Enhancing the QUAlity and Transparency Of health Research

Reporting guidelines under development for clinical trials

 

Reporting guidelines under development for clinical trials and CONSORT extensions

(year of registration in brackets)

 

CONSORT-C – Trials in Child Health (2014)

RoHVER – Reporting of Home Visiting Effectiveness/Efficacy Research (2015)

STItCh-IT – Standardizing surgical Interventions & Co-interventions; establishing quality assurance for surgical interventions in randomised controlled trials (2016)

SUCCEED/SUCCÈS – Standards for reporting trials assessing the impact of scaling up interventions of evidence-based practices (2017)

Cluster randomised crossover trials (2017)

Trials Conducted in Existing Data Structures (2017)

STEDI – Standards for Reporting of Digital Health Education Intervention Trials (2017)

CONSORT-Nut – CONSORT extension for RCTs of nutritional interventions (2018)

Multicenter Clinical Trials (2018)

ARRIVE for Acupuncture (2018)

RCTRaCk – Rehabilitation (2019)

CREWS – Consolidated reporting items for REal World Study (2019)

Triple C – Guidelines for reporting Case study-based research into the influence of Context for Complex health interventions (2019)

AGREE-S – AGREE II Extension for Reporting of Guidelines in Surgery – AGREE-S (2019)

CONSORT-Path – Reporting Guidelines for Pathology in Randomised Controlled Trials (2020)

CONSORT 2022 Statement (Update) (2020)

CONSORT-iNeurostim Extension (2021)

SWATs – Guidelines for the concise reporting of randomised recruitment and retention Studies within a Trial (2021)

Reporting Guideline for Mesenchymal Stromal Cells (MSC) Therapy (2021)

VALUE – VAccine cLinical research reporting gUidEline (2022)

CONSORT-SURROGATE – CONSORT extension for trials using surrogate primary endpoints (2022)

Guidelines for Reporting Single Group Trial for traditional Chinese medicine with Objective Performance Criteria or Performance Goal (2022)

RECONSIDER – Reporting extension of CONSORT and SPIRIT for Inclusion, Diversity, Ethnicity and Race (2022)

Guidelines for Reporting Clinical Trials on Integrated Chinese and Western Medicine (2023)

Endo-STAR Framework – Standardised reporting framework for lower limb endovascular interventions (2023)

Reflexology Specific Guidance for the Template for the Intervention Description and Replication (TIDieR) (2023)

SAPs for CRTs – Guidelines for the Content of Statistical Analysis Plans for Cluster Randomised Trials (2023)

Standardised frameworks to design and report anaesthesia interventions in clinical trials (2023)

ReFiND – checklist and recommendations for evaluating and Reporting Fidelity of Non-Drug interventions (2023)

BEST-CHMF – BEtter reporting of Safety assessment in clinical Trials with Chinese Herbal Medicine Formulas (2024)

AD ASTRA – SPIRIT and CONSORT extensions for dog-assisted interventions (2024)

 

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CONSORT Extension for trials in Child Health: CONSORT-C (registered 22 September 2014, last updated 31 January 2024)

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 January 2024: The updates to CONSORT-C are underway. Periodic updates are shared on the EnRICH website.

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Reporting of Home Visiting Effectiveness/Efficacy Research (RoHVER) (registered 2 September 2015)

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.

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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.

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SUCCEED/SUCCÈS: Standards for reporting trials assessing the impact of scaling up interventions of evidence-based practices (registered 3 March 2017)

“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.

Project website

Canada Research Chair in Shared Decision Making and Knowledge Translation and Unité de Soutien Composantes

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CONSORT extension for cluster randomised crossover trials (registered 23 June 2017)

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

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CONSORT Extension for Trials Conducted in Existing Data Structures (registered 27 April 2017, updated 6 October 2017)

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)

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Standards for Reporting of Digital Health Education Intervention Trials (STEDI) (registered 6 October 2017)

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)

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CONSORT-Nut – CONSORT extension for RCTs of nutritional interventions (registered 12 April 2018, updated 13 June 2022)

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.

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CONSORT Extension for Multicenter Clinical Trials 2020: Recommendations, Explanation, and Elaboration (registered 12 November 2018, updated 9 January 2024)

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.

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ARRIVE for Acupuncture – An extension of the ARRIVE Statement for Animal Research on Acupuncture (registered 21 November 2018)

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

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RCTRaCk – Randomized Controlled Trials in Rehabilitation Checklist (registered on 9th of July, 2019)

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.

Details: RCTraCk project webpage and description (PDF)

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Consolidated reporting items for REal World Study (CREWS) (registered on 16th of September 2019)

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.

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Guidelines for reporting Case study-based research into the influence of Context for Complex health interventions (Triple C) (registered on 30th of October 2019)

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.

Project website

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AGREE II Extension for Reporting of Guidelines in Surgery – AGREE-S (registered on 6th of November 2019, updated November 2019)

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.

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Reporting Guidelines for Pathology in Randomised Controlled Trials (CONSORT-Path) (registered 4 June 2020)

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:

  1. A systematic review of existing guidance relating to the practice of pathology within clinical trials and the creation of a unified item list.
  2. Consensus modified Delphi process informed by the systematic review unified item list.
  3. 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.

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CONSORT 2022 Statement (Update) (registered 18 November 2020)

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.

 

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CONSORT-iNeurostim – Reporting guidelines for clinical trial reports of implantable neurostimulation devices (registered 23 February 2021)

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.

 

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Guidelines for the concise reporting of randomised recruitment and retention Studies within a Trial (SWATs) (registered 25 March 2021)

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.

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Reporting Guideline for Mesenchymal Stromal Cells (MSC) Therapy (registered 4 November 2021)

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.

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VALUE – VAccine cLinical research reporting gUidEline (registered 25 January 2022)

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.

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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.

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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.

 

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.

 

Guidelines for Reporting Clinical Trials on Integrated Chinese and Western Medicine (registered 9 January 2023, updated 9 January 2024)

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. 

 

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.

 

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.

 

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.

 


Standardised frameworks to design and report anaesthesia interventions in clinical trials (registered 4 July 2023)

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.

 


ReFiND – checklist and recommendations for evaluating and Reporting Fidelity of Non-Drug interventions (registered 4 July 2023)

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 

 


BEST-CHMF – BEtter reporting of Safety assessment in clinical Trials with Chinese Herbal Medicine Formulas (registered 16 January 2024)

The developers of this reporting guideline have found evidence that clinical trials of Chinese herbal medicine formulae frequently fail to report on adverse events. They propose to create a checklist to help researchers report more explicitly methods and procedures for observing adverse reactions as well as provide more thorough and in-depth information on the population, severity, and medication conditions of adverse reactions in such trials, toxicological tests and safety evaluations.

Developers plan to review the literature to identify potential items for the checklist, run Delphi surveys and a consensus meeting to finalise wording, pilot test and finalise and publish the reporting guideline and an explanation and elaboration documents in open-access journals in 2027. They also plan to submit the work to conferences. The project leaders have applied for funding by the Chinese Medicine Development Fund Hong Kong.

 


AD ASTRA – SPIRIT and CONSORT extensions for dog-assisted interventions (registered 16 January 2024)

Dog-assisted interventions (DAIs) are therapeutic activities that involve a dog and aim to improve people’s health and wellbeing, usually with a focus on improving mental health. DAIs can vary widely between providers and settings. Most existing DAI evidence is based on small studies with scientific flaws, which lack important details when published, including the risks to both human and dog partners.

The AD ASTRA group will develop SPIRIT and CONSORT extensions for trials involving DAIs. The statements will provide authors with a standard reporting structure to facilitate completeness and transparency and aid in critical appraisal and interpretation of DAIs. 

Representatives will be invited from dog-assisted intervention providers, clinicians, academics, and patients/their caregiver/support teams, to participate in the development. A systematic review will be conducted to identify randomised controlled trials using DAIs and reporting gaps. A Delphi survey and consensus workshop will finalise the items. The project is funded by an NIHR Program Development Grant. The group plans to publish the reporting guideline in the end of 2025 as an open access document.

Page last updated on 31 January 2024