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 on 16 September 2014. The evidence synthesis, Delphi survey and international consensus have been completed. The checklists have been finalised (available on request).

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

Read the results of the systematic review
Read a viewpoint article published in JAMA Pediatrics
Read the project protocol
Contact: Dr Martin Offringa, [email protected]

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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.

Contact: Lance Till. E-mail: [email protected]

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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 trial 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: [email protected]

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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

Contact: France Legare. E-mail: [email protected]

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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)

Contact: Linda Kwakkenbos, PhD ([email protected]) or Brett D. Thombs, PhD ([email protected])

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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)

Contact: Josip Car, Centre for Population Health Sciences (CePHaS), Lee Kong Chian School of Medicine, Singapore. E-mail: [email protected]

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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.

The project is also registered in the Open Science Framework platform and the detailed project can be found here.
Contact: Michael Schlüssel. E-mail: [email protected]

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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 aiming 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.

Read the protocol
Read the results of a survey investigating the current reporting quality of multicenter randomised trials
Contact: Prof. Zhao-Xiang Bian, Hong Kong Chinese Medicine Clinical Study Centre, School of Chinese Medicine, Hong Kong Baptist University. E-mail: [email protected]

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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

Contact: Yuting Duan. E-mail: [email protected]

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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)

Contact: Stefano Negrini – Cochrane Rehabilitation. The University of Brescia – IRCCS Fondazione Don Gnocchi Milan (Italy). E-mail: [email protected]

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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.

Contact: Professor Zhaoxiang Bian, Hong Kong Chinese Medicine Clinical Study Centre, School of Chinese Medicine, Hong Kong Baptist University. E-mail: [email protected]

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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.

Contact: Stavros A. Antoniou, MD. European University Cyprus, Nicosia, Cyprus, and Mediterranean Hospital of Cyprus, Limassol, Cyprus. E-mail: [email protected]

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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:

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, [email protected] or Dr Max Robinson, Cellular Pathology, The Newcastle upon Tyne Hospitals NHS Foundation Trust, [email protected]

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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.

Dr David Moher. E-mail: [email protected]

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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.

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 protected]

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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.

Contact: Zhaoxiang Bian or Yuting Duan. E-mails: [email protected]; [email protected]

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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.

Contact: Mei Han, Center for Evidence-Based Medicine of Beijing University of Chinese Medicine. E-mail: [email protected].

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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: [email protected]

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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.

Read the protocol
Read the results of two studies investigating the reporting quality of clinical trials with integrated Chinese and Western medicine in angina pectoris and ulcerative colitis.
Contact: Zhao-xiang Bian, Xuan Zhang. E-mails: [email protected]; [email protected]

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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: [email protected]

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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.

Contact: Lucy Elliott, NIHR Academic Clinical Fellow in Anaesthesia, University of Bristol Population Health Sciences. E-mail: [email protected]

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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

Contact: Fernando Sousa, Monash University, School of Primary and Allied Health Care. E-mail: [email protected]

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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.

Contact: Xuan Zhang, Hong Kong Baptist University. E-mail: [email protected]

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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.

Protocol: https://osf.io/59fwh
Contact: Sophie Hall, Nottingham Clinical Trials Unit, University of Nottingham. E-mail: [email protected]

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FAIR – Fidelity to Acupuncture Intervention Reporting (registered 2 May 2024)

Treatment “fidelity” refers to the degree to which an intervention is implemented as intended. Acupuncture trials are guided by the Standards for Reporting Interventions in Controlled Trials of Acupuncture (STRICTA) checklist. This project aims to extend STRICTA for trial reporting, so that users of STRICTA can report fidelity of acupuncture interventions. The developers are in contact with STRICTA authors to collaborate and get their input.

The group will conduct a literature review to identify items potentially relevant to fidelity for acupuncture trials, consolidate items into a checklist, and engage an expert panel of acupuncture researchers in a modified Delphi process to arrive at consensus of items for a FAIR checklist. The panel will include STRICTA authors and researchers in acupuncture from US, Korea, New Zealand, Europe, Japan and possibly China, UK, and other countries. A consensus meeting is planned as well.

The group doesn’t have any funding for the initiative yet, but they plan to publish the reporting guideline as an open access document.

Contact: Arya Nielsen, Icahn School of Medicine at Mount Sinai, Department of Family Medicine & Community Health. E-mail: [email protected]

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CONSORT Social Work – Reporting Guideline for Social Work intervention trials: CONSORT Extension (registered 2 May 2024)

This project aims to develop a reporting checklist for randomised controlled trials (RCTs) in the field of social work. Social work interventions often involve complex, multi-component programs that target various psychosocial, behavioural, and environmental factors. The contexts and mechanisms of these interventions can be quite different from clinical interventions in healthcare. A tailored reporting guideline would ensure that crucial details about the nature, content, delivery modes, and contextual factors of social work interventions are clearly reported. Reporting guidelines need to capture important details about these study settings, partnerships with providers/agencies, implementation processes and fidelity aspects. This ensures better contextualisation and transferability of findings.

The following steps are planned in the development:

A systematic literature review of the current state of social work RCT research, identifying major reporting quality issues;
Establishment of a multidisciplinary steering committee;
Drafting the initial version of the guideline items and run a consensus meeting for feedback;
Pilot testing in a sample of completed, high-quality social work RCT studies, where researchers will be asked to use the draft guideline to prepare reports, and collect user feedback;
Incorporating feedback from the pilot testing, finalise, and publish as an open access document.

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Contact: Bei Pan, Evidence-Based Medicine Center, School of Basic Medical Sciences, Lanzhou University, Lanzhou, China. E-mail: [email protected]

AE-ACU – Reporting guidelines for Adverse Events in ACUpuncture clinical trials (registered 2 May 2024)

Acupuncture therapy, with its unique advantages, has been widely used worldwide to treat various diseases. However, due to its unique operation method of inserting needles into acupoints, it inevitably leads to bleeding, haematoma, and even more serious adverse events. These may cause undue pain to patients and unnecessary trouble to medical practitioners, especially affecting the development and promotion of acupuncture therapy. Attention should be paid to various adverse events during the acupuncture treatment process, and measures should be taken to prevent and mitigate various adverse events. Furthermore, it is essential to accurately recognise and precisely report various adverse events in acupuncture clinical trials. This reporting guideline developments plan to release guidance to help standardise the reporting of adverse events in acupuncture clinical trials, improve the quality of their reporting, and effectively promote the advancement of research on acupuncture adverse events.

A steering group will be gathered including content experts for acupuncture, methodologists, journal editors, professional medical writers, and patients and public representatives. The literature will be reviewed, a Delphi survey will be conducted, as well as a final consensus meeting. The group plans to publish the reporting guideline in 2027.

Contact: Yan Shiyan, School of Acupuncture-Moxibustion, Beijing University of Chinese Medicine. E-mail: [email protected]

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Reporting Guideline for Environmental Outcomes in Clinical Trials: CONSORT Extension (registered 18 June 2024)

This CONSORT extension will help authors report the environmental impacts of the clinical interventions being tested in randomised controlled trials, considering the progression of climate change. According to developers, If clinical outcomes show no significant differences, the results of environmental outcomes could be crucial in determining which intervention to choose.

This project is linked to the development of the SPIRIT extension for environmental outcomes in clinical trials protocols, also registered here.

Representatives of the CONSORT-SPIRIT Executive Group, recently involved in CONSORT and SPIRIT update, are involved in the project.

The group will start with a systematic review of relevant methods in reporting of environmental effects of interventions in randomised clinical trials. Next, the generated reporting standards will be evaluated in a Delphi process to reach consensus on the guideline items. This will be followed by pilot testing in multiple randomised clinical trials, and then the proposed guideline will be tested. The feedback from the pilot testing will then be incorporated to the finalised reporting guideline.

Development is starting in June 2024, and the group is applying for funding. They plan to publish the reporting guideline, as an open-access document, in 2027.

Contact: Johanne Juul Petersen, Copenhagen Trial Unit, Rigshospitalet, Denmark. E-mail: [email protected]

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CONSORT Extension for Herbal Harms Reporting (registered 14 August 2024)

The chemical composition of herbal medicinal products varies depending on the geographic source of the plant material, the climate in which it was grown, the time of harvest, and others. Even when herbal products are standardised for the content of known active or marker compounds to achieve more consistent pharmaceutical quality, there is variation in the concentrations of other constituents. Herbal medicines are often used as complementary therapies to conventional Western medicine, making it difficult to determine potential interactions between the two treatments, which may lead to unknown adverse events. These variations can result in differences in pharmacologic activity in vitro and in bioavailability in humans. In some traditional medical systems, such as Traditional Chinese Medicine, toxic herbs are also used. This is risk information that requires additional attention.

The developers of this reporting guideline have found evidence that clinical trials of herbal medicine frequently fail to report 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, herb-drug interaction information and safety evaluations. Developers intend to conduct a literature review to identify potential items for the checklist. They will then carry out three Delphi surveys and hold a consensus meeting to finalise the wording. The next steps include pilot testing, finalising, and publishing in open-access journals.

The group involves experts from universities in Hong Kong, Canada, and others and received funding from Beijing University, including representatives from CONSORT and the Chinese EQUATOR Centre. They plan to publish the reporting guideline as an open-access document in 2027.

Contact: Hongcai Shang and Rui Zheng, Key Laboratory of Chinese Internal Medicine of Ministry of Education and Beijing, Dongzhimen Hospital, Beijing University of Chinese Medicine. E-mails: [email protected] and [email protected]

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CRT-Estimands – Consensus statement on reporting estimands for cluster randomised trials (registered 16 October 2024)

An estimand is a description of the exact treatment effect that reflects tue clinical question in a clinical trial. The International Conference on Harmonization released an addendum setting out a framework for using estimands in trials to clarify the interpretation of reported treatment effects. This addendum describes five attributes which need to be reported in order for the treatment effect to be well defined:
• Population of patients
• Treatment condition(s)
• Endpoint/variable
• Population-level summary measure
• Strategies for handling intercurrent events

The addendum was primarily developed for individually randomised trials. However, there is growing recognition that cluster randomised trials (in which “clusters” of participants, such as hospitals, schools, or villages, are randomised) may have additional considerations when defining the estimand, including the population of clusters that are of interest, and how patients and clusters should be weighted in the estimand definition.

A group researchers based on the MRC Clinical Trials Unit at UCL is developing a reporting guideline for estimates in cluster randomised trials. They plan to conduct a scoping review, a three-round Delphi survey, and a consensus meeting to develop the checklist. They plan to publish the reporting guideline as an open-access document in 2026.

Protocol registration: https://osf.io/a5kdy/
Contact: Brennan Kahan, UCL. E-mail: [email protected]

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MARMAR-Guidelines for the measurement, analysis, and reporting of medication adherence in the run-in phase of clinical trials (registered 23 May 2025)

Guideline rationale: Trial run-in phases are used as an enrichment strategy in later phase clinical studies to select participants based on certain factors or characteristics to reduce variability and increase effect size. Participants may typically be ineligible for randomisation in the main trial based on a lack of adherence, placebo response, or intolerance to the active medicine.

Previous reviews have characterized the frequency and reporting of clinical trial run-in phases. Other literature has also examined the assessment and reporting of medication adherence during drug development. Despite this, no published articles specifically examine medication adherence in the run-in phase of trials. In response to this, a systematic review was conducted examining the methodological and reporting rigour of medication adherence during the run-in phase of phase 2 and 3 drug trials (6). The review reports poor characterization and reporting of medication adherence during the run-in phase, with the methods used often at high risk of bias.

The Food and Drug Administration’s guidance for Enrichment Strategies for Clinical Trials and the World Health Organization’s guidance for Best Practices for Clinical Trials both describe run-in phases as an enrichment strategy to select adherent participants for the main trial. However, neither these, or other regulatory authorities (e.g. European Medicines Agency, or Medicines and Healthcare Products Regulatory Agency) provide guidance about how best to measure, characterise and report adherence in the run-in phase. Moreover, the Consolidated Standards of Reporting Trials (CONSORT) statement also fails to mention the run-in phase.

The findings of the review, coupled with the lack of regulatory guidance on run-ins highlights the need for guidance on the measurement, analysis and reporting of medication adherence during the run-in phase of trials.

Project aim: To develop guidelines on best practice for the measurement, analysis and reporting of medication adherence in the run-in phase of trials. This guidance will apply to run-ins that measure medication adherence.

Website: https://osf.io/hctxf
Contact: Non Wyn Davies, Centre for Health Economics and Medicines Evaluation (CHEME), North Wales Medical School, Bangor University, Wales. Email: [email protected]

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OPTIMISE-AR (incOrporating PaTIent-reported outcoMes In doSE-finding oncology trials – Analysis Recommendations) (registered 23 May 2025)

In line with the FDA’s Project Optimus initiative, there is increasing recognition of the value of Patient-reported Outcome (PRO) data to inform the tolerability assessment for investigational therapies in early phase dose-finding oncology trials (DFOTs). PROs, where patients directly report their symptomatic adverse events or quality of life, offer a complementary perspective to clinician-assessed toxicities and can enhance dose optimisation. Whilst tools such as PRO-CTCAE enable patients to self-assess their treatment- related toxicities, investigating and reporting the right PRO research objectives is crucial to ensure these early phase trials provide meaningful, patient-centred insights.

However, research indicates that PRO objectives in DFOTs are often unclear, with reporting and analyses not always aligned with the study aims. Clear recommendations for critical PRO objectives to be prioritised in DFOTs and their reporting are necessary to guide trialists in generating robust data.

The OPTIMISE-AR project is establishing guidelines for the reporting of PRO data within DFOTs. After firstly identifying critical PRO objectives (Part 1), we will develop guidelines for the reporting of such objectives within data visualisations figures and statistical analysis
methods to ensure PROs are reported rigorously and clearly by authors. The project aims to enhance the quality and clarity of PRO research objectives and PRO statistical analysis in early phase trial reports and publications. This guidance will enable trialists to systematically integrate PROs into their trials. By doing so, it supports more informed, patient-centred decision-making, and contributes to the development of safer, more effective therapies.

Contact: Emily Alger / Christina Yap. Clinical Trial and Statistics Unit, Institute of Cancer Research, London, UK. Email [email protected] or [email protected]

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CONSORT and SPIRIT extensions for non-inferiority and equivalence trials (registered 23 May 2025)

The 2012 This project aims to update the 2012 CONSORT extension for non-inferiority and equivalence trials, and to develop a SPIRIT extension for non-inferiority and equivalence trials.

No SPIRIT extension currently exists for non-inferiority and equivalence trials, and while a CONSORT extension was published in 2006 and updated in 2012, it is now 13 years old and based on the CONSORT 2010 statement, so it may be misaligned to the forthcoming CONSORT 2025 statement. Updating of existing CONSORT and/or SPIRIT extensions is essential to ensure these statements remain current and relevant.

Protocol: https://osf.io/gpz2n/
Contact: Brennan Kahan, MRC Clinical Trials Unit at UCL, UK. Email: [email protected]

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CONSORT-CHI: An extension of the CONSORT reporting guideline for Controlled Human Infection studies (registered 23 May 2025)

Controlled human infection (CHI) studies — also known as human challenge studies or controlled human infection models (CHIMs) — involve the deliberate exposure of healthy volunteers to microorganisms under controlled conditions. These studies are increasingly used to explore microbial pathogenesis, investigate host-pathogen interactions, and accelerate vaccine and drug development, all within a rigorously monitored research environment.

Despite their scientific value and growing prominence, CHI studies currently lack a dedicated reporting guideline. As such, reporting practices have naturally varied, particularly regarding key methodological elements such as inoculum production and dose, colonisation or disease endpoints, adverse event classification, ethical safeguards, and stakeholder engagement. The absence of harmonised guidance may limit reproducibility, comparability, and potentially even confidence in reported findings.

CONSORT-CHI is an extension of the CONSORT statement, developed to enhance quality, transparency, and completeness of CHI study reporting across diverse settings. It provides CHI-specific guidance on reporting study design, inoculum characteristics, endpoints, and adverse events. The guideline also addresses the unique ethical and operational aspects of CHI studies, including community engagement, regulatory variation between countries, and special circumstances such as use of genetically-modified organisms and inclusion of traditionally under-represented populations.

CONSORT-CHI is intended primarily for researchers, but may also be useful to regulators, ethics committees, funders, journal editors, and policy-makers. It is applicable to a broad range of CHI study types, including bacterial, viral, and parasitic models, as well as both mechanistic and therapeutic studies.

By supporting more consistent, transparent reporting, CONSORT-CHI aims to strengthen scientific and public confidence in CHI as a rigorous and ethical research methodology.

Contact: Anastasia A Theodosiou, University of Glasgow (Email: anastasia.[email protected]), Diane F Gbesemete, University of Southampton (Email: [email protected])

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STRICTA Ⅲ – The Standards for Reporting Interventions in Clinical Trials of Acupuncture (registered 23 May 2025)

The STRICTA (Standards for Reporting Interventions in Clinical Trials of Acupuncture) reporting guidelines, first published in 2001, as an official extension of the CONSORT statement, has general guiding significance in improving the reporting norms of clinical trials for acupuncture interventions. During the past 14 years after the adoption of the STRICTA II, scholars have put forward suggestions (such as organization of treatment: individual therapy or group therapy) for improved reporting of acupuncture interventions in clinical trials. The STRICTA could be further updated and improved in the light of the current situation to help improve the transparency and standardization of the reporting of interventions in acupuncture-related clinical trials.
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Contact: Yutong Fei, Centre for Evidence-Based Chinese Medicine, Beijing University of Chinese Medicine (BUCM) School of Traditional Chinese Medicine, BUCM. Email: [email protected]

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APT-SAP: Enhancing the design, conduct and analysis of Adaptive and Platform Trials through consensus-driven Statistical Analysis Plan guidance (registered 17 June 2025)

The increasing need for efficient and innovative trial designs to rapidly evaluate investigative treatments and expedite clinical decision-making for the quick benefit of patients has led to the growing use of Adaptive and Platform Trials (APTs) in a randomised setting. Adaptive designs allow for pre-specified changes to trial design aspects (trial adaptations) based on accrued interim outcome data while maintaining valid conclusions. Examples of trial adaptations include early stopping of ineffective treatment arms, early trial stopping upon gathering sufficient evidence to reach conclusions, or allocating more participants to promising treatment arms. Platform trials further enhance this flexibility by enabling the addition of new treatment arms (or study populations/subpopulations) to an ongoing study, with or without interim analyses.

While APTs offer clear benefits, their inherent flexibility and statistical efficiency introduce considerable operational and statistical complexities across the design, conduct, analysis, and reporting stages. Trial adaptations should be accounted for in all these stages to yield valid, trustworthy, and interpretable results, and to maintain public confidence in the generated evidence. Therefore, timely access to high-quality Statistical Analysis Plans (SAPs) for APTs, addressing both interim and final analyses alongside detailed protocols, is vital for enhancing transparency and facilitating accurate interpretation of results.

However, current SAP guidance does not adequately address the specific considerations posed by APTs in randomised setting. Many publicly available APT-SAPs, including related reports of published results, provide insufficient detail on statistical methods. This makes it difficult to interpret reported results and reproduce methods and findings – hindering the credibility of reported results. This lack of transparency undermines public trust and contributes to research waste. In addition, there is a notable absence of guidance on the proportionate level of interim information that can be released (e.g., to trial participants, patients, investigators, or the research community at conferences) from ongoing APTs without compromising trial integrity.

Contact: Munya Dimairo, Sheffield Centre for Health and Related Research (SCHARR), School of Medicine and Population Health (SMPH), Division of Population Health, University of Sheffield. Email: [email protected]

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Reporting Guidelines for Organoid-Based Clinical Trials: An Extension of the CONSORT Statement (registered 18 June 2025)

Organoids are stem cell- or tissue-derived three-dimensional structures that recapitulate the key pathological features and genetic background of their tissue of origin. They offer a physiologically relevant model for simulating human organ development, function, and disease progression, while overcoming limitations inherent to animal models, such as species-specific differences in metabolism and immune responses. Their spatial architecture and cellular fidelity enable real-time observation of disease dynamics, and when combined with gene-editing technologies, organoids facilitate rapid validation of gene functions or therapeutic targets, significantly enhancing experimental reproducibility. Moreover, organoid models align with the “3Rs” principle—Replacement, Reduction, and Refinement—by reducing the reliance on animal models for drug toxicity testing and lowering associated research and development costs. Food and Drug Administration (FDA) and pharmaceutical research institutions recommend organoid research as an effective alternative to animal experiments.

The increasing number of organoid-related clinical trials in recent years further underscores the need of establishing clinical guidelines. As interest in organoid research continues to grow, so does the need for standardized reporting guidelines. However, no dedicated reporting framework currently exists for organoid-based clinical trials, increasing the risk of incomplete reporting and the prevalence of spin. For example, clinical trials involving organoids typically require reporting on the organoid’s composition, source, and the gene editing techniques used. But, the CONSORT guidelines do not include items addressing this information.

Therefore, the project leads advocate for the development of a reporting guideline specific to organoid clinical trials. Such a guideline would not only improve the quality and transparency of organoid research reporting but also facilitate the translation of basic science into clinical applications, ultimately accelerating the advancement of personalized medicine and interdisciplinary innovation.

Contact: Yuting Duan or LinShi, Evidence-based Medicine Center (Clinical Research Center), the Affiliated Traditional Chinese Medicine Hospital, Guangzhou Medical University. Email: [email protected] (Yuting Duan) or [email protected] (LinShi)

TIDieR‑aqua: Template for the Intervention Description and Replication (TIDieR) for reporting of aquatic interventions (registered 25 July 2025)

Aquatic therapy/exercise is widely used intervention for diverse populations. It offers unique therapeutic benefits due to the physical properties of water, such as buoyancy, viscosity, hydrostatic pressure, and thermal effects. However, despite a growing body of research on aquatic interventions, studies often lack sufficient detail to allow replication, clinical implementation, or meaningful comparison between trials. This hinders the translation of evidence into practice and limits the inclusion of aquatic therapy studies in systematic reviews and meta-analyses.

Currently, there is no reporting guideline specifically designed for aquatic therapy interventions. While the original TIDieR (Template for Intervention Description and Replication) checklist is a valuable tool for improving the quality of intervention reporting, it does not adequately capture critical components unique to aquatic settings. These include environmental factors (e.g., water depth and temperature), therapist positioning, equipment use in water, safety procedures, and the influence of hydrodynamic forces on movement. As a result, published studies often omit key contextual and procedural details that are essential for replication and for understanding intervention effects.

The TIDieR-aqua considerations are being planned to be developed to fill this gap. It will adapt and extend the original TIDieR checklist to reflect the specific requirements of aquatic therapy. Its aim is to support researchers in providing complete and transparent descriptions of their interventions, ensuring that all critical information is reported consistently across studies. This will facilitate replication, improve intervention fidelity, enhance the interpretation of study findings, and strengthen the evidence base for aquatic studies.

Contact: Anna Ogonowska-Slodownik, KITE Research Institute, Toronto Rehabilitation Institute – University Health Network, Canada. Email: [email protected]

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CONSORT-A 2026: Consolidated Standards of Reporting Trials for Acupuncture 2026 (registered 27 July 2025)

CONSORT-A 2026 is essential to address the limitations of the outdated 2010 version, integrate fully with CONSORT 2025 statement, incorporate lessons learned and methodological advances from the past 15 years, and ultimately ensure the quality, transparency, and usability of acupuncture clinical trials.

Contact: Yuting Duan, Email: [email protected]. Evidence-based Medicine Center (Clinical Research Center), the Affiliated Traditional Chinese Medicine Hospital, Guangzhou Medical University Chinese EQUATOR Center, Hong Kong Baptist University Chinese GRADE Center, Lanzhou University

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TIDIER-A 2026: TIDieR extension for acupuncture: Template for Acupuncture Intervention Description and Replication (registered 27 July 2025)

Acupuncture is a cornerstone of distinctive Traditional Chinese Medicine therapies and one of the most globally recognized complementary and alternative medicine modalities. With its low cost, ease to operate, and minimal side effects, acupuncture plays an irreplaceable role in primary healthcare, chronic disease management, and geriatric healthcare worldwide.

The key characteristics of acupuncture interventions are individualized treatment and dynamic adjustment. Its effectiveness relies on the synergy of various unique elements, such as acupoint location and needling parameters (needle type, depth, angle, manipulation techniques). However, in current acupuncture research, issues like vague descriptions of interventions, missing information on intervention content, and a lack of standardized reporting have become major obstacles to its advancement. Prof. Tammy C Hoffmann et al. developed reporting guidelines for interventions in 2014, the TIDieR framework lacks the specificity and comprehensive coverage needed for acupuncture research. As a generic intervention reporting framework, it doesn’t include personalized elements crucial to acupuncture, such as precise acupoint location, specific needling techniques, and syndrome differentiation for point selection, making it difficult to address the unique requirements of acupuncture interventions. While the STRICTA guidelines for acupuncture primarily focus on the methodological reporting of acupuncture RCTs, they leave out other types of studies like cohort studies and case reports. Furthermore, STRICTA’s descriptions of acupuncture interventions are often too general and vague, leading to low study reproducibility and making it difficult to replicate findings.

Therefore, we’re developing acupuncture intervention reporting guidelines as a TIDieR extension. Our aim is to address the limitations of the original TIDieR (lack of specificity) and STRICTA (only covering RCTs). We want to provide detailed guidance on acupuncture techniques, improve the quality of acupuncture evidence, provide clinicians with replicable treatment protocols, and facilitate the translation of research findings into clinical practice.

Contact: Yuting Duan, Email: [email protected]. Evidence-based Medicine Center (Clinical Research Center), the Affiliated Traditional Chinese Medicine Hospital, Guangzhou Medical University

Clinical research on medicinal plant extracts and natural products (including herbal medicines) and bioactive natural products differs from work with single compounds. Extracts from plants, fungi, or animals are complex mixtures containing active, partially active, and inactive components, often affecting multiple targets. Their composition can change based on preparation methods and source materials, making it challenging to report and interpret the pharmacological, toxicological and clinical findings in a reproducible and transparent way. The quality, safety, and efficacy of such products are highly product-specific. Therefore, the medicinal plant extracts and natural products used in a clinical intervention must be clearly defined to ensure that clinical outcomes can be accurately linked to the specific product tested.

The initial CONSORT Extension for Herbal Interventions was published in 2006, providing a solid basis for the reporting of the intervention used in publication of clinical trials. However, an assessment by the non-profit organisation Empoweredbyevidence.org in collaboration with Monash University, Melbourne, Australia of scientific literature on herbal medicine as Curcuma longa, Sylibum marianum and Echinacea found a limited and partly or entirely lacking adaptation of the CONSORT herbal extension 2006 in published clinical trials, thereby limiting the possibility of replication, interpreting and translating these into practice. Therefore, almost 20 years after the intial CONSORT extention for Herbal Medicine Interventions, this project aims to provide an updated CONSORT statement with the ambitions of improving research conduct, report and practice in the field as well as via the involvement of different stakeholders, the team aims to promote better implementation of and covering all natural complex ingredients with a medical claim in the updated CONSORT statement across the sector over the next 5 years.

Contact: Dr Banaz Jalil, Email: [email protected]. University College London, UK

Page last updated on 10 November 2025

Reporting guidelines under development for clinical trials

Reporting guidelines for main study types