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)
Factorial Design RCTs (2017)
Nutritional interventions (2018)
RIGHT for Acupuncture (2018)
Multicenter Clinical Trials (2018)
ARRIVE for Acupuncture (2018)
Artificial Intelligence (2019)
Rehabilitation: RCTRaCk (2019)
Cupping: STRICTOC (2019)
The IDEAL (Idea, Development, Exploration, Assessment and Long term follow up) framework (1,2) allows for the phased and sequential development of surgical innovation, optimizing patient safety as the evidence-base builds in a controlled and purposeful manner.
These guidelines aim to improve the completeness of reports and protocols for IDEAL Prospective Development Studies (PDS – phase 2a) and Prospective Exploration Studies (PES – phase 2b).
McCulloch P, Altman DG, Campbell WB, et al, for the Balliol Collaboration. No surgical innovation without evaluation: the IDEAL recommendations. Lancet. 2009; 374: 1105–12. PMID: 19782876
2. Hirst A, Philippou Y, Blazeby J, Campbell B, Campbell M, Feinberg J, Rovers M, Blencowe N, Pennell C, Quinn T, Rogers W, Cook J, Kolias AG, Agha R, Dahm P, Sedrakyan A, McCulloch P. No Surgical Innovation Without Evaluation: Evolution and Further Development of the IDEAL Framework and Recommendations. Ann Surg. 2018. PMID: 29697448
Read the guideline development protocol (25 June 2018)
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 Q3 2019.
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.
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.
This guideline is intended as an extension or add-on to other guidelines for specific research designs. It addresses how orthotic interventions should be reported within the context of any given quantitative study design.
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.
Guidance to help trials teams design surgical interventions in RCTs – to supplement information from CONSORT-NPT, SPIRIT and TIDieR.
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 are 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 aim is to develop reporting guidance to cover randomised trials that are designed using 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.
Read the ACE Project Protocol
Read about the development process published in this paper: Dimairo M, Coates E, Pallmann P, Todd S, Julious SA, Jaki T, Wason J, Mander AP, Weir CJ, Koenig F, Walton MK, Biggs K, Nicholl J, Hamasaki T, Proschan MA, Scott JA, Ando Y, Hind D, Altman DG. The development process of a consensus-driven CONSORT extension for randomised trials using adaptive design. BMC Med. 2018 Nov 16;16(1):210. doi: 10.1186/s12916-018-1196-2. PubMed PMID: 30442137; PubMed Central PMCID: PMC6238302.
“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.”
Additional information here. 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).
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 (Update – December 2016)
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Extension to CONSORT for trials where participants are simultaneously randomised to more than one research question.
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
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
Development of a guideline to strengthen transparent and comprehensive reporting of quantitative measurement of unfinished nursing care (also known as missed care, implicit rationing of care, care left undone, tasks left undone). Embedded in the EU-COST Action 15208 (www.rancare-action.eu). This guideline should be considered in addition to the guideline specified for the underlying study’s design (e.g. STROBE).
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
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.
In 2017, the International Standard for Reporting Items for practice Guideline in HealThcare (RIGHT) statement was published to enhance transparency and clarity in the process of developing clinical practice guidelines. Although there was a reporting checklist for health care guidelines, there were some barriers in their applicability to acupuncture due to its specificity in terms of manipulations, locations and channels compared to other health care interventions. It is necessary to standardize the reporting checklist for clinical practice guidelines on acupuncture.
This reporting guideline will be prepared as an extended version of the RIGHT, which has the following advantages: 1) To provide regulations for guideline developers; 2) To obtain more precise and clear guidelines for readers and clinical practitioners; and 3) To evaluate the reporting quality of clinical practice guidelines on acupuncture and improve the transparency of research reports for editors and reviewers
The study design will refer to the methodology recommended by the EQUATOR (Enhancing the QUAlity and Transparency Of health Research) Network, modified as appropriate. A literature review will be conducted, and an international multidisciplinary team, including a Development Group, a Delphi Panellists Group and an Advisory Group, will be established. Three rounds of modified Delphi surveys, face-to-face consensus meetings, consultations with advisors, pilot tests of the draft list of reports and promotion of the checklist are designed. The group plans to update the reporting guideline regularly.
Institution: Clinical Research Center, South China Research Center for Acupuncture and Moxibustion, Medical College of Acu-Moxi and Rehabilitation, Guangzhou University of Chinese Medicine
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.
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 strength 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; and 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 on December 2021.
Institution: Hong Kong Chinese Medicine Clinical Study Centre, School of Chinese Medicine, Hong Kong Baptist University
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 benefits 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 the development of the guideline include:
1. Background document
2. Reviewing the literature
3. Generate a long list of placebo/sham components
4. Delphi survey and consensus meeting
5. Developing and refining accompanying guide
6. Publishing and disseminating results
The 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.
Read the TIDieR Placebo Protocol
Background paper: Howick J, Hoffmann T. How placebo characteristics can influence estimates of intervention effects in trials. CMAJ. 2018;190(30):E908-E911. PMID: 30061325
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
More than 4000 peer-reviewed scientific papers are published in the artificial intelligence (AI) field every year. 110 clinical trials under the topic of AI was registered on ClinicalTrials.gov in 2018 alone. The CONSORT (Consolidated Standards of Reporting Trials) Statement aims to improve the reporting of randomised controlled trials (RCTs), however there are distinct challenges in AI interventional trials (such as transparency and description of the algorithm, availability of data, description and replicability of the human-AI interaction and quality control of the algorithm) which are not addressed by the current guidance. Given the rapid expansion of research in this area, there is an urgent need for guidance on the conduct and reporting of clinical trials involving AI and machine learning interventions.
This project will be conducted in 4 phases. The first phase is a systematic literature search for any existing recommendations and current practice for clinical trials of AI interventions. Phase 2 formalises the CONSORT-AI steering group and engagement with international experts and the CONSORT group for the consensus process. Phase 3 will be a modified Delphi process with the wider expert group to achieve consensus on items that should be included in the CONSORT-AI extension. Phase 4 will be the consensus meeting. After which there will be a consultation period for final feedback and revisions before the publication of the CONSORT-AI standards.
The group plans to publish the reporting guideline by March 2020, in an open-access journal.
Steering Group: Professor Alastair Denniston, Professor Melanie Calvert, Dr Christopher Yau, Professor David Moher, Professor An-Wen Chan, Dr Pearse Keane, Professor Lucas Bachmann, Professor Chris Holmes, Dr Sebastian Vollmer, Dr Xiaoxuan Liu, Dr Livia Faes
Contact: Professor Alastair Denniston (University Hospitals Birmingham NHS Foundation Trust, and Academic Unit of Ophthalmology, Institute of Inflammation and Ageing, College of Medical and Dental Sciences, University of Birmingham) or Dr Xiaoxuan Liu (University Hospitals Birmingham NHS Foundation Trust, and Academic Unit of Ophthalmology, Institute of Inflammation and Ageing, College of Medical and Dental Sciences, University of Birmingham).
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, on 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.
Concerns with the quality of the reports on trials using cupping (a form of alternative medicine) as the intervention led a group in the Hong Kong Baptist University, School of Chinese Medicine, to start developing a reporting guideline in 2017. The planned developing process includes a systematic review on clinical trials on cupping therapy, a drafted checklist, a consensus meeting for the checklist approval, the preparation of documents of explanation and elaboration and dissemination. Six items have already been defined: cupping rationale, details of cupping, treatment regimen, other components of treatment, treatment provider background, and control or comparator interventions. There will be 17 subitems. The group plans to publish the reporting guideline as an open-access document in 2020.
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 on 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.
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.
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 have already performed a structured review in 2018 to identify clinical practice guidelines published in a 10-year period in the field of surgery (Antoniou SA et al. Ann Surg. 2019. doi: 10.1097/SLA.0000000000003036). They have also been working on exploring the reliability and internal consistency of AGREE II and using a Delphi process to develop the extension document.
The executive group consists of surgeons, members of surgical quality and research boards, guideline developers, evidence synthesis experts, GRADE methodologists, biostatisticians, and 2 leads of the AGREE Group.
They plan to publish the explanation and elaboration manuscript as an open-access paper in the Winter of 2020.
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 of traditional medicines, or non-pharmacological interventions that include massage, could refer 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.
Page last updated on 21 February 2020
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