Enhancing the QUAlity and Transparency Of health Research
Reporting guidelines under development for clinical trials and CONSORT extensions
(year of development in brackets)
Adaptive designs (ACE) (2016)
Multi-arm parallel RCTs (2017)
Factorial Design RCTs (2017)
Nutritional interventions (2018)
Multicenter Clinical Trials (2018)
Other clinical trials reporting guidelines:
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.
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.
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.
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.
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.
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.
Extension to CONSORT for trials where participants are simultaneously randomised to more than one research question.
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.
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).
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.
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.
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.
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.
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.
The Template for Intervention Description and Replication (TIDieR) is a checklist and guide to describing interventions used in clinical trials. It was developed because (active) interventions used in trials were often not described in sufficient detail to be replicated. Not surprisingly the TIDieR has received most of its uptake from non-drug trials, in which the replication of complex psychosocial interventions greatly benefit from this detailed reporting.
However, the TIDieR does mention placebo controls, and that trial reports should contain complete information about placebo control characteristics. Yet, placebo controls are still not well described according to the TIDieR, and there are some characteristics of placebo controls that are important to report, but are not required by the original TIDieR checklist. These include characteristics such as whether the placebo control was similar to the experimental intervention. In a previous study, we found that poor reporting of placebo control can lead to over- or under-estimation of experimental intervention benefits and harms (see Background paper). In order for trials that use placebo controls to be adequately reported, the original TIDieR needs to be adapted to create a reporting guideline that is specific for placebo controls.
The TIDieR-Placebo project team comprises of 12 members, all with experience of producing, publishing, evaluating, or reviewing reporting guidelines, and/or with extensive knowledge of placebo control interventions (including psychological placebos, sham surgery, and sham acupuncture). Steps towards development of the guideline include:
1. Background document
2. Reviewing the literature
3. Surveying placebo experts
4. Testing identified placebo characteristics
5. Delphi survey and consensus meeting
6. Developing and refining accompanying guide
7. Publishing and disseminating results
Development of the TIDieR–Placebo started in July 2018 with the publication of the background document. Current status: Reviewing the literature on the current use of TIDieR in placebo-controlled trials. The group plan to publish the guideline in October 2019 as an open access document.
The CheckList stAndardising the Reporting of Interventions For Yoga will guide the reporting of non-pharmacological interventions based on yoga. The authors plan to conduct a Delphi process with experts in the field of yoga research that starts the drafting based on on existing intervention reporting guidelines, including the Template for Intervention Description and Replication (TIDieR) and the Consensus on Exercise Reporting Template (CERT). However, the group intends to build a reporting guideline applicable to other study designs too, such as observational studies (in which yoga would be taken as an exposure).
Page last updated on 15 March 2019
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