A longitudinal assessment of trial protocols approved by research ethics committees: The Adherance to SPIrit REcommendations in the UK (ASPIRE-UK) study

Speich, Benjamin; Odutayo, Ayodele; Peckham, Nicholas; Ooms, Alexander; Stokes, Jamie R.; Saccilotto, Ramon; Gryaznov, Dmitry; Niederhäusern, Belinda von; Copsey, Bethan; Altman, Douglas G.; Briel, Matthias; Hopewell, Sally

doi:10.1186/s13063-022-06516-1

Cited by 6 publications

(4 citation statements)

References 23 publications

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“…Therefore, this is likely a critical step in increasing awareness, uptake, and adherence to the newly developed SPIRIT/CONSORT-C to improve reporting comprehensiveness in future trial protocols and reports. However, endorsement from journals is not sufficient, particularly for trial protocols, as adherence to SPIRIT guidelines is still suboptimal [ 77 ]. While trial protocols are often reviewed at early stages by funders, Institutional Review Boards, and regulatory bodies, these early review efforts need to be more transparent, connected, and require structured guidelines for peer review [ 78 ].…”

Section: Methodsmentioning

confidence: 99%

Guidelines for reporting pediatric and child health clinical trial protocols and reports: study protocol for SPIRIT-Children and CONSORT-Children

Baba,

Smith,

Potter

et al. 2024

Trials

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Background Despite the critical importance of clinical trials to provide evidence about the effects of intervention for children and youth, a paucity of published high-quality pediatric clinical trials persists. Sub-optimal reporting of key trial elements necessary to critically appraise and synthesize findings is prevalent. To harmonize and provide guidance for reporting in pediatric controlled clinical trial protocols and reports, reporting guideline extensions to the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) and Consolidated Standards of Reporting Trials (CONSORT) guidelines specific to pediatrics are being developed: SPIRIT-Children (SPIRIT-C) and CONSORT-Children (CONSORT-C). Methods The development of SPIRIT-C/CONSORT-C will be informed by the Enhancing the Quality and Transparency of Health Research Quality (EQUATOR) method for reporting guideline development in the following stages: (1) generation of a preliminary list of candidate items, informed by (a) items developed during initial development efforts and child relevant items from recent published SPIRIT and CONSORT extensions; (b) two systematic reviews and environmental scan of the literature; (c) workshops with young people; (2) an international Delphi study, where a wide range of panelists will vote on the inclusion or exclusion of candidate items on a nine-point Likert scale; (3) a consensus meeting to discuss items that have not reached consensus in the Delphi study and to “lock” the checklist items; (4) pilot testing of items and definitions to ensure that they are understandable, useful, and applicable; and (5) a final project meeting to discuss each item in the context of pilot test results. Key partners, including young people (ages 12–24 years) and family caregivers (e.g., parents) with lived experiences with pediatric clinical trials, and individuals with expertise and involvement in pediatric trials will be involved throughout the project. SPIRIT-C/CONSORT-C will be disseminated through publications, academic conferences, and endorsement by pediatric journals and relevant research networks and organizations. Discussion SPIRIT/CONSORT-C may serve as resources to facilitate comprehensive reporting needed to understand pediatric clinical trial protocols and reports, which may improve transparency within pediatric clinical trials and reduce research waste. Trial Registration The development of these reporting guidelines is registered with the EQUATOR Network: SPIRIT-Children (https://www.equator-network.org/library/reporting-guidelines-under-development/reporting-guidelines-under-development-for-clinical-trials-protocols/#35) and CONSORT-Children (https://www.equator-network.org/library/reporting-guidelines-under-development/reporting-guidelines-under-development-for-clinical-trials/#CHILD).

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Section: Methodsmentioning

confidence: 99%

Guidelines for reporting pediatric and child health clinical trial protocols and reports: study protocol for SPIRIT-Children and CONSORT-Children

Baba,

Smith,

Potter

et al. 2024

Trials

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“…The selection of the 10 most important and poorly reported items for CONSORT-PR was completely based on previous literature. 18 For SPIRIT-PR, we considered all available assessments of reporting 19 , 20 , 21 and chose 10 items through a consensus process within the study team. More details on this process as well as the development of a brief description for each item is presented in eAppendix 3 in Supplement 3 .…”

Section: Methodsmentioning

confidence: 99%

Reminding Peer Reviewers of Reporting Guideline Items to Improve Completeness in Published Articles

et al. 2023

Self Cite

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ImportanceNumerous studies have shown that adherence to reporting guidelines is suboptimal.ObjectiveTo evaluate whether asking peer reviewers to check if specific reporting guideline items were adequately reported would improve adherence to reporting guidelines in published articles.Design, Setting, and ParticipantsTwo parallel-group, superiority randomized trials were performed using manuscripts submitted to 7 biomedical journals (5 from the BMJ Publishing Group and 2 from the Public Library of Science) as the unit of randomization, with peer reviewers allocated to the intervention or control group.InterventionsThe first trial (CONSORT-PR) focused on manuscripts that presented randomized clinical trial (RCT) results and reported following the Consolidated Standards of Reporting Trials (CONSORT) guideline, and the second trial (SPIRIT-PR) focused on manuscripts that presented RCT protocols and reported following the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) guideline. The CONSORT-PR trial included manuscripts that described RCT primary results (submitted July 2019 to July 2021). The SPIRIT-PR trial included manuscripts that contained RCT protocols (submitted June 2020 to May 2021). Manuscripts in both trials were randomized (1:1) to the intervention or control group; the control group received usual journal practice. In the intervention group of both trials, peer reviewers received an email from the journal that asked them to check whether the 10 most important and poorly reported CONSORT (for CONSORT-PR) or SPIRIT (for SPIRIT-PR) items were adequately reported in the manuscript. Peer reviewers and authors were not informed of the purpose of the study, and outcome assessors were blinded.Main Outcomes and MeasuresThe difference in the mean proportion of adequately reported 10 CONSORT or SPIRIT items between the intervention and control groups in published articles.ResultsIn the CONSORT-PR trial, 510 manuscripts were randomized. Of those, 243 were published (122 in the intervention group and 121 in the control group). A mean proportion of 69.3% (95% CI, 66.0%-72.7%) of the 10 CONSORT items were adequately reported in the intervention group and 66.6% (95% CI, 62.5%-70.7%) in the control group (mean difference, 2.7%; 95% CI, −2.6% to 8.0%). In the SPIRIT-PR trial, of the 244 randomized manuscripts, 178 were published (90 in the intervention group and 88 in the control group). A mean proportion of 46.1% (95% CI, 41.8%-50.4%) of the 10 SPIRIT items were adequately reported in the intervention group and 45.6% (95% CI, 41.7% to 49.4%) in the control group (mean difference, 0.5%; 95% CI, −5.2% to 6.3%).Conclusions and RelevanceThese 2 randomized trials found that it was not useful to implement the tested intervention to increase reporting completeness in published articles. Other interventions should be assessed and considered in the future.Trial RegistrationClinicalTrials.gov Identifiers: NCT05820971 (CONSORT-PR) and NCT05820984 (SPIRIT-PR)

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“…However, uptake of J o u r n a l P r e -p r o o f SPIRIT by trialists has been limited. Moreover, a recent randomized controlled trial (RCT) has shown that adherence to those guidelines is not effective (6).…”

Section: J O U R N a L P R E -P R O O Fmentioning

confidence: 99%

Peer review before trial conduct could increase research value and reduce waste

Siebert

Naudet

Ioannidis

2023

Journal of Clinical Epidemiology

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A longitudinal assessment of trial protocols approved by research ethics committees: The Adherance to SPIrit REcommendations in the UK (ASPIRE-UK) study

Cited by 6 publications

References 23 publications

Guidelines for reporting pediatric and child health clinical trial protocols and reports: study protocol for SPIRIT-Children and CONSORT-Children

Guidelines for reporting pediatric and child health clinical trial protocols and reports: study protocol for SPIRIT-Children and CONSORT-Children

Reminding Peer Reviewers of Reporting Guideline Items to Improve Completeness in Published Articles

Peer review before trial conduct could increase research value and reduce waste

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