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
- Artificial intelligence and machine learning, modelling, coding, informatics
- Reporting guidelines for clinical practice guidelines
- Laboratory, studies in vitro and using devices
- Education and training
- Health economics
- Qualitative or mixed-methods studies
- Alternative, complementary and traditional Chinese medicine
- Other study designs and clinical areas
Epidemiology, primary care, public health and clinical outcomes
Artificial intelligence and machine learning, modeling, coding, informatics
Reporting guidelines for clinical practice guidelines
Laboratory, studies in vitro and using devices
Education and training
Qualitative or mixed-methods studies
Alternative, complementary, and traditional Chinese medicine
Other study designs and clinical areas
RIMES-SE – An Extension of the Standards for Reporting Implementation Studies- StaRI Checklist Extension (SE) for Reporting recommendations Intended for pharmaceutical risk Minimization Evaluation Studies (RIMES) Statement (2023)
Checklist for the conduct and reporting of micro-costing studies in health care (registered 9 June 2014, updated 2019 and 2021)
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. A systematic review was published in 2021 in Health Economics Review journal.
- Contact: Dr. Jennifer Prah-Ruger, firstname.lastname@example.org
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 a 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
- Contact: Jogikalmat Krithikadatta. E-mail: email@example.com
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.
- Contact: William R. Phillips, MD, MPH (firstname.lastname@example.org) or Dr Liz Sturgiss, FRACGP, MPH, BMed (email@example.com)
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.
- Contact: Charlotte Albury, firstname.lastname@example.org
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
- Contact: Alessandra N. Bazzano PhD, MPH, email@example.com
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.
- Contact: Oliver Mytton, MRC Epidemiology Unit, University of Cambridge, Otm21@medschl.cam.ac.uk
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.
- Contact: Daeria Lawson (firstname.lastname@example.org), cc: Lawrence Mbuagbaw (email@example.com), Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada
Reporting of Artificial Intelligence and Machine Learning Studies (TRIPOD-AI) (registered 7 May 2019, updated on 29 March 2023)
This guideline will be an extension to the TRIPOD Statement for prediction model studies (including imaging studies) using artificial intelligence or machine learning. Developers have already conducted a Delphi study, a consensus meeting, including involvement of the public (PPI), and developed the checklist. As of March 2023, they are preparing the Statement and the Explanation and Elaboration documents for publication as open access documents.
- An announcement marking this initiative was published in The Lancet.
- Read the TRIPOD-AI protocol
- Contact: Professor Gary Collins (firstname.lastname@example.org) or Professor Karel Moons (K.G.M.Moons@umcutrecht.nl)
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
- Contact: Dr Hannah Davies, University of Liverpool: email@example.com
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.
- Contact: Wouter A. Keijser MD: firstname.lastname@example.org
University of Twente, Faculty of Behavioural, Management and Social Sciences, Change Management & Organizational Behaviour (CMOB), Campus building Ravelijn, Enschede, the Netherlands
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.
- Contact: Allison B. McCoy, PhD, Vanderbilt University Medical Center: email@example.com
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.
- Contact: Tanja Stamm. Email: firstname.lastname@example.org
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.
- Read the STARD-AI protocol
- Contact: Dr Hutan Ashrafian and Dr Viknesh Sounderajah. E-mail: email@example.com
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.
- Contact: Prof. Zhaoxiang Bian, Hong Kong Chinese Medicine Clinical Study Centre
Hong Kong Baptist University, firstname.lastname@example.org, or Dr Yuting Duan, Hong Kong Chinese Medicine Clinical Study Centre Hong Kong Baptist University, email@example.com
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:
- Literature search (January – May 2020) – a scoping review to identify existing guidelines for reporting a process evaluation.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Website: https://www.amsterdamresearch.org/web/public-health/about/conphes.htm
- Contact: Dr Femke van Nassau, Amsterdam UMC, location VUmc and Amsterdam Public Health research institute. E-mail: firstname.lastname@example.org
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.
- Contact: Dr Hutan Ashrafian and Dr Viknesh Sounderajah. Imperial College London and the Institute for Global Health Innovation. E-mail: email@example.com
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.
- Contact: Maddie Whalen, Johns Hopkins Health System. E-mail: Mwhalen8@jhmi.edu
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/).
- Contact: Edward Tsai, Center for Public Health Systems Science, Brown School, Washington University in St. Louis. E-mail: firstname.lastname@example.org
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.
- Contact: Steven Woloshin and Mary O’Keeffe, Dartmouth Institute and the Lisa Schwartz Institute for Truth in Medicine (SW) and National University of Ireland Galway (MOK). Emails: Steven.email@example.com and M.OKeeffe13@nuigalway.ie
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.
- Contact: Yang Xie, Co-construction Collaborative Innovation Center for Chinese Medicine and Respiratory Diseases by Henan & Education Ministry of P.R. E-mail: firstname.lastname@example.org
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.
- Contact: Lynn Kemp and Ann Dadich, Western Sydney University. E-mails Lynn.Kemp@westernsydney.edu.au and A.Dadich@westernsydney.edu.au
CASSR/CARSR – Guidelines for Case Series/Case Reports with a Systematic Review (registered 25 March 2021, updated November 2021)
The proposed reporting guidelines under development will provide a framework for standardized reporting of case studies and 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 or case series and systematic review, ensuring that necessary components of a case report/series and systematic review are taken into consideration in one unified guideline.
Relevant stakeholders will be invited to the meeting to develop these guidelines. Before the 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.
This register was updated on 19 of November to inform that two reporting guidelines will be developed: one for case reports, another for case series, separately (and not together as planned before). This was a decision made at a consensus meeting.
- Contact: Mohamed Amin Soliman, Western University. E-mail: Msolim8@uwo.ca
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.
- Contact: Aradhna Kaushal, University College London (UCL). E-mail: email@example.com
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.
- Contact: Rachel Davis, Centre for Implementation Science, Centre for Implementation Science, Health Service & Population Research Department, Institute of Psychiatry, Psychology and Neuroscience King’s College London. E-mail: firstname.lastname@example.org
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: email@example.com
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.
- Cao Yulong, Peking University People’s Hospital, Beijing, China. E-mail: firstname.lastname@example.org
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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.
- Contact: Xufei Luo, School of Public Health, Lanzhou University, China. E-mail: email@example.com
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.
- Contact: Giovanni Cacciamani, Young Academic Urologist (YAU) working group in urologic technology of the European Urology Association (EAU), and USC Institute of Urology, University of Southern California. E-mail: firstname.lastname@example.org
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.
- Contact: Yangqin Xun, School of Basic Medical Sciences, Lanzhou University, China. E-mail: email@example.com
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 a case series 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).
- Contact: Abhijit Dutta, Office of Medical Research &Data Management (OMRDM), Sanjiban Hospital, Howrah, India. E-mail: firstname.lastname@example.org
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: the 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.
- Contact: Mark Richards and Cat Chatfield (BMJ) and Juan Franco (BMJ Evidence-Based Medicine). E-mails: email@example.com; firstname.lastname@example.org; email@example.com
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.
- Contact: Joshua Zadro, Institute for Musculoskeletal Health, Sydney School of Public Health, Faculty of Medicine and Health, The University of Sydney and Sydney Local Health District. E-mail: Joshua.firstname.lastname@example.org
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 vary 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 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).
- Contact: Xuan Yu, Evidence-Based Medicine Centre, School of Basic Medical Sciences, Lanzhou University, China. E-mail: email@example.com
Guidelines for clinical decision-making may be formulated based on expert consensus only in situations where there is no robust evidence available, when divergent guidance exists, or when there is a need for collective judgement to increase reliability and validity. Consensus methods provide the opportunity to harness the knowledge of experts to support clinical decision-making in areas of uncertainty. Consensus methods can also be used to decide priorities in research or healthcare, core outcome sets, disease classification and policy formulation. However, the lack of an appropriate description of the consensus methods used in publications (including the definition or threshold for agreement, the analytical methods, the expert recruitment process, funding sources, and others) suggests that a reporting guideline is needed.
This project aimed to systematically develop a reporting guideline to help the scientific community describe the methods used to reach consensus in a complete and transparent manner. A literature review confirmed the absence of existing guidelines, except for the CREDES Statement, which is focused on palliative care only. A Delphi process guided the development of a checklist and the reporting guideline, submitted for publication and also preprinted. An explanation and elaboration (E&E) document is under development with examples of good reporting for each ACCORD checklist item.
- The project has been registered at the OSF platform and can be assessed on this page: https://osf.io/2rzm9
- Read the study protocol
- Read the systematic review
- Access the ACCORD Statement preprint in MedRxiv (not peer reviewed)
- Contact: Niall Harrison. E-mail: NiallHarrison@openhealthgroup.com
The BIBLIO project, which started in 2019, develops a reporting guideline for manuscripts including a bibliometric review of the biomedical literature. The developers reviewed published bibliometric studies, generated a pool of items for a checklist, and submitted these candidate items to a group of epidemiologists, clinicians, librarians, statisticians, editors, and researchers using three Delphi rounds. They plan to publish the new guideline as an open-access document by 2022.
- Contact: Ali Montazeri, Health Metrics Research Centre, Iranian Institute for Health Sciences Research, ACECR, Tehran, Iran. E-mail: firstname.lastname@example.org
Three-dimensional models can be used as a teaching aid in medical training or as tools to improve surgical outcomes. They are common in minimally-invasive surgeries such as laparoscopic, robotic, endoscopic, and percutaneous procedures. A group of surgeons and engineers has started to develop a guideline for the reporting of the criteria and workflow steps in research projects for the production of three-dimensional models. The group plans to review the medical literature to identify terminology and common procedural steps, to perform a Delphi exercise with experienced engineers and surgeons, and to create a final checklist for reporting guidance. They plan to publish the reporting guideline in February 2022.
- Contact: Stefano Puliatti, Young Academic Urologist Working Group, European Urology Association, University of Modena, and ORSI Academy. E-mail: email@example.com
COMPARE – StatistiCal analyses and repOrting in cardiac output method coMPARison studiEs (registered 4 December 2021)
Many methods and systems were developed recently for the measurement of cardiac output, i.e., the product of stroke volume and heart rate, a key cardiovascular variable reflecting global blood flow. Cardiac output method comparison studies are performed to validate innovative cardiac output monitoring systems in comparison with reference methods.
This project aims to develop a statement and checklist on how to report statistical methods and results of studies involving cardiac output methods in which one technique is compared with another. Involved in the project are specialists in anesthesiology, intensive care, and biostatistics who have already reviewed the literature.
The reporting guideline will be published with an explanation document including examples, and the checklist items will be decided in consensus meetings (some of which already happened in 2021). The group plans to publish the guideline in 2022 as an open-access document and disseminate the tool afterwards.
- Contact: Bernd Saugel (firstname.lastname@example.org) and Karim Kouz (email@example.com), University Medical Center Hamburg-Eppendorf
ENLIGHT – Expert Network on LIGHT Interventions (registered 4 January 2022)
This project starts with a review of studies about how light exposure affects the 24-hour light-dark cycle in human bodies. Then it will develop a series of Delphi exercises, in multiple rounds, to refine a checklist of items that should be reported in such studies. The aim is to produce a standardisation of reporting of light interventions in human health. A focus group will help the Steering Committee finish the reporting guideline for interventions to study the non-visual effects of light.
Project webpage: https://lightcat.group/enlight
- The ENLIGHT reporting guideline is now available as a preprint (publication forthcoming)
- Contact: Manuel Spitschan, Technical University of Munich. E-mail: firstname.lastname@example.org
PRECOG – PREdiction of COunterfactuals Guideline (registered 8 March 2022)
The PRECOG project aims to fill a gap in reporting standards for counterfactual prediction modeling (i.e., models that merge causal inference and statistical learning, providing frameworks for the development of interventions and treatments). The group plans to consult external advisors, conduct a systematic review of the literature on counterfactual modeling, and a Delphi survey to consolidate a checklist for reporting items. They plan to publish the reporting guideline as an open-access document by 2023.
- A protocol is available as a preprint: https://www.medrxiv.org/content/10.1101/2021.11.19.21266604v1.full.pdf and is published in BMJ Open.
- Contact: Jie Xu, Department of Health Outcomes and Biomedical Informatics, University of Florida. E-mail: email@example.com
TRIPOD-P – TRIPOD Statement for Protocols (registered 9 March 2022)
This will be an extension of the TRIPOD (Transparent Reporting of a multivariable prediction model of Individual Prognosis Or Diagnosis) Statement focused on protocols. To avoid duplication of efforts, TRIPOD-P will cover protocols of studies that develop and validate prediction models using statistical (TRIPOD) or machine learning models (TRIPOD-AI). TRIPOD-P will apply to all clinical specialities.
The development of this reporting guideline will involve a review of the reporting quality of published protocols of prediction models, a Delphi survey, and a final consensus meeting. The group plans to publish the reporting guideline at the end of 2022, as an open-access document.
- Contact: Paula Dhiman. E-mail: firstname.lastname@example.org.
GLcMAP – GuideLine for concept MAPping study (registered 29 March 2022)
Group concept mapping is a type of mixed-methods (combining qualitative and quantitative approaches) structured methodology for organizing and synthesising ideas from a group visually. This project aims to develop a reporting guideline for concept mapping research.
The developers will use the EQUATOR Network Toolkit and have already registered the project at OSF. However, they will use concept mapping instead of Delphi to identify candidate items to include in the reporting guideline and will integrate the findings of a systematic review and concept mapping. They plan to publish the reporting guideline as an open-access document and also deposit it in Figshare.
- Contact: Sandesh Pantha, School of Nursing and Midwifery, La Trobe University, Australia. E-mail: email@example.com
SOS-Prehab – Standards for reporting research methods, interventions and Outcomes in Surgical Prehabilitation (registered 11 April 2022)
This project proposes the development of a reporting guideline for research on surgical pre-habilitation. This includes nutrition, exercise and other interventions aimed at correcting modifiable risk factors, including malnutrition, to enhance recovery after surgery. The project Steering Group will use the EQUATOR Toolkit for reporting guideline development and plans to start with literature reviews, identification of existing relevant reporting guidelines, and a three-round Delphi panel to decide on the checklist items. The project leaders plan to publish a protocol in 2022. If the project gets funding, they intend to publish the final reporting guideline as an open-access document.
- Contact: Chelsia Gillis, McGill University, Canada. E-mail: firstname.lastname@example.org
DELPHISTAR – Delphi studies in social and health sciences – recommendations for standardized reporting (registered 3 May 2022)
Delphi techniques are used to find consensus, collect ideas, and forecast possible future developments based on expert judgments. Variations and modifications to the original technique Delphi are increasingly used, but systematic reviews have identified inconsistencies and incomplete descriptions of the methodology.
The DELPHISTAR group is developing a new reporting guideline for Delphi techniques to be used both in the health and social sciences fields. A mapping literature review of Delphi studies and the identification of existing reporting guidelines have been completed. The conduction of an international Delphi study with Delphi practitioners and methods researchers is underway.
The group plans to publish the reporting guideline as an open-access document in 2023.
- Project website (in German): https://delphi.ph-gmuend.de/
- Project registration at OSF: https://osf.io/gc4jk
- Contact: Marlen Niederberger, University of Education Schwäbisch Gmünd (Germany)
- E-mail: Marlen.email@example.com
This project aims to develop “Standards for Rapid Evaluation and Appraisal Methods (STREAM)” to be used as 1) guidelines for the design and implementation of rapid evaluations, assessments and appraisals, 2) reporting templates, and 3) a quality assessment tool. This reporting guideline will apply to observational studies, qualitative research and mixed methods studies, service quality improvement studies and any study using rapid evaluation approaches.
The MRC-UKRI-funded project started in May 2022. The group developing the reporting guideline, based at the Department of Targeted Intervention, UCL, plans to conduct a systematic review, and after ethics approval, a three-round e-Delphi survey, and workshops with piloting. They plan to have several outputs: two peer-reviewed publications (systematic review and agreed standards); a manual, and a visual toolkit in English, Spanish and French to promote accessibility and use of the methods. The main document is planned to be published in September 2023 as an open-access document.
- See the project registration at OSF
- See the systematic review registration at PROSPERO
- Contact: Sigrún Clark, UCL – Department of Targeted Intervention. E-mail: firstname.lastname@example.org
REALISE – Improving the REporting of totAL dIet StudiEs (registered 2 August 2022)
Total diet studies (TDS) are conducted to determine the levels of substances occurring in foods to explore the dietary exposure of populations to them. The lists of foods may contain raw products like fruits or entire cooked dishes. All foods from the food list are purchased representatively, based on consumption and market share data, and (if required) prepared as typically consumed. Preparation steps might include thermal treatments such as frying, baking or cooking, as well as peeling, washing or mixing various ingredients into one dish. Analytical methods are employed to investigate different levels of substances from different regions, seasons or farming techniques. However, there is no guidance available on how to report, for example, the methodology of generating the foods lists, the gathering of food samples, the methods for purchase and preparation and parameters for homogenisation and analysis and also exposure estimation. Inadequate reporting of TDS results can compromise the proper use of TDS data for scientific or regulatory purposes and in systematic reviews.
A group of researchers from Germany has been working, since July 2022, on developing a reporting guideline for the protocols of TDS. The steering committee will involve representatives of regulatory agencies, researchers, journal editors and other stakeholders to develop the reporting guideline according to the general EQUATOR Network guidance, including literature review, Delphi rounds, consensus meetings, the statement and explanation and elaboration documents and dissemination. They plan to publish the reporting guideline in 2023, as an open-access document.
- Contact: Irmela Sarvan and Tanja Berg, MEAL Study Center, National Total Diet Study, German Federal Institute for Risk Assessment (BfR). E-mails: Irmela.Sarvan@bfr.bund.de and Tanja.Berg@bfr.bund.de
Accelerometry reporting guidance (registered 14 September 2022)
Body-worn accelerometers are devices used for the objective assessment of human behaviours, especially related to physical activity. Pragmatic decisions on planning and analysing accelerometer data can have critical implications for the resulting estimates of behaviour. Complete, consistent, and transparent reporting of accelerometer methodology and data interpretation has the potential to enhance and facilitate the use of research for a variety of stakeholders, encouraging reproducibility and increasing clarity for clinicians, patients, clinical and public health guideline developers, and policy decision-makers.
Researchers from the University of Glasgow aim to develop reporting guidance for randomised clinical trials and their protocols, and observational studies, whose primary outcome or exposure (physical activity, sedentary behaviour, or sleep) is measured via accelerometry. The group has already reviewed the literature (PROSPERO registration: CRD42021272228) and they will conduct a 2-3-round Delphi exercise to decide on the checklist items. The Delphi panel will include researchers, policymakers and journal editors. A final consensus meeting will include inputs from experts from the CONSORT, STROBE AND SPIRIT statements. They plan to publish the results of this MRC-funded project during 2023, as open-access documents. The checklists will be used by the author to help them write the whole manuscript.
- Project website: https://www.gla.ac.uk/researchinstitutes/healthwellbeing/research/mrccsosocialandpublichealthsciencesunit/programmes/complexity/methods-development/complexaccelerometry/
- Contact: Grace Dibben, MRC/CSO Social and Public Health Sciences Unit, University of Glasgow. E-mail: email@example.com
RATE-VR – Reporting of eArly-phase Trials Evaluating Virtual Reality applications in healthcare (registered 14 September 2022)
The use of virtual reality (VR) as a healthcare technology is increasing. Researchers from the Netherlands, Italy, Spain and United States gathered to develop reporting guidelines for small-scale and early-stage clinical studies involving VR applications in healthcare. It will cover, therefore, studies between the preclinical technological development of VR and the design of large-scale clinical VR intervention trials. The group is currently reviewing the literature to determine VR-based healthcare applications and identify preliminary items for the checklist. They are currently seeking ethical approval for the project and will next conduct a Delphi process, in two rounds, and a consensus meeting to define the final list. They plan to publish the reporting guideline in 2023, as an open-access document.
- Contact: Michel E. van Genderen, Department of Intensive Care Adults, Erasmus Medical Center, Rotterdam, the Netherlands. E-mail: firstname.lastname@example.org
CaReD – Consensus-based Case Reporting Guideline for Dentistry(registered 28 October 2022)
A case report or case series can help assess new clinical implications due to their ability to identify new and innovative approaches, ideas, materials, and protocols in dentistry. According to this project developers, a reporting guideline is needed to guide the writing of case reports in dentistry, so that they mention unique features of the field, such as specific jaw regions, description of materials, appraisal of lab procedures, unusual complications, compliance to post-operative instructions and others.
The group leading the development of this guideline plans to publish it as an extension of the CARE reporting guideline for case reports, as an open-access document. They plan to conduct a systematic review and a Delphi survey, inviting experts from the original CARE original guideline, and an online consensus meeting. The project development starts on November 2022, with no funding.
- Contact: Aditya S. Patel, Sharad Pawar Dental College, Datta Meghe Institute of Medical Sciences, India. E-mail: email@example.com
GLOBAL – Guidance List for the repOrting of Bibliometric AnaLyses (registered 18 November 2022)
The Guidance List for the repOrting of Bibliometric AnaLyses (GLOBAL) plans to develop minimum guidelines for the reporting of bibliometric and scientometric analyses, helping to promote transparency and completeness in reporting bibliometric and related analyses and providing a framework for authors to report methods and results. According to the developers, especially over the past decade, there has been a growing number of bibliometric analyses published in the peer-reviewed literature, and of greatly varying quality. Despite this growth, few published articles provide guidance on how a bibliometric analysis ought to be reported, and to their knowledge, these articles have been written based on the opinions/experiences of different researchers, as opposed to best evidence-informed practices.
The group proposes to perform a literature review and expert consultation to generate a series of candidate items, which will then be assessed by an international multi-stakeholder group in a multi-stage Delphi survey and refined through a checklist pilot. They started the work on the Summer of 2022 and plan to publish the guidance, as an open-access document, in 2024. They also plan to publish a protocol.
- Contact: Jeremy Y. Ng, Centre for Journalology, Ottawa Hospital Research Institute. E-mail: firstname.lastname@example.org
A reporting tool for evidence-based guidelines on Chinese medicine for public health emergencies: an extension of the RIGHT statement (registered 9 January 2023)
A group of Chinese researchers secured funding to conduct this study aiming to develop reporting standard for scientific reports on the formulation process of evidence-based guidelines for Chinese medicine in response to public health emergencies. This will be an extension of the RIGHT Statement, and the authors inform they obtained approval for the development from the RIGHT working group.
The work started in April 2022 with a literature review of existing clinical practice guidelines on Chinese medicine for public health emergencies, including a content analysis, a reporting quality assessment and a systematic review of methodological research, aiming at generating the initial checklist. In a second step, a semi-structured interview of potential users of the reporting tool, aiming at revising the checklist, will be conducted, followed by a Delphi exercise.
Developers plan to publish this reporting guideline in 2024, as an open access document.
- Contact: Xiaojia Ni, Guangdong Provincial Hospital of Chinese Medicine, and Yaolong Chen, from Lanzhou University. E-mails: email@example.com; firstname.lastname@example.org.
STRIMAM – STandards for Reporting Interventions in Moxibustion using Animal Models (registered 9 January 2023)
Moxibustion is an external treatment modality of traditional Chinese medicine, based on burning moral a wooly mass next to accupoints to stimulate meridians. Studies using animals are conducted using moxibustion but their reporting can be suboptimal, as the size of the moxa column, the duration of moxibustion, the selection of acupoints, and the smoke processing failed to be described in sufficient detail.
A group of researchers from Shanghai are developing this reporting guideline for animal studies on interventions with moxibustion. They plan to reach the ARRIVE group to make it an ARRIVE extension. They started with a literature review for defining the draft checklist and lexicon to be used. After internal discussions, the group will conduct 2-3 rounds of Delphi to finalise the guidance. The reporting guideline is planned to be published before 2024, as an open access document.
- Contact: Huan-Gan Wu, Li-Ming Chen, Shanghai Research Institute of Acupuncture and Meridian, Yueyang Hospital of integrated Chinese and Weatern medicine, Shanghai University of Traditional Chinese Medicine. E-mails:email@example.com; firstname.lastname@example.org
Updating the Reporting Guidelines for Music-based Interventions (registered 9 January 2023)
Published in 2011, the Reporting Guidelines for Music-Based Interventions focuses on the description of the music intervention and is intended to be used in conjunction with methods-specific reporting guidelines (e.g., CONSORT, TREND, STROBE, PRISMA etc.). The guideline is now under review for updating. The project involves the conduction of two survey rounds with a pool of researchers on music and music-based interventions to reach consensus on the updated checklist items. The first round started on November 2022. The work is funded and the group plans to publish the update in 2023. Authors of the original guideline are involved.
- Contact: Sheri L Robb, Indiana University School of Nursing. E-mail: email@example.com
CHEERS-AI – Consolidated Health Economic Evaluation Reporting Standards Artificial Intelligence Extension (registered 7 February 2023)
The available reporting guideline for economic evaluation, the CHEERS (Consolidated Health Economic Evaluation Reporting Standards) statement, does not include specific items related to health technologies using artificial intelligence (AI). Htx, partnering with NICE (National Institute for Health and Care Excellence), are leading the development of a CHEERS extension for AI, funded by the European Union’s Horizon 2020 programme.
The steps taken until January 2023 include this registration, forming a steering group to oversee the project and agree on a protocol, and seeking ethical approval. The group will publish the protocol, produce a list of candidate items of the checklist and conduct a Delphi survey and a consensus meeting. Piloting planned.The leaders plan to publish the reporting guideline extension as an open access document still in 2023.
- Contact: Claire Hawksworth, National Institute for Health and Care Excellence (NICE). E-mail: Claire.firstname.lastname@example.org
GRACE – Guidelines for the Reporting of A Clinical Electroencephalogram (EEG) in the medical literature (registered 27 February 2023)
The results of clinical electroencephalograms (EEGs) are frequently described in case reports and other types of studies in the scientific literature. These can add crucial diagnostic and prognostic information. However, the way in which such reports is described is very variable.
The group leading the GRACE reporting guideline development aims to provide guidance on what information authors should provide about a clinical EEG when it is written up for the medical literature. The guidance will help authors describing EEGs methods and results in trials, case reports and series and other observational studies, and diagnostic accuracy studies.
The group includes representation from clinical neurophysiology, neurology, neurosurgery, psychiatry and paediatric neurology. They already reviewed the literature and they plan to conduct a two-round Delphi survey, and a consensus meeting. They also plan to pilot the guideline before publication.
The GRACE reporting guideline development started in September 2022 still with no specific funding. They plan to publish in 2023 as an open access paper.
- Contact: Jonathan Rogers, Division of Psychiatry, University College London. E-mail: email@example.com
RIMES-SE – An Extension of the Standards for Reporting Implementation Studies- StaRI Checklist Extension (SE) for Reporting recommendations Intended for pharmaceutical risk Minimization Evaluation Studies (RIMES) Statement (registered 15 March 2023)
Pharmaceutical risk minimization programs are public health complex interventions designed to support safe and appropriate use of medicines, and implemented in a highly regulated context within healthcare settings. The developers of this project have found out that most of the evaluation studies which have been published to date about risk minimisation have been of poor reporting quality, especially in regard to providing consistent and detailed information concerning the process, methods, healthcare delivery contexts and results associated with program implementation.
The project started in 2017 with the publication of a systematic review on the subject. In parallel, the Standards for reporting of Implementation Studies (StaRI) was developed as reporting guideline for implementation studies. This project is an extension of StaRI for risk minimisation studies, and an electronic Delphi survey started in January 2023, using items from both the StaRI and the RIMES Statements (an evaluation tool) as the basis. An in-person consensus meeting is planned for August 2023during the International Conference of Pharmacoepidemiology & Therapeutic Risk Management, involving regulators, researchers, pharmaceutical industry professionals, patients and consultants from contract research organisations and industry leaders. Members of the StaRI guideline development group are involved in the review panel and in the Executive Committee.
- Contact: Meredith Smith, Evidera Inc. E-mail: Meredith.firstname.lastname@example.org
CANGARU – ChatGPT and Artificial Intelligence Natural Large Language Models for Accountable Reporting and Use Guidelines (registered 29 March 2023)
The CANGARU checklist aims to provide a comprehensive evaluation of the use of ChatGPT and large language models (LLMs) in healthcare and scientific research and its impact on scientific writing. ChatGPT has gained attention in the medical and scientific community since its launch in December 2022 as a potential tool for decreasing workload while maintaining the workflow. However, its use has raised concerns about its impact on the integrity of scientific literature. CANGARU will focus on standardising the reporting of methods and results for clinical and scientific studies using ChatGPT and other LLMs. The tool will list the most relevant technical details a data scientist needs to report for future reproducibility.
The group developing CANGARU, including representatives from EQUATOR, COPE and editorial members of biomedical and scientific leading journals will conduct a systematic review of the literature, already registered in the PROSPERO database (CDR: CRD42023406875). The topics identified will be ranked through a Delphi exercise, and after that a team of experts will evaluate the guideline. The panel will include scientists, clinicians, researchers, statisticians, computer scientists, engineers, methodologists, and journal editors. The group plans to publish the reporting guideline in March 2024 as an open-access document, later translated to Spanish, French and Chinese.
- Contact: Giovanni E. Cacciamani, USC Institute of Urology, University of Southern California. E-mail: email@example.com
SCOBe – Systematic Coding of Observed human Behaviour (registered 29 March 2023)
Systematic coding of observed human behaviour, states and attributes is a methodology used across disciplines, including health research, where coding schemes categorise elements of a behavioural or interaction process. As the scientific reporting of systematic observational methodologies has been inconsistent, a group of researchers from the Netherlands is developing this reporting guideline, that will be applicable for observational studies and their protocols and mixed methods studies.
A leading group has been set and funding has been obtained from the Lorentz Center for Interdisciplinary Scientific Workshops, with the work starting in January 2022. A panel of 25 international experts has been identified and a literature review was conducted. The group drafted a list of topics from the review and the expertise of the group members and organised a five-day workshop in February 2023 for identifying and refining the items. They plan to publish the reporting guideline as an open access document in late 2023.
- Contact: Marij Hillen, Amsterdam University Medical Centers (UMC). E-mail: firstname.lastname@example.org
APOSTEL-AS – Advised Protocol for Optical coherence tomography (OCT) Study Terminology and Elements – extension for studies involving Anterior Segment OCT (registered 29 March 2023)
This project is for the development of an extension to the APOSTEL reporting guideline, specifically focused on the anterior segment structures in optical coherence tomography (OCT), such as corneal thickness, angle parameters, and quantification of inflammation. The ophthalmologists leading the project will form a panel of experts (authors of published studies reporting quantitative AS-OCT data) and conduct a Delphi study to evaluate APOSTEL recommendations. In a second stage, a consensus meeting online will review the list of items based on the changes proposed, and a second Delphi round will give opportunity to the panel to accept or reject items.
The development will start in May 2023, when the group expects to have responses from the original authors of APOSTEL. They plan to publish the reporting guideline on late 2025 as an open access document.
- Contact: Ameenat Lola Solebo, National Institute for Health Research (NIHR); UCL Great Ormond Street Institute of Child Health. E-mail: email@example.com
CORES – CO-creation REporting Standards for research (registered 17 April 2023)
Co-creation is an overarching and encompassing approach, which is inclusive of the different stages of co-planning, co-management, co-design, co-production and co-evaluation. Co-creation research is based on Participatory Action Research where co-creators are considered co-researchers rather than participants. The group involved in the development of this reporting guideline explains that co-creation research uses methods “focusing more on creative tools to encourage innovation, change and disruptive thinking”. They aim to create reporting standards for co-creation research, as publications have highlighted the need for them. There may be some overlap with intervention development, service quality improvement, qualitative research and PPI (patient and public involvement).
This project, funded by Erasmus programme, will start with a review of reviews about co-creation, then a 3-4 round Delphi survey will be conducted with an international expert panel, consensus meetings and gathering of feedback from the panel. The final checklist will be translated, using robust methodology (including back translation) to five languages. The final document will be published until the end of 2024, as open-access papers. A website will be launched soon.
- Read the CORES Protocol
- Contact: Gemma Pearce, Coventry University. E-mail: firstname.lastname@example.org
Guideline for reporting experimental vignette studies conducted in a healthcare context (registered 9 May 2023)
Vignettes are scripted scenes, for example of a healthcare consultation, delivered in a written, video, or audio format, developed to closely resemble real-life situations. Vignettes have been used in research conducted in healthcare settings for studying the effects of healthcare professional or patient/client characteristics, communication, and/or behaviour on outcomes and experiences. According to the developers of this reporting guideline, although the experimental vignettes design is increasingly used in the healthcare setting, yet authors of these studies are offered little guidance in how to report, which may result in variability and lack of comprehensiveness in reporting.
The group developing this reporting guideline aims to develop a reporting guideline specific to experimental studies that use vignettes in a healthcare context. In this context, they explain that certain aspects of reporting are rather specific to the experimental vignettes design, such as the development of a valid script, description of experimental variables/manipulations, and choices made regarding the mode of delivery and the type of participants (‘analogue patients’).
A Steering Group has been formed and is planning the development. A preliminary checklist is under development and will be first presented in 2024 during a conference in communication in healthcare, revised and discussed again in the next conference. The group plans to publish the guidance as an open access document.
- Contact: Ellen M.A. Smets, Amsterdam UMC. E-mail: email@example.com
ECoHealth – Reporting Guideline for Assessments of the Environmental Consequences of Healthcare (registered 24 May 2023)
The healthcare sector contributes to greenhouse gas and other environmental emissions, and there has been an increase in publications about the “sustainable healthcare space”, including healthcare products, services, and systems. However, there is no reporting standard for these studies. The ECoHealth project aims to increase the quality of publications to enable critical appraisal, interpretation and replication.
The development of this reporting guideline started in 2022, funded by Harvard Medical School, with a review of the literature, and a three-round Delphi survey, after ethics approval was obtained, is planned. The Delphi panel will include healthcare practitioners and environmental and industrial engineers, healthcare administrators, healthcare product regulatory agency representatives and journal editors. The group plans to publish the reporting guideline in 2024.
- Contact: Jonathan E. Slutzman, Massachusetts General Hospital, Harvard Medical School. E-mail: firstname.lastname@example.org
RIGHT for CPM – The RIGHT Extension Statement for Chinese Patent Medicine (registered 1 June 2023)
Chinese patent medicines are herbal medicines in ready-to-use forms such as tablets or solutions. In order to standardize the rational application of CPM, a large number of CPM application guidelines have been formulated. However, there is no reporting specification for clinical application guidelines of CPM at present. Therefore, a group from the Zhejiang Chinese Medical University decided to develop a reporting guideline for studies using or evaluating CPM products, as an extension for the RIGHT reporting guideline for clinical practice guidelines.
According to the authors, the development of RIGHT for CPM has received support from Pro. Yaolong Chen, the initiator of the RIGHT statement, providing methodological guidance for the development of the extension version of RIGHT for CPM. The development already started in 2023 with a review of the literature. A Delphi survey and piloting will follow. A protocol will be published, and the final guidance will be available at the RIGHT website. The group plans to publish the guidance as an open access document.
- Contact: Xuanlin Li, Zhejiang Chinese Medical University. E-mail: email@example.com
CLAIM 2023 update – Checklist for Artificial Intelligence in Medical Imaging: 2023 Update (registered 4 July 2023)
This project aims to update the CLAIM reporting guideline, published in 2020. It will incorporate recent developments in imaging artificial intelligence (AI) and imaging biomarkers, reflecting the role of these techniques in current AI research. The update development started April 2023, including Delphi surveys, and the team plans to publish the updated document in 2024, as an open access document.
- Contact: Charles Kahn (Hospital of the University of Pennsylvania) and Ali Tejani (University of Texas Southwestern Medical Center). E-mails: Charles.Kahn@pennmedicine.upenn.edu; firstname.lastname@example.org
ORIOCE – Guidelines for transparent reporting of Outbreak Reports and Intervention Of Community Epidemics (registered 4 July 2023)
Outbreak reports offer a timeline-based narrative of methods, findings, and public health responses in active or recently finished outbreaks or public health inquiries. These reports typically encompass the reason for the investigation, symptoms or pathogens involved, time and place of the outbreak, identification of affected individuals, as well as the investigation methods, results, and implications for public health. The ideal structure for these reports is a narrative format that sequentially presents the events. A group of physicians in the Department of Family Medicine Kangdong Sacred Heart Hospital, in South Korea, started developing this reporting guideline for reports of outbreaks of transmissible diseases and the community-level interventions to mitigate them. They have funding from Korea Disease Control and Prevention Agency and they plan to publish the guideline, as an open access document, in 2023.
- Contact: Soo Young Kim and Wonyoung Jung, Department of Family Medicine, Kangdong Sacred Heart Hospital, Hallym University, South Korea. email@example.com; firstname.lastname@example.org
CORMMIX – Consolidated Checklist for Reporting Mixed-Methods Research (registered 11 July 2023)
This project aims to develop a Consolidated Checklist for Reporting Mixed-Methods Research (CORMMIX) to enhance the reporting quality and transparency of studies using both qualitative and quantitative methods (mixed methods). CORMMIX will provide a structured framework covering all aspects of the research process, from planning and data collection to analysis and reporting. The first steps of the development started in March 2023, with literature review, generation of a pool of items to report, and a Delphi survey will follow. The team has funding from the Qatar university through a student grant, and they plan to publish the reporting guideline as an open access document.
- Contact: Muhammad Abdul Hadi, Department of Clinical Pharmacy and Practice, College of Pharmacy, Qatar University. E-mail: email@example.com
ARCH_DCE – A reporting checklist for discrete choice experiments in health (registered 13 July 2023)
Discrete choice experiments (DCEs) are a survey-based method used in health economics to ascertain people’s preferences for health, for healthcare, and for goods and services that affect health. Since October 2021, a group from Australia is developing a reporting guideline for DCEs, including a scoping review (that showed there is no available guidance for reporting DCEs) and a Delphi survey of experts.
They plan to publish the reporting guideline as an open access document in 2024.
- Contact: Jemimah Ride, Monash University. Contact: firstname.lastname@example.org
SEB – Standards for EEG Biomarkers (registered 14 August 2023)
Electroencephalogram (EEG) is a test used to help diagnose and monitor conditions affecting the brain, especially epilepsy. With the endorsement of the International Federation of Clinical Neurophysiology (IFCN) in November 2022, a group of 11 collaborators are developing this reporting guideline including literature reviews, a Delphi study (which has already started) and a final consensus meeting planned. The final product will guide authors, reviewers and editors toward specifying important technical parameters for reproducible diagnostic accuracy studies and prediction models.
The guideline will focus on studies specifically related to the development and validation of EEG-based biomarkers, including a number of methodological details related specifically to EEG (both during a cognitive task and spontaneous/resting-stata recording). The group declares, however, that EEG-based biomarkers are involved in a number of contexts-of-use beyond diagnosis: real-time monitoring of physiological changes, prediction of change to an intervention and prognostication of natural history, for example. The group plans to publish the guidance in 2023 in IFCN’ journal, Clinical Neurophysiology.
- Contact: Joshua Ewen, Kennedy Krieger Institute/Johns Hopkins University and Lurie Children’s Hospital/Northwestern University. E-mail: email@example.com
Page last updated on 14 September 2023