Reporting guidelines under development for clinical trials
Reporting guidelines under development for clinical trials and CONSORT extensions
(year of development in brackets)
Factorial Design RCTs (2017)
Nutritional interventions (2018)
Multicenter Clinical Trials (2018)
ARRIVE for Acupuncture (2018)
Rehabilitation: RCTRaCk (2019)
CONSORT-iNeurostim Extension (2021)
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 in Q2-3 2014. A Consensus meeting was held 16 September 2014. The evidence synthesis, Delphi survey and international consensus have been completed. The checklists have been finalized (available on request). CONSORT-C Statement and Explanation and Elaboration document will be published in Q2 2021.
Details from the systematic review can be found here: Clyburne-Sherin AVP, Thurairajah P, Kapadia M.Z, Sampson M, Chan WWY, Offringa M (2015). Recommendations and evidence for reporting items in pediatric clinical trial protocols and reports: two systematic reviews – BMC Trials, 16: 417.
- Contact: Dr Martin Offringa, firstname.lastname@example.org
This project aims to develop a comprehensive set of reporting guidelines for home visiting that improve and enhance the accuracy of reporting home visiting intervention evaluations. Specifically, the reporting guidelines focus on: (1) reporting effectiveness and efficacy studies, (2) incorporation of study designs endorsed by the Home Visiting Effectiveness of Evidence (HomVEE), and (3) inclusion of more thorough guidelines for reporting home visiting intervention design and implementation data.
- Contact: Lance Till. E-mail: Till@jbassoc.com
The guideline aims to provide items to use in the reporting of randomised controlled trials in which chronic medication is discontinued. The guideline can be used as an addition to the CONSORT statement.
- Contact: J.W.Blom, MD, PhD. E-mail: J.W.Blom@lumc.nl
Guidance to help trials teams design surgical interventions in RCTs – to supplement information from CONSORT-NPT, SPIRIT and TIDieR.
- Contact: Natalie Blencowe. E-mail: email@example.com
“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) and the needs of policymakers in Canada. As director of the knowledge translation component of the CIHR FRQS MSSS Quebec SPOR SUPPORT unit, we have been asked by policymakers 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 policymakers 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 about 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 guideline on scaling up trials.”
The group will draw the needed resources from the Canada Research Chair and explore if the same can be done with resources from the CIHR FRQS MSSS Quebec SPOR SUPPORT unit (post-doctoral student).
Read the project protocol.
- Contact: France Legare. E-mail: firstname.lastname@example.org
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.
Research to establish reporting practices in cluster randomised crossover trials has been published in the following article: Arnup SJ, Forbes AB, Kahan BC, Morgan KE, McKenzie JE. The quality of reporting in cluster randomised crossover trials: proposal for reporting items and an assessment of reporting quality. Trials. 2016; 17(1):575. PMID: 27923384
Funded by CIHR Canada, the work to develop 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.
Read the project summary (PDF – Update – December 2016)
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- Contact: Dr Martin Offringa, Child Health Evaluation Sciences, The Hospital for SickKids, Canada. E-mail: email@example.com
Extension to CONSORT for trials where participants are simultaneously randomised to more than one research question.
- Contact: Brennan Kahan, firstname.lastname@example.org
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.
Read the project summary (PDF)
- Contact: Linda Kwakkenbos, PhD (Kwakkenbosl@gmail.com) or Brett D. Thombs, PhD (Brett.email@example.com)
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).
Read the study protocol (PDF)
- Contact: Josip Car, Centre for Population Health Sciences (CePHaS), Lee Kong Chian School of Medicine, Singapore. E-mail: firstname.lastname@example.org
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.
Read the executive summary (PDF)
- Contact: Michael Schlüssel. E-mail: email@example.com
Reporting of early phase dose-finding clinical trials, encompassing those with or without expansion cohorts. This guideline will cover both Phases I and Phase I/II trials in oncology and non-oncology settings.
- Contact: Professor Christina Yap, The Institute of Cancer Research. Email: firstname.lastname@example.org
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 centres. 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 developing 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 centres and avoid excessive centre 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 EQUATOR (Enhancing the Quality and Transparency of Health Research) 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 in 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.
- Contact: Prof. Zhao-Xiang Bian, Hong Kong Chinese Medicine Clinical Study Centre, School of Chinese Medicine, Hong Kong Baptist University. E-mail: email@example.com
In June 2010, “Improving Bioscience Research Reporting: The ARRIVE Guidelines for Reporting Animal Research” was published in PLOS BIOLOGY by Carol Kilkenny and has received considerable attention. Although it offered a reporting checklist for animal pre-clinical studies, there were some barriers in their applicability to acupuncture due to its specificity in terms of rationales, details of manipulation, the operation locations and different strengths of evidence compared to other health care interventions. Several studies stated that the reporting quality of animal research on acupuncture is poor. It is necessary to standardise the reporting guideline for animal research as an extended version of the ARRIVE guidelines, which has the following advantages: 1) To provide regulations for animal research developers; 2) To obtain more precise and clear guidelines for readers and experimental researchers; 3) To evaluate the reporting quality of animal research on acupuncture and improve the transparency of research reports for editors and reviewers.
The group will develop the study design according to the methodology recommended by EQUATOR Network, modified as appropriate. They will establish an international multidisciplinary group including clinical practitioners, acupuncturists, researchers of reporting guidelines on acupuncture, clinical epidemiologists and statisticians. The research team consists of three groups: the Development Group, the Delphi Panellists Group and the Advisor Group. They are currently performing a literature review to systematic review the reporting guidelines of acupuncture and case reports of acupuncture published in peer-review articles. Then they will conduct three rounds of modified Delphi surveys, a face-to-face consensus meeting, consultations with advisers, pilot tests of the draft list of reports and promotion of the checklist.
The group plans to publish the study protocol in a peer-review paper soon, and the reporting guideline in December 2021.
Institution: Hong Kong Chinese Medicine Clinical Study Centre, School of Chinese Medicine, Hong Kong Baptist University
- Contact: Yuting Duan. E-mail: firstname.lastname@example.org
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 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).
Contact: Steffany Moonaz. E-mail: email@example.com
Maryland University of Integrative Health, Laurel, Maryland, USA
The aim of the RCTRaCk is to expand the existing CONSORT (Consolidated Standards of Reporting Trials) for Non-Pharmacological Treatment Studies checklist with a set of items that directly address the reproducibility of rehabilitation research, and involving clinical and observational trials.
The group had a discussion on the methodological problems in rehabilitation research during a meeting held in Paris, France, in July 2018 (the Cochrane Rehabilitation Methodological Meeting). After a scoping review of the literature, a second meeting, held in Kobe, Japan, in June 2019, the group discussed the project of creating a reporting guideline as an extension of CONSORT, aimed for complex interventions in rehabilitation.
Eight Technical Working Groups were created and will carry on further literature reviews for building a first list of items of a checklist. The draft will be discussed in a Consensus Conference in Orlando, United States, in March 2020. Delphi rounds for refinement of the preliminary items will be carried out afterwards.
The group intends to publish the reporting guideline in 2021, as an open-access document.
- Contact: Stefano Negrini – Cochrane Rehabilitation. The University of Brescia – IRCCS Fondazione Don Gnocchi Milan (Italy). E-mail: firstname.lastname@example.org
Journal editors, methodologists and researchers of real-world trials have gathered in a group led by Hong Kong Chinese Medicine Clinical Study Centre, Hong Kong Baptist University, and started developing a reporting guideline for this type of study. The group plans to conduct a literature review, that started in August 2019 and establish an international multidisciplinary team, including a Development Group, a Delphi Panellists Group and an Advisory Group. They will run three rounds of modified Delphi surveys, face-to-face consensus meetings, consultations with advisors, pilot tests of the draft list of checklist items. The group plans to publish the reporting guideline, as an open-access document, in 2020.
- Contact: Professor Zhaoxiang Bian, Hong Kong Chinese Medicine Clinical Study Centre, School of Chinese Medicine, Hong Kong Baptist University. E-mail: email@example.com
This reporting guideline will help authors to better describe case studies in the context of complex interventions (and these may include clinical trials, observational studies e other types). The group plans to address these issues: case study theory; theoretical perspectives on context and the relationship with case-study design; generalising from case studies; designing case studies; conducting, analysing and reporting a case study. The group intends to include examples of good reporting.
The development of the tool involves a wide-ranging literature review, a Delphi survey and pilot testing. The group plans to publish the reporting guideline as an open-access document at the end of 2020. Within the guidelines, there will also be a discussion of quality principles which are both for guiding authors on writing and for guiding editors on quality assessment.
- Contact: Dr Sara Shaw. Nuffield Department of Primary Care Health Sciences,
University of Oxford Radcliffe Observatory Quarter. E-mail: firstname.lastname@example.org
AGREE II (Appraisal of Guidelines for Research and Evaluation) is a framework for developing, appraising and reporting clinical practice guidelines. The group involved in the development of this reporting guideline extension has hypothesised that the original AGREE II document may not be fully relevant to surgical clinical practice guidelines. They performed a structured review in 2018 to identify clinical practice guidelines published in a 10-year period in the field of surgery. A Delphi process was conducted to develop the extension document. The group has published the protocol for the development of the guideline as an open-access paper.
The executive group consists of surgeons, members of surgical quality and research boards, guideline developers, evidence synthesis experts, GRADE methodologists, biostatisticians, and 2 leaders of the AGREE Group.
They plan to publish the explanation and elaboration manuscript as an open-access paper in the Winter of 2021.
- Contact: Stavros A. Antoniou, MD. European University Cyprus, Nicosia, Cyprus, and Mediterranean Hospital of Cyprus, Limassol, Cyprus. E-mail: email@example.com
Recently, there is an increasing number of clinical trials about the efficacy and safety of TCM-based Tuina as well as different types of CAM-based massage interventions (e.g., Japanese massage, Thai massage). However, the developers state that reporting quality of these clinical trials is not optimal due to the inadequate reporting of intervention details and relevant rationale and background of selected intervention(s). To address this inadequacy, the reporting guideline of STRICTOTM will be developed to include a checklist of the necessary information on clinical trials with massage interventions, especially for TCM-based Tuina (Chinese massage). Other massage types or non-pharmacological interventions that include massage could refer to this guideline as a base to report.
The developers hope that this checklist could be a useful tool for reporting a broad range of clinical studies with Tuina or massage intervention, not limited to the RCTs (e.g., uncontrolled outcome studies, case reports, etc.).
The project started in 2019 and is currently focused on the literature review and the extraction of initial items.
- Contact: Prof. Zhao-Xiang Bian, Hong Kong Chinese Medicine Clinical Study Centre, Chinese EQUATOR Centre, School of Chinese Medicine, Hong Kong Baptist University, firstname.lastname@example.org.
The CONSORT-Path Core Delivery and Advisory groups propose to create an extension to the CONSORT statement to define the minimum reporting of pathology items within a study.
The guideline development process follows the methodology recommended by the EQUATOR network and will consist of the following phases:
- A systematic review of existing guidance relating to the practice of pathology within clinical trials and the creation of a unified item list.
- Consensus modified Delphi process informed by the systematic review unified item list.
- Final consensus meeting. An international group of diverse stakeholders, including clinical trialists of all specialities, regulators, journal editors, industry and patient partners will produce the final elements defining the CONSORT-Path standards. Planned for Autumn 2020.
- Contact: Dr Tim Kendall, the University of Edinburgh Centre for Inflammation Research, University of Edinburgh, Tim.Kendall@ed.ac.uk or Dr Max Robinson, Cellular Pathology, The Newcastle upon Tyne Hospitals NHS Foundation Trust, email@example.com
Combinations of the types of resistance exercise (e.g. using different equipment) and training parameters (such as intensity, rest interval, and movement velocity) are limitless and complicated. Many published studies describe the types of exercise and parameters incompletely and/or opaquely, which can make the practical application, research replication and comparison between studies difficult.
The authors of this reporting guideline focussed on resistance training are two PhD students and a supervisor from the Department of Physical Education, National Taiwan Normal University, who plan to perform a systematic review of the literature regarding the topic and then select applicable items, adapting or modifying them from published reporting guidelines. They do not plan a Delphi survey or consensus meetings. The PRIRES checklist is developed to be used alongside another reporting guideline or as a standalone checklist.
The authors plan to finish and publish this guideline in an open-access journal in May 2021.
- Contact: Ting-Yu Lin (firstname.lastname@example.org), Ting-Yu Chueh and Dr Tsung-Min Hung
This reporting guideline will cover the reporting of the placebo device used in clinical trials with acupuncture as the main intervention. The purpose of the authors is to promote an accurate and comprehensive understanding of the possible placebo effects obtained with the experiment.
The working group has finished a review on clinical trials using acupuncture and plan to start a three-round Delphi study to reach a consensus on a checklist containing items in six categories:
– Type of placebo needle
– Details of sham needling
– Location of sham needling
– Treatment regimen
– Protocol and settings.
The group plans to publish the reporting guideline, as an open-access paper, by June 2021.
- Contact: Ye-Seul Lee (College of Korean Medicine, Gachon University), Myungsoo Lee (Korea Institute of Oriental Medicine), Younbyoung Chae (College of Korean Medicine, Kyung Hee University) – email@example.com
The CONSORT authors plan to update the CONSORT 2010 Statement, which includes a 25-item checklist and the flow diagram. The 2022 CONSORT update will provide guidance for reporting all randomized, controlled trials but focuses on the most common design type—individually randomized, 2-group, parallel trials. Other trial designs, such as cluster randomized trials and noninferiority trials, require varying amounts of additional information. They plan to also update the explanation and elaboration article, which explains the inclusion of each checklist item, provides methodological background and gives published examples of transparent reporting.
The CONSORT and SPIRIT groups have merged, and the resulting combined group will update both guidelines simultaneously. The individuals in SPIRIT-CONSORT are An-Wen Chan, Kenneth Schulz, David Moher, Asbjørn Hróbjartsson, Isabelle Boutron, and Sally Hopewell. They started development in 2019 and are currently conducting a comprehensive literature search for evidence. As part of the development process, they will organize an international face-to-face consensus meeting. With the COVID-19 pandemic, they do not believe they can hold that meeting until late 2021. Thus, at present, they plan to publish the materials in 2022 as open access documents.
- Dr David Moher. E-mail: firstname.lastname@example.org
This project aims to develop an extension to the CONSORT 2010 statement for clinical trial reports of implantable neurostimulation devices. Implantable neurostimulation devices include for example deep brain stimulation, occipital nerve stimulation, sacral nerve stimulation and spinal cord stimulation (SCS) and can be used for the management of several clinical indications. Recent systematic reviews show that methodological and reporting deficiencies in trials of SCS were common.
The CONSORT-iNeurostim extension will be developed through a funded staged consensus process involving literature review for the generation of candidate items, a two-stage Delphi survey and a two-day face-to-face (or videoconference) consensus meeting. The group plans to publish the reporting guideline as an open-access document in February 2022. They are also involved in another reporting guideline under development on the same topic but focused on protocols, an extension to the SPIRIT reporting guideline.
- Contact: Rui Duarte, Liverpool Reviews and Implementation Group, University of Liverpool. email@example.com
Studies within a Trial (SWATs) are an efficient way of testing recruitment and retention interventions in an ongoing randomised controlled trial. SWATs need to concisely report the methodological information and results that are essential when reporting an RCT to enable the results to enter into an aggregate meta-analysis of the same intervention. The objective of this project is to describe a new concise, methodologically robust reporting format for SWATs with fewer than 1000 or 1500 words, keeping with CONSORT guidelines, for researchers publishing randomised recruitment and/or retention SWATs to use.
The guidelines have been developed in collaboration with the PROMETHEUS and Trial Forge teams. The PROMETHEUS team at the York Trials Unit, University of York, drafted initial guidelines. A meeting was held in July 2019 where the guidelines and the reporting of SWATs were discussed with the wider PROMETHEUS team. Two concisely reported SWAT manuscripts were examined and it was agreed by consensus that the methodological information included was sufficient to recommend the robust publication of the randomised SWATs and inclusion into an aggregate meta-analysis. Following this meeting, the guidelines were redrafted with specific input from the team who developed the original guidelines on publishing embedded trials before recirculating them to the wider PROMETHEUS and Trial Forge teams for review.
The group plans to publish the reporting guideline in May 2021, as an open-access document.
- Contact: PROMETHEUS group, firstname.lastname@example.org; Laura Clark, University of York, email@example.com; Catherine Arundel: Catherine.firstname.lastname@example.org
Page last updated on 23 September 2021