End-stage renal disease and recruitment to randomized trials: Why is it so difficult? Results from a survey among Norwegian nephrologists

Abstract

Objective. Recruitment is one of the most serious challenges in randomized clinical trials (RCTs), especially in the old and frail population. A Norwegian multicentre RCT targeting end-stage renal disease (ESRD) patients older than 70 years was initiated to compare the impact on quality of life of early or late start of dialysis. Owing to poor inclusion the RCT was closed. The aim of the present study was to explore possible reasons for the recruitment failure. Material and methods. A questionnaire was distributed to all Norwegian nephrologists. The questionnaire presented 11 statements which cited possible reasons for not including elderly ESRD patients in the RCT in question. Results. The highest rated reasons for non-inclusion were the physician's wish to decide the timing of dialysis individually and the patient's wish to postpone the start of treatment. High mean scores were also found for reasons related to workload and capacity at the dialysis unit, whereas the influence of the doctor–patient relationship and competing studies were judged not to be important. Conclusions. The results indicate that confidence in individually decided treatment and fear of losing professional autonomy make Norwegian nephrologists reluctant to include patients in RCTs. To succeed in recruitment, there seems to be a need for cultural changes as well as increased resources to meet practical challenges.

Key Words::

• Clinical trials
• dialysis
• elderly
• recruitment

Acknowledgements

This study was supported by a grant from The Norwegian University of Science and Technology (NTNU). We acknowledge the assistance in manuscript handling by Ingrid I. Riphagen, NTNU.

Declaration of interest: The authors report no conflicts of interest. The authors alone are responsible for the content and writing of the paper.