AIMS: The purpose of this integrative literature review was to explore and discuss the methodological challenges nurse researchers report after conducting nurse-led randomised controlled trials in clinical hospital settings. Our research questions were (i) what are the most commonly experienced methodological barriers and challenges and (ii) which lessons can be learned from these reports?
METHOD: A database search of Medline, Cinahl, The Cochrane Library and Embase was carried out. Variants of the following search terms were used: randomised controlled trial, controlled clinical trial, clinical trial, methods, nursing research, nursing, research, challenges, barriers, nurse’s role, nurse attitude, attitude of health personnel.
FINDINGS: The literature on reported challenges and barriers between 1999 and 2009 showed that the most often experienced problems were (i) sufficient patient recruitment, (ii) nonadherence to research protocols and (iii) economic and organisational obstacles. These three challenges and barriers were inter-related and all were affected by time and timing.
CONCLUSION: Randomised controlled trials are complex, expensive, time-consuming and highly demanding for researchers and the clinical nursing staff. Two lessons learned from this integrative review can be highlighted. First, we recommend researchers openly to share their experiences of barriers and challenges. They should describe factors that may have inhibited the desired outcome. Second, efforts to improve the collaboration between nurse researchers and clinicians, including education, training and support may increase the success rate and quality of nurse-led studies using the randomised controlled trial.