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There is an urgent need for effective interventions to aid diabetes-related foot ulcer (DFU) healing. This study aimed to test the deliverability of a proposed trial of extracorporeal shockwave therapy (ESWT) for DFU healing. A pilot double-blinded randomised controlled trial. Patients with a DFU present for ≥ 4 weeks were randomised to high dose (500 shocks/cm2), low dose (100 shocks/cm2) or sham (0 shocks/cm2) ESWT, plus standard care. Follow-up was for 24 weeks. Primary outcome was deliverability of the trial. Secondary outcomes were healing, quality of life and healthcare resource use. One-hundred and forty-one (15.6%) screened patients were eligible and 74 (52.5%) patients were recruited. Follow-up attendance was 97.3% (72/74), 93.2% (69/74) and 87.8% (65/74) at 6, 12 and 24 weeks. The median DFU healing time was high dose: 54.0 (IQR 119.0), low dose: 78.5 (IQR 61.0) and sham: 83.0 (IQR 85.0) days. The mean EQ-5D-5L utility value at 24 weeks was high dose: 0.621 (95% CI 0.438–0.804), low dose: 0.779 (95% CI 0.683–0.876) and sham: 0.806 (95% CI 0.717–0.895). Healthcare resource use was lowest in the low-dose ESWT arm. The pilot trial has demonstrated that patients with a DFU are willing to engage in the proposed trial and suggest the optimal way to deliver the definitive trial.
Increased popularity of stepped-wedge cluster randomised trials (SW-CRT) highlights the importance of understanding and appropriate mitigation of sources of bias within this trial design. While current evidence suggests that ‘conventional’ cluster randomised controlled trials (RCTs) are at a higher risk of recruitment bias than individually randomised trials, this review aims to estimate the risk of recruitment bias in SW-CRTs.
Systematic review with search conducted on four databases. Risk of bias (RoB) was assessed using subdomain 1a (randomisation process) and 1b (timing of identification or recruitment of participants) of the Cochrane RoB tool 2.0 (extension for cluster RCTs).
MEDLINE, Embase, CINAHL, Cochrane Library were searched on 9 February 2024.
SW-CRTs published in 2023 were included.
Two independent reviewers screened and extracted all eligible papers. RoB was assessed with the Cochrane RoB tool.
Overall, 808 papers were screened, and 64 studies were included in the review. Most studies were deemed to have a high RoB (n=35, 55%), some concerns were noticed in 20 studies (31%), and 9 (14%) were considered to have a low RoB. The description of the randomisation process in the included papers was sometimes poorly reported (in 15 studies (23%) problems with the randomisation process were identified), and 21 studies (33%) had issues with sampling strategy (recruiting participants after randomisation by unmasked staff).
The review revealed that SW-CRTs are prone to recruitment bias, but the risks are comparable to cluster RCTs. When SW-CRTs are unable to recruit prior to randomisation, mitigation strategies could be implemented to reduce bias. A separate tool for RoB assessment in SW-CRTs is required to address the complexities of this trial design.
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