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Registration and primary outcome reporting in behavioral health trials

BACKGROUND: Registration of research studies is designed to lock investigators into a data collection and analysis plan before a study starts and thereby limit their ability to engage in flexible data analysis and selective outcome reporting. Studies of registered clinical trials show that one- to t...

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Autores principales: Taylor, Nicholas J., Gorman, Dennis M.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8818241/
https://www.ncbi.nlm.nih.gov/pubmed/35125101
http://dx.doi.org/10.1186/s12874-021-01500-w
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author Taylor, Nicholas J.
Gorman, Dennis M.
author_facet Taylor, Nicholas J.
Gorman, Dennis M.
author_sort Taylor, Nicholas J.
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description BACKGROUND: Registration of research studies is designed to lock investigators into a data collection and analysis plan before a study starts and thereby limit their ability to engage in flexible data analysis and selective outcome reporting. Studies of registered clinical trials show that one- to two-thirds are registered after the study has started and that non-adherence to important design and analytic features, such as reporting data pertaining to all primary outcomes, remains high. Less is known about the effects of registration on research transparency and integrity outside of clinical trials. To address this gap in knowledge, the current study examined the effects of registration on the reporting of research findings in a sample of behavioral health trials published in BMC Public Health. METHODS: Registered trials published in the BMC Public Health section “Health Behavior, Health Promotion and Society” between 2011 and 2015 were included in the study. For each trial, we reviewed associated online submissions from 13 different registration sites. For those determined to have been prospectively registered, we used the trial registry, MEDLINE (Pubmed), PsychINFO, Web of Science and e-mails to investigators to identify subsequent publications from the study that reported results pertaining to primary outcomes. The two investigators then independently reviewed the outcome publication(s) and compared the primary outcomes reported in these to the registered primary outcomes. RESULTS: The final analytic sample comprised 136 locatable, registered trials with an identifiable start date. Sixty-eight of the 136 were prospectively registered. Among these prospectively registered trials, only 16 published manuscripts reported outcomes and methods that were concordant with their registrations. CONCLUSIONS: Retrospective submission of protocols for publication and retrospective registration remain common in public health research, and adherence to prespecified outcomes is rare. In its current form, registration of behavioral and health promotion trials is likely to have minimal effect on preventing selective outcome reporting in publications, and the pervasiveness of vague and incomplete registry entries means that registries will have limited utility in terms of facilitating replication studies. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s12874-021-01500-w.
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spelling pubmed-88182412022-02-07 Registration and primary outcome reporting in behavioral health trials Taylor, Nicholas J. Gorman, Dennis M. BMC Med Res Methodol Research BACKGROUND: Registration of research studies is designed to lock investigators into a data collection and analysis plan before a study starts and thereby limit their ability to engage in flexible data analysis and selective outcome reporting. Studies of registered clinical trials show that one- to two-thirds are registered after the study has started and that non-adherence to important design and analytic features, such as reporting data pertaining to all primary outcomes, remains high. Less is known about the effects of registration on research transparency and integrity outside of clinical trials. To address this gap in knowledge, the current study examined the effects of registration on the reporting of research findings in a sample of behavioral health trials published in BMC Public Health. METHODS: Registered trials published in the BMC Public Health section “Health Behavior, Health Promotion and Society” between 2011 and 2015 were included in the study. For each trial, we reviewed associated online submissions from 13 different registration sites. For those determined to have been prospectively registered, we used the trial registry, MEDLINE (Pubmed), PsychINFO, Web of Science and e-mails to investigators to identify subsequent publications from the study that reported results pertaining to primary outcomes. The two investigators then independently reviewed the outcome publication(s) and compared the primary outcomes reported in these to the registered primary outcomes. RESULTS: The final analytic sample comprised 136 locatable, registered trials with an identifiable start date. Sixty-eight of the 136 were prospectively registered. Among these prospectively registered trials, only 16 published manuscripts reported outcomes and methods that were concordant with their registrations. CONCLUSIONS: Retrospective submission of protocols for publication and retrospective registration remain common in public health research, and adherence to prespecified outcomes is rare. In its current form, registration of behavioral and health promotion trials is likely to have minimal effect on preventing selective outcome reporting in publications, and the pervasiveness of vague and incomplete registry entries means that registries will have limited utility in terms of facilitating replication studies. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s12874-021-01500-w. BioMed Central 2022-02-06 /pmc/articles/PMC8818241/ /pubmed/35125101 http://dx.doi.org/10.1186/s12874-021-01500-w Text en © The Author(s) 2022 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
spellingShingle Research
Taylor, Nicholas J.
Gorman, Dennis M.
Registration and primary outcome reporting in behavioral health trials
title Registration and primary outcome reporting in behavioral health trials
title_full Registration and primary outcome reporting in behavioral health trials
title_fullStr Registration and primary outcome reporting in behavioral health trials
title_full_unstemmed Registration and primary outcome reporting in behavioral health trials
title_short Registration and primary outcome reporting in behavioral health trials
title_sort registration and primary outcome reporting in behavioral health trials
topic Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8818241/
https://www.ncbi.nlm.nih.gov/pubmed/35125101
http://dx.doi.org/10.1186/s12874-021-01500-w
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