Reporting quality of pilot clinical trials in chronic kidney disease patients on hemodialysis: a methodological survey
Abstract Background The conduct of high-quality pilot studies can help inform the success of larger clinical trials. Guidelines have been recently developed for the reporting of pilot trials. Objective This methodological survey evaluates the completeness of reporting in pilot randomized controlled...
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doaj-7ec30489e555419ca2a3f3b2edcb4bc42020-11-25T02:28:51ZengBMCPilot and Feasibility Studies2055-57842019-04-01511810.1186/s40814-019-0436-3Reporting quality of pilot clinical trials in chronic kidney disease patients on hemodialysis: a methodological surveySarah Daisy Kosa0Jillian Monize1Alvin Leenus2Selvin Leenus3Simranjit Samra4Sylwia Szwiega5Daniel Shi6Sara Valvasori7Amiram Gafni8Charmaine E. Lok9Lehana Thabane10Kidney CARE Network InternationalKidney CARE Network InternationalFaculty of Health Sciences, McMaster UniversityFaculty of Health Sciences, McMaster UniversityKidney CARE Network InternationalKidney CARE Network InternationalFaculty of Health Sciences, Queen’s UniversityFaculty of Health Sciences, McMaster UniversityDepartment of Health Research, Evidence, and Impact, McMaster UniversityKidney CARE Network InternationalDepartment of Health Research, Evidence, and Impact, McMaster UniversityAbstract Background The conduct of high-quality pilot studies can help inform the success of larger clinical trials. Guidelines have been recently developed for the reporting of pilot trials. Objective This methodological survey evaluates the completeness of reporting in pilot randomized controlled trials in chronic kidney disease patients on hemodialysis (HD patients) and explores factors associated with better completion of reporting. Methods The authors searched Pubmed on July 1, 2018, for all pilot trials conducted in HD patients. Reporting quality was assessed against the 40-item Consolidated Standards of Reporting Trials (CONSORT) Extension for Pilot Trials. Study factors including year and country of publication, intervention, number of centers, type of funding, and journal endorsement of CONSORT were also examined. Results The mean number of items reported from the CONSORT extension for pilot trials across all included articles was 18.4 (standard deviation [SD] = 4.4). In the adjusted analysis, studies reported in later years (IRR = 1.026, 95% CI [1.018, 1.034], p < 0.001) and an increase of 20 persons in sample size (adjusted IRR = 1.021, 95% CI [1.010, 1.031], p < 0.001) were associated with a significantly higher number of CONSORT pilot items reported. Conclusions Current reporting completeness of pilot trials in HD patients is suboptimal. Endorsing the CONSORT extension specific to pilot and feasibility studies and ensuring that pilot trials focus on the feasibility objectives may improve reporting completeness of these trials.http://link.springer.com/article/10.1186/s40814-019-0436-3Pilot trialsFeasibility trialsReporting qualityTransparencyGuideline adherenceHemodialysis |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Sarah Daisy Kosa Jillian Monize Alvin Leenus Selvin Leenus Simranjit Samra Sylwia Szwiega Daniel Shi Sara Valvasori Amiram Gafni Charmaine E. Lok Lehana Thabane |
spellingShingle |
Sarah Daisy Kosa Jillian Monize Alvin Leenus Selvin Leenus Simranjit Samra Sylwia Szwiega Daniel Shi Sara Valvasori Amiram Gafni Charmaine E. Lok Lehana Thabane Reporting quality of pilot clinical trials in chronic kidney disease patients on hemodialysis: a methodological survey Pilot and Feasibility Studies Pilot trials Feasibility trials Reporting quality Transparency Guideline adherence Hemodialysis |
author_facet |
Sarah Daisy Kosa Jillian Monize Alvin Leenus Selvin Leenus Simranjit Samra Sylwia Szwiega Daniel Shi Sara Valvasori Amiram Gafni Charmaine E. Lok Lehana Thabane |
author_sort |
Sarah Daisy Kosa |
title |
Reporting quality of pilot clinical trials in chronic kidney disease patients on hemodialysis: a methodological survey |
title_short |
Reporting quality of pilot clinical trials in chronic kidney disease patients on hemodialysis: a methodological survey |
title_full |
Reporting quality of pilot clinical trials in chronic kidney disease patients on hemodialysis: a methodological survey |
title_fullStr |
Reporting quality of pilot clinical trials in chronic kidney disease patients on hemodialysis: a methodological survey |
title_full_unstemmed |
Reporting quality of pilot clinical trials in chronic kidney disease patients on hemodialysis: a methodological survey |
title_sort |
reporting quality of pilot clinical trials in chronic kidney disease patients on hemodialysis: a methodological survey |
publisher |
BMC |
series |
Pilot and Feasibility Studies |
issn |
2055-5784 |
publishDate |
2019-04-01 |
description |
Abstract Background The conduct of high-quality pilot studies can help inform the success of larger clinical trials. Guidelines have been recently developed for the reporting of pilot trials. Objective This methodological survey evaluates the completeness of reporting in pilot randomized controlled trials in chronic kidney disease patients on hemodialysis (HD patients) and explores factors associated with better completion of reporting. Methods The authors searched Pubmed on July 1, 2018, for all pilot trials conducted in HD patients. Reporting quality was assessed against the 40-item Consolidated Standards of Reporting Trials (CONSORT) Extension for Pilot Trials. Study factors including year and country of publication, intervention, number of centers, type of funding, and journal endorsement of CONSORT were also examined. Results The mean number of items reported from the CONSORT extension for pilot trials across all included articles was 18.4 (standard deviation [SD] = 4.4). In the adjusted analysis, studies reported in later years (IRR = 1.026, 95% CI [1.018, 1.034], p < 0.001) and an increase of 20 persons in sample size (adjusted IRR = 1.021, 95% CI [1.010, 1.031], p < 0.001) were associated with a significantly higher number of CONSORT pilot items reported. Conclusions Current reporting completeness of pilot trials in HD patients is suboptimal. Endorsing the CONSORT extension specific to pilot and feasibility studies and ensuring that pilot trials focus on the feasibility objectives may improve reporting completeness of these trials. |
topic |
Pilot trials Feasibility trials Reporting quality Transparency Guideline adherence Hemodialysis |
url |
http://link.springer.com/article/10.1186/s40814-019-0436-3 |
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