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Background Dose-expansion cohort (DEC) has been increasingly used as the pivotal trial to demonstrate preliminary efficacy and safety of target anticancer drugs. We aimed to investigate the reporting quality in the published articles of DECs. Methods We retrospectively identified the published articles of DEC pivotal trials of the FDA-approved targeted anticancer drugs between Jan 1st, 2012 and March 31st, 2023. All published articles were evaluated by using the CONSORT Dose-finding Extension (CONSORT-DEFINE) guidance. Results Forty-one articles on DEC trials were identified, of which 32 (78.0%) were published in journals with a high impact factor (≥ 50). The median proportion of adequately reported items in the evaluated 41 articles was 83.7% (with an interquartile range of 79.1% to 88.4%). Inadequacies were observed in several areas of DEC trial reporting. Specifically, planned cohort size (item 3a8), dose modification and discontinuation (item 5b), sample size calculation (item 7a), interim analysis (item 7b), adjusted analyses (item 12b) for efficacy endpoints, data monitoring (item 26), safety review committee (item 26a), and the role of funders (item 25) were mentioned in only 4 (9.8%), 17 (41.5%), 30 (73.2%), 14 (34.1%), 30 (73.2%), 6 (14.6%), 4 (9.8%), and 12 (29.3%) articles, respectively. Additionally, inconsistencies were noted in the definition of DEC across different articles, revealing irregular naming methods being used. Conclusions Despite being published in high-impact journals, DEC pivotal trials were inadequately reported. There is still a need to improve the completeness and transparency in reporting DEC trials to facilitate external review and evaluation of the DEC evidence.

Background Feasibility and pilot studies are essential components of planning or preparing for a larger randomized controlled trial (RCT). They are intended to provide useful information about the feasibility of the main RCT—with the goal of reducing uncertainty and thereby increasing the chance of successfully conducting the main RCT. However, research has shown that there are serious inadequacies in the reporting of pilot and feasibility studies. Reasons for this include a lack of explicit publication policies for pilot and feasibility studies in many journals, unclear definitions of what constitutes a pilot or feasibility RCT/study, and a lack of clarity in the objectives and methodological focus. All these suggest that there is an urgent need for new guidelines for reporting pilot and feasibility studies. Objectives The aim of this paper is to describe the methods and processes in our development of an extension to the Consolidated Standards of Reporting Trials (CONSORT) Statement for reporting pilot and feasibility RCTs, that are executed in preparation for a future, more definitive RCT. Methods/design There were five overlapping parts to the project: (i) the project launch —which involved establishing a working group and conducting a review of the literature; (ii) stakeholder engagement —which entailed consultation with the CONSORT group, journal editors and publishers, the clinical trials community, and funders; (iii) a Delphi process —used to assess the agreement of experts on initial definitions and to generate a reporting checklist for pilot RCTs, based on the 2010 CONSORT statement extension applicable to reporting pilot studies; (iv) a consensus meeting —to discuss, add, remove, or modify checklist items, with input from experts in the field; and (v) write-up and implementation— which included a guideline document which gives an explanation and elaboration (E&E) and which will provide advice for each item, together with examples of good reporting practice. This final part also included a plan for dissemination and publication of the guideline. Conclusions We anticipate that implementation of our guideline will improve the reporting completeness, transparency, and quality of pilot RCTs, and hence benefit several constituencies, including authors of journal manuscripts, funding agencies, educators, researchers, and end-users.

Background Adequate reporting of adaptive designs (ADs) maximises their potential benefits in the conduct of clinical trials. Transparent reporting can help address some obstacles and concerns relating to the use of ADs. Currently, there are deficiencies in the reporting of AD trials. To overcome this, we have developed a consensus-driven extension to the CONSORT statement for randomised trials using an AD. This paper describes the processes and methods used to develop this extension rather than detailed explanation of the guideline. Methods We developed the guideline in seven overlapping stages: Building on prior research to inform the need for a guideline; A scoping literature review to inform future stages; Drafting the first checklist version involving an External Expert Panel; A two-round Delphi process involving international, multidisciplinary, and cross-sector key stakeholders; A consensus meeting to advise which reporting items to retain through voting, and to discuss the structure of what to include in the supporting explanation and elaboration (E&E) document; Refining and finalising the checklist; and Writing-up and dissemination of the E&E document. The CONSORT Executive Group oversaw the entire development process. Results Delphi survey response rates were 94/143 (66%), 114/156 (73%), and 79/143 (55%) in rounds 1, 2, and across both rounds, respectively. Twenty-seven delegates from Europe, the USA, and Asia attended the consensus meeting. The main checklist has seven new and nine modified items and six unchanged items with expanded E&E text to clarify further considerations for ADs. The abstract checklist has one new and one modified item together with an unchanged item with expanded E&E text. The E&E document will describe the scope of the guideline, the definition of an AD, and some types of ADs and trial adaptations and explain each reporting item in detail including case studies. Conclusions We hope that making the development processes, methods, and all supporting information that aided decision-making transparent will enhance the acceptability and quick uptake of the guideline. This will also help other groups when developing similar CONSORT extensions. The guideline is applicable to all randomised trials with an AD and contains minimum reporting requirements.

Background: The quality of randomized crossover studies on digestive diseases is unclear. We aimed to review crossover trials in digestive disease journals and evaluate their reporting quality and risk of bias. Methods: We searched the PubMed, Web of Science, and Scopus databases for all crossover trials in 39 digestive journals between January 2011 and September 2021. Reporting adherence was based on the CONSORT 2010 statement: extension to randomized crossover trials published in July 2019. A newly released Cochrane risk of bias tool 2.0 extension for crossover trials was applied to assess the risk of bias. Results: In total, 173 studies were included in the analysis, and 16.2% were published following the CONSORT statement extension. The crossover design was not only widely used in drug efficacy trials (48.6%) but also in endoscopic ultrasound trials (23.7%) and dietary studies (17.9%) in the field of digestive diseases. The overall reporting adherence was 37.6% for full texts and 43.4% for abstracts. The proportions of trials with low, some concerns, and high risk of bias were 13.9%, 15.6%, and 70.5%, respectively. The difference in reporting adherence and high risk of bias between pre- and post-CONSORT was not significant. Having a sample size plan, defining primary end points, and pre-registration showed higher reporting adherence and lower risk of bias than those who did not. Conclusion: These findings demonstrated the inadequate quality of randomized crossover trials for digestive diseases. Compliance with the CONSORT extension for crossover trials must be strengthened and improved (PROSPERO CRD: 42021248723).

Background The standards for reporting interventions in clinical trials of cupping (STRICTOC), in the form of a checklist and explanations for users, were designed to improve reporting of cupping trials, particularly the interventions, and thereby facilitating their interpretation and replication. Methods A group of clinical experts, methodologists, epidemiologists, and editors has developed this STRICTOC checklist through a comprehensive process, including registration of this guideline, literature review, solicitation of comments, consensus meeting, revision, and finalization. Results The STRICTOC checklist includes 6 items and 16 sub-items, namely cupping rationale, details of cupping, treatment regimen, other components of treatment, treatment provider background, and control or comparator interventions. Illustrative examples of each item are also provided. Conclusions It is intended that the STRICTOC, in conjunction with both the main Consolidated Standards of Reporting Trials (CONSORT) Statement and extension for nonpharmacologic treatment, will raise the reporting quality of clinical trials of cupping. Trial registration We have registered this study on the Enhancing the Quality and Transparency of Health Research (EQUATOR) Network: http://www.equator-network.org/library/reporting-guidelines-under-development/reporting-guidelines-under-development-for-clinical-trials/#STRICTOC .

Our aim was to determine the coverage of randomized controlled trials (RCTs) by the Consolidated Standards of Reporting Trial (CONSORT) Statement and its extensions and to evaluate the potential workload for authors to adhere to the guidelines. We identified CONSORT extensions from the CONSORT Web site. We randomly selected a sample of 1,000 RCTs indexed in PubMed in 2016 and recorded whether they were covered by CONSORT extensions for specific study designs or interventions. We evaluated the potential workload for authors by counting the number of documents and pages they have to consult to have a full understanding of the guidelines. We identified 14 extensions. Only one extension was updated concurrently with the main CONSORT in 2010, three were updated after 2–7 years, and three are still based on CONSORT 2001. Overall, 81% of RCTs are covered by relevant CONSORT guidelines; missing extensions for specific study designs were under development at the time of the search (Nov 2018). However, 6 of 10 extensions covered <2% of the trials. A median [Q1–Q3] of 4 [4–5] documents and 67 [57–78] pages should be consulted. Most RCTs indexed in PubMed are covered by the CONSORT Statement and extensions, but the potential workload for authors could be high.

Objective To assess the reporting quality of randomised controlled trials (RCTs) of massage, particularly whether necessary elements related to massage interventions were adequately reported. Methods A total of 8 electronic databases were systematically searched for massage RCTs published in English and Chinese from the date of their inception to June 22, 2020. Quality assessment was performed using three instruments, namely the CONSORT (Consolidated Standards of Reporting Trials) 2010 Checklist (37 items), the CONSORT Extension for NPT (Nonpharmacologic Treatments) 2017 checklist (18 items), and a self-designed massage-specific checklist (16 items) which included massage rationale, intervention and control group details. Descriptive statistics were additionally used to analyse the baseline characteristics of included trials. Results A total of 2,447 massage RCTs were identified, of which most (96.8%) were distributed in China. For the completeness of CONSORT, NPT Extension, and massage-specific checklists, the average reporting percentages were 50%, 10% and 45%, respectively. Of 68 assessed items in total (exclusion of 3 repeated items on intervention), 42 were poorly presented, including 18 CONSORT items, 15 NPT items, and 9 massage-specific items. Although the overall quality of reporting showed slightly improvement in articles published after 2010, the international (English) journals presented a higher score of the CONSORT and NPT items, while the Chinese journals were associated with the increased score of massage-specific items. Conclusion The quality of reporting of published massage RCTs is variable and in need of improvement. Reporting guideline “CONSORT extension for massage” should be developed.

To assess and compare the immediate and long-term change in reporting quality of randomized controlled trial (RCT) abstracts published in Pediatrics, The Journal of Pediatrics, and JAMA Pediatrics before and after the publication of Consolidated Standards of Reporting Trial (CONSORT)-abstract statement. Study had “Interrupted time-series” design. Eligible RCT abstracts were retrieved by PubMed search in two study periods from January 2003 to December 2007 (pre-CONSORT) and January 2010 to December 2014 (post-CONSORT). These abstracts were matched with the CONSORT checklist for abstracts. The primary outcome measure was CONSORT-abstract score defined as number of CONSORT items correctly reported divided by 18 and expressed as percentage. The mean percentage scores were used to compare reporting quality between pre- and post-CONSORT using segmented linear regression. A total of 424 RCT abstracts in pre-CONSORT and 467 in post-CONSORT were analyzed. A significant change in slope of regression line between two time periods (0.151 [confidence interval CI, 0.004–0.298], P = 0.044) was observed. Intercepts did not show a significant difference (−2.39 [CI, 4.93–0.157], P = 0.065). The overall reporting quality of RCT abstracts in the high-impact pediatrics journals was suboptimal (<50%); however, it improved when assessed over a 5-year period, implying slow but gradual adoption of guideline.

To describe characteristics of randomized controlled trials (RCTs) conducted using electronic health records (EHRs), including completeness and transparency of reporting assessed against the 2021 CONSORT Extension for RCTs Conducted Using Cohorts and Routinely Collected Data (CONSORT-ROUTINE) criteria. MEDLINE and Cochrane Methodology Register were searched for a sample of RCTs published from 2011–2018. Completeness of reporting was assessed in a random sample using a pre-defined coding form. Of the 183 RCT publications identified, 122 (67%) used EHRs to identify eligible participants, 139 (76%) used the EHR as part of the intervention and 137 (75%) to ascertain outcomes. When 60 publications were evaluated against the CONSORT 2010 item and the corresponding extension for the 8 modified items, four items were 'adequately reported' for most trials. Five new reporting items were identified for the CONSORT-ROUTINE extension; when evaluated, one was ‘adequately reported’, three were reported ‘inadequately or not at all’, the other ‘partially’. There were, however, some encouraging signs with adequate and partial reporting of many important items, including descriptions of trial design, the consent process, outcome ascertainment and interpretation. Aspects of RCTs using EHRs are sub-optimally reported. Uptake of the CONSORT-ROUTINE Extension may improve reporting.

Background Data collected within clinical trials often overlaps with routinely collected Health Systems Data (HSD). There is potential for HSD to reduce burdens for trials and understanding HSD use can help triallists make decisions about using HSD in future trials. However, it is unknown to what extent HSD use has been reported in trial publications, despite the development of guidelines such as ESMO-GROW and CONSORT-ROUTINE extension for reporting HSD use in trials. This study expands on work previously conducted by Lensen and colleagues (Trials 21(1):398, 2020). It aims to provide insights into how HSD use is reported in main result publications that present main trial results, before and after the release of the CONSORT-ROUTINE extension. Methods This was a systematic review of the reporting of HSD use in primary results publications of trials that accessed HSD between 2017 and 2018. Of 90 trials identified by Lensen and colleagues, those that had published primary outcome results were included in the review. Trials were excluded if (1) primary results were not yet due to be reported; (2) not yet published; (3) they were published prior to June 2017; (4) they were published in 2017, but HSD was accessed in 2018 and (5) the primary publication only reported HSD use in secondary, interim or Study Within a Trial (SWAT) analysis. Eligible publications were identified using ISRCTN, ClinicalTrials.gov, EU Clinical Trials Registries, PubMed and Embase. The reporting of HSD use was compared against expectations for reporting outlined in the CONSORT-ROUTINE extension. Results Forty-nine primary publications from 46 trials were included in the review . Overall, none of the included publications reported all the information suggested in the CONSORT-ROUTINE. However, there has been an improvement in the reporting of HSD use, since the publication of the CONSORT-ROUTINE guidelines. Conclusions Reporting of HSD use has improved over time. However, it still does not meet the expectations set out in the CONSORT-ROUTINE extension. Triallists should be encouraged to provide further information in publications about the use of HSD as per the CONSORT-ROUTINE extension guidelines. This would allow greater transparency in reporting, facilitating effective HSD use in future trials.