Enhancing the QUAlity and Transparency Of health Research

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Reporting guidelines under development for other study designs

Other study designs or clinical areas:

(year of registration in brackets)

_____________

Epidemiology, primary care, public health and clinical outcomes

CRISP – Consensus Reporting Items for Research in Primary Care (2018)

REDR – REporting Design Research: proposed checklist for reporting on health research involving human-centred design (2018)

ReCoMuTe – A Checklist for Reporting Complex Multi-professional Healthcare Teamwork Training (2019)

ConPHES – Consensus-based Process evaluation reporting guidelines for public Health intErvention Studies (2020)

Checklist for Theoretical Reports in Epidemiological Studies (2020)

EBP – Evidence-Based Practice Projects in Nursing and Healthcare (2020)

Co-designing for child health (2021)

Guidelines for transparent reporting of healthcare-associated infection outbreaks (2021)

__________

Artificial intelligence and machine learning, modelling, coding, informatics

Reporting Guidelines for Public Health Non-Communicable Diseases Modelling Studies (2019)

TRIPOD-AI – Reporting of Artificial Intelligence and Machine Learning Studies(2019)

GLACIeR – Guidelines for Large-Scale, Applied Clinical Informatics Research (2019)

STARD-AI Extension – Reporting Guidelines for Diagnostic Accuracy Studies Evaluating Artificial Intelligence Interventions (2019)

STARD-AI for Abstracts Extension – Reporting Guidelines for Diagnostic Accuracy Studies Evaluating Artificial Intelligence Interventions (2020)

CLAIM – Checklist for Artificial Intelligence in Medical imaging (2020)

DECIDE-AI – Reporting guidelines for the Developmental and Exploratory Clinical Investigation of DEcision Support systems driven by Artificial Intelligence (2021)

REMARK 2021 – Reporting recommendations for diagnostic and prognostic marker studies (2021)

______

Reporting guidelines for clinical practice guidelines

ADAPT – Extension for the RIGHT statement for Reporting Adapted Practice Guidelines in Health Care: the RIGHT-Ad@pt Checklist (2019)

RIGHT-P Statement – An extension of RIGHT for clinical practice guideline protocols (2021)

RIGHT-CoI – The RIGHT extension for reporting conflicts of interest of practice guidelines in healthcare (2021)

______

Laboratory, in vitro studies and devices

CRIS Statement – Checklist for Reporting In-vitro Studies (2017)

REPORT – Reporting Recommendations for Research on Human Tissues(2019)

Reporting guidelines for Whole Body Vibration studies in humans, animals and cell cultures (2019)

______

Education and training

DOCTRINE – DevelOpment of Curricula: Tools for Reporting INnovations in Education (2018)

CONFERD-HP – Guideline for the reporting of COmpeteNcy FramEwoRk Development in Healthcare Professions (2019)

TiDIRP – Training in Dissemination and Implementation Research and Practice (2021)

______

Health economics

Checklist for the conduct and reporting of micro-costing studies in health care (2014)

CHEERS 2022 – Consolidated Health Economic Evaluation Reporting Standards 2022 (2021)

______

Surgery

SUPER – Surgical techniqUe rePorting chEcklist and standaRds (2020)

SUVIRE – SUrgical VIdeo REporting Guidelines (2021)

ICARUS – The Intraoperative Complication Assessment and Reporting with Universal Standards Guidelines (2021)

______

Qualitative studies

CHAT – CHecklist for conversation Analysis reporTing (2018)

EX-QUAL – Standards for reporting qualitative research: extension for multi-centre, multinational and multi-language studies(2019)

______

Alternative, complementary and traditional Chinese medicine

CORE for TCM – COnsolidated REporting standard of pattern differentiation and treatment for Traditional Chinese Medicine (2020)

Reporting Checklists for Diagnostic Criteria for TCM Syndromes (2021)

The PITCH Statement – Preferred Items for Reporting Case series in Homeopathy (2021)

______

Other study designs and clinical areas

PERFORM – The Principles of Evidence-based Reporting in Forensic Medicine Guidelines (2016)

DEVELOPTOOLS (2017)

MISTIC – MethodologIcal STudy reportIng Checklist – guidelines for reporting methodological studies in health research (2019)

Reporting guidelines for social network analysis studies in health research (2020)

CLUDA Guideline for clustered data (2020)

PR-Rx – Press Release Reporting Exemplar (2021)

Reporting guideline for clinical case report/series with a systematic review (2021)

RESOME – Reporting Guidelines for Social Media Interventions (2021)

Multi-purpose reporting guideline for the consideration of diversity and inclusion in academic publishing (2021)

TERRI – checklisT to improvE how infogRaphics Report the findings of comparative studies of health and medical Interventions (2021)

STEP – STandard reporting guideline of Evidence briefs for Policy (2021)

CoDe-EHR – Best practice checklist for the use of coded electronic healthcare records in clinical research (2021)

SIFHR – Social Innovation for Health Research Checklist (2021)

______

 

Checklist for the conduct and reporting of micro-costing studies in health care (registered 9 June 2014, updated 2019)

A protocol for this guideline was published in 2016: PMID 27707687.

In April 2019, the group informed EQUATOR that the reporting guideline was still under development.

 

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The Principles of Evidence-based Reporting in Forensic Medicine (PERFORM) Guidelines (registered 8 August 2016, updated 5 August 2021)

The guideline contains international consensus on the minimum items that need to be included in a forensic medical expert opinion and how they should be reported. The group reported that the guideline development finished in 2020, and is currently undergoing peer review for publication.

Read the study protocol (Word)

 

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Checklist for Reporting In-vitro Studies – CRIS Statement (registered 29 November 2017, updated 16 January 2020 and 18 November 2020)

CRIS statement is a checklist for uniform reporting across in-vitro studies involving dental materials. CRIS will also help in conducting effective systematic reviews and meta-analyses of specific topics, thus bringing out the best evidence. It includes sections that were not previously reported in in-vitro studies such as sample size calculation, sample preparation and handling, randomisation and blinded assessment and improved reporting of statistical methods and results. This checklist aims to promote transparency, reproducibility, validity, and completeness while reporting in-vitro studies involving dental materials.

The group finished compiling the Delphi results in 2019.

A website has been created, with the description of the core group, the chronology of activities and publications, here: http://www.thecris.org.

Read the concept note: Krithikadatta J, Gopikrishna V, Datta M. CRIS Guidelines (Checklist for Reporting In-vitro Studies): A concept note on the need for standardized guidelines for improving quality and transparency in reporting in-vitro studies in experimental dental research. J Conserv Dent. 2014;17(4):301-304. PMID: 25125839

 

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DEVELOPTOOLS (registered 21 June 2017)

This reporting guideline addresses the development of tools such as medical devices, physical assistive devices, eHealth and mHealth applications, patient decision aids, and other tools developed for patients to use.

Read the protocol for the systematic review on which this reporting guideline is based.

 

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DevelOpment of Curricula: Tools for Reporting INnovations in Education (DOCTRINE) (registered 16 March 2018)

The group is developing a reporting checklist for curriculum development in health professions education. The purpose of this checklist is to ensure that prospective authors report all essential elements of an educational project to allow future readers to replicate their work. The group’s review of other reporting checklists in the EQUATOR network database showed them that some checklists are specific to certain content areas (such as evidence-based practice or team-based learning), whereas this new checklist would be generalisable to any health professions educator describing their curriculum as an educational innovation.

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Consensus Reporting Items for Research in Primary Care (CRISP) (registered 28 August 2018)

The CRISP working group is an international, interprofessional, interdisciplinary team working to improve the reporting of primary care research. Globally, there are no guidelines on the reporting of primary care research. There are specific factors related to primary care research and research translation that warrant guidance in reporting. We will perform a needs assessment to identify common and important areas for improvement in reporting of primary care research. Based on this review, they will propose either extensions of existing guidelines (one or more) or a new guideline. We plan to use a transparent, explicit, iterative group process to develop guidelines that will be useful across the many methods, populations, and settings where primary care research is performed, reported, and applied.

Website: https://sites.uw.edu/crisprec/

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CHecklist for conversation Analysis reporTing (CHAT) (registered 29 August 2018)

The scope of this checklist is to enable researchers to assess the quality of conversation analytic studies. It can be used to:
(1) assess the quality of reporting, therefore facilitating systematic review and synthesis
(2) provide clear guidelines for authors to ensure that results are presented in a standardised way that maximises their external applicability

This checklist is being developed via the Delphi Consensus process, in collaboration with experts in the field of conversation analysis.

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REporting Design Research: proposed checklist for reporting on health research involving human-centred design (REDR) (registered 4 October 2018)

Publications reporting on health interventions or other health research that involves human-centred design or design thinking often omit detailed information related to methodology, ethical considerations, and evaluation details. These omissions make it difficult to assess, review, and catalogue such research across disciplines of health and biomedicine. This dearth of information in a research area that is increasingly funded by public agencies, and carried out by and with health stakeholders, presents a problem in that it hinders the ability for building an evidence base, inhibits the opportunity to diffuse innovations, and reduces the dissemination of critically important information back to the public. Many issues have resulted in this absence, including barriers of disseminating interdisciplinary research in public health and biomedical journals, lack of incentive for organizations conducting such work to publish it in the scholarly literature (many of whom exist in the private or non-academic sectors), the unfamiliarity of the wider health community with the process of research grounded in design, and a lack of rigorous guidance appropriate for scholarly work in this field. The proposed draft set of guidelines is intended to support researchers and practitioners with reporting on the planning, writing, reviewing, and interpreting of research that has used a human-centred design or design thinking. A draft checklist is intended to serve as a jumping-off point for the collaborative development of conclusive guidelines that would represent a thorough overview of consensus-based best practices for utilising design in research to improve health outcomes. Without more frequent reporting and documenting of transparent and evaluable design-based practices in scholarly literature, such research will not fulfil its potential to complement existing approaches and take further the goal of global health equity. The draft guidance would provide an initial step in a consensus-building process for the development of a more definitive set of guidelines for the conduct and review of health research using design.

Background: Bazzano AN, Martin J, Hicks E, Faughnan M, Murphy L. Human-centred design in global health: A scoping review of applications and contexts. PLoS One. 2017;12(11):e0186744. PMID: 29091935

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Reporting Guidelines for Public Health Non-Communicable Diseases Modelling Studies (registered on 28 January 2019)

Public health non-communicable diseases (NCD) modelling studies are concerned with quantifying the health impact of changes in risk factors for NCDs without directly measuring health impact. They include both health impacts models and futures models. Health impact modelling estimates the impact of changes in risk factors that relate to scenarios (e.g. policy goals), arise from interventions (e.g. policies, regulatory initiatives) or arise from public health preventative programmes (either single or multi-component programmes). The interventions or programmes being studied operate by affecting wider socio-economic determinants, environmental, behavioural or medical risk factors for NCDs. Futures models estimate the future burden of disease based on changes in risk factors. These studies include, as a direct or intermediate input to the model, changing one or more risk factors for one or more NCDs within a population according to a specified scenario or intervention. They model the change in exposures through to at least one NCD specific health outcome and/or to a general measure of health outcome (e.g. quality-adjusted life years, all-cause mortality).

The Reporting Guidelines for Public Health Non-Communicable Diseases Modelling Studies should apply to all public health models concerned with quantifying the relationship between a risk factor and health (i.e. health impact models or futures models). Models that focus on describing disease transmission (e.g. infectious disease modelling, social contagion) will be out of scope. The World Health Organization (WHO) definition of non-communicable diseases, which recognises the five major NCDs are cardiovascular diseases, diabetes, chronic respiratory diseases, cancer and mental health conditions, will be used in the development of this guideline.

The group is producing these guidelines, in part, in response to a call by the Medical Research Council in the UK. Initial consultation was taken to agree on the scope of the guidelines and establish a network of participants to support their development globally. The group will follow the five-step process outlined by EQUATOR: literature review; online consensus Delphi; expert consensus meeting (face-to-face); writing of guidelines by a small committee; dissemination.

The group is currently seeking funding to undertake the full work and plans to start the systematic review in September 2019, with a view to publishing the guidelines in 2021. They plan to publish this computer-based modelling reporting guideline, as an open-access document, in the Summer/Autumn of 2021.

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MISTIC – MethodologIcal STudy reportIng Checklist – guidelines for reporting methodological studies in health research (registered 25 February 2019)

Methodological studies are an efficient way of assessing research methods and summarising methodological issues in the conduct and reporting of health research. As part of the ongoing development of this concept and the most appropriate nomenclature, the group has established a working definition for methodological studies as “studies that appraise the design, conduct, analysis and reporting of other studies”. As such, methodological studies are seen as highly informative because they allow researchers to generate empirical evidence on the quality, completeness and accuracy of reporting; document the variety of methods used in health research studies; investigate adherence to guidelines; assess approaches to analyses; demonstrate changes in reporting over time; determine consistency between abstracts/trial registries and published articles, and many other issues. Despite an increase in their development and usage, there is limited published guidance on the conduct and reporting of methodological studies. The current body of literature shows wide inconsistencies in methodological study nomenclature and reporting practices. The aim of this guideline is to standardise the nomenclature and reporting of methodological studies in the context of health research. Based on consensus by expert stakeholders, this guideline and accompanying statement will highlight the necessary features that should be included for the complete reporting of methodological studies.

The development of this guideline started in November 2017 as follows:

Part 1 – Methodological Review: Conduct a full review to identify and describe methodological studies, and report on current methods, summarise the variety of questions being addressed, and develop a preliminary conceptual framework for methodological studies, (link to pilot study: https://pilotfeasibilitystudies.biomedcentral.com/articles/10.1186/s40814-019-0544-0);

Part 2 – Consensus Study: Establish a working group of expert stakeholders (e.g. methodologists, epidemiologists, biostatisticians, journals, guideline groups) to validate and refine the conceptual framework for methodological study nomenclature and reporting, (link to the protocol: https://bmjopen.bmj.com/content/10/12/e040478.full);

Part 3 – Publication and Dissemination: Incorporate expert feedback from the consensus meeting to finalise the methodological study reporting guideline as a checklist. This document will include the consensus statement and outline standardised criteria for appropriate methodological study terminology and reporting. The group plans to publish the reporting guideline as an open-access document by September 2021.

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Reporting of Artificial Intelligence and Machine Learning Studies (TRIPOD-AI) (registered 7 May 2019)

This guideline will be an extension to the TRIPOD Statement for prediction model studies (including imaging studies) using artificial intelligence or machine learning.

An announcement marking this initiative was published in The Lancet.

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Reporting Recommendations for Research on Human Tissues (REPORT) (registered 17 June 2019)

From a literature review, the authors identified the need for a simple guideline to improve the reporting of studies using human tissue, especially in cardiology (aortic tissue). They aim to address aspects of reproducibility and data interpretation in the new reporting guideline, especially regarding a clear description of the cohort used, the source and site of tissue sampling and sample division, patient metadata, availability of raw and processed data and study limitations.

The multidisciplinary team involved in the reporting guideline development includes computational biologists, surgeons, engineers, biobank managers, and basic scientists. They plan a two-day symposium to happen on the Summer of 2020 in Liverpool to discuss and develop preliminary guidelines, to be collated and circulated amongst the group for feedback, revisions and iterations.

The group plans to publish the reporting guideline as an open-access document by the end of 2020.

Working group: Dr Hannah Davies, Dr Jill Madine, Dr Riaz Akhtar, Mr Mark Field, Dr Hannah Levis, Dr Vijay Sharma, Dr Eva Caamaño-Gutiérrez, Dr Marie Phelan, Prof. Robert Moots, Dr Nicola Tempest

 

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A Checklist for Reporting Complex Multi-professional Healthcare Teamwork Training (ReCoMuTe) (registered 15 July 2019)

Research of protocols and results of interventions involving the training of healthcare staff need to be reported in transparent and reproducible ways. Equivocation in evidence or weak evidence as to whether complex team training interventions ultimately affect patient outcomes. Reproducibility and transparency of scientific reports are needed in order to enhance the understanding of effective design, deployment and evaluation and to inform wise decisions on investing in such interventions. The group intends to produce a checklist for reporting complex multi-professional healthcare teamwork training and plans to publish this checklist in the Fall of 2019. Then, in a second phase, an expert panel will evaluate the checklist. The adjusted checklist and the explanation and elaboration document are planned to be published in the Fall of 2020. The checklist will encompass any study design describing healthcare professionals training interventions.

 

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Guidelines for Large-Scale, Applied Clinical Informatics Research (GLACIeR) (registered 3 October 2019)

Organisations adopting various commercial health information technology (HIT) applications choose different configurations, use systems in distinct ways, and learn from mistakes during such processes. Most studies that do get published lack details on the implementation context, which prevent healthcare organisations and HIT producers from adopting best practices. A research group from Vanderbilt University Medical Center plans to develop a guideline for the reporting on collaborative applied clinical informatics projects across multiple institutions and HIT applications, such as electronic health records, computerised provider order entry systems, or clinical decision support systems.

The group plans to perform a systematic literature review, including reporting guidelines and has applied for funding. The guideline is expected to be published in 2023, as an open-access document.

 

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Extension for the RIGHT statement for Reporting Adapted Practice Guidelines in Health Care: the RIGHT-Ad@pt Checklist (registered 30 October 2019)

RIGHT-Ad@pt is an extension of the RIGHT reporting guideline, which has been developed to help authors improve the completeness and reporting quality of healthcare practice guidelines. The RIGHT-Ad@pt will take care of adapted clinical guidelines, i.e., those that are not produced de novo, but developed as adaptations of existing guidelines. This is frequent in low- and middle-income scenarios, with fewer resources to develop high quality de novo guidelines.

The working group plans to use Delphi consensus methods to develop the checklist, and to publish the reporting guideline as an open-access document around December 2020. The protocol for this reporting guideline development has been published in BMJ Open.

 

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Reporting guidelines for Whole Body Vibration studies in humans, animals and cell cultures (registered 16 December 2019)

A group of experts from several nations gathered to discuss the development or updating of reporting guidelines for studies on whole-body vibration, a therapeutic modality for the improvement of neuromuscular performance, in which subjects are exposed to vibrations through a vibrating platform. A reporting guideline was published about this in 2010. However, the group feels that it needs to be updated and expanded, with new outcomes and a better description of the parameters used (such as direction, frequency, magnitude and duration of vibrations) and items on animal and cell cultures studies and study protocols.

The Executive Group has 13 participants from several professional backgrounds. The experts have met twice to review the literature and reach an initial set of items for the reporting guideline. Three rounds of Delphi consensus were completed with 51 respondents. Another meeting is planned for June 2020 and the publication of the reporting guideline, as an open-access paper, is planned for 2021.

Contact: Dr. Marieke van Heuvelen. E-mail: m.j.g.van.heuvelen@umcg.nl

 

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Standards for reporting qualitative research: extension for multi-centre, multinational and multi-language studies (EX-QUAL) (registered 18 December 2019)

A wide range of stakeholders with differing areas of expertise in qualitative research in multi-centre, multinational and/or multi-language studies, including invited members of the development team of the original reporting guidelines, aims to develop an extension of the Standards for reporting qualitative research (SRQR) and the Consolidated criteria for reporting qualitative research (COREQ) for reporting qualitative multi-centre, multinational and multi-language studies.

The group believes that the existing standards/criteria for reporting qualitative research (SRQR and COREQ) are excellent guidelines increasingly used, but are not specific enough to sufficiently cover multi-centre, multinational and multi-language issues in qualitative studies. Transparent and standardized reporting of qualitative research results from studies being conducted in several countries including various languages will increase methodological quality and publication priority.

They plan to write a protocol, build an international task force including the developers of SRQR and COREQ, conduct a systematic review, carry out Delphi exercises and a consensus meeting. The group plans to publish the new extension in 2021 as an open-access document.

 

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STARD-AI Extension: Reporting Guidelines for Diagnostic Accuracy Studies Evaluating Artificial Intelligence Interventions(registered 18 December 2019)

The STARD (Standards for Reporting Diagnostic Accuracy) statement is a minimum set of reporting standards for studies that evaluate the diagnostic accuracy of medical interventions, published in 2003, in an attempt to ensure that studies which report diagnostic accuracy are sufficiently informative. However, studies using AI are not adequately covered by the STARD reporting guideline. There are discrepancies in the quality and size of the training datasets employed, and the metrics that are used to report diagnostic performance as well as terminology, so the generalisability and real-world applicability of diagnostic accuracy of studies using AI are hindered.

A group of experts in AI and prognostic modelling are developing an international, multidisciplinary, consensus-based, AI-specific extension to the STARD statement (STARD-AI) that will specifically focus on AI-centric clinical trials which report diagnostic accuracy.

The group has already undertaken a systematic review and gathered a steering group of experts, and now they plan to start an electronic Delphi process to achieve consensus on items that should be included in the STARD-AI extension. They plan to publish the reporting guideline, as an open-access document, in several journals, in the first quarter of 2020.

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Guideline for the reporting of COmpeteNcy FramEwoRk Development in Healthcare Professions (CONFERD-HP) (registered 20 December 2019)

This reporting guideline is intended to provide guidance on the reporting of the development of competency frameworks in healthcare professions. It will outline the key reporting items that should be reported by those who develop competency frameworks in order to improve the standard of reporting and provide consistency to the reporting process.

The research team developing the reporting guideline has already published a scoping review on the need for competency framework development in healthcare professions.

https://link.springer.com/article/10.1007/s10459-019-09946-w

They will now review the published checklists and guidelines for conducting, reporting and publishing qualitative and mixed-methods studies. An initial pool of items will be evaluated by an expert panel in a modified Delphi process. A pilot test will be conducted on a selection of the articles. The group plans to publish the reporting guideline in early 2021 at the latest, as an open-access document.

 

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Checklist for Artificial Intelligence in Medical imaging (registered 5 March 2020)

To aid authors and reviewers of AI manuscripts in medical imaging, we propose CLAIM, the Checklist for AI in Medical Imaging. CLAIM is modelled after the STARD guideline and has been extended to address applications of AI in medical imaging that include classification, image reconstruction, text analysis, and workflow optimization.
The working group, composed of an expert panel of physicians, AI researchers, and data scientists, began work in January 2019. Phase 1 involved an extensive review of the literature on artificial intelligence and medical imaging. We reviewed various best-practice guidelines for manuscript preparation and for reporting medical research. Phase 2 focused on feedback and achieving consensus with a wider expert panel that included editorial board members of Radiology: Artificial Intelligence. Phase 3 will be a consensus meeting and revisions of the guidelines before the publication of the CLAIM guideline.

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COnsolidated REporting standard of pattern differentiation and treatment for Traditional Chinese Medicine (CORE for TCM) (registered 14 May 2020)

Pattern Differentiation and Treatment (PDT) is the core of the theory and practice system of traditional Chinese medicine (TCM). It is applicable to all types of TCM clinical studies, including case reports, observational studies, randomized controlled trials, systematic reviews, and clinical practice guidelines. The group will formulate a unified reporting checklist for PDT of TCM to avoid research waste and promote the standardization of clinical research in TCM.

1. Two systematic reviews (SRs) will be conducted. One focusing on an assessment of reporting of all kinds of TCM clinical studies. Currently published reporting quality assessment reviews will be included. If necessary, we will also include reviews of reporting quality assessments of specific types of TCM clinical studies. The other review will focus on published reporting guidelines on TCM. The items which focus on TCM characteristics will be analysed. – Ongoing
2. An international multidisciplinary research team will be formed, including an advisory group, a Delphi panellists’ group and a development group. (Several academic scholars in TM from South Korea, Japan and methodologists from Mainland China, Canada and Australia have been invited.) – Ongoing
3. A reporting checklist of TM syndrome differentiation and treatment according to the results of the SRs will be drafted.
4. A three-round Delphi survey seeking comments and suggestions on the checklist will be conducted. The Delphi panellists will consist of methodologists, TM practitioners, TM clinical researchers and journal editors.
5. An international consensus meeting will be held to finalize the checklist items.
6. The checklist will be pilot-tested and revised according to the feedback from the pilot.
7. The development process, the consensus-based checklist and its explanatory documents will be published in a peer-reviewed journal.
8. The reporting checklist will be promoted by the EQUATOR website, the Chinese EQUATOR Centre WeChat Official Account, and academic conferences.

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Consensus-based Process evaluation reporting guidelines for public Health intErvention Studies (ConPHES) (registered 3 June 2020)

The aim of this project is to develop consensus- and expert-based guidelines for reporting process evaluations of public health intervention studies.

The project is divided into 7 steps:

  1. Literature search (January – May 2020) – a scoping review to identify existing guidelines for reporting a process evaluation.
  2. Consensus-building e-Delphi study (May – September 2020) – an online consensus-building e-Delphi study with an international working group of multidisciplinary experts. The full questionnaire will be pre-tested prior to administration. Reaching agreement – the traditional 9- point scale (1 = extremely irrelevant to 9 = extremely relevant). After ranking rounds, the group will organise an online consensus meeting to obtain the final consensus for the included items in the reporting guideline.
  3. Translate the results into the new guideline and an Explanation and Elaboration document (October-November 2020). Next, the group will draft a first version of the Explanation and Elaboration document. This will be sent to all expert panel members who have been involved in the Delphi rounds to provide written feedback. If needed extra iterations of the written document will be planned.
  4. Pilot test (November 2020) – Before launching the new reporting guideline, the group will pilot the reporting guideline with 15 non-expert users. They will ask members of the e-Delphi study to nominate potential users for testing. Building on their feedback we will make final changes to the language used.
  5. Sign Off phase (December 2020) – The group will ask all expert members who have participated in the Delphi study to sign off on the final text.
  6. Dissemination of the new guideline (December 2020) – Finally, the group will disseminate the guidelines through a scientific open access publication. In addition, they will submit the new guideline to EQUATOR and disseminate it through social media channels.
  7. Official launch at the European Implementation Science conference (May 2021) – As part of the European Implementation Science conference held on 28 May 2021 in Rotterdam, the group will organise a satellite meeting to launch the new guideline and deliver a workshop for future users on how to apply the guidelines.

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STARD-AI for Abstracts Extension: Reporting Guidelines for Diagnostic Accuracy Studies Evaluating Artificial Intelligence Interventions (registered 18 June 2020)

The same group that is undertaking the STARD-AI extension (see above) decided to also update the STARD-AI for Abstracts reporting guideline, in order to appropriately harmonise both. They plan to publish the reporting guideline, as an open-access document, in several journals, in the first quarter of 2021.

 

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Checklist for Theoretical Reports in Epidemiological Studies (registered 22 July 2020)

This checklist will present 15 items to be considered when reporting the theoretical basis of epidemiological studies: one item in the title, one in the abstract, four in the introduction, one in methods, two in results, two in the discussion section and one in the conclusion. The reporting guideline will offer examples of good report for each item and explanations.

The authors first performed a literature review about theoretical models in several databases from July 2018 to August 2019. A qualitative synthesis of the topics related to the development of theoretical models was carried out. They inform that three consensus meetings were organised in which the checklist prototype was discussed by 10 experts. The review and the article with the checklist and the explanation and elaboration are under review by Physis: Revista de Saúde Coletiva.

 

 

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Evidence-Based Practice (EBP) Projects in Nursing and Healthcare (registered 30 July 2020)

This reporting guideline will provide structure for the reporting of evidence-based practice (EBP) projects in nursing and healthcare in general. The authors completed a literature review on the subject to determine the need for a reporting guideline on the topic and also the variation on journals’ instructions for authors. They plan to apply for funding in the second semester of 2020, to conduct a multi-round Delphi study to build the reporting guideline. They plan to publish the reporting guideline in 2022.

 

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Reporting guidelines for social network analysis studies in health research (registered 18 November 2020)

Social network analysis has been increasingly applied in health research across several fields, such as epidemiology and disease transmission, interprofessional care team dynamics in clinical settings, community health coalition collaboration networks, evaluations of network interventions, and impact of the implementation of evidence-based practices in healthcare systems. There is a need for rigorous best practices and reporting standards, as the nature of network data necessitates special considerations for sampling, data collection, analysis, and interpretation compared to non-network studies. The group from Washington University School of Medicine in St. Louis decided to develop a new reporting guideline for the field of social network analysis in health. They started by reviewing the literature and seeking funding for the project. They plan to conduct a Delphi survey and a consensus process and to develop a statement guideline, and an explanation and elaboration document and publish these in open access journals at the end of 2021. The reporting guideline will also be available at the Center for Public Health Systems Science website (https://cphss.wustl.edu/).

 

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Surgical techniqUe rePorting chEcklist and standaRds (SUPER) (registered 18 December 2020)

The aim of this reporting guideline is to improve the description of surgical techniques (specific methods and skills of performing a particular operation) in scientific papers. SUPER is developed to be used with other existing reporting guidelines, such as CONSORT, STROCSS, TIDieR, and others. Potential users are surgeons and other team members involved in the surgery, such as surgical nurses, anesthesiologists, and others, describing techniques in research.

The working group started the project in August 2020 and plans to publish the reporting guideline as an open-access document in the first half of 2022, including the statement and an explanation and elaboration article. A literature review has been completed and a three-round Delphi survey is planned for 2021, as well as a consensus meeting.

The group has a website where news about the project will be updated regularly: http://www.thesuper.org

 

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CLUDA Guideline for identifying and reporting clustered data (registered 22 January 2021)

The purpose of the CLUDA Reporting Guideline is to help plastic surgeons identify and report clustered data. Research articles in plastic surgery are often based on groups consisting of patients that have undergone bilateral procedures, such as bilateral breast surgery for example. Therefore, there is a need for a guide on how to identify and report clustered data. Plastic surgeons may be unaware of the issues with clustered data, which can result in statistical errors and faulty conclusions.

The group involved in this reporting guideline development has searched the literature and found that there was an issue with clustered data reporting in plastic surgery literature. The review process began in December 2019 and was finalized in the spring of 2020.

The group meets regularly to discuss the content of a list of items that should be included in articles containing clustered data. The Executive Committee, consisting of biostatisticians with a specific interest in clustered data and medical doctors with significant experience with scientific writing, is reviewing each item in the checklist and plans to have a consensus meeting in January 2021. The group plans to publish the list in the spring of 2021.

 

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DECIDE-AI – Reporting guidelines for the Developmental and Exploratory Clinical Investigation of DEcision Support systems driven by Artificial Intelligence (registered 9 February 2021)

The DECIDE-AI project aims to develop a new reporting guideline to make the early-stage clinical evaluation of clinical decision support systems (CDSS) based on artificial intelligence (AI) more consistent, comprehensive and reproducible. A robust early formative evaluation, with an emphasis on human users, is necessary to bridge algorithm development to implementation and to pave the way toward large-scale summative evaluation.

The four main axes of this reporting guideline focus on:

● the algorithm performance when first used with humans, at small-scale, and in a representative clinical environment,

● the safety profile of the algorithm prior to its wider-scale utilisation,

● the human factors (ergonomic) evaluation of the algorithm,

● the preparatory steps towards large-scale (randomised controlled) clinical trials.

The reporting guideline developers are conducting a two-round Delphi process followed by a consensus meeting. The preliminary list of items has been developed in October and November 2020. The first Delphi round was planned for January 2021. The group plans to publish the reporting guideline in the Summer of 2021, as an open-access document.

The project launching announcement has been published: https://www.nature.com/articles/s41591-021-01229-5

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PR-Rx – Press Release Reporting Exemplar (registered 23 February 2021)

Press releases are used by industry, academic medical centres, medical journals and others to communicate with the press about research results. Journalists find press releases inspiring and useful to their stories. However, research has documented that press releases commonly fail to report basic study facts, results with absolute numbers, study limitations or researcher or funder conflicts of interest. The quality of press releases can be associated with the quality of subsequent news media stories.

A reporting guideline focused on press releases is under development with the objective of improving the completeness and quality of reporting in the press release, and ultimately the quality of news stories. A group from Ireland and the US is currently reviewing the literature and planning to interview press officers (who write press releases), medical journalists/editors (the main proximate target audience for press releases), and members of the public (typically the ultimate target audience for press released information) to get candidate items for a checklist. An international Delphi consensus exercise will refine the list.

The group also plans a randomised controlled trial testing whether providing press officers with the reporting criteria improves (a) the quality of the press releases and (b) the quality of subsequent media coverage.

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Reporting Checklists for Diagnostic Criteria for TCM Syndromes (registered 10 March 2021)

The diagnostic criteria for syndromes identified in traditional Chinese medicine (TCM) is an important part of the TCM theory. However, the way these criteria are described (for content and form) is different according to teams or institutions, and the reporting quality varies a lot. This impairs the standardisation, application and dissemination of standards of TCM syndromes diagnosis.
The developers of this reporting guideline seek to provide help for researchers, clinicians and journal editors to make use of a checklist of diagnostic criteria for syndromes in TCM that should be reported in manuscripts. The guidance will help researchers report on the specific elements of each syndrome, and the specific syndromes contained in each disease.
The group reviewed the literature available in 2020 and obtained funding for this reporting guideline development. They are currently working on the recruitment of participants of a Delphi process to generate the initial list of items for consideration in further rounds, conducted online. They plan to pilot the checklist, and to finish development by 2022, publishing it as an open-access paper. A protocol will be published before that.

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Co-designing for child health (registered 15 March 2021)

The reporting guideline under development will deal with the reporting of projects that involve co-design processes to promote child health. The authors define co-design studies as those involving the engagement of end-users in health research, bringing together all stakeholders in the community in the design of care and services. They feel the ways in which co-design processes are understood, operationalised, and reported is unhelpfully inconsistent in the literature — if described at all. The reporting guideline developers will conduct a rapid review of the literature to identify publications reporting co-design processes and prepare a reporting guideline that defines co-design, describes its tenets and gives examples. The group plans to publish the reporting guideline during 2022, as an open-access document.

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Reporting guideline for clinical case report/series with a systematic review (registered 25 March 2021)

The proposed reporting guideline under development will provide a framework for standardized reporting of case studies or series with a concomitant systematic review, and it will be important in the case that authors wish to include a systematic review in the discussion of a case report, or wish to use a case report to illustrate a pertinent point in a systematic review. The goal is to provide a list of reporting items essential for inclusion when writing a combined case report and systematic review, ensuring that necessary components of a case report and systematic review are taken into consideration in one unified guideline.

Relevant stakeholders will be invited to the meeting to develop these guidelines. Pre-meeting, a list of reporting items will be created using empirical evidence from a thorough literature search.  At the meeting, each item will be discussed, items included will be decided by consensus. Other guideline requirements, the publication strategy and the dissemination strategy will also be discussed at this time. The publication will include a statement along with an elaboration and explanation document.

 

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RESOME – Reporting Guidelines for Social Media Interventions (registered 7 April 2021)

Despite the high level of research interest, there is no consensus or guidance on how to report social media interventions. The aim of this project is to develop, publish and promote a reporting guideline for studies designing, evaluating and implementing interventions delivered through social media platforms. 

The group developing this reporting guideline will use the Delphi approach (with meetings scheduled for May-June 2021) and a final consensus meeting (July 2021). They plan to publish the reporting guideline, as an open-access document, by December 2021.

 

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TiDIRP – Training in Dissemination and Implementation Research and Practice (registered 28 of April 2021)

This reporting guideline is intended to provide guidance on the writing up of teaching and training endeavours in the field of dissemination and implementation (D&I) science, that investigates ways to efficiently implement research-driven best practices. The group leading the development of this reporting guideline has already published a systematic review showing significant variability in how training in D&I is currently reported. 

The group has already curated a list of criteria informed by the literature reviews, including the guidelines available (published and in development) on the EQUATOR network website, and a brainstorming exercise with the study team. They will further refine the list through a Delphi process with a wider pool of D&I experts and assess the validity of each criterion (and calculate inter-rater reliability) by extracting data from a pool of the articles identified in the systematic review. They plan to publish the reporting guideline by December 2021, as an open-access document.

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The Intraoperative Complication Assessment and Reporting with Universal Standards (ICARUS) Guidelines (registered 14 of May 2021)

The primary goal of the ICARUS project is to provide guidance for reporting intraoperative complications in research papers about surgical procedures in general, especially focusing on the report of intraoperative adverse events. These will include clinical trials, systematic reviews and several other types of papers.

The group developing this reporting guideline has already reviewed the literature about the reporting of intraoperative adverse events and consulted with an expert panel about it. They also performed a Delphi survey.

They plan to publish the reporting guideline by July 2021, as an open-access document. In the final phase of the ICARUS project, the group plans to disseminate the newly developed guidelines globally into each surgical field: cardiothoracic surgery, colon and rectal surgery, general surgery, gynaecology and obstetrics, gynecologic oncology, neurological surgery, ophthalmic surgery, oral and maxillofacial surgery, orthopaedic surgery, otorhinolaryngology, pediatric surgery, plastic and maxillofacial surgery, urology, and vascular surgery.

 

REMARK 2021 – Reporting recommendations for diagnostic and prognostic marker studies (registered 21 of May 2021)

The update of the REMARK reporting guideline is underway. The guideline will now include any type of marker for any type of diagnostic or prognostic outcome, in and outside oncology. The statement will guide the reporting of clinical trials, observational studies and diagnostic and prognostic studies. The group developing the update, including members from the original REMARK guideline, plans to draft a list of potential items from systematic reviews, conduct a Delphi study and a virtual consensus meeting to reach a final checklist. They will also write the explanation and elaboration paper and publish the materials in the first half of 2022 as an open-access document. A protocol is to be published soon.

Contact: Ben Van Calster, KU Leuven. E-mail: ben.vancalster@kuleuven.be 

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Guidelines for transparent reporting of healthcare-associated infection outbreaks (registered 25 of May 2021)

With an epidemiologic focus, this project aims to develop guidance for the report of outbreaks of nosocomial infections, allowing authors of such articles to identify the most important characteristics of such episodes quickly and to report them completely and timely. The reporting guideline will not be restricted to clinical trials and will include observational, mixed methods and experimental studies as well.

The group is seeking support for the project and plans to publish the reporting guideline in 2025, as an open-access document.

 

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RIGHT-P Statement – An extension of RIGHT for clinical practice guideline protocols (registered 11 June 2021)

The RIGHT-P extension of RIGHT intends to help clinical practice guideline developers better report their development protocols. A multidisciplinary international team of experts will be constituted to develop the extension. The first of the 12 steps or phases of the project is a systematic review, which has been already registered with PROSPERO (CRD42021135732). A protocol of RIGHT-P is to be published soon. The group leading the work plans to publish the final Statement in December 2022, as an open-access document.

 

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SUrgical VIdeo REporting (SUVIRE) Guidelines (registered 11 June 2021)

Videos on surgery techniques have been increasingly published in peer-reviewed journals to disseminate new procedures, report on cases or for medical students and surgeons training. However, despite the broad acceptance and use of surgical videos at congresses and in peer-reviewed journals no common guidelines have been developed in order to summarize the criteria that should be satisfied when reporting surgical videos for open, endoscopic, and minimally invasive surgical approaches. This reporting guideline aims to improve the reporting of surgical videos techniques for open, endoscopic, and minimally invasive surgical approaches in any speciality. 

The development will be within the framework outlined by the EQUATOR Network. It will start with a review of all the surgical videos published in the Surgical Endoscopy and Surgical Video Journals between 2019-2021 in order to collect a list of common criteria. Delphi survey will follow to reach an agreement on the items.

The group leading the reporting guideline development plans to publish the statement in September 2021. However, it will probably not be an open-access document.

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CHEERS 2022 – Consolidated Health Economic Evaluation Reporting Standards 2022 (registered 28 June 2021)

This is the project of updating the CHEERS reporting guideline, published originally in 2013. CHEERS is intended to guide authors when reporting economic evaluations of health interventions. The idea now is to consider the emergence of methods other than cost-effectiveness and cost-utility analyses, including more recent techniques and procedures. Also, the update will clear confusion about the use and objectives of CHEERS and increase public involvement in reporting guidelines development.

The review of CHEERS began with an informal review of reporting guidelines published since CHEERS was undertaken, with new items proposed for the existing CHEERS checklist. A patient and public involvement (PPI) leader was designated to nominate and guide a group of PPI contributors who reviewed the checklist items list and provided suggestions on language and the need for additional items. They also participated with other panellists in a modified web-based two-round Delphi process (a protocol was published, link provided below). Feedback from each round of the Delphi process was discussed by the ISPOR Task Force members, who ultimately finalized the item list based on the input provided.

The ISPOR Task Force intends to publish the updated CHEERS reporting guideline in January 2022 as an open-access document.

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RIGHT-CoI – The RIGHT extension for reporting conflicts of interest of practice guidelines in healthcare (registered 15 July 2021)

The RIGHT (Reporting Items for practice Guidelines in HealThcare) Statement has been published to guide the good reporting of clinical practice guidelines. The RIGHT-CoI Statement will deal specifically with the reporting of conflicts of interest (CoIs) in such documents.

Conflicts of interest are common and can affect the reliability, fairness and authority of clinical practice guidelines. The purpose of RIGHT-CoI Statement authors is to help clinical practice guidelines developers better report conflicts of interest. 

The development protocol of RIGHT-CoI, including 12 phases, is to be published soon.

 

Preferred Items for Reporting Case series in Homeopathy: The PITCH Statement (registered 3 August 2021)

Although the HOM-CASE reporting guideline was published in 2016, to guide the reporting of case reports in homeopathy, the group developing the PITCH Statement felt there was a need for a reporting guideline for series of cases in homeopathy. These case series would be retrospective examinations of groups of patients who share a common feature, such as exposure (including treatment) or outcome, or both.

The group plans to conduct Delphi rounds, including the items of HOM-CASE, with 20-30 experts (homeopaths and others with extensive experience in reviewing or editing case reports). They plan to publish their reporting guideline by December 2021 (not specified if open access).

 

 

Multi-purpose reporting guideline for the consideration of diversity and inclusion in academic publishing (registered 3 August 2021)

The group from the BMJ/BMJ Evidence-Based Medicine journals are developing a reporting guideline aiming to tackle discriminatory discourses in academia: to raise awareness to discriminatory language or biases related to aspects of human diversity that authors may consciously or unconsciously replicate and that should be avoided when writing an academic article. The aspects related to human diversity may include, among others: place of residence, race, ethnicity, culture, language, occupation, gender, sexual orientation, disability, religion, education, socioeconomic status, social capital.

The group will start with a scoping review to identify the main themes, then conduct a consensus study with experts in diversity, researchers, journal editors and authors. They plan to publish the reporting guideline by 2022, as an open-access document.

 


checklisT to improvE how infogRaphics Report the findings of comparative studies of health and medical Interventions (TERRI) (registered 3 August 2021)

The aim of this group is to develop a checklist to improve how infographics report the findings of comparative studies of health and medical Interventions — “Infographic” here understood as an abbreviated term for an information graphic, using images and data visualisations (pie charts, bar graphs, line graphs) to increase the attention and to improve comprehension and recall. The contents of the infographics may be crucial for understanding a study, especially when people view infographics as stand-alone resources and use this information to guide their practice, particularly when infographics are available as open access resources but the main paper is behind a paywall.
The authors of this reporting guideline plan to create a checklist to facilitate clear, transparent, and sufficiently detailed infographics summarising comparative studies of health and medical interventions (e.g. randomised controlled trials, systematic reviews) as content, not formatting guidance. Such a checklist could improve the communication of research findings without the need of checking the main paper.

The steering group has already reviewed the literature and collected examples of infographics and their relation with the studies and identified potential items for the checklist (whose reporting is suboptimal), including harms, confidence intervals, clinically important effect sizes and others. A Delphi survey will be conducted in two rounds with statisticians, methodologists, graphic editors and designers, policymakers, consumers and others. A consensus meeting and piloting will follow.

The group aims to publish the reporting guideline by 2022, as an open-access document.

 


STandard reporting guideline of Evidence briefs for Policy (STEP) (registered 6 September 2021)

Evidence briefs for policy (EBP) which includes all health and social systems, are increasingly used to support evidence-informed policymaking (EIP). However, the reporting format, characteristics, and lengths of EBP varies greatly among different development organizations and groups. This project aims to develop a reporting guideline fostering clear, accurate and complete EBPs that can not only help policymakers, decision-makers, and other stakeholders correctly understand the content of the brief but also help users make evidence-informed decision making. 

The first phase of the project began in July 2021, when authors started a literature review, obtained funding and established the working groups. A Delphi round is planned with the draft initial items for 2021. The group plans to publish the reporting guideline in February 2022, as an open-access document. The statement, the explanation and elaboration document and the checklist will be made available on the RIGHT website (right-statement.org).

 



Best practice checklist for the use of coded electronic healthcare records in clinical research (CoDe-EHR) 
(registered 6 September 2021)

The European Society of Cardiology and the BigData@Heart Consortium have brought together a range of international stakeholders, including patient representatives, clinicians, scientists, regulators, journal editors and industry to develop a roadmap towards more robust research utilisation of electronic healthcare record (EHR) systems data. The group proposes the CoDe-EHR Minimum Standards Framework as a means to enhance transparency and provide a pathway towards more effective and valuable use of EHR data for research within trials and observational studies. 

Stakeholders convened for meetings in July and October 2020. They reviewed the current state-of-the-art and formulated recommendations on key topic areas, discussing them in plenary sessions. The meetings were followed by email communication to reach a consensus on the application of coded data to improve clinical research and clinical practice. Reports of the meetings are available on these web pages:

The group plans to publish the reporting guideline by the end of 2021, as an open-access document.

 


SIFHR: Social Innovation for Health Research Checklist (registered 6 September 2021)

The Social Innovation in Health Research Checklist aims to strengthen reporting of social innovation in health research studies. The checklist was modified and finalized with three rounds of Delphi surveys conducted between May and June 2020. The checklist development project has been published (preprint: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7654927/) and the final reporting guideline has already been submitted for publication, as an open-access document.

 

Page last updated on 6 September 2021