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

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.

Pilot randomised clinical trial of an eHealth, self-management support intervention (iVERVE) for stroke: feasibility assessment in survivors 12–24 months post-event

“…Well-designed randomised controlled trials (RCTs) provide the highest level of quality for assessing the efficacy of interventions [ 46 ]. However, achieving recruitment targets can be difficult, leading to extended study timeframes, additional costs or wastage of valuable research money when studies fail to reach targets [ 47 ]. As an alternate strategy, clinical registries may provide vehicles to facilitate recruitment for clinical trials, particularly trials recruiting community-dwelling stroke survivors.…”

Biopsychosocial intervention for stroke carers (BISC): results of a feasibility randomised controlled trial and nested qualitative interview study

“…The greatest challenge we faced was recruitment of participants however our difficulties are not unique and indeed our recruitment of two participants per month is in line with a recent systematic review. 26 Similarly, the attendance levels seen within the group intervention are reflective of attendance levels for other face-toface group therapy interventions. 25,27 Although initial contact on the stroke unit proved challenging and resulted in difficulties in recruitment, conversely a delayed approach in some cases resulted in the intervention being delivered after the time that it was reported as most needed.…”

Recruitment challenges in stroke rehabilitation randomized controlled trials: a qualitative exploration of trialists’ perspectives using Framework analysis

“…18,19 Invitation emails, including the information sheet and study protocol, were sent to 177 stroke rehabilitation trialists identified by applying the purposeful sampling criteria to authors contacted during an earlier systematic review. 20 Initially 22 trialists responded, indicating an interest in participation, however, one trialist later declined without providing a reason and another was excluded as they had not conducted a stroke rehabilitation trial within the last 10 years. Interviews were conducted between November 2017 and January 2018.…”

“…2 Stroke rehabilitation trials are complex and may experience increased recruitment difficulties due to the involvement of multidisciplinary teams, the variance in settings and the variety of interventions used. 11 Despite notable difficulties recruiting stroke survivors, and limited improvement over the past two decades, 3,12 little research has focused on trialists’ perspectives of recruitment for stroke trials. Trialist’s have wealth of recruitment knowledge that they often do not get the chance to share widely.…”