Representativeness of honeypot trial participants to Australasian PD patients

Lei Zhang, Sunil V. Badve, Elaine M. Pascoe, Elaine Beller, Alan Cass, Carolyn Clark, Janak de Zoysa, Nicole M. Isbel, Xusheng Liu, Steven McTaggart, Alicia T. Morrish, Geoffrey Playford, Anish Scaria, Paul Snelling, Liza A. Vergara, Carmel M. Hawley, David W. Johnson, The HONEYPOT Trial Writing Committee, HONEYPOT Study Collaborative Group

    Research output: Contribution to journalArticle

    Abstract

    Background: The HONEYPOT trial failed to establish the superiority of exit-site application of Medihoney compared with nasal mupirocin prophylaxis for the prevention of peritonitis in peritoneal dialysis (PD) patients. This study aimed to assess the representativeness of the patients in the HONEYPOT trial to the Australian and New Zealand PD population. 

    Methods: This study compared baseline characteristics of the 371 PD patients in the HONEYPOT trial with those of 6,085 PD patients recorded on the Australia and New Zealand Dialysis and Transplant (ANZDATA) Registry. 

    Results: Compared with the PD population, the HONEYPOT sample was older (standardized difference [d] = 0.19, p = 0.003), more likely to be treated with automated PD (d = 0.58, p < 0.001), had higher residual renal function (d = 0.26, p < 0.001) and a higher proportion of participants with end-stage kidney disease due to polycystic kidney disease (d = 0.17) and lower proportion due to diabetes (d = -0.17) and glomerulonephritis (d = -0.18) (p < 0.001), and lower proportions of indigenous people (d = -0.17, p < 0.001), current smokers (d = -0.10, p < 0.001), and people with prior histories of hemodialysis (d = -0.16, p < 0.001), diabetes mellitus (d = -0.18, p < 0.001), and coronary artery disease (d = -0.15, p < 0.001). 

    Conclusions: HONEYPOT trial participants tended to be healthier than the Australian and New Zealand PD patient population. Although the differences between the groups were generally modest, it is possible that their cumulative effect may have had some impact on external generalizability, which is not an uncommon occurrence in clinical trials.

    Original languageEnglish
    Pages (from-to)516-522
    Number of pages7
    JournalPeritoneal Dialysis International
    Volume37
    Issue number5
    DOIs
    Publication statusPublished - 1 Sep 2017

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  • Cite this

    Zhang, L., Badve, S. V., Pascoe, E. M., Beller, E., Cass, A., Clark, C., de Zoysa, J., Isbel, N. M., Liu, X., McTaggart, S., Morrish, A. T., Playford, G., Scaria, A., Snelling, P., Vergara, L. A., Hawley, C. M., Johnson, D. W., The HONEYPOT Trial Writing Committee, & HONEYPOT Study Collaborative Group (2017). Representativeness of honeypot trial participants to Australasian PD patients. Peritoneal Dialysis International, 37(5), 516-522. https://doi.org/10.3747/pdi.2016.00065