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A meta-research study of randomized controlled trials found infrequent and delayed availability of protocols

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A meta-research study of randomized controlled trials found infrequent and delayed availability of protocols. / Schönenberger, Christof Manuel; Griessbach, Alexandra; Taji Heravi, Ala; Gryaznov, Dmitry; Gloy, Viktoria L; Lohner, Szimonetta; Klatte, Katharina; Ghosh, Nilabh; Lee, Hopin; Mansouri, Anita; Marian, Ioana R; Saccilotto, Ramon; Nury, Oshika Edris; Busse, Jason W; von Niederhäusern, Belinda; Mertz, Dominik; Blümle, Anette; Odutayo, Ayodele; Hopewell, Sally; Speich, Benjamin; Briel, Matthias.

in: J CLIN EPIDEMIOL, Jahrgang 149, 09.2022, S. 45-52.

Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung

Harvard

Schönenberger, CM, Griessbach, A, Taji Heravi, A, Gryaznov, D, Gloy, VL, Lohner, S, Klatte, K, Ghosh, N, Lee, H, Mansouri, A, Marian, IR, Saccilotto, R, Nury, OE, Busse, JW, von Niederhäusern, B, Mertz, D, Blümle, A, Odutayo, A, Hopewell, S, Speich, B & Briel, M 2022, 'A meta-research study of randomized controlled trials found infrequent and delayed availability of protocols', J CLIN EPIDEMIOL, Jg. 149, S. 45-52. https://doi.org/10.1016/j.jclinepi.2022.05.014

APA

Schönenberger, C. M., Griessbach, A., Taji Heravi, A., Gryaznov, D., Gloy, V. L., Lohner, S., Klatte, K., Ghosh, N., Lee, H., Mansouri, A., Marian, I. R., Saccilotto, R., Nury, O. E., Busse, J. W., von Niederhäusern, B., Mertz, D., Blümle, A., Odutayo, A., Hopewell, S., ... Briel, M. (2022). A meta-research study of randomized controlled trials found infrequent and delayed availability of protocols. J CLIN EPIDEMIOL, 149, 45-52. https://doi.org/10.1016/j.jclinepi.2022.05.014

Vancouver

Schönenberger CM, Griessbach A, Taji Heravi A, Gryaznov D, Gloy VL, Lohner S et al. A meta-research study of randomized controlled trials found infrequent and delayed availability of protocols. J CLIN EPIDEMIOL. 2022 Sep;149:45-52. https://doi.org/10.1016/j.jclinepi.2022.05.014

Bibtex

@article{b9e9a54744484c99a096bb045b75758b,
title = "A meta-research study of randomized controlled trials found infrequent and delayed availability of protocols",
abstract = "OBJECTIVES: Availability of randomized controlled trial (RCT) protocols is essential for the interpretation of trial results and research transparency.STUDY DESIGN AND SETTING: In this study, we determined the availability of RCT protocols approved in Switzerland, Canada, Germany, and the United Kingdom in 2012. For these RCTs, we searched PubMed, Google Scholar, Scopus, and trial registries for publicly available protocols and corresponding full-text publications of results. We determined the proportion of RCTs with (1) publicly available protocols, (2) publications citing the protocol, and (3) registries providing a link to the protocol. A multivariable logistic regression model explored factors associated with protocol availability.RESULTS: Three hundred twenty-six RCTs were included, of which 118 (36.2%) made their protocol publicly available; 56 (47.6% 56 of 118) provided as a peer-reviewed publication and 48 (40.7%, 48 of 118) provided as supplementary material. A total of 90.9% (100 of 110) of the protocols were cited in the main publication, and 55.9% (66 of 118) were linked in the clinical trial registry. Larger sample size (>500; odds ratio [OR] = 5.90, 95% confidence interval [CI], 2.75-13.31) and investigator sponsorship (OR = 1.99, 95% CI, 1.11-3.59) were associated with increased protocol availability. Most protocols were made available shortly before the publication of the main results.CONCLUSION: RCT protocols should be made available at an early stage of the trial.",
keywords = "Humans, Randomized Controlled Trials as Topic, Germany, Odds Ratio, Sample Size, Research Personnel, Registries",
author = "Sch{\"o}nenberger, {Christof Manuel} and Alexandra Griessbach and {Taji Heravi}, Ala and Dmitry Gryaznov and Gloy, {Viktoria L} and Szimonetta Lohner and Katharina Klatte and Nilabh Ghosh and Hopin Lee and Anita Mansouri and Marian, {Ioana R} and Ramon Saccilotto and Nury, {Oshika Edris} and Busse, {Jason W} and {von Niederh{\"a}usern}, Belinda and Dominik Mertz and Anette Bl{\"u}mle and Ayodele Odutayo and Sally Hopewell and Benjamin Speich and Matthias Briel",
note = "Copyright {\textcopyright} 2022 The Author(s). Published by Elsevier Inc. All rights reserved.",
year = "2022",
month = sep,
doi = "10.1016/j.jclinepi.2022.05.014",
language = "English",
volume = "149",
pages = "45--52",
journal = "J CLIN EPIDEMIOL",
issn = "0895-4356",
publisher = "Elsevier USA",

}

RIS

TY - JOUR

T1 - A meta-research study of randomized controlled trials found infrequent and delayed availability of protocols

AU - Schönenberger, Christof Manuel

AU - Griessbach, Alexandra

AU - Taji Heravi, Ala

AU - Gryaznov, Dmitry

AU - Gloy, Viktoria L

AU - Lohner, Szimonetta

AU - Klatte, Katharina

AU - Ghosh, Nilabh

AU - Lee, Hopin

AU - Mansouri, Anita

AU - Marian, Ioana R

AU - Saccilotto, Ramon

AU - Nury, Oshika Edris

AU - Busse, Jason W

AU - von Niederhäusern, Belinda

AU - Mertz, Dominik

AU - Blümle, Anette

AU - Odutayo, Ayodele

AU - Hopewell, Sally

AU - Speich, Benjamin

AU - Briel, Matthias

N1 - Copyright © 2022 The Author(s). Published by Elsevier Inc. All rights reserved.

PY - 2022/9

Y1 - 2022/9

N2 - OBJECTIVES: Availability of randomized controlled trial (RCT) protocols is essential for the interpretation of trial results and research transparency.STUDY DESIGN AND SETTING: In this study, we determined the availability of RCT protocols approved in Switzerland, Canada, Germany, and the United Kingdom in 2012. For these RCTs, we searched PubMed, Google Scholar, Scopus, and trial registries for publicly available protocols and corresponding full-text publications of results. We determined the proportion of RCTs with (1) publicly available protocols, (2) publications citing the protocol, and (3) registries providing a link to the protocol. A multivariable logistic regression model explored factors associated with protocol availability.RESULTS: Three hundred twenty-six RCTs were included, of which 118 (36.2%) made their protocol publicly available; 56 (47.6% 56 of 118) provided as a peer-reviewed publication and 48 (40.7%, 48 of 118) provided as supplementary material. A total of 90.9% (100 of 110) of the protocols were cited in the main publication, and 55.9% (66 of 118) were linked in the clinical trial registry. Larger sample size (>500; odds ratio [OR] = 5.90, 95% confidence interval [CI], 2.75-13.31) and investigator sponsorship (OR = 1.99, 95% CI, 1.11-3.59) were associated with increased protocol availability. Most protocols were made available shortly before the publication of the main results.CONCLUSION: RCT protocols should be made available at an early stage of the trial.

AB - OBJECTIVES: Availability of randomized controlled trial (RCT) protocols is essential for the interpretation of trial results and research transparency.STUDY DESIGN AND SETTING: In this study, we determined the availability of RCT protocols approved in Switzerland, Canada, Germany, and the United Kingdom in 2012. For these RCTs, we searched PubMed, Google Scholar, Scopus, and trial registries for publicly available protocols and corresponding full-text publications of results. We determined the proportion of RCTs with (1) publicly available protocols, (2) publications citing the protocol, and (3) registries providing a link to the protocol. A multivariable logistic regression model explored factors associated with protocol availability.RESULTS: Three hundred twenty-six RCTs were included, of which 118 (36.2%) made their protocol publicly available; 56 (47.6% 56 of 118) provided as a peer-reviewed publication and 48 (40.7%, 48 of 118) provided as supplementary material. A total of 90.9% (100 of 110) of the protocols were cited in the main publication, and 55.9% (66 of 118) were linked in the clinical trial registry. Larger sample size (>500; odds ratio [OR] = 5.90, 95% confidence interval [CI], 2.75-13.31) and investigator sponsorship (OR = 1.99, 95% CI, 1.11-3.59) were associated with increased protocol availability. Most protocols were made available shortly before the publication of the main results.CONCLUSION: RCT protocols should be made available at an early stage of the trial.

KW - Humans

KW - Randomized Controlled Trials as Topic

KW - Germany

KW - Odds Ratio

KW - Sample Size

KW - Research Personnel

KW - Registries

U2 - 10.1016/j.jclinepi.2022.05.014

DO - 10.1016/j.jclinepi.2022.05.014

M3 - SCORING: Journal article

C2 - 35654268

VL - 149

SP - 45

EP - 52

JO - J CLIN EPIDEMIOL

JF - J CLIN EPIDEMIOL

SN - 0895-4356

ER -