Data extraction error in pharmaceutical versus non-pharmaceutical interventions for evidence synthesis: Study protocol for a crossover trial

BackgroundData extraction is the foundation for research synthesis evidence, while data extraction errors frequently occur in the literature. An interesting phenomenon was observed that data extraction error tend to be more common in trials of pharmaceutical interventions compared to non-pharmaceuti...

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Main Author: Yi, Zhu (author)
Other Authors: Ren, Pengwei (author), Doi, Suhail A.R. (author), Furuya-Kanamori, Luis (author), Lin, Lifeng (author), Zhou, Xiaoqin (author), Tao, Fangbiao (author), Xu, Chang (author)
Format: article
Published: 2023
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Online Access:http://dx.doi.org/10.1016/j.conctc.2023.101189
https://www.sciencedirect.com/science/article/pii/S2451865423001357
http://hdl.handle.net/10576/47491
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_version_ 1857415087541714944
author Yi, Zhu
author2 Ren, Pengwei
Doi, Suhail A.R.
Furuya-Kanamori, Luis
Lin, Lifeng
Zhou, Xiaoqin
Tao, Fangbiao
Xu, Chang
author2_role author
author
author
author
author
author
author
author_facet Yi, Zhu
Ren, Pengwei
Doi, Suhail A.R.
Furuya-Kanamori, Luis
Lin, Lifeng
Zhou, Xiaoqin
Tao, Fangbiao
Xu, Chang
author_role author
dc.creator.none.fl_str_mv Yi, Zhu
Ren, Pengwei
Doi, Suhail A.R.
Furuya-Kanamori, Luis
Lin, Lifeng
Zhou, Xiaoqin
Tao, Fangbiao
Xu, Chang
dc.date.none.fl_str_mv 2023-09-13T05:28:44Z
2023-10-31
dc.format.none.fl_str_mv application/pdf
dc.identifier.none.fl_str_mv http://dx.doi.org/10.1016/j.conctc.2023.101189
24518654
https://www.sciencedirect.com/science/article/pii/S2451865423001357
http://hdl.handle.net/10576/47491
35
dc.language.none.fl_str_mv en
dc.publisher.none.fl_str_mv Elsevier
dc.rights.none.fl_str_mv http://creativecommons.org/licenses/by-nc-nd/4.0/
info:eu-repo/semantics/openAccess
dc.subject.none.fl_str_mv Data extraction error
Pharmaceutical intervention
Non-pharmaceutical intervention
Randomized controlled trial
Protocol
dc.title.none.fl_str_mv Data extraction error in pharmaceutical versus non-pharmaceutical interventions for evidence synthesis: Study protocol for a crossover trial
dc.type.none.fl_str_mv Article
info:eu-repo/semantics/publishedVersion
info:eu-repo/semantics/article
description BackgroundData extraction is the foundation for research synthesis evidence, while data extraction errors frequently occur in the literature. An interesting phenomenon was observed that data extraction error tend to be more common in trials of pharmaceutical interventions compared to non-pharmaceutical ones. The elucidation of which would have implications for guidelines, practice, and policy. Methods and analysesWe propose a crossover, multicenter, investigator-blinded trial to elucidate the potential variants on the data extraction error rates. Eligible 90 participants would be 2nd year or above post-graduate students (e.g., masters, doctoral program). Participants will be randomized to one of the two groups to complete pre-defined data extraction tasks: 1) group A will contain 10 randomized controlled trials (RCTs) of pharmaceutical interventions; 2) group B will contain 10 RCTs of non-pharmaceutical interventions. Participants who finish the data extraction would then be assigned to the alternative group for another round of data extraction after a 30 min washout period. Finally, those participants assigned to A or B group will be further 1:1 randomly matched based on a random-sequenced number for the double-checking process on the extracted data. The primary outcome will be the data extract error rates of the pharmaceutical intervention group and non-pharmaceutical group, before the double-checking process, in terms of the cell level, study level, and participant level. The secondary outcome will be the data error rates of the pharmaceutical intervention group and non-pharmaceutical group after the double-checking process, again, in terms of the cell level, study level, and participant level. A generalized linear mixed effects model (based on the above three levels) will be used to estimate the potential differences in the error rates, with a log link function for binomial data. Subgroup analyses will account for the experience of individuals on systematic reviews and the time used for the data extraction. DiscussionThis trial will provide useful evidence for further systematic review of data extraction practices, improved data extraction strategies, and better guidelines. Trial registrationChinese Clinical Trial Register Center (Identifier: ChiCTR2200062206).
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network_acronym_str qu
network_name_str Qatar University repository
oai_identifier_str oai:qspace.qu.edu.qa:10576/47491
publishDate 2023
publisher.none.fl_str_mv Elsevier
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rights_invalid_str_mv http://creativecommons.org/licenses/by-nc-nd/4.0/
spelling Data extraction error in pharmaceutical versus non-pharmaceutical interventions for evidence synthesis: Study protocol for a crossover trialYi, ZhuRen, PengweiDoi, Suhail A.R.Furuya-Kanamori, LuisLin, LifengZhou, XiaoqinTao, FangbiaoXu, ChangData extraction errorPharmaceutical interventionNon-pharmaceutical interventionRandomized controlled trialProtocolBackgroundData extraction is the foundation for research synthesis evidence, while data extraction errors frequently occur in the literature. An interesting phenomenon was observed that data extraction error tend to be more common in trials of pharmaceutical interventions compared to non-pharmaceutical ones. The elucidation of which would have implications for guidelines, practice, and policy. Methods and analysesWe propose a crossover, multicenter, investigator-blinded trial to elucidate the potential variants on the data extraction error rates. Eligible 90 participants would be 2nd year or above post-graduate students (e.g., masters, doctoral program). Participants will be randomized to one of the two groups to complete pre-defined data extraction tasks: 1) group A will contain 10 randomized controlled trials (RCTs) of pharmaceutical interventions; 2) group B will contain 10 RCTs of non-pharmaceutical interventions. Participants who finish the data extraction would then be assigned to the alternative group for another round of data extraction after a 30 min washout period. Finally, those participants assigned to A or B group will be further 1:1 randomly matched based on a random-sequenced number for the double-checking process on the extracted data. The primary outcome will be the data extract error rates of the pharmaceutical intervention group and non-pharmaceutical group, before the double-checking process, in terms of the cell level, study level, and participant level. The secondary outcome will be the data error rates of the pharmaceutical intervention group and non-pharmaceutical group after the double-checking process, again, in terms of the cell level, study level, and participant level. A generalized linear mixed effects model (based on the above three levels) will be used to estimate the potential differences in the error rates, with a log link function for binomial data. Subgroup analyses will account for the experience of individuals on systematic reviews and the time used for the data extraction. DiscussionThis trial will provide useful evidence for further systematic review of data extraction practices, improved data extraction strategies, and better guidelines. Trial registrationChinese Clinical Trial Register Center (Identifier: ChiCTR2200062206).This work was supported by the National Natural Science Foundation of China (72204003) and program grant #NPRP-BSRA01-0406-210030 from the Qatar National Research Fund (a member of Qatar Foundation).Elsevier2023-09-13T05:28:44Z2023-10-31Articleinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleapplication/pdfhttp://dx.doi.org/10.1016/j.conctc.2023.10118924518654https://www.sciencedirect.com/science/article/pii/S2451865423001357http://hdl.handle.net/10576/4749135enhttp://creativecommons.org/licenses/by-nc-nd/4.0/info:eu-repo/semantics/openAccessoai:qspace.qu.edu.qa:10576/474912024-07-23T10:58:25Z
spellingShingle Data extraction error in pharmaceutical versus non-pharmaceutical interventions for evidence synthesis: Study protocol for a crossover trial
Yi, Zhu
Data extraction error
Pharmaceutical intervention
Non-pharmaceutical intervention
Randomized controlled trial
Protocol
status_str publishedVersion
title Data extraction error in pharmaceutical versus non-pharmaceutical interventions for evidence synthesis: Study protocol for a crossover trial
title_full Data extraction error in pharmaceutical versus non-pharmaceutical interventions for evidence synthesis: Study protocol for a crossover trial
title_fullStr Data extraction error in pharmaceutical versus non-pharmaceutical interventions for evidence synthesis: Study protocol for a crossover trial
title_full_unstemmed Data extraction error in pharmaceutical versus non-pharmaceutical interventions for evidence synthesis: Study protocol for a crossover trial
title_short Data extraction error in pharmaceutical versus non-pharmaceutical interventions for evidence synthesis: Study protocol for a crossover trial
title_sort Data extraction error in pharmaceutical versus non-pharmaceutical interventions for evidence synthesis: Study protocol for a crossover trial
topic Data extraction error
Pharmaceutical intervention
Non-pharmaceutical intervention
Randomized controlled trial
Protocol
url http://dx.doi.org/10.1016/j.conctc.2023.101189
https://www.sciencedirect.com/science/article/pii/S2451865423001357
http://hdl.handle.net/10576/47491