Recruitment of patients with chronic kidney disease and obstructive sleep apnoea for a clinical trial.

Autor: Rimke AN; Sleep Centre, Foothills Medical Centre, University of Calgary, Calgary, AB, Canada.; Libin Cardiovascular Institute of Alberta, Calgary, AB, Canada., Ahmed SB; Libin Cardiovascular Institute of Alberta, Calgary, AB, Canada.; Department of Medicine, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada.; Alberta Kidney Disease Network, Calgary, AB, Canada., Turin TC; Department of Family Medicine, University of Calgary, Calgary, AB, Canada., Pendharkar SR; Sleep Centre, Foothills Medical Centre, University of Calgary, Calgary, AB, Canada.; Department of Medicine, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada.; Department of Community Health Sciences, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada., Raneri JK; Sleep Centre, Foothills Medical Centre, University of Calgary, Calgary, AB, Canada., Lynch EJ; Sleep Centre, Foothills Medical Centre, University of Calgary, Calgary, AB, Canada., Hanly PJ; Sleep Centre, Foothills Medical Centre, University of Calgary, Calgary, AB, Canada.; Department of Medicine, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada.; Department of Community Health Sciences, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada.; Hotchkiss Brain Institute, University of Calgary, Calgary, AB, Canada.
Jazyk: angličtina
Zdroj: Journal of sleep research [J Sleep Res] 2021 Dec; Vol. 30 (6), pp. e13384. Date of Electronic Publication: 2021 May 11.
DOI: 10.1111/jsr.13384
Abstrakt: Obstructive sleep apnoea is common in chronic kidney disease (CKD) and may accelerate the decline in kidney function. Recruitment for a randomised controlled trial to address whether treatment of sleep apnoea with continuous positive airway pressure (CPAP) slows the progression of kidney failure may be challenging because sleep apnoea is often asymptomatic in this patient population. The present report outlines recruitment challenges and how to address them. Adult patients with CKD were recruited for a 12-month randomised, controlled, non-blinded, parallel clinical trial to evaluate the impact of CPAP therapy on kidney function. Patients completed a home sleep apnoea test and those that met pre-specified sleep apnoea and nocturnal hypoxaemia severity criteria were randomised to receive CPAP or no therapy. Although 1,665 patients were eligible to participate in the study over 3 years, only 57 (3.4%) were ultimately randomised. The sequential reasons (and number of patients) for recruitment failure were: no show at clinic appointment (137), insufficient recruiters to approach every eligible patient (461), on therapy for sleep apnoea (122), unable to provide informed consent (67), refused consent (645), home sleep apnoea test not completed (47) or inclusion criteria not met (116), and declined pre-randomisation education session (12). Many challenges limit effective recruitment, which may be addressed by hiring additional recruiters and increasing the awareness of sleep apnoea among patients with CKD. These findings can be used to improve recruitment strategies and the design of future studies.
(© 2021 European Sleep Research Society.)
Databáze: MEDLINE
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