Scope and heterogeneity of outcomes reported in randomized trials in patients receiving peritoneal dialysis.
outcomes
patient-reported outcomes
peritoneal dialysis
trials
Journal
Clinical kidney journal
ISSN: 2048-8505
Titre abrégé: Clin Kidney J
Pays: England
ID NLM: 101579321
Informations de publication
Date de publication:
Jul 2021
Jul 2021
Historique:
received:
22
07
2020
accepted:
14
09
2020
entrez:
5
7
2021
pubmed:
6
7
2021
medline:
6
7
2021
Statut:
epublish
Résumé
Randomized trials can provide evidence to inform decision-making but this may be limited if the outcomes of importance to patients and clinicians are omitted or reported inconsistently. We aimed to assess the scope and heterogeneity of outcomes reported in trials in peritoneal dialysis (PD). We searched the Cochrane Kidney and Transplant Specialized Register for randomized trials in PD. We extracted all reported outcome domains and measurements and analyzed their frequency and characteristics. From 128 reports of 120 included trials, 80 different outcome domains were reported. Overall, 39 (49%) domains were surrogate, 23 (29%) patient-reported and 18 (22%) clinical. The five most commonly reported domains were PD-related infection [59 (49%) trials], dialysis solute clearance [51 (42%)], kidney function [45 (38%)], protein metabolism [44 (37%)] and inflammatory markers/oxidative stress [42 (35%)]. Quality of life was reported infrequently (4% of trials). Only 14 (12%) trials included a patient-reported outcome as a primary outcome. The median number of outcome measures (defined as a different measurement, aggregation and metric) was 22 (interquartile range 13-37) per trial. PD-related infection was the most frequently reported clinical outcome as well as the most frequently stated primary outcome. A total of 383 different measures for infection were used, with 66 used more than once. Trials in PD include important clinical outcomes such as infection, but these are measured and reported inconsistently. Patient-reported outcomes are infrequently reported and nearly half of the domains were surrogate. Standardized outcomes for PD trials are required to improve efficiency and relevance.
Sections du résumé
BACKGROUND
BACKGROUND
Randomized trials can provide evidence to inform decision-making but this may be limited if the outcomes of importance to patients and clinicians are omitted or reported inconsistently. We aimed to assess the scope and heterogeneity of outcomes reported in trials in peritoneal dialysis (PD).
METHODS
METHODS
We searched the Cochrane Kidney and Transplant Specialized Register for randomized trials in PD. We extracted all reported outcome domains and measurements and analyzed their frequency and characteristics.
RESULTS
RESULTS
From 128 reports of 120 included trials, 80 different outcome domains were reported. Overall, 39 (49%) domains were surrogate, 23 (29%) patient-reported and 18 (22%) clinical. The five most commonly reported domains were PD-related infection [59 (49%) trials], dialysis solute clearance [51 (42%)], kidney function [45 (38%)], protein metabolism [44 (37%)] and inflammatory markers/oxidative stress [42 (35%)]. Quality of life was reported infrequently (4% of trials). Only 14 (12%) trials included a patient-reported outcome as a primary outcome. The median number of outcome measures (defined as a different measurement, aggregation and metric) was 22 (interquartile range 13-37) per trial. PD-related infection was the most frequently reported clinical outcome as well as the most frequently stated primary outcome. A total of 383 different measures for infection were used, with 66 used more than once.
CONCLUSIONS
CONCLUSIONS
Trials in PD include important clinical outcomes such as infection, but these are measured and reported inconsistently. Patient-reported outcomes are infrequently reported and nearly half of the domains were surrogate. Standardized outcomes for PD trials are required to improve efficiency and relevance.
Identifiants
pubmed: 34221389
doi: 10.1093/ckj/sfaa224
pii: sfaa224
pmc: PMC8243273
doi:
Types de publication
Journal Article
Langues
eng
Pagination
1817-1825Informations de copyright
© The Author(s) 2020. Published by Oxford University Press on behalf of ERA-EDTA.
Références
Int J Nephrol. 2012;2012:305424
pubmed: 23050149
Clin J Am Soc Nephrol. 2017 May 8;12(5):839-847
pubmed: 28314806
Am J Kidney Dis. 2018 Jul;72(1):62-74
pubmed: 29475768
Kidney Int. 2019 Sep;96(3):699-710
pubmed: 31200941
J Am Soc Nephrol. 2002 May;13(5):1307-1320
pubmed: 11961019
PLoS One. 2014 Oct 16;9(10):e109400
pubmed: 25329377
Sci Rep. 2018 Mar 5;8(1):3980
pubmed: 29507305
Eur J Clin Pharmacol. 1992;43(3):235-44
pubmed: 1425885
Kidney Blood Press Res. 2017;42(4):717-727
pubmed: 29049991
Br J Clin Pharmacol. 2005 May;59(5):491-4
pubmed: 15842546
N Engl J Med. 2017 Jan 26;376(4):383-391
pubmed: 28121511
Perit Dial Int. 2010 Jul-Aug;30(4):393-423
pubmed: 20628102
J Pediatr. 2017 Jul;186:110-117.e11
pubmed: 28449820
Semin Dial. 2016 Jul;29(4):258-9
pubmed: 27081745
Can J Kidney Health Dis. 2019 Dec 18;6:2054358119893335
pubmed: 31897304
Perit Dial Int. 2020 Mar;40(2):112-114
pubmed: 32063221
BMJ. 2013 Jan 28;346:f167
pubmed: 23358487
Perit Dial Int. 2019 Jul-Aug;39(4):306-314
pubmed: 31296776
Perit Dial Int. 2016 9-10;36(5):481-508
pubmed: 27282851
Perit Dial Int. 2020 Mar;40(2):132-140
pubmed: 32063197
Qual Life Res. 2009 Feb;18(1):115-23
pubmed: 19105048
Nephrol Dial Transplant. 2020 Dec 4;35(12):2172-2182
pubmed: 31981353
Clin J Am Soc Nephrol. 2010 Jun;5(6):1123-31
pubmed: 20430945
Am J Kidney Dis. 2020 Mar;75(3):404-412
pubmed: 31955922
Clin Nephrol. 2015 Jan;83(1):1-10
pubmed: 25345384
Am J Kidney Dis. 2014 Aug;64(2):278-89
pubmed: 24751170
J Ren Care. 2015 Sep;41(3):177-86
pubmed: 25727142
Clin J Am Soc Nephrol. 2019 Jan 7;14(1):74-83
pubmed: 30573659
Health Qual Life Outcomes. 2006 Oct 11;4:79
pubmed: 17034633
Transplantation. 2018 Dec;102(12):2065-2071
pubmed: 29781954
Nephrology (Carlton). 2020 Jan;25(1):14-21
pubmed: 30838732
Am J Nephrol. 2018;48(5):319-325
pubmed: 30343294