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

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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
Early online date1 Dec 2016
DOIs
Publication statusPublished - 1 Sep 2017

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Peritoneal Dialysis
New Zealand
Mupirocin
Population
Polycystic Kidney Diseases
Glomerulonephritis
Peritonitis
Nose
Chronic Kidney Failure
Registries
Renal Dialysis
Coronary Artery Disease
Dialysis
Diabetes Mellitus
Clinical Trials
Transplants
Kidney

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Zhang, L., Badve, S. V., Pascoe, E. M., Beller, E., Cass, A., Clark, C., ... Johnson, D. W. (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
Zhang, Lei ; Badve, Sunil V ; Pascoe, Elaine M ; Beller, Elaine ; Cass, Alan ; Clark, Carolyn ; de Zoysa, Janak ; Isbel, Nicole M ; Liu, Xusheng ; McTaggart, Steven ; Morrish, Alicia T ; Playford, Geoffrey ; Scaria, Anish ; Snelling, Paul ; Vergara, Liza A ; Hawley, Carmel M ; Johnson, David W. / Representativeness of honeypot trial participants to Australasian PD patients. In: Peritoneal Dialysis International. 2017 ; Vol. 37, No. 5. pp. 516-522.
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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.",
author = "Lei Zhang and Badve, {Sunil V} and Pascoe, {Elaine M} and Elaine Beller and Alan Cass and Carolyn Clark and {de Zoysa}, Janak and Isbel, {Nicole M} and Xusheng Liu and Steven McTaggart and Morrish, {Alicia T} and Geoffrey Playford and Anish Scaria and Paul Snelling and Vergara, {Liza A} and Hawley, {Carmel M} and Johnson, {David W}",
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Zhang, L, Badve, SV, Pascoe, EM, Beller, E, Cass, A, Clark, C, de Zoysa, J, Isbel, NM, Liu, X, McTaggart, S, Morrish, AT, Playford, G, Scaria, A, Snelling, P, Vergara, LA, Hawley, CM & Johnson, DW 2017, 'Representativeness of honeypot trial participants to Australasian PD patients' Peritoneal Dialysis International, vol. 37, no. 5, pp. 516-522. https://doi.org/10.3747/pdi.2016.00065

Representativeness of honeypot trial participants to Australasian PD patients. / Zhang, Lei; Badve, Sunil V; Pascoe, Elaine M; Beller, Elaine; Cass, Alan; Clark, Carolyn; de Zoysa, Janak; Isbel, Nicole M; Liu, Xusheng; McTaggart, Steven; Morrish, Alicia T; Playford, Geoffrey; Scaria, Anish; Snelling, Paul; Vergara, Liza A; Hawley, Carmel M; Johnson, David W.

In: Peritoneal Dialysis International, Vol. 37, No. 5, 01.09.2017, p. 516-522.

Research output: Contribution to journalArticleResearchpeer-review

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T1 - Representativeness of honeypot trial participants to Australasian PD patients

AU - Zhang, Lei

AU - Badve, Sunil V

AU - Pascoe, Elaine M

AU - Beller, Elaine

AU - Cass, Alan

AU - Clark, Carolyn

AU - de Zoysa, Janak

AU - Isbel, Nicole M

AU - Liu, Xusheng

AU - McTaggart, Steven

AU - Morrish, Alicia T

AU - Playford, Geoffrey

AU - Scaria, Anish

AU - Snelling, Paul

AU - Vergara, Liza A

AU - Hawley, Carmel M

AU - Johnson, David W

PY - 2017/9/1

Y1 - 2017/9/1

N2 - ♦ 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.

AB - ♦ 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.

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