.; Hussain, J. A.; Pitsillides, C.; Abernethy, A. P.; Johnson, M. J. A systematic review of strategies used to increase recruitment of people with cancer or organ failure into clinical trials: implications for palliative care research. Journal of Pain & Symptom Management 2015;49(4):762-772.e5 • Montalvo, W.; Larson, E. Participant comprehension of research for which they volunteer: a systematic review. Journal of Nursing Scholarship 2014;46(6):423-31 • Nishimura, A.; Carey, J.; Erwin, P. J.; Tilburt, J. C.; Murad, M. H.; McCormick, J. B. Improving understanding in the research informed consent process: a systematic review of 54 interventions tested in randomized control trials. BMC Medical Ethics 2013;14:28 • Treweek, S.; Lockhart, P.; Pitkethly, M.; Cook, J. A.; Kjeldstrom, M.; Johansen, M.; Taskila, T. K.; Sullivan, F. M.; Wilson, S.; Jackson, C.; Jones, R.; Mitchell, E. D. Methods to improve recruitment to randomised controlled trials: Cochrane systematic review and meta-analysis. BMJ Open 2013;3(2): • Synnot, A.; Ryan, R.; Prictor, M.; Fetherstonhaugh, D.; Parker, B. Audio-visual presentation of information for informed consent for participation in clinical trials. Cochrane Database of Systematic Reviews 2014;9(5):CD003717 • Wilman, E.; Megone, C.; Oliver, S.; Duley, L.; Gyte, G.; Wright, J. M. The ethical issues regarding consent to clinical trials with pre-term or sick neonates: a systematic review (framework synthesis) of the empirical research. Trials [Electronic Resource] 2015;16:502
10. What are the advantages and disadvantages to using technology during the recruitment process? • No evidence available