dc.contributor.author |
Collister, David |
|
dc.contributor.author |
Mbuagbaw, Lawrence |
|
dc.contributor.author |
Guyatt, Gordon |
|
dc.contributor.author |
Devereaux, PJ |
|
dc.contributor.author |
Tennankore, Karthik K |
|
dc.contributor.author |
Reis, Gilmar |
|
dc.contributor.author |
Sola, Laura |
|
dc.contributor.author |
Xavier, Denis |
|
dc.contributor.author |
Jha, Vivekanand |
|
dc.contributor.author |
Gallagher, Martin |
|
dc.contributor.author |
Dans, Antonio L |
|
dc.contributor.author |
Liu, Wen |
|
dc.contributor.author |
de Zoysa, Janak |
|
dc.contributor.author |
Félix, Camilo |
|
dc.contributor.author |
Mark, Patrick B |
|
dc.contributor.author |
Li, Zuo |
|
dc.contributor.author |
Tyrwhitt, Jessica |
|
dc.contributor.author |
Wilkinson, Joanne |
|
dc.contributor.author |
Sheridan, Patrick |
|
dc.contributor.author |
Yuan, Fei |
|
dc.contributor.author |
Walsh, Michael |
|
dc.contributor.author |
ACHIEVE investigators |
|
dc.coverage.spatial |
United States |
|
dc.date.accessioned |
2022-03-03T01:55:49Z |
|
dc.date.available |
2022-03-03T01:55:49Z |
|
dc.date.issued |
2021-8 |
|
dc.identifier.issn |
1551-7144 |
|
dc.identifier.uri |
https://hdl.handle.net/2292/58394 |
|
dc.description.abstract |
<h4>Background/aims</h4>To examine how measuring adherence at 3 weeks by self-report and pill counts compares to measurements at 7 weeks in a pre-randomization run-in period.<h4>Methods</h4>Study within a trial of an international parallel group randomized controlled trial (RCT) that compares spironolactone to placebo. Adults receiving dialysis enter an 8-week active run-in period with spironolactone. Adherence was assessed by both self-report and pill counts in a subgroup of participants at both 3 weeks and 7 weeks.<h4>Results</h4>332 participants entered the run-in period of which 166 had complete data. By self-report, 146/166 (94.0%) and 153/166 (92.2%) had at least 80% adherence at 3 and 7 weeks respectively (kappa = 0.27 (95% C.I. 0.16 to 0.38). By pill counts, the mean (SD) adherence was 96.5% (16.1%) and 92.4% (18.2%) at 3 and 7 weeks respectively (r = 0.32) with a mean (SD) difference of 3.1% (17.8%) and a 95% limit of agreement from -31.7% to +37.9%. The proportion of adherent participants by self-report and pill counts at 3 weeks agreed in 87.4% of participants (McNemar's p-value 0.58, kappa 0.11, p = 0.02) and at 7 weeks agreed in 92.2% (McNemar's p-value 0.82, kappa 0.47, p < 0.001).<h4>Conclusions</h4>Three and seven-week run-in periods and both self-reported and pill count assessments performed similarly.<h4>Trial registration</h4>ClinicalTrials.gov Identifier: NCT03020303. |
|
dc.format.medium |
Print-Electronic |
|
dc.language |
eng |
|
dc.publisher |
Elsevier BV |
|
dc.relation.ispartofseries |
Contemporary clinical trials |
|
dc.rights |
Items in ResearchSpace are protected by copyright, with all rights reserved, unless otherwise indicated. Previously published items are made available in accordance with the copyright policy of the publisher. |
|
dc.rights.uri |
https://researchspace.auckland.ac.nz/docs/uoa-docs/rights.htm |
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dc.subject |
ACHIEVE investigators |
|
dc.subject |
Humans |
|
dc.subject |
Renal Dialysis |
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dc.subject |
Random Allocation |
|
dc.subject |
Adult |
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dc.subject |
Medication Adherence |
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dc.subject |
Self Report |
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dc.subject |
Adherence |
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dc.subject |
Dialysis |
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dc.subject |
Run-in period |
|
dc.subject |
Study within a trial |
|
dc.subject |
Adult |
|
dc.subject |
Humans |
|
dc.subject |
Medication Adherence |
|
dc.subject |
Random Allocation |
|
dc.subject |
Renal Dialysis |
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dc.subject |
Self Report |
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dc.subject |
11 Medical and Health Sciences |
|
dc.title |
Three week compared to seven week run-in period length and the assessment of pre-randomization adherence: A study within a trial. |
|
dc.type |
Journal Article |
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dc.identifier.doi |
10.1016/j.cct.2021.106466 |
|
pubs.begin-page |
106466 |
|
pubs.volume |
107 |
|
dc.date.updated |
2022-02-10T21:43:56Z |
|
dc.rights.holder |
Copyright: The author |
en |
pubs.author-url |
https://www.ncbi.nlm.nih.gov/pubmed/34098039 |
|
pubs.publication-status |
Published |
|
dc.rights.accessrights |
http://purl.org/eprint/accessRights/RestrictedAccess |
en |
pubs.subtype |
Randomized Controlled Trial |
|
pubs.subtype |
Journal Article |
|
pubs.elements-id |
857502 |
|
dc.identifier.eissn |
1559-2030 |
|
dc.identifier.pii |
S1551-7144(21)00202-0 |
|
pubs.number |
106466 |
|