Electronic Versus Traditional Data Collection: A Multicenter Randomized Controlled Perioperative Pain Trial
Background: Electronic data collection is increasingly available as a means to collect pain-related clinical trial data; however, effectiveness and costs relative to traditional data collection are uncertain. Aims: The aim of this study was to evaluate data quality, protocol adherence, satisfaction,...
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doaj-82da331ee863480f8038edab01f214a22020-11-24T21:40:20ZengTaylor & Francis GroupCanadian Journal of Pain2474-05272019-07-0132162510.1080/24740527.2019.15875841587584Electronic Versus Traditional Data Collection: A Multicenter Randomized Controlled Perioperative Pain TrialJames S. Khan0Lindsay A. Jibb1Jason W. Busse2Ian Gilron3Stephen Choi4James E. Paul5Michael McGillion6Sean Mackey7D. Norman Buckley8Shun Fu Lee9P. J. Devereaux10Mount Sinai Hospital, University of TorontoUniversity of OttawaMcMaster UniversityQueen’s UniversityMount Sinai Hospital, University of TorontoMcMaster UniversityMcMaster UniversityStanford UniversityMcMaster UniversityMcMaster UniversityEvidence, and Impact, McMaster UniversityBackground: Electronic data collection is increasingly available as a means to collect pain-related clinical trial data; however, effectiveness and costs relative to traditional data collection are uncertain. Aims: The aim of this study was to evaluate data quality, protocol adherence, satisfaction, and resource requirements of electronic data collection (i.e., Internet-based electronic submission) compared to traditional data collection methods (i.e., paper-based diaries and telephone interviews) in a perioperative factorial randomized controlled trial. Methods: This study was an open-label two-arm parallel randomized controlled trial. Women (18–75 years) undergoing breast cancer surgery were allocated to either electronic or traditional data collection and completed pain-related questionnaires at baseline, postoperative period, and 3-month follow-up (NCT02240199). Results: We acquired outcome data at all time points from 78 randomized patients, 38 in the electronic group and 40 in the traditional group. The number of data queries (e.g., erroneously entered data) per patient was higher in the electronic data group (4.92 [SD = 4.67] vs. 1.88 [SD = 1.51]; P < 0.001). No between-group differences were observed for compliance with medications, data completeness, loss to follow-up, or patient or research assistant satisfaction. More research assistant time per patient was spent collecting data in the traditional group (42.6 min [SD = 12.8] vs. 9.92 min [SD = 7.6]; P < 0.001); however, costs per patient were higher in the electronic group ($176.85 [SD = 2.90] vs. $16.33 [SD = 4.90]; P < 0.001). Conclusion: Electronic data collection is feasible for perioperative pain clinical trials. Additional trials, including different surgical populations, are needed to confirm our findings and optimize use of electronic data capture methods.http://dx.doi.org/10.1080/24740527.2019.1587584painperioperativeclinicalclinical trialsrandomized controlled trials |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
James S. Khan Lindsay A. Jibb Jason W. Busse Ian Gilron Stephen Choi James E. Paul Michael McGillion Sean Mackey D. Norman Buckley Shun Fu Lee P. J. Devereaux |
spellingShingle |
James S. Khan Lindsay A. Jibb Jason W. Busse Ian Gilron Stephen Choi James E. Paul Michael McGillion Sean Mackey D. Norman Buckley Shun Fu Lee P. J. Devereaux Electronic Versus Traditional Data Collection: A Multicenter Randomized Controlled Perioperative Pain Trial Canadian Journal of Pain pain perioperative clinical clinical trials randomized controlled trials |
author_facet |
James S. Khan Lindsay A. Jibb Jason W. Busse Ian Gilron Stephen Choi James E. Paul Michael McGillion Sean Mackey D. Norman Buckley Shun Fu Lee P. J. Devereaux |
author_sort |
James S. Khan |
title |
Electronic Versus Traditional Data Collection: A Multicenter Randomized Controlled Perioperative Pain Trial |
title_short |
Electronic Versus Traditional Data Collection: A Multicenter Randomized Controlled Perioperative Pain Trial |
title_full |
Electronic Versus Traditional Data Collection: A Multicenter Randomized Controlled Perioperative Pain Trial |
title_fullStr |
Electronic Versus Traditional Data Collection: A Multicenter Randomized Controlled Perioperative Pain Trial |
title_full_unstemmed |
Electronic Versus Traditional Data Collection: A Multicenter Randomized Controlled Perioperative Pain Trial |
title_sort |
electronic versus traditional data collection: a multicenter randomized controlled perioperative pain trial |
publisher |
Taylor & Francis Group |
series |
Canadian Journal of Pain |
issn |
2474-0527 |
publishDate |
2019-07-01 |
description |
Background: Electronic data collection is increasingly available as a means to collect pain-related clinical trial data; however, effectiveness and costs relative to traditional data collection are uncertain. Aims: The aim of this study was to evaluate data quality, protocol adherence, satisfaction, and resource requirements of electronic data collection (i.e., Internet-based electronic submission) compared to traditional data collection methods (i.e., paper-based diaries and telephone interviews) in a perioperative factorial randomized controlled trial. Methods: This study was an open-label two-arm parallel randomized controlled trial. Women (18–75 years) undergoing breast cancer surgery were allocated to either electronic or traditional data collection and completed pain-related questionnaires at baseline, postoperative period, and 3-month follow-up (NCT02240199). Results: We acquired outcome data at all time points from 78 randomized patients, 38 in the electronic group and 40 in the traditional group. The number of data queries (e.g., erroneously entered data) per patient was higher in the electronic data group (4.92 [SD = 4.67] vs. 1.88 [SD = 1.51]; P < 0.001). No between-group differences were observed for compliance with medications, data completeness, loss to follow-up, or patient or research assistant satisfaction. More research assistant time per patient was spent collecting data in the traditional group (42.6 min [SD = 12.8] vs. 9.92 min [SD = 7.6]; P < 0.001); however, costs per patient were higher in the electronic group ($176.85 [SD = 2.90] vs. $16.33 [SD = 4.90]; P < 0.001). Conclusion: Electronic data collection is feasible for perioperative pain clinical trials. Additional trials, including different surgical populations, are needed to confirm our findings and optimize use of electronic data capture methods. |
topic |
pain perioperative clinical clinical trials randomized controlled trials |
url |
http://dx.doi.org/10.1080/24740527.2019.1587584 |
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