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Reporting guidelines under development for clinical trials

Reporting guidelines under development for clinical trials and CONSORT extensions

(year of development in brackets)

 

CONSORT extensions:

Stepped wedge cluster randomised controlled trial (2014)

Trials in Child Health: CONSORT-C (2014)

Adaptive designs (ACE) (2016)

Cluster randomised crossover trials (2017)

Multi-arm parallel RCTs (2017)

Factorial Design RCTs (2017)

Trials Conducted in Existing Data Structures (2017)

Early phase dose-finding clinical trials (2018)

N-of-1 trials for Traditional Chinese Medicine (2018)

Nutritional interventions  (2018)

Multicenter Clinical Trials (2018)

 

 

Other clinical trials reporting guidelines:

AGREMA: a guideline for reporting mechanism evaluations in randomised controlled trials (2016)

Instrument for reporting of Planned Endpoints in Clinical Trials (InsPECT) – An evidence and consensus based reporting tool (2017)

Standards for Reporting of Digital Health Education Intervention Trials (STEDI) (2017)

SUCCEED/SUCCÈS: Standards for reporting trials assessing the impact of scaling up interventions of evidence based practices (2017)

 

 

 

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Consort extension to stepped wedge cluster randomised controlled trials

To develop an extension to the reporting guidelines for parallel cluster trials and produce recommended reporting guidelines for stepped wedge cluster randomised controlled trials.

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CONSORT Extension for trials in Child Health: CONSORT-C (registered 22 September 2014)

An official extension of the CONSORT 2010 Statement for reporting randomised controlled trials in children is currently under development. A Delphi process to generate possible reporting standards for the guideline has taken place in 2009-2010. A systematic review of the literature was conducted Q2-3 2014. A Consensus meeting was held 16 September 2014.

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Adaptive designs CONSORT Extension (ACE) (registered 4 November 2016)

The aim is to develop reporting guidance to cover randomised trials that are designed using an adaptive design. This will encompass studies investigating the efficacy and effectiveness of investigative interventions on humans using either frequentist or Bayesian approach; phases 2, 2/3, and 3.

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AGREMA: a guideline for reporting mechanism evaluations in randomised controlled trials (registered 18 August 2016)

Studies investigating causal mechanisms from randomised controlled trials (RCTs) are becoming increasingly common. Despite growing numbers of publications and trialist embedding mechanism evaluations into RCTs, the reporting accuracy and consistency of mechanism studies is suboptimal. The heterogeneity in the reporting of mechanism evaluations stifles systematic reviews, complicates meta-analyses, and limits transparency and replication. The aim of this initiative is to develop a reporting guideline for mechanism evaluations in RCTs.

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CONSORT Extension for Trials Conducted in Existing Data Structures (registered 27 April 2017, updated 6 October 2017)

The objective of the proposed project is to develop a consensus driven guideline to improve the reporting of trials conducted in existing data structures, including researcher-generated cohorts, registries, electronic health records, and administrative databases. This will be done as an extension of the Consolidated Standards of Reporting Trials (CONSORT) for trials conducted in existing data structures.

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CONSORT extension for cluster randomised crossover trials (registered 23 June 2017)

This reporting guideline is being developed for cluster randomised crossover trials (CRXO). CRXO trials involve random assignment of groups of individuals (clusters) to a sequence of interventions, where each cluster receives each intervention in a separate period of time. A formal consensus process will be undertaken to refine and agree upon reporting items. Methodologists, trialists and statisticians will be engaged in this process. The development of the reporting guideline is funded through an Australian National Health and Medical Research Council project grant.

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CONSORT statement: extension to multi-arm parallel RCTs (registered 6 July 2017)

Multi-arm trials that use a parallel group design but have three or more groups are relatively common. The quality and emphasis of the reporting of multi-arm trials varies greatly, making judgements and interpretation difficult. Whilst almost all the elements of the CONSORT Statement apply equally to multi-arm trials some elements need adaptation, and in some cases additional issues need to be discussed.

This document presents an extension to the 2010 version of the CONSORT Statement for reporting multi-arm trials, with a view to facilitating the reporting of such trials. The CONSORT extension for multi-arm trials extends ten items on the CONSORT 2010 checklist and provides examples of good reporting and an evidence-based rationale for the importance of each extension item.

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CONSORT for Factorial Design RCTs (registered 18 September 2017)

Extension to CONSORT for trials where participants are simultaneously randomised to more than one research question.

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Instrument for reporting of Planned Endpoints in Clinical Trials (InsPECT) – An evidence and consensus based reporting tool (registered 18 November 2015, update June 2017)

Funded by CIHR Canada, the work to develop a new evidence and consensus based reporting checklist for primary outcomes in clinical trial protocols and reports has started in April 2017. Clinical trialists, evidence end-users including systematic reviewers, and those involved in reporting guidelines development would be major beneficiaries of this checklist. It is the next step forward in current efforts to produce and harmonize transparent and reproducible RCT protocols and reports.

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Standards for Reporting of Digital Health Education Intervention Trials (STEDI) (registered 6 October 2017)

Digital health education is an umbrella term encompassing a broad spectrum of educational interventions characterised by their technological contents, learning objectives/outcomes, measurement tools, learning approaches and delivery settings used for health. These interventions, although varying greatly in content and quality, are widely evaluated in randomised controlled trials (RCTs).

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SUCCEED/SUCCÈS: Standards for reporting trials assessing the impact of scaling up interventions of evidence based practices (registered 3 March 2017)

This proposed reporting guideline is born out of our work in the field of implementing large scale evidence based practices. We are currently involved in 3 systematic reviews of scaling up trials, one that we lead (see Effective interventions for scaling up evidence-based practices in primary care: a systematic review https://www.crd.york.ac.uk/PROSPERO/display_record.asp?ID=CRD42016041461) and the needs of policy makers in Canada. As director of the knowledge translation component of the CIHR FRQS MSSS Quebec SPOR SUPPORT unit, we have been asked by policy makers to provide evidence of effective scaling up intervention. However, up to this point we observed very poor reporting. As concluded in one of our reports, “there are still many gaps in the science of scaling up in real-world health care settings”. These gaps are hampering policy makers as well as system managers, to ensure that the vast majority can benefit from the favourable impact of EBP. Canada is perceived as a country of perpetual pilot projects and there is a mounting frustration of not getting the return on investment of the billions of dollars spent on research in this country. The scaling-up of evidence-based practice (EBP) is a relatively new emerging concept in health. Although there is no definitive agreed upon definition, the World Health Organization defines it as deliberate efforts to increase the impact of successfully tested health innovations (EBP) so as to benefit more people and to foster policy and programme development on a lasting basis. Yet, there is a persistent failure to scale up EBPs, especially in high-income countries. Our ongoing systematic review on effective strategies for scaling up EBP in primary care, identified 25 studies. We observed the following gaps in knowledge: a) poor reporting; b) lack of a clear measure of the scaling up outcome (i.e., a measure of coverage with a numerator – the number of units covered by the EBP and a denominator – total number of units targeted); c) unclear distinction between the EBP and the strategies used to scale up the EBP; d) lack of rigorous studies from high income countries; d) poor representation of primary care clinical contexts; e) little assessment of potential harms; and f) absence of patients and public engagement in designing the scaling up strategies. Therefore, we would like to address the lack of a specific reporting guidelines on scaling up trials.

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CONSORT extension for RCTs of nutritional interventions (registered 12 April 2018)

This evidence-based and consensus-driven reporting guideline is being developed for randomised controlled trials (RCTs) of nutritional interventions. Although almost all of the elements in the CONSORT Statement apply equally to the reporting of RCTs of nutritional interventions, some elements need adaptation and additional specific issues must be discussed.
The consolidated standards of reporting trials of nutritional interventions is an official extension to the CONSORT 2010 checklist and will provide examples of good reporting for each item, with explanations for each adaptation and additional item.
Interested stakeholders should contact the project team to get involved in the development and dissemination of this reporting guideline.

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CONSORT extension for early phase dose-finding clinical trials (registered 28 August 2018)

Reporting of early phase dose-finding clinical trials, encompassing those with or without expansion cohorts. This guideline will cover both Phase I and Phase I/II trials in oncology and non-oncology settings.

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CONSORT Extension for reporting N-of-1 trials for Traditional Chinese Medicine (CENT for TCM) (registered 28 August 2018)

Traditional Chinese Medicine (TCM) is characterized as the Pattern differentiation and treatment, and N-of-1 trial for TCM reveals the core concept of individualized treatment. The quality and emphasis of the reporting N-of-1 trial for TCM varies. Items in CONSORT Extension for reporting N-of-1 Trials (CENT) need adaptation to TCM and elements especially relevant to TCM need to be discussed and elaborated.
This document presents an extension to the 2015 version of CENT for reporting N-of-1 trial for TCM. CENT for TCM includes a checklist of 26 items on the basis of CENT and an evidence-based rationale for the necessity of each extension item.

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CONSORT Extension for Multicenter Clinical Trials 2020: Recommendations, Explanation, and Elaboration (registered 12 November 2018)

With the encouragement of the policy on drug and medical device innovation, multicenter clinical trials and multiregional clinical trials are facing an unprecedented opportunity. Trials with a multicenter design are far more common now than before. However, we need to recognize that there are still some shortcomings in current multicenter trials, especially in terms of heterogeneity between study centers. Thus, it is urgent to develop an extension of the CONSORT statement which aims to improve the overall quality of multicentre clinical trials.

Trials quality relies on design, implementation and reporting. Therefore, the scope of this reporting guideline includes develop design, implementation and reporting checklists of multicentre clinical trials. Based on the summary of problems and challenges in current multicentre trials, the guideline of CONSORT Extension for Multicentre Clinical Trials 2020 aims to provide corresponding solutions with the aim to reduce heterogeneity between study centers and avoid excessive center effect in treatment. We hope that this reporting guideline will influence design methods of multicentre trials, improve the quality of trials, and promote better reporting.

Firstly, our working group of CONSORT Extension for Multicenter Clinical Trial plan to register the project on the Enhancing the Quality and Transparency of Health Research (EQUATOR) Network. Secondly, we will draft the original items of this reporting guideline based on a survey of the current status of multicentre clinical trials. We will use the CONSORT statement as a starting point, and conduct this study referring to other CONSORT extension reporting guidelines. Thirdly, the process of items collection will consist of several methods: (1) collecting and framing the initial items, (2) scoring and selecting the items by experts through Delphi consensus; (3) discussing and approving the checklist in a face-to-face meeting; (4) revision: the advisory experts provide comments to revise the checklist; and (5) testing: pilot tests will be applied to seek feedback to refine the final checklist. The project has started from 2017, and the current status focused on project registration, baseline survey and draft initial items.

The group plans to publish the reporting guideline in 2020, as an open access document.

 

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Page last updated on 15 November 2018