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Trials
Published in: Trials 1/2020

Open Access 01-12-2020 | Stroke | Review

A systematic review of the efficiency of recruitment to stroke rehabilitation randomised controlled trials

Authors: Kris McGill, Catherine M. Sackley, Jon Godwin, Jodie McGarry, Marian C. Brady

Published in: Trials | Issue 1/2020

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Abstract

Introduction

Randomised controlled trials (RCTs) that fail to meet their recruitment target risk increasing research waste. Acute stroke RCTs experience notable recruitment issues. The efficiency of recruitment to stroke rehabilitation RCTs has not been explored.

Aims and objectives

To explore recruitment efficiency and the trial features associated with efficient recruitment to stroke rehabilitation RCTs.

Methods

A systematic review of stroke rehabilitation RCTs published between 2005 and 2015 identified in a search of the Cochrane Stroke Group (CSG) Trials Register from 35 electronic databases (e.g. Medline, CINAHL; EMBASE), clinical trial registers, and hand-searching. Inclusion criteria are stroke rehabilitation intervention, delivered by a member of the rehabilitation team, and clinically relevant environment. We extracted data on recruitment efficiency and trial features.

Results

We screened 12,939 titles, 1270 abstracts and 788 full texts, before extracting data from 512 included RCTs (n = 28,804 stroke survivor participants). This is the largest systematic review of recruitment to date. A third of stroke survivors screened consented to participate (median 34% (IQR 14–61), on average sites recruited 1.5 participants per site per month (IQR 0.71–3.22), and one in twenty (6% (IQR 0–13) dropped out during the RCT. Almost half (48%) of those screened in the community were recruited compared to hospital settings (27%). Similarly, almost half (47%) those screened at least 6 months after stroke participated, compared to 23% of stroke survivors screened within a month of stroke. When one recruiter screened multiple sites, a median of one stroke survivor was recruited every 2 months compared to more than two per month when there was a dedicated recruiter per site. RCT recruitment was significantly faster per site, with fewer dropouts, for trials conducted in Asia (almost three stroke survivors monthly; 2% dropout) compared to European trials (approximately one stroke survivor monthly; 7% dropout).

Conclusions

One third of stroke survivors screened were randomised to rehabilitation RCTs at a rate of between one and two per month, per site. One in twenty did not complete the trial. Our findings will inform recruitment plans of future stroke rehabilitation RCTs. Limited reporting of recruitment details restricted the subgroup analysis performed.

Trial registration

Prospective Register of Systematic Reviews, registration number CRD42016033067.
Appendix
Available only for authorised users
Literature
1.
Chalmers I, Glasziou P. Avoidable waste in the production and reporting of research evidence. Lancet. 2009;374(9683):86–9.PubMedCrossRef
2.
Salman RA-S, Beller E, Kagan J, Hemminki E, Phillips RS, Savulescu J, et al. Increasing value and reducing waste in biomedical research regulation and management. Lancet. 2014;383(9912):176–85.PubMedCentralCrossRef
3.
Foy R, Parry J, Duggan A, Delaney B, Wilson S. Lewin-van den Broek N, et al. How evidence based are recruitment strategies to randomized controlled trials in primary care? Experience from seven studies. Fam Pract. 2003;20(1):83–92.PubMedCrossRef
4.
Haidich A-B, Ioannidis JP. Determinants of patient recruitment in a multicenter clinical trials group: trends, seasonality and the effect of large studies. BMC Med Res Methodol. 2001;1(1):1–11.CrossRef
5.
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.PubMedPubMedCentralCrossRef
6.
Button KS, Ioannidis JP, Mokrysz C, Nosek BA, Flint J, Robinson ES, et al. Power failure: why small sample size undermines the reliability of neuroscience. Nat Rev Neurosci. 2013;14(5):365–76.PubMedCrossRef
7.
Moore R, Gavaghan D, Tramer M, Collins S, McQuay H. Size is everything–large amounts of information are needed to overcome random effects in estimating direction and magnitude of treatment effects. Pain. 1998;78(3):209–16.PubMedCrossRef
8.
Turner RM, Bird SM, Higgins JP. The impact of study size on meta-analyses: examination of underpowered studies in Cochrane reviews. PLoS One. 2013;8(3):e59202.PubMedPubMedCentralCrossRef
9.
Thorlund K, Imberger G, Walsh M, Chu R, Gluud C, Wetterslev J, et al. The number of patients and events required to limit the risk of overestimation of intervention effects in meta-analysis—a simulation study. PLoS One. 2011;6(10):e25491.PubMedPubMedCentralCrossRef
10.
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(1):9–16.PubMedPubMedCentralCrossRef
11.
Hadidi N, Buckwalter K, Lindquist R, Rangen C. Lessons learned in recruitment and retention of stroke survivors. J Neurosci Nurs. 2012;44(2):105–10.PubMedCrossRef
12.
Treweek S, Mitchell E, Pitkethly M, Cook J, Kjeldstrøm M, Taskila T, et al. Strategies to improve recruitment to randomised controlled trials. Cochrane Database Syst Rev. 2010;4(4):MR000013.
13.
Elkins JS, Khatabi T, Fung L, Rootenberg J, Johnston SC. Recruiting subjects for acute stroke trials a meta-analysis. Stroke. 2006;37(1):123–8.PubMedCrossRef
14.
15.
Sully BG, Julious SA, Nicholl J. A reinvestigation of recruitment to randomised, controlled, multicenter trials: a review of trials funded by two UK funding agencies. Trials. 2013;14(1):166–9.PubMedPubMedCentralCrossRef
16.
Brueton VC, Tierney J, Stenning S, Harding S, Meredith S, Nazareth I, et al. Strategies to improve retention in randomised trials. Cochrane Database Syst Rev. 2013;12:MR000032.
17.
Brueton V, Tierney J, Stenning S, Meredith S, Harding S, Nazareth I, et al. Strategies to improve retention in randomised trials: a Cochrane systematic review and meta-analysis. BMJ Open. 2014;4(2):e003821.PubMedPubMedCentralCrossRef
18.
Fewtrell MS, Kennedy K, Singhal A, Martin RM, Ness A, Hadders-Algra M, et al. How much loss to follow-up is acceptable in long-term randomised trials and prospective studies? Arch Dis Child. 2008;93(6):458–61.PubMedCrossRef
19.
Schulz KF, Grimes DA. Sample size slippages in randomised trials: exclusions and the lost and wayward. Lancet. 2002;359(9308):781–5.PubMedCrossRef
20.
21.
22.
Toerien M, Brookes ST, Metcalfe C, De Salis I, Tomlin Z, Peters TJ, et al. A review of reporting of participant recruitment and retention in RCTs in six major journals. Trials. 2009;10(1):52.PubMedPubMedCentralCrossRef
23.
Hopewell S, Dutton S, Yu L-M, Chan A-W, Altman DG. The quality of reports of randomised trials in 2000 and 2006: comparative study of articles indexed in PubMed. BMJ. 2010;340:c723.PubMedPubMedCentralCrossRef
24.
Feldman WB, Kim AS, Josephson SA, Lowenstein DH, Chiong W. Effect of waivers of consent on recruitment in acute stroke trials a systematic review. Neurology. 2016;86(16):1543–51.PubMedPubMedCentralCrossRef
25.
Scottish Stroke Care Audit. Scottish stroke improvement programme, 2018 national report. 2018.
26.
Royal College of Physicians. Sentinel Stroke National Audit Programme (SSNAP), national clinical audit annual results portfolio. 2017.
27.
Scarborough P, Peto V, Bhatnagar P, Kaur A, Leal J, Luengo-Fernandez R, et al. Stroke statistics. Oxford: British Heart Foundation & Stroke Association; 2009.
28.
Feigin VL, Forouzanfar MH, Krishnamurthi R, Mensah GA, Connor M, Bennett DA, et al. Global and regional burden of stroke during 1990–2010: findings from the Global Burden of Disease Study 2010. Lancet. 2014;383(9913):245–55.PubMedPubMedCentralCrossRef
29.
Rudd AG, Wolfe CD. Age and ethnic disparities in incidence of stroke over time. Stroke. 2013;44(12):3298–304.PubMedCrossRef
30.
World Health Organization. World report on disability, chapter 4 rehabilitation. 2011.
31.
32.
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.PubMedPubMedCentralCrossRef
33.
34.
Tversky A, Kahneman D. Judgment under uncertainty: heuristics and biases. Science. 1974;185(4157):1124–31.PubMedCrossRef
35.
Moher D, Hopewell S, Schulz KF, Montori V, Gøtzsche PC, Devereaux P, et al. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. J Clin Epidemiol. 2010;63(8):e1–e37.PubMedCrossRef
36.
Haidich A-B, Ioannidis JP. Determinants of patient recruitment in a multicenter clinical trials group: trends, seasonality and the effect of large studies. BMC Med Res Methodol. 2001;1(1):4.PubMedPubMedCentralCrossRef
37.
McGill K, Brady MC, Sackley C, Godwin J. Efficiency of recruitment to stroke rehabilitation randomised controlled trials: secondary analysis of recruitment data. In: Feinberg J, Ashton C, Hirst A, Pennell C, McCulloch P, editors. Trials: Meeting abstracts from the 4th International Clinical Trials Methodology Conference (ICTMC) and the 38th Annual Meeting of the Society for Clinical Trials 2017. p. 200.
38.
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(1):9.PubMedPubMedCentralCrossRef
39.
Howard L, de Salis I, Tomlin Z, Thornicroft G, Donovan J. Why is recruitment to trials difficult? An investigation into recruitment difficulties in an RCT of supported employment in patients with severe mental illness. Contemp Clin Trials. 2009;30(1):40–6.PubMedPubMedCentralCrossRef
40.
MacFarland TW, Yates JM. Kruskal–Wallis H-test for oneway analysis of variance (ANOVA) by ranks. In: MacFarland TW, Yates JM editors Introduction to nonparametric statistics for the biological sciences using R. Springer: Berlin; 2016. p. 177–211.CrossRef
41.
42.
Armitage P, Berry G, Matthews JNS. Statistical methods in medical research. Hoboken: Wiley; 2008.
43.
Keppel G, Wickens T. Simultaneous comparisons and the control of type I errors. Design and analysis: A researcher’s handbook 4th ed. Upper Saddle River: Pearson Prentice Hall; 2004. p. 111–30.
44.
Massey FJ Jr. The Kolmogorov-Smirnov test for goodness of fit. J Am Stat Assoc. 1951;46(253):68–78.CrossRef
45.
Greif A. Cultural beliefs and the organization of society: a historical and theoretical reflection on collectivist and individualist societies. J Polit Econ. 1994;102(5):912–50.CrossRef
46.
Ralston DA, Holt DH, Terpstra RH, Kai-Cheng Y. The impact of national culture and economic ideology on managerial work values: a study of the United States, Russia, Japan, and China. J Int Bus Stud. 1997;29:177–207.CrossRef
47.
Triandis HC. Individualism & collectivism. Boulder: Westview Press; 1995.
48.
Oyserman D, Coon HM, Kemmelmeier M. Rethinking individualism and collectivism: evaluation of theoretical assumptions and meta-analyses. Physchol Bull. 2002;128(1):3–72.CrossRef
49.
Claramita M, Nugraheni MD, van Dalen J, van der Vleuten C. Doctor–patient communication in Southeast Asia: a different culture? Adv Health Sci Educ. 2013;18(1):15–31.CrossRef
50.
Cong Y. Doctor-family-patient relationship: the Chinese paradigm of informed consent. J Med Philos. 2004;29(2):149–78.PubMedCrossRef
51.
Hou X, Xiao L. An analysis of the changing doctor-patient relationship in China. J Int Bioethique. 2012;23(2):83–94.PubMedCrossRef
52.
Kaba R, Sooriakumaran P. The evolution of the doctor-patient relationship. Int J Surg. 2007;5(1):57–65.PubMedCrossRef
53.
Getz KA. Informed consent process. Appl Clin Trials. 2002;11(11):30–6.
54.
Vickers A, Goyal N, Harland R, Rees R. Do certain countries produce only positive results? A systematic review of controlled trials. Control Clin Trials. 1998;19(2):159–66.PubMedCrossRef
55.
Pittler M, Abbot N, Harkness E, Ernst E. Location bias in controlled clinical trials of complementary/alternative therapies. J Clin Epidemiol. 2000;53(5):485–9.PubMedCrossRef
56.
Moher D, Fortin P, Jadad AR, Jüni P, Klassen T, Le Lorier J, et al. Completeness of reporting of trials published in languages other than English: implications for conduct and reporting of systematic reviews. Lancet. 1996;347(8998):363–6.PubMedCrossRef
57.
Wu Y, Howarth M, Chunlan Z, Xue J, Jiexia O, Xiaojin L. Reporting of ethical approval and informed consent in clinical trials in 12 nursing journals in China between 2013 and 2016. Nurs Ethics. 2017:1–11.
58.
Kong DT, Dirks KT, Ferrin DL. Interpersonal trust within negotiations: meta-analytic evidence, critical contingencies, and directions for future research. Acad Manag J. 2014;57(5):1235–55.CrossRef
59.
George S, Duran N, Norris K. A systematic review of barriers and facilitators to minority research participation among African Americans, Latinos, Asian Americans, and Pacific Islanders. Am J Public Health. 2014;104(2):e16–31.PubMedPubMedCentralCrossRef
60.
French C, Stavropoulou C. Specialist nurses’ perceptions of inviting patients to participate in clinical research studies: a qualitative descriptive study of barriers and facilitators. BMC Med Res Methodol. 2016;16(1):96.PubMedPubMedCentralCrossRef
61.
Garcia SM, Weaver K, Moskowitz GB, Darley JM. Crowded minds: the implicit bystander effect. J Pers Soc Psychol. 2002;83(4):843–53.PubMedCrossRef
62.
Fischer P, Krueger JI, Greitemeyer T, Vogrincic C, Kastenmüller A, Frey D, et al. The bystander-effect: a meta-analytic review on bystander intervention in dangerous and non-dangerous emergencies. Psychol Bull. 2011;137(4):517–37.PubMedCrossRef
63.
Darley JM, Latane B. Bystander intervention in emergencies: diffusion of responsibility. J Pers Soc Psychol. 1968;8(4):377–83.PubMedCrossRef
64.
Cramer RE, Mcmaster MR, Bartell PA, Dragna M. Subject competence and minimization of the bystander effect. J Appl Soc Psychol. 1988;18(13):1133–48.CrossRef
65.
Metadata
Title
A systematic review of the efficiency of recruitment to stroke rehabilitation randomised controlled trials
Authors
Kris McGill
Catherine M. Sackley
Jon Godwin
Jodie McGarry
Marian C. Brady
Publication date
01-12-2020
Publisher
BioMed Central
Keyword
Stroke
Published in
Trials / Issue 1/2020
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-019-3991-2

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