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Published in: Trials 1/2018

Open Access 01-12-2018 | Commentary

Improving trial recruitment processes: how qualitative methodologies can be used to address the top 10 research priorities identified within the PRioRiTy study

Authors: Marita Hennessy, Andrew Hunter, Patricia Healy, Sandra Galvin, Catherine Houghton

Published in: Trials | Issue 1/2018

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Abstract

How can we improve recruitment to trials? In their recently published paper, Healy et al. outline the top 10 prioritised questions for trial recruitment research identified by the PRioRiTy study. The challenge now is for researchers to answer these questions; but how best can these be answered? In this commentary, we illustrate how qualitative research can be utilised to generate in-depth insight into trial recruitment issues, either as a stand-alone methodology, or through a mixed-methods approach. Consideration is given to how different forms of qualitative research can be used to address these priorities and to help researchers set out an agenda to optimise its value.
Literature
1.
Healy P, Galvin S, Williamson PR, Treweek S, Whiting C, Maeso B, et al. Identifying trial recruitment uncertainties using a James Lind Alliance Priority Setting Partnership—the PRioRiTy (Prioritising Recruitment in Randomised Trials) study. Trials. 2018;19(1):147.CrossRef
2.
Donovan J, Little P, Mills N, Smith M, Brindle L, Jacoby A, et al. Improving design and conduct of randomised trials by embedding them in qualitative research: ProtecT (prostate testing for cancer and treatment) study. BMJ. 2002;325(7367):766–70.CrossRef
3.
O'Cathain A, Thomas KJ, Drabble SJ, Rudolph A, Hewison J. What can qualitative research do for randomised controlled trials? A systematic mapping review. BMJ Open. 2013;3(6):e002889.CrossRef
4.
Plano Clark VL, Schumacher K, West C, Edrington J, Dunn LB, Harzstark A, et al. Practices for embedding an interpretive qualitative approach within a randomized clinical trial. J Mix Methods Res. 2013;7(3):219–42.CrossRef
5.
O’Cathain A, Goode J, Drabble SJ, Thomas KJ, Rudolph A, Hewison J. Getting added value from using qualitative research with randomized controlled trials: a qualitative interview study. Trials. 2014;15(1):215.CrossRef
6.
Houghton C, Casey D, Shaw D, Murphy K. Approaches to rigour in qualitative case study research. Nurse Researcher. 2012;20(4):12–7.CrossRef
7.
Lewin S, Glenton C, Oxman AD. Use of qualitative methods alongside randomised controlled trials of complex healthcare interventions: methodological study. Br Med J. 2009;339:b3496.CrossRef
8.
Lewin S, Booth A, Glenton C, Munthe-Kaas H, Rashidian A, Wainwright M, Noyes J. Applying GRADE-CERQual to qualitative evidence synthesis findings: introduction to the series. Implement Sci 2018;13(1), 2.CrossRef
9.
Creswell JW, Plano Clark VL. Designing and conducting mixed methods research. 3rd ed. London: Sage Publications Ltd; 2018.
10.
Bazeley P. Qualitative data analysis: practical strategies. Los Angeles: Sage Publications; 2013.
11.
Elam G, Fenton KA. Researching sensitive issues and ethnicity: lessons from sexual health. Ethn Health. 2003;8(1):15–27.CrossRef
12.
Greenbaum T. Moderating focus groups. Thousand Oaks: Sage Publications; 2000.CrossRef
13.
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(1):5.CrossRef
14.
Oakley A, Strange V, Bonell C, Allen E, Stephenson J. Process evaluation in randomised controlled trials of complex interventions. BMJ. 2006;332(7538):413–6.CrossRef
15.
Dormandy E, Kavalier F, Logan J, Harris H, Ishmael N, Marteau TM. Maximising recruitment and retention of general practices in clinical trials: a case study. Br J Gen Pract. 2008;58(556):759–66.CrossRef
16.
Healy P, Smith V, Savage G, Clarke M, Devane D, Gross MM, et al. Process evaluation for OptiBIRTH, a randomised controlled trial of a complex intervention designed to increase rates of vaginal birth after caesarean section. Trials. 2018;19(1):9.CrossRef
17.
Maguire R. “Trying for a VBAC”: an ethnography of cultural change within a randomised trial aimed at increasing vaginal birth after caesarean section: the OptiBIRTH study. Dublin: University of Dublin, Trinity College; 2016.
18.
Donovan JL, Rooshenas L, Jepson M, Elliott D, Wade J, Avery K, et al. Optimising recruitment and informed consent in randomised controlled trials: the development and implementation of the QuinteT Recruitment Intervention (QRI). Trials. 2016;17(1):283.CrossRef
19.
Simons H. Case study research in practice. London: Sage Publications; 2009.CrossRef
20.
Bechhofer F, Paterson L. Principles of research design in the social sciences. London: Routledge; 2000.
21.
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.CrossRef
22.
Shah SK, Corley KG. Building better theory by bridging the quantitative–qualitative divide. J Manage Stud. 2006;43(8):1821–35.CrossRef
23.
Mays N, Pope C, Popay J. Systematically reviewing qualitative and quantitative evidence to inform management and policy-making in the health field. J Health Serv Res Policy. 2005;10(1_suppl):6–20.CrossRef
24.
Barnett-Page E, Thomas J. Methods for the synthesis of qualitative research: a critical review. BMC Med Res Methodol. 2009;9(1):59.CrossRef
25.
Limkakeng A, Phadtare A, Shah J, Vaghasia M, Wei DY, Shah A, et al. Willingness to participate in clinical trials among patients of Chinese heritage: a meta-synthesis. PLoS One. 2013;8(1):e51328.CrossRef
26.
Nalubega S, Evans C. Participant views and experiences of participating in HIV research in sub-Saharan Africa: a qualitative systematic review. JBI Database of System Rev Implement Rep. 2015;13(5):330–420.
27.
Wilman E, Megone C, Oliver S, Duley L, Gyte G, Wright JM. The ethical issues regarding consent to clinical trials with pre-term or sick neonates: a systematic review (framework synthesis) of the empirical research. Trials. 2015;16(1):502.CrossRef
28.
Eltorki M, Uleryk E, Freedman SB, Adams J. Waiver of informed consent in pediatric resuscitation research: a systematic review. Acad Emerg Med. 2013;20(8):822–34.CrossRef
29.
Houghton C, Dowling M, Meskell P, Hunter A, Gardner H, Conway A, Treweek S, Sutcliffe K, Noyes J, Devane D, Nicholas JR, Biesty LM. Factors that impact on recruitment to randomised trials in health care: a qualitative evidence synthesis. Cochrane Database of Syst Rev. 2017, Issue 5. Art. No.: MR000045.
30.
Treweek S, Lockhart P, Pitkethly M, Cook JA, Kjeldstrøm M, Johansen M, et al. Methods to improve recruitment to randomised controlled trials: Cochrane systematic review and meta-analysis. BMJ Open. 2013;3(2):e002360.CrossRef
31.
Cooper C, O'Cathain A, Hind D, Adamson J, Lawton J, Baird W. Conducting qualitative research within clinical trials units: avoiding potential pitfalls. Contemp Clin Trials. 2014;38(2):338–43.CrossRef
Metadata
Title
Improving trial recruitment processes: how qualitative methodologies can be used to address the top 10 research priorities identified within the PRioRiTy study
Authors
Marita Hennessy
Andrew Hunter
Patricia Healy
Sandra Galvin
Catherine Houghton
Publication date
01-12-2018
Publisher
BioMed Central
Published in
Trials / Issue 1/2018
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-018-2964-1

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