Reporting guidelines under development for clinical trials
Reporting guidelines under development for clinical trials and CONSORT extensions
(year of registration in brackets)
Multicenter Clinical Trials (2018)
ARRIVE for Acupuncture (2018)
CONSORT-iNeurostim Extension (2021)
An official extension of the CONSORT 2010 Statement for reporting randomised controlled trials in children is currently under development. A Delphi process to generate possible reporting standards for the guideline has taken place in 2009-2010. A systematic review of the literature was conducted in Q2-3 2014. A Consensus meeting was held 16 September 2014. The evidence synthesis, Delphi survey and international consensus have been completed. The checklists have been finalized (available on request).
Update March 2023: The checklists will be updated once CONSORT 2023 becomes available. CONSORT-C Statement and Explanation and Elaboration document will be published in Q1 2024.
- Read the results of the systematic review
- EnRICH Website
- Contact: Dr Martin Offringa, email@example.com
This project aims to develop a comprehensive set of reporting guidelines for home visiting that improve and enhance the accuracy of reporting home visiting intervention evaluations. Specifically, the reporting guidelines focus on: (1) reporting effectiveness and efficacy studies, (2) incorporation of study designs endorsed by the Home Visiting Effectiveness of Evidence (HomVEE), and (3) inclusion of more thorough guidelines for reporting home visiting intervention design and implementation data.
- Contact: Lance Till. E-mail: Till@jbassoc.com
Standardizing surgical Interventions & Co-interventions; establishing quality assurance for surgical interventions in randomised controlled trials (STItCh-IT) (registered 22 September 2016, record updated November 2021)
Guidance is under development to help trials teams report surgical interventions in randomised controlled trials (RCTs) to supplement information from CONSORT-NPT, SPIRIT and TIDieR. The guideline will provide a structured approach for reporting quality assurance measures for surgical interventions in RCTs and their protocols so that the reports offer details about intervention standardisation and adherence to these standards (i.e., quality assurance). A Delphi process and a consensus meeting are planned.
The author informed that funding for the project was obtained in April 2019. The group plans to publish the guideline in 2023 as an open-access document.
- Contact: Natalie Blencowe. E-mail: firstname.lastname@example.org
“This proposed reporting guideline is born out of our work in the field of implementing large-scale evidence-based practices. We are currently involved in 3 systematic reviews of scaling-up trials, one that we lead (see Effective interventions for scaling up evidence-based practices in primary care: a systematic review) and the needs of policymakers in Canada. As director of the knowledge translation component of the CIHR FRQS MSSS Quebec SPOR SUPPORT unit, we have been asked by policymakers to provide evidence of effective scaling-up intervention. However, up to this point, we observed very poor reporting. As concluded in one of our reports, ‘there are still many gaps in the science of scaling up in real-world health care settings’. These gaps are hampering policymakers as well as system managers, to ensure that the vast majority can benefit from the favourable impact of EBP. Canada is perceived as a country of perpetual pilot projects and there is a mounting frustration of not getting the return on investment of the billions of dollars spent on research in this country. The scaling-up of evidence-based practice (EBP) is a relatively new emerging concept in health. Although there is no definitive agreed-upon definition, the World Health Organization defines it as deliberate efforts to increase the impact of successfully tested health innovations (EBP) so as to benefit more people and to foster policy and programme development on a lasting basis. Yet, there is a persistent failure to scale up EBPs, especially in high-income countries. Our ongoing systematic review about effective strategies for scaling up EBP in primary care identified 25 studies. We observed the following gaps in knowledge: a) poor reporting; b) lack of a clear measure of the scaling up outcome (i.e., a measure of coverage with a numerator – the number of units covered by the EBP and a denominator – total number of units targeted); c) unclear distinction between the EBP and the strategies used to scale up the EBP; d) lack of rigorous studies from high-income countries; d) poor representation of primary care clinical contexts; e) little assessment of potential harms; and f) absence of patients and public engagement in designing the scaling-up strategies. Therefore, we would like to address the lack of a specific reporting guideline on scaling up trials.”
The group will draw the needed resources from the Canada Research Chair and explore if the same can be done with resources from the CIHR FRQS MSSS Quebec SPOR SUPPORT unit (post-doctoral student).
Read the project protocol.
- Contact: France Legare. E-mail: email@example.com
This reporting guideline is being developed for cluster randomised crossover trials (CRXO). CRXO trials involve random assignment of groups of individuals (clusters) to a sequence of interventions, where each cluster receives each intervention in a separate period of time. A formal consensus process will be undertaken to refine and agree upon reporting items. Methodologists, trialists and statisticians will be engaged in this process. The development of the reporting guideline is funded through an Australian National Health and Medical Research Council project grant.
Research to establish reporting practices in cluster randomised crossover trials has been published in the following article: Arnup SJ, Forbes AB, Kahan BC, Morgan KE, McKenzie JE. The quality of reporting in cluster randomised crossover trials: proposal for reporting items and an assessment of reporting quality. Trials. 2016; 17(1):575. PMID: 27923384
This is an extension to the CONSORT reporting guideline, focusing on trials with factorial design, i.e., where participants are simultaneously randomised to more than one research question. The RAFT (Reporting Factorial Trials) group is developing, at the same time, the extensions for CONSORT and SPIRIT (the reporting guideline for trials protocols). The four-stage process of development are:
- Synthesising results from a scoping review to generate an initially long list of concepts for consideration for inclusion in the CONSORT and SPIRIT extensions;
- Evaluating the concepts identified in the scoping review through an online Delphi survey with expert stakeholders to develop a shorter list of concepts;
- Hosting a consensus meeting to finalise the concepts to be included in the extension documents;
- Developing SPIRIT and CONSORT extensions items for factorial trials, including an Explanation and Elaboration document, and disseminating these documents widely.
A protocol has been prepared for this project, available as a PDF document: RAFT Study Protocol. The group plans to publish complete the project by 2023 and then publish the reporting guideline as an open-access document.
The objective of the proposed project is to develop a consensus-driven guideline to improve the reporting of trials conducted in existing data structures, including researcher-generated cohorts, registries, electronic health records, and administrative databases. This will be done as an extension of the Consolidated Standards of Reporting Trials (CONSORT) for trials conducted in existing data structures.
Read the project summary (PDF)
- Contact: Linda Kwakkenbos, PhD (Kwakkenbosl@gmail.com) or Brett D. Thombs, PhD (Brett.firstname.lastname@example.org)
Digital health education is an umbrella term encompassing a broad spectrum of educational interventions characterised by their technological contents, learning objectives/outcomes, measurement tools, learning approaches and delivery settings used for health. These interventions, although varying greatly in content and quality, are widely evaluated in randomised controlled trials (RCTs).
Read the study protocol (PDF)
- Contact: Josip Car, Centre for Population Health Sciences (CePHaS), Lee Kong Chian School of Medicine, Singapore. E-mail: email@example.com
This evidence-based and consensus-driven reporting guideline is being developed for randomised controlled trials (RCTs) of nutritional interventions. Although almost all of the elements in the CONSORT Statement apply equally to the reporting of RCTs of nutritional interventions, some elements might need to be adapted, tailored or extended.
The “Consolidated Standards Of Reporting Trials of NUTritional interventions” is an official CONSORT development aiming at consolidating existing – and potentially new – guidance for reporting such studies. It will provide examples of good reporting for each item in the final consolidated checklist, with explanations for each adaptation or additional item.
Interested stakeholders should contact the project team to get involved in the development and dissemination of this reporting guideline.
- The project is also registered in the Open Science Framework platform and the detailed project can be found here.
- Contact: Michael Schlüssel. E-mail: firstname.lastname@example.org
Early phase trials, often termed “dose-finding” or “dose escalation” studies, are a critical step in therapy development. This project develops a reporting guideline for early phase dose-finding clinical trials, encompassing those with or without expansion cohorts. This guideline will cover both phases I and phase I/II trials in oncology and non-oncology settings. The Executive Committee comprises a multi-disciplinary team of international statistical methodologists and trialists in early phase trials from academia and the pharmaceutical industry, a CONSORT group and patient and public representatives.
- The guideline development protocol (PDF) was updated in November 2021 and again in May 2022.
- Read a paper published in BMC Medicine about the development of the guideline
- Project website
- Contact: Professor Christina Yap, The Institute of Cancer Research. Email: email@example.com
With the encouragement of the policy on drug and medical device innovation, multicenter clinical trials and multiregional clinical trials are facing an unprecedented opportunity. Trials with a multicenter design are far more common now than before. However, we need to recognize that there are still some shortcomings in current multicenter trials, especially in terms of heterogeneity between study centres. Thus, it is urgent to develop an extension of the CONSORT statement which aims to improve the overall quality of multicentre clinical trials.
Trials quality relies on design, implementation and reporting. Therefore, the scope of this reporting guideline includes developing design, implementation and reporting checklists of multicentre clinical trials. Based on the summary of problems and challenges in current multicentre trials, the guideline of CONSORT Extension for Multicentre Clinical Trials 2020 aims to provide corresponding solutions with the aim to reduce heterogeneity between study centres and avoid excessive centre effect in treatment. We hope that this reporting guideline will influence design methods of multicentre trials, improve the quality of trials, and promote better reporting.
Firstly, our working group of CONSORT Extension for Multicenter Clinical Trial plan to register the project on the EQUATOR (Enhancing the Quality and Transparency of Health Research) Network. Secondly, we will draft the original items of this reporting guideline based on a survey of the current status of multicentre clinical trials. We will use the CONSORT statement as a starting point, and conduct this study referring to other CONSORT extension reporting guidelines. Thirdly, the process of items collection will consist of several methods: (1) collecting and framing the initial items, (2) scoring and selecting the items by experts through Delphi consensus; (3) discussing and approving the checklist in a face-to-face meeting; (4) revision: the advisory experts provide comments to revise the checklist; and (5) testing: pilot tests will be applied to seek feedback to refine the final checklist. The project has started in 2017, and the current status focused on project registration, baseline survey and draft initial items.
The group plans to publish the reporting guideline in 2020, as an open-access document.
- Contact: Prof. Zhao-Xiang Bian, Hong Kong Chinese Medicine Clinical Study Centre, School of Chinese Medicine, Hong Kong Baptist University. E-mail: firstname.lastname@example.org
In June 2010, “Improving Bioscience Research Reporting: The ARRIVE Guidelines for Reporting Animal Research” was published in PLOS BIOLOGY by Carol Kilkenny and has received considerable attention. Although it offered a reporting checklist for animal pre-clinical studies, there were some barriers in their applicability to acupuncture due to its specificity in terms of rationales, details of manipulation, the operation locations and different strengths of evidence compared to other health care interventions. Several studies stated that the reporting quality of animal research on acupuncture is poor. It is necessary to standardise the reporting guideline for animal research as an extended version of the ARRIVE guidelines, which has the following advantages: 1) To provide regulations for animal research developers; 2) To obtain more precise and clear guidelines for readers and experimental researchers; 3) To evaluate the reporting quality of animal research on acupuncture and improve the transparency of research reports for editors and reviewers.
The group will develop the study design according to the methodology recommended by EQUATOR Network, modified as appropriate. They will establish an international multidisciplinary group including clinical practitioners, acupuncturists, researchers of reporting guidelines on acupuncture, clinical epidemiologists and statisticians. The research team consists of three groups: the Development Group, the Delphi Panellists Group and the Advisor Group. They are currently performing a literature review to systematic review the reporting guidelines of acupuncture and case reports of acupuncture published in peer-review articles. Then they will conduct three rounds of modified Delphi surveys, a face-to-face consensus meeting, consultations with advisers, pilot tests of the draft list of reports and promotion of the checklist.
The group plans to publish the study protocol in a peer-review paper soon, and the reporting guideline in December 2021.
Institution: Hong Kong Chinese Medicine Clinical Study Centre, School of Chinese Medicine, Hong Kong Baptist University
- Contact: Yuting Duan. E-mail: email@example.com
The aim of the RCTRaCk is to expand the existing CONSORT (Consolidated Standards of Reporting Trials) for Non-Pharmacological Treatment Studies checklist with a set of items that directly address the reproducibility of rehabilitation research, and involving clinical and observational trials.
The group had a discussion on the methodological problems in rehabilitation research during a meeting held in Paris, France, in July 2018 (the Cochrane Rehabilitation Methodological Meeting). After a scoping review of the literature, a second meeting, held in Kobe, Japan, in June 2019, the group discussed the project of creating a reporting guideline as an extension of CONSORT, aimed for complex interventions in rehabilitation.
Eight Technical Working Groups were created and will carry on further literature reviews for building a first list of items of a checklist. The draft will be discussed in a Consensus Conference in Orlando, United States, in March 2020. Delphi rounds for refinement of the preliminary items will be carried out afterwards.
The group intends to publish the reporting guideline in 2021, as an open-access document.
- Contact: Stefano Negrini – Cochrane Rehabilitation. The University of Brescia – IRCCS Fondazione Don Gnocchi Milan (Italy). E-mail: firstname.lastname@example.org
Journal editors, methodologists and researchers of real-world trials have gathered in a group led by Hong Kong Chinese Medicine Clinical Study Centre, Hong Kong Baptist University, and started developing a reporting guideline for this type of study. The group plans to conduct a literature review, that started in August 2019 and establish an international multidisciplinary team, including a Development Group, a Delphi Panellists Group and an Advisory Group. They will run three rounds of modified Delphi surveys, face-to-face consensus meetings, consultations with advisors, pilot tests of the draft list of checklist items. The group plans to publish the reporting guideline, as an open-access document, in 2020.
- Contact: Professor Zhaoxiang Bian, Hong Kong Chinese Medicine Clinical Study Centre, School of Chinese Medicine, Hong Kong Baptist University. E-mail: email@example.com
This reporting guideline will help authors to better describe case studies in the context of complex interventions (and these may include clinical trials, observational studies e other types). The group plans to address these issues: case study theory; theoretical perspectives on context and the relationship with case-study design; generalising from case studies; designing case studies; conducting, analysing and reporting a case study. The group intends to include examples of good reporting.
The development of the tool involves a wide-ranging literature review, a Delphi survey and pilot testing. The group plans to publish the reporting guideline as an open-access document at the end of 2020. Within the guidelines, there will also be a discussion of quality principles which are both for guiding authors on writing and for guiding editors on quality assessment.
- Contact: Dr Sara Shaw. Nuffield Department of Primary Care Health Sciences,
University of Oxford Radcliffe Observatory Quarter. E-mail: firstname.lastname@example.org
AGREE II (Appraisal of Guidelines for Research and Evaluation) is a framework for developing, appraising and reporting clinical practice guidelines. The group involved in the development of this reporting guideline extension has hypothesised that the original AGREE II document may not be fully relevant to clinical practice guidelines for surgical interventions and embarked therefore on the Guideline Assessment Project (GAP), divided into three phases (GAP I, II and III). The executive group consists of surgeons, members of surgical quality and research boards, guideline developers, evidence synthesis experts, GRADE methodologists, biostatisticians, and 2 leaders of the AGREE Group.
The group has published the protocol for the development of the guideline as an open-access paper. They first performed a structured review in 2018 to identify clinical practice guidelines published in a 10-year period in the field of surgery (GAP I). Using statistical models, they have developed and published an evaluation of 67 existing guidelines in 2020 (GAP II). Furthermore, they conducted a Delphi process of a panel of stakeholders (GAP III) to inform the development of the extension document. The executive group discussed the results of the three parts of the project and finalised the document in a consensus meeting in September 2021. In this meeting, they decided on the name of the guideline: AGREE-S.
They plan to publish the explanation and elaboration manuscript as an open-access paper in 2022.
- Contact: Stavros A. Antoniou, MD. European University Cyprus, Nicosia, Cyprus, and Mediterranean Hospital of Cyprus, Limassol, Cyprus. E-mail: email@example.com
The CONSORT-Path Core Delivery and Advisory groups propose to create an extension to the CONSORT statement to define the minimum reporting of pathology items within a study.
The guideline development process follows the methodology recommended by the EQUATOR network and will consist of the following phases:
- A systematic review of existing guidance relating to the practice of pathology within clinical trials and the creation of a unified item list.
- Consensus modified Delphi process informed by the systematic review unified item list.
- Final consensus meeting. An international group of diverse stakeholders, including clinical trialists of all specialities, regulators, journal editors, industry and patient partners will produce the final elements defining the CONSORT-Path standards. Planned for Spring 2022.
- Contact: Dr Tim Kendall, the University of Edinburgh Centre for Inflammation Research, University of Edinburgh, Tim.Kendall@ed.ac.uk or Dr Max Robinson, Cellular Pathology, The Newcastle upon Tyne Hospitals NHS Foundation Trust, firstname.lastname@example.org
Combinations of the types of resistance exercise (e.g. using different equipment) and training parameters (such as intensity, rest interval, and movement velocity) are limitless and complicated. Many published studies describe the types of exercise and parameters incompletely and/or opaquely, which can make the practical application, research replication and comparison between studies difficult.
The authors of this reporting guideline focussed on resistance training are two PhD students and a supervisor from the Department of Physical Education, National Taiwan Normal University, who plan to perform a systematic review of the literature regarding the topic and then select applicable items, adapting or modifying them from published reporting guidelines. They do not plan a Delphi survey or consensus meetings. The PRIRES checklist is developed to be used alongside another reporting guideline or as a standalone checklist.
The authors plan to finish and publish this guideline in an open-access journal in May 2021.
- Contact: Ting-Yu Lin (email@example.com), Ting-Yu Chueh and Dr Tsung-Min Hung
The CONSORT authors plan to update the CONSORT 2010 Statement, which includes a 25-item checklist and the flow diagram. The 2022 CONSORT update will provide guidance for reporting all randomized, controlled trials but focuses on the most common design type—individually randomized, 2-group, parallel trials. Other trial designs, such as cluster randomized trials and noninferiority trials, require varying amounts of additional information. They plan to also update the explanation and elaboration article, which explains the inclusion of each checklist item, provides methodological background and gives published examples of transparent reporting.
The CONSORT and SPIRIT groups have merged, and the resulting combined group will update both guidelines simultaneously. The individuals in SPIRIT-CONSORT are An-Wen Chan, Kenneth Schulz, David Moher, Asbjørn Hróbjartsson, Isabelle Boutron, and Sally Hopewell. They started development in 2019 and are currently conducting a comprehensive literature search for evidence. As part of the development process, they will organize an international face-to-face consensus meeting. With the COVID-19 pandemic, they do not believe they can hold that meeting until late 2021. Thus, at present, they plan to publish the materials in 2022 as open access documents.
- Dr David Moher. E-mail: firstname.lastname@example.org
This project aims to develop an extension to the CONSORT 2010 statement for clinical trial reports of implantable neurostimulation devices. Implantable neurostimulation devices include for example deep brain stimulation, occipital nerve stimulation, sacral nerve stimulation and spinal cord stimulation (SCS) and can be used for the management of several clinical indications. Recent systematic reviews show that methodological and reporting deficiencies in trials of SCS were common.
The CONSORT-iNeurostim extension will be developed through a funded staged consensus process involving literature review for the generation of candidate items, a two-stage Delphi survey and a two-day face-to-face (or videoconference) consensus meeting. The group plans to publish the reporting guideline as an open-access document in February 2022. They are also involved in another reporting guideline under development on the same topic but focused on protocols, an extension to the SPIRIT reporting guideline.
- Contact: Rui Duarte, Liverpool Reviews and Implementation Group, University of Liverpool. email@example.com
Studies within a Trial (SWATs) are an efficient way of testing recruitment and retention interventions in an ongoing randomised controlled trial. SWATs need to concisely report the methodological information and results that are essential when reporting an RCT to enable the results to enter into an aggregate meta-analysis of the same intervention. The objective of this project is to describe a new concise, methodologically robust reporting format for SWATs with fewer than 1000 or 1500 words, keeping with CONSORT guidelines, for researchers publishing randomised recruitment and/or retention SWATs to use.
The guidelines have been developed in collaboration with the PROMETHEUS and Trial Forge teams. The PROMETHEUS team at the York Trials Unit, University of York, drafted initial guidelines. A meeting was held in July 2019 where the guidelines and the reporting of SWATs were discussed with the wider PROMETHEUS team. Two concisely reported SWAT manuscripts were examined and it was agreed by consensus that the methodological information included was sufficient to recommend the robust publication of the randomised SWATs and inclusion into an aggregate meta-analysis. Following this meeting, the guidelines were redrafted with specific input from the team who developed the original guidelines on publishing embedded trials before recirculating them to the wider PROMETHEUS and Trial Forge teams for review.
The group plans to publish the reporting guideline in May 2021, as an open-access document.
- Contact: PROMETHEUS group, firstname.lastname@example.org; Laura Clark, University of York, email@example.com; Catherine Arundel: Catherine.firstname.lastname@example.org
This guideline is being developed for creating standards for complete and transparent reporting of clinical trials using mesenchymal stromal cells (MSC). It starts with the development of a consensual definition of MSC and will work on MSC characteristics, manufacturing methods and interventions. A scoping review has started and a two-round Delphi consensus method will be used, with the first round planned for November 2021. A face-to-face consensus meeting will follow. The group leading the project plans to publish the reporting guideline as an open-access document in 2022.
- Scoping review results available in the Open Science Framework: https://osf.io/3dsqx
- Protocol published in BMJ Open: https://bmjopen.bmj.com/content/11/10/e054740
- Contact: Dr Bernard Thébaud, Ottawa Hospital Research Institute. E-mail: email@example.com
The Chinese EQUATOR Centre is developing this reporting guideline for clinical trials of vaccine interventions. A literature review has shown areas where the publication of such trials lacks clarity, such as the eligibility criteria for participants, the basis for sample size calculation, duration of follow-up, the definition of seroconversion, and adverse events description.
The development started on 18 of May 2021, following the EQUATOR toolkit for developers, and the group plans to publish the reporting guideline in 2022, as an open-access document.
CONSORT-SURROGATE – CONSORT extension for trials using surrogate primary endpoints (registered 10 March 2022)
This reporting guideline, an extension of CONSORT, will focus on the randomised trials whose primary (or primary composite) endpoint is a surrogate endpoint. Surrogate endpoints are physical measurements made objectively that are considered valid, representative or predictors of patient-relevant outcomes, i.e., variables that reflect how patients feel, function or survive.
A Project Management Group (PMG) and Advisory Executive Committee have been set up and started working in November 2021. The group will review the literature, conduct a Delphi study and a consensus meeting. This project, funded by UK MRC, is developed together with the development of SPIRIT-SURROGATE reporting guideline. The group plans to publish the guideline, as an open-access document, in 2023.
- Read the protocol for the development of this reporting guideline
- Read a commentary in the journal Trials
- Contact: Anthony Manyara, MRC/CSO Social and Public Health Sciences Unit, University of Glasgow. E-mail: Anthony.Manyara@glasgow.ac.uk or firstname.lastname@example.org
Guidelines for Reporting Single Group Trial for traditional Chinese medicine with Objective Performance Criteria or Performance Goal (registered 11 March 2022)
Single-group trials are interventional studies without a control group. Objective performance criteria (OPC) or performance goal (PG) can be used to evaluate the intervention effect in situations where it is difficult to perform randomised controlled trials. As it is difficult to implement randomisation and use placebos in traditional Chinese medicine (TCM), single-group trials with OPC and PG have become common to evaluate non-drug therapy and syndrome differentiation in TCM. The existing reporting guidelines for trials (such as CONSORT) are not applicable for single-group trials, so a group of 15 researchers from the Evidence-Based Centre of Beijing University of Traditional Chinese Medicine decided to develop one.
The group is applying for funding for the project and is conducting a literature review about single-group trials and reporting guidelines for TCM. A survey with trial investigators, health care professionals, methodologists, statisticians, trial coordinators, journal editors and representatives from the research ethics community is planned for 2023, as well as a consensus meeting, to decide on the checklist items for reporting. The group plans to publish the reporting guideline as an open-access document in 2024.
- Contact: Mei Han, Center for Evidence-Based Medicine of Beijing University of Chinese Medicine. E-mail: email@example.com.
RECONSIDER – Reporting extension of CONSORT and SPIRIT for Inclusion, Diversity, Ethnicity and Race (registered 18 November 2022)
This project to develop an extension of CONSORT and SPIRIT reporting guidelines will focus on the reporting of variables relevant to ethnically, culturally and linguistically diverse participants in randomised controlled trials (RCTs). The resulting guideline will cover both methodological (for example, techniques of recuitment) and reporting aspects (relevant data for ethnically diverse people) of RCTs and will apply to both the main manuscript and supplementary materials.
The leading group plans to review the literature, consult with diverse ethnic communities in Australia, UK and Canada and conduct a Delphi survey. The development of the project, funded by the Commonwealth of Australia (represented by the National Health and Medical Research Council) started in February 2022, and the group plans to publish the guideline as an open-access document.
- Contact: Peter Feldman, National Ageing Research Australia. E-mail: firstname.lastname@example.org
Guidelines for Reporting Clinical Trials on Integrated Chinese and Western Medicine (registered 9 January 2023)
The Chinese EQUATOR Centre is involved in the development of this reporting guideline for clinical trials combining both Western Medicine and Chinese Medicine interventions. The work started, with funding, in January 2022, and group is currently reviewing the literature for the generation of a draft checklist. Next steps are a three-round Delphi survey, a consensus meeting and the publication of the guidance as an open access document, which the group plans for 2024.
- Read the protocol
- Contact: Zhao-xiang Bian, Xuan Zhang. E-mails: email@example.com; firstname.lastname@example.org
Endo-STAR Framework – Standardised reporting framework for lower limb endovascular interventions (registered 10 March 2023)
According to the leaders of this project, the rapid progress of endovascular technologies has not been followed by complete published descriptions of interventions, without which clinicians cannot reliably implement them to improve amputation-free survival and reduce morbidity and mortality. Developing a reporting framework for lower limb endovascular will enable researchers to improve the quality of randomised controlled trials (RCTs) in the area. This project aims to develop guidance to ensure a clear description of interventions being investigated in trial protocols and also the reporting of trial results.
The project started in October 2021, after ethics approval, with a systematic review of reporting standards of trials evaluating endovascular surgeries in lower limbs and a draft framework has been developed. The group plans to start focus groups in March 2023 to revise this preliminary framework, including health professionals, researchers, journal editors and industry representatives. Thematic analysis will follow. Next, interviews with professionals undertaking endovascular trials in the UK to pilot it. The research is being funded by the Department of Vascular Surgery at North Bristol NHS Trust. The guidance is planned to be published as an open-access document in 2024.
- Contact: Ewa Magdalena Zywicka, University of Bristol . E-mail: Ewa.email@example.com
Reflexology Specific Guidance for the Template for the Intervention Description and Replication (TIDieR) (registered 30 March 2023, updated 17 July 2023)
Reflexology is a holistic, complementary therapy which is carried out on the feet, hands, ears or face, aiming to reduce stress. Reflexology practices, techniques and protocols vary significantly, and they can also be incorporated in other therapies. Given the wide range of different techniques and approaches which are known as reflexology, it is essential to understand exactly what was included in the intervention in order to assess the quality of the study, repeat the study and most importantly allow practitioners to understand what does and does not work, to enable practitioners to incorporate successful techniques and potentially eliminate ineffective practices.
After conducting a systematic review scoring the published studies on reflexology, researchers in the University of Portsmouth decided to develop an extension of the TidiER reporting guideline for interventions using reflexology. At least two rounds of a Delphi survey and an online consensus meeting will be organised with an interdisciplinary panel including authors of TIDieR. The protocol of the study is registered at OSF. The group plans to publish the reporting guideline as an open access document in late 2023.
- Contact: Jacqueline James, University of Portsmouth. E-mail: UP930406@myport.ac.uk
SAPs for CRTs – Guidelines for the Content of Statistical Analysis Plans for Cluster Randomised Trials (registered 1 June 2023)
The statistical analysis for cluster randomised trials has many complexities not yet addressed by the available guidance for statistical analysis plans. A group from the Institute of Applied Health Research University of Birmingham, Queen Mary University of London, University College London, and Ottawa Hospital Research Institute started developing an extension for the Guidelines for the Content of Statistical Analysis Plans in Clinical Trials. One member of the team of the original guideline will join the group.
A systematic review of the literature and a Delphi survey are planned, as well as a consensus meeting and piloting before publication. The group obtained partial funding from the UK NIHR Collaborations for Leadership in Applied Health Research and Care West Midlands initiative and the MRC-NIHR Develop Guidance for Better Research Methods grant for Developing guidance. They plan to publish the guidance as an open access document in 2024.
- Contact: Karla Hemming, Institute of Applied Health Research University of Birmingham. E-mail: firstname.lastname@example.org
Anaesthesia-directed perioperative interventions are complex, often comprising multiple interacting components and elements of preoperative and postoperative care. The complex nature of these interventions has major implications for the design and delivery of perioperative RCTs. To improve the reporting of clinical trials in anaesthesia, this group is working on a reporting guideline that will help authors to describe interventions in sufficient detail to enable replication, and that they are delivered in a sufficiently standardised fashion to ensure protocol adherence and to facilitate robust comparisons with other interventions. The reporting guideline will cover the reporting of the anaesthesia intervention in trials and trials protocols, and development started in 2021. The team has already worked on thematic analysis of anaesthetic intervention components, drafting frameworks for each mode of anaesthesia. Focus groups were conducted in 2022 with triallists, key stakeholders and journal editors to elicit additional categories to be added and consider clarity and feasibility issues. The frameworks are being refined through ongoing cognitive interviews.
This study is supported by a grant from the Association of Anaesthetists of Great Britain and Ireland (AAGBI) via the National Institute of Academic Anaesthesia that was awarded in January 2022, and the group plan to publish the reporting guideline, as an open access document, in 2023.
- Contact: Lucy Elliott, NIHR Academic Clinical Fellow in Anaesthesia, University of Bristol Population Health Sciences. E-mail: Le17602@bristol.ac.uk
Intervention fidelity refers to how an intervention is delivered and engaged as intended in a clinical trial. If an intervention has poor fidelity but shows effective outcomes, the observed effects may be derived from other factors rather than from intervention itself. These interpretations are only possible when intervention fidelity is clearly reported in clinical trials.
After conducting a literature review to identify the available checklists and reporting guidelines of intervention fidelity, a research team based in Australia confirmed the need for a new reporting guidelines and wrote a protocol for its development, submitted to ethics review.
Findings from the literature review (e.g., previous checklists) were used to inform the development of the preliminary survey items. The initial list of items will be extensively discussed with the steering committee and then used in a three-round Delphi survey alongside open-ended questions. The first Delphi round is planned to start in January 2024.
A subsequent consensus meeting will involve clinical trialists, methodology experts, and journal editors. Following, the guideline will be piloted, wording will be revised accordingly, and the group plans to publish the final statement and explanation and elaboration documents in an open access journal in 2024.
The group has obtained funding from the Australian Government Research Training Program (RTP) Scholarship
- Contact: Fernando Sousa, Monash University, School of Primary and Allied Health Care. E-mail: Fernando.email@example.com
Page last updated on 18 August 2023