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Reporting guidelines under development for observational studies

Observational studies or STROBE extensions and case reports or CARE extensions

(year of registration in brackets)

 

GREEN – Guideline for Reporting Environmental Epidemiology aNalyses (2016)

SPIROS – Standardized Protocol Items: Recommendations for Observational Studies (2017)

GOALS – Guidelines On Assessments in LMIC Settings (2018)

SPoRTIER – Social Prescribing Reporting Template to Improve Evaluation and Replication (2018)

PREHOSPITAL-CARE – A consensus-based guideline for publishing pre-hospital case reports (2018)

STROBE for TCM – Reporting Guideline for observational studies on Traditional Chinese Medicine (formerly Chinese Herbal Medicine Formulas) (2019)

STORMS – Strengthening The Organising and Reporting of Microbiome Studies (2019)

MEASURE Statement – Medical Education Assessment Studies Uniform REporting statement – A reporting guideline for validity investigation studies (2020)

STROBE-pregnancy outcomes (2020)

STROBE-Vision – an extension of the STROBE statement (2021)

STROBE-MetEpi – Guidelines for Strengthening the Reporting of Metabolomic Epidemiology Studies (2021)

Trial Emulations (2021)

PhyCaRe – Reporting guideline for physiotherapy case reports (2022)

CRCA&M – Consensus-Based Recommendations for Case Report in Acupuncture and Moxibustion (2022)

EPIC – Enhanced Prevalence and Incidence Criteria (2023)

CARITS – Complete and Accurate Reporting of Interrupted Time Series studies (2023)

STROBE-prev – Strengthening the Reporting of Studies of Prevalence (2023)

Chinese Medicine Formulas – STrengthening the Reporting of Observational Real-World Studies about Chinese Medicine Formulas: STROBE extension (2023)

Chinese Medicine Formulas Protocols – Standard Protocol Items for Observational Real-World Studies about Chinese Medicine Formulas (2023)

SUMO-cross – Reporting cross-sectional SUrveys conducted in Multiple cOntexts (SUMO-cross) (2024)

CRIMP – Case Reports in Mental Health and Psychiatry Reporting Guidelines (2024)

RECASE – Reporting Acupuncture-related Adverse Events following the CARE guidelines for case reports (2024)

SAPI – Statistical Analysis Plan for Observational Studies with Initial Data Analysis (2024)

NUR-Case – Nursing Case Reporting Framework (2025)

POCUS-REPORT: Reporting Guideline for Clinical and Research Studies Using Point-of-Care Ultrasound (2025)

RETAICS-PV: The REporting a Time-to-onset Anaysis using Individual Case Safety reports in PharmacoVigilance (2025)

COREMILK: COnsensus Guidelines for REsearch on Human MILK (2025)

UNITE: Reporting Guideline for Youth and Family Specific Engagement in Research (2025)

Strengthening the Reporting of Observational Studies in Epidemiology for Drowning (STROBE-D): An Extension of the STROBE Statement for Drowning Research (2025)

Consolidated Guidelines for Reporting and Evaluation of studies using Transcranial Electrical Stimulation/strong> (2025)

Research reporting guidelines for health RESearch involving People who arE inCarceraTed: The RESPECT Guidelines (2025)

Inclusivity Checklist for Clinical Research (2025)

Standards of reporting for studies on medical grade footwear for adults (2025)

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Guideline for Reporting Environmental Epidemiology aNalyses (GREEN) (registered 20 December 2016, updated 2 November 2021)

This guideline will encompass studies that report on the association between environmental exposures and health outcomes. The group informs they reviewed the literature and are now seeking partnerships to develop a Delphi process.

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Standardized Protocol Items: Recommendations for Observational Studies (SPIROS) (registered 7 February 2017)

The guidelines aim to define a comprehensive set of standard protocol items for observational studies, and by doing so facilitates and encourages researchers to prepare a study protocol of sufficient quality, prior to data collection.

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Guidelines On Assessments in LMIC Settings (GOALS) (registered 28 August 2018)

Outcome-based and observational metrics in surgical studies conducted in Lower-Middle Income Countries (LMICs).

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SPoRTIER: Social Prescribing Reporting Template to Improve Evaluation and Replication (registered 28 August 2018)

This guideline is being developed by researchers at the Centre for Health Services Studies, University of Kent, to improve the quality and completeness of reporting for Social Prescribing programmes. Social prescribing provides a non-medical referral option to improve health and wellbeing. Referrals can be to a range of programmes from befriending schemes, volunteering opportunities, supported education, arts, physical activity, as well as support with employment or legal advice.

Different Social Prescribing models have evolved across England reflecting local needs, service provider expertise and commissioning contracts. Consequently, models vary greatly in terms of aims of the service, delivery partners, referral pathways, staffing, and service user outcomes making it difficult to identify features of a successful model, for whom social prescribing benefits, and under what circumstances.

SPoRTIER will provide a standardised useable template to capture contextual details on different programmes and how these programmes are being implemented to aid understanding of how social prescribing contributes to changes in health and wellbeing.
Development of SPoRTIER is based on the EQUATOR Network methodological framework for developing reporting guidelines.

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PREHOSPITAL-CARE: A consensus-based guideline for publishing pre-hospital case reports (registered 4 October 2018)

PREHOSPITAL-CARE is a consensus-based guideline under development for publishing pre-hospital case reports. It will be an extension to the CAse REport (CARE) clinical case reporting guideline.

Currently, case reports published on pre-hospital care rarely follow the CARE guideline. The quality of these publications is highly variable. The aim of the PREHOSPITAL-CARE guideline is to improve the quality of pre-hospital care case reports. In January 2021, the authors published a protocol for the project.

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STROBE for TCM – Reporting Guideline for observational studies on Traditional Chinese Medicine (formerly Chinese Herbal Medicine Formulas) (Registered on 29 July 2019 2019)

Chinese herbal medicine (CHM) formulas are the major components of traditional Chinese medicine interventions. The group aims to develop an extension of STROBE focused on CHM, to enhance the transparency and quality of observational studies on CHM, and following the methodology recommended by the EQUATOR Network.

The development of STROBE for CHM started on 1st July 2019, with a literature review to draft the checklist items. The group will establish an international multidisciplinary team, including a Development Group, a Delphi Panellists Group, and an Advisory Group, and run three rounds of modified Delphi surveys, face-to-face consensus meetings, consultations with advisors, pilot tests of the draft list of reports and promotion of the checklist.

September 2019 Update: please note that the reporting guideline development group originally planned to focus this guideline on Chinese herbal medicine (CHM) but following a literature review broadened the scope to cover traditional Chinese medicine (TCM). The title of this reporting guideline under development has therefore been revised in order to reflect this change.

August 2020 Update: the group informs they finished a systematic review on the quality of reporting of cohort, case-control and cross-sectional studies on TCM, to be published soon. They plan to contact the original STROBE authors for comments and suggestions before drafting the initial checklist.

The group plans to publish the reporting guideline as an open-access document on December 2022.

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STORMS – Strengthening The Organising and Reporting of Microbiome Studies (Registered on 22 October 2019)

The group from the Department of Epidemiology and Biostatistics, City University of New York School of Public Health, is preparing a guideline for the reporting of epidemiological studies of the human microbiome. These studies typically address microbiome diversity, richness, and composition across categories of exposure, disease, or other phenotypes. Individual taxa of bacteria that are differentially abundant between groups are usually identified. They are typically observational, although experimental human microbiome studies are possible.

The project began in June 2019 with a systematic review of microbiome literature. A working group of bioinformaticians, epidemiologists, biostatisticians, and graduate students with an interest and expertise in the human microbiome was convened. an initial draft of guidelines was drafted. Working group members then tested the guidelines by reviewing recent microbiome articles using the guidelines. Revisions were made based on the ensuing discussion. The checklist is currently in the second set of pilot testing and revisions.

The group prepared a draft of the guidelines and accompanying paper and plan to pre-publish it on bioRxiv by the end of 2019, with a formal publication as an open-access article in 2020.

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MEASURE Statement – Medical Education Assessment Studies Uniform REporting statement – A reporting guideline for validity investigation studies (registered on 10 September 2020)

The objective of this working group is to develop a reporting guideline for studies investigating the validity in medical education tests. The reporting guideline will cover all types assessment tools (i.e. checklists, rating scales and simulator metrics) for health professional education (i.e. doctors, dentists, medical students, nurses, midwives, radiology assistants).

The international steering committee has conducted and published a literature review on the subject, to ascertain the need for a reporting guideline. The group plans to conduct a three-round Delphi study to reach consensus on the checklist items. They plan to publish the reporting guideline in early 2021, if possible as an open-access paper. They are also setting a website for the tool.

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STROBE-pregnancy outcomes (registered on 27 November 2020)

This guideline will relate to observational studies that report measures of maternal, fetal, and neonatal outcomes, for example, cohort studies examining exposures during pregnancy and subsequent outcomes. An extension to the STROBE reporting guideline is necessary to capture the complexity of perinatal studies, enabling assessment of data plausibility and completeness. The guideline is needed to ensure appropriate reporting of multiple (and competing) outcomes with a clear description of populations included, definitions used and analytical methods applied.

The executive group developing this extension of the STROBE reporting guideline has already finished a review on the quality of reporting of perinatal outcomes and data in the literature and plans to conduct a Delphi exercise in the second quarter of 2021. Consensus meetings will be held in the third quarter, and the development of the statement and piloting at the end of 2021. The group plans to publish the reporting guideline extension in 2022, as an open-access document.

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STROBE-Vision – an extension of the STROBE statement (registered on 23 February 2021)

This reporting guideline aims to adopt and extend the STROBE (STrengthening the Reporting of OBservational studies in Epidemiology) reporting guideline focusing on observational studies on human vision. Specifically, the reporting guideline under development aims to encourage the comprehensive reporting of surveys on population-based vision impairment prevalence, outlining the risks of bias concerning this type of study and recommending reporting items on prevalence estimates and meta-analyses, to permit their proper assessment. The need for a reporting guideline was made clear from the last WHO World Report on Vision (2019), the Lancet Global Health Commission on Global Eye Health (2021) and the Vision Loss Expert Group and the Global Burden of Disease Study (2021).

Ethics committee approval was obtained for this project from the London School of Hygiene and Tropical Medicine Institutional Review Board (December 2019). A two-round Delphi survey will reach a list of agreed items made from the original STROBE items and additional, vision-related ones. Panellists will include epidemiologists, statisticians, journal editors, Cochrane editors, vision impairment and eye disease subject matter experts, guideline developers, and representatives of non-governmental organisations.

The group plans to publish the reporting guideline as an open-access document in 2021.

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STROBE-MetEpi – Guidelines for Strengthening the Reporting of Metabolomic Epidemiology Studies (registered 14 May 2021)

The aim of STROBE-MetEpi, an extension of the STROBE reporting guideline, is to define a comprehensive list of protocol items that should be reported in every published metabolomic epidemiology study. The guideline will include reporting standards for both the metabolomic aspects of a study (sample collection, sample storage, profiling platforms quality control, etc.) and the epidemiological aspects (study design, study population, data processing, statistical analyses etc.). It will include observational and diagnostic and prognostic studies.

Experts recruited from across the field of metabolomic epidemiology representing broad diversity in experience and expertise, including epidemiologists, chemists, and computational biologists, are collaborating in the project. The writing team plans to conduct several meetings and literature review to reach a consensus on a checklist of items, that they intend to publish together with an elaboration and explanation document, in an open-access format by 2022.

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Trial Emulations (registered 4 November 2021)

In situations where randomised controlled trials (RCTs) are not feasible or ethical, observational studies can emulate a “target trial” to inform decision-making. However, the lack of consistency in the reporting of target trial emulations, usually cohort and case-control studies makes it difficult to benchmark their results against RCTs.

The authors of this reporting guideline on trial emulations are working on a six-phase project that will first establish executive and advisory groups, review the literature, perform a Delphi exercise and a consensus meeting and then publish a reporting guideline with an explanation and elaboration document, as open-access publications. The project started in February 2021 and is planned to be completed in early 2024.

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PhyCaRe – Reporting guideline for physiotherapy case reports (registered 14 September 2022)

Based on the CARE reporting guidelines, this project aims to develop guidance for the reporting of case reports for the physiotherapeutic field. The group involved in the project, conducted in India, wants to help physiotherapists draft their manuscripts in a more structured way, enhancing the reproducibility of the assessment and management in clinical or community settings. Cases should report in detail physiotherapeutic interventions that use exercise, electrotherapy, manual therapy, hydrotherapy and others, and also describe in detail the assessment of range of motion, joint mobility restrictions, and functional limitations as evaluated by validated tools.

Following a literature review, the group will conduct a Delphi exercise with a panel including physiotherapists, clinical practitioners, journal editors, peer reviewers, academic editors and researchers, including authors of the original CARE reporting guideline, who they plan to invite.

The group, working with no funding, plans to start the work in November 2022 and publish the reporting guideline in 2023, as an open-access document.

 

CRCA&M – Consensus-Based Recommendations for Case Report in Acupuncture and Moxibustion (registered 20 December 2022)

This project will develop a new reporting guideline for manuscripts of case reports covering the description of clinical cases in acupuncture, moxibustion, electroacupuncture, scalp acupuncture, auricular acupuncture, fire needling, dermal needling, wrist and ankle needling, transcutaneous point electrical stimulation, laser acupuncture and other acupuncture treatments. It started in September 2022 with the convening of a working group and a literature review. A three-round Delphi survey is planned. The China Association for Acupuncture and Moxibustion financially supports the project. The reporting guideline is planned to be submitted for publication in 2023 as an open-access document.

 

EPIC – Enhanced Prevalence and Incidence Criteria (registered 27 February 2023)

The lack of standardisation in reports on the prevalence and incidence of diseases and other health-related events inspired a group of international experts on infectious diseases, epidemiology and modelling to meet in December 2022. At the meeting, the participants agreed that there was a considerable need for a STROBE guideline extension for observational studies of the prevalence and incidence of infectious and non-communicable diseases.

The core executive group aims to develop an extension of STROBE, for which they are trying to contact STROBE authors for collaboration.

They already conducted a Delphi exercise including 31 international experts on a preliminary checklist; 22 of whom were present in a face-to-face consensus meeting in South Africa on 6 December 2022. Participants discussed and reached a consensus on the rationale for including items in the checklist, developed a flow diagram and the strategy for producing documents, decided who would be involved in which activities, authorship, and knowledge translation strategy, and generated an early version of the checklist. They are now preparing to conduct the second Delphi exercise, and they plan to pilot-test the checklist. The work receives funding from the Bill & Melinda Gates Foundation through the University of Maryland. The group plans to publish the reporting guideline in 2024 as an open-access paper.

 

CARITS – Complete and Accurate Reporting of Interrupted Time Series studies (registered 9 May 2023)

Interrupted time series (ITS) designs are commonly used to evaluate the effects of interventions targeted at populations (for example, changes to public health policy) or the impacts of exposures (such as natural disasters). In an ITS, a series of observations are collected both before and after an interruption. The impact of the interruption can then be quantified by comparing the observed post-interruption trend with the counterfactual. The design is less susceptible to bias than some other non-randomised designs (such as before-after design) and can be strengthened by the addition of control series. Complete and accurate reporting of the design and statistical methods is required so that readers can understand, for example, the details of the interruption(s), features of the design (e.g. number of periods, number of data points), the structure of the fitted model, statistical methods, and the effect measures used to quantify the interruption’s impact. A number of studies examining the methods of ITS studies have identified incomplete reporting of key design and statistical details.

The core group developing this reporting guideline is primarily based at the School of Public Health and Preventive Medicine at Monash University. They received funding from the Australian National Health and Medical Research Council (NHMRC) to develop a reporting guideline for ITS studies.

The group plans to publish a protocol including literature reviews, surveys with stakeholders, and a face-to-face consensus meeting. They plan to publish their reporting guideline as an explanation and elaboration open-access document around 2025-6.

 

STROBE-prev – Strengthening the Reporting of Studies of Prevalence (registered 7 June 2023)

Studies to estimate the prevalence of a condition, disease or risk factor are fundamental to observational epidemiology and public health. The main STROBE reporting guideline covers three study designs: cross-sectional, case-control and cohort studies. Whilst cross-sectional studies are the study design most applicable to the measurement of prevalence, the STROBE items focus on features of analytic cross-sectional studies rather than descriptive studies. These recommendations are not precise enough to ensure that authors report how they arrived at the numerator and denominator for the prevalence estimate. A group from the University of Bern decided to develop an extension to the STROBE reporting guideline for studies of prevalence, making specific recommendations about issues that could result in selection and misclassification biases in prevalence estimates.

The group held two face-to-face meetings (August 2022 and May 2023) as part of an initiative to develop a risk of bias tool for the assessment of studies of prevalence. During these meetings, they identified a list of STROBE items that need to be revised or added to and drafted a flow chart. According to their plans, they will conduct a systematic review of the completeness of reporting based on the first draft of the checklist and online meetings to plan the next steps. A representative of the main STROBE author group is participating in this development. The group is also in discussion with the EPIC group about a possible overlap between the projects (updates to be published here).

 

Chinese Medicine Formulas – STrengthening the Reporting of Observational Real-World Studies about Chinese Medicine Formulas: STROBE extension (2023)

The developers of this reporting guideline, a group from West China Observational studies about traditional ChiHospital, Sichuan University, have identified that traditional Chinese medicine (TCM) formulae or Chinese patent drugs use are increasing, but the reporting of the studies about them lack transparency. 

The reporting guideline under development will focus on improving the transparent reporting of studies about fixed or individualised formulae (including Chinese patent drugs approved for listing). It will capture reporting elements considered fundamental when using real-world data (RWD) and routinely collected data (RCD) in TCM.

It will probably not include acupuncture, moxibustion, cupping, massage and other TCM  therapies already covered by STROBE-TCM, another reporting guideline currently under development.

The group has been in contact with STROBE lead authors to develop this guideline as a STROBE extension. The development started in November 2021 with a literature mapping of observational real-world studies and field-specific guidelines, a Delphi survey, a face-to-face consensus meeting, pilot testing and dissemination. The group plans to publish the reporting guideline as an open access document in the end of 2024. 

The project is registered in the Open Science Framework platform.

 

Chinese Medicine Formulas Protocols – Standard Protocol Items for Observational Real-World Studies about Chinese Medicine Formulas  (2023)

Closely related to the project above, this project aims to develop a reporting guideline for protocols of observational studies on traditional Chinese Medicine (TCM) formulas. According to the developers, study protocol serves as the foundation for study design, conduct, reporting and appraisal. The transparent reporting of protocol can help reducing selective reporting, publication bias, and result driven data mining. The group from Sichuan University aims to develop a minimum set of standard protocol items to be reported for observational real-world studies about  TCM formulae, one of the main TCM treatments. The guideline will be mainly used for transparent reporting protocols about observational real-world studies regarding fixed or individualised formulas (covering Chinese patent drugs approved for listing by the National Medical Products Administration). It will probably not include acupuncture, moxibustion, cupping, massage and other TCM therapies.

The development started in November 2021 with a literature mapping of the protocols of observational real-world studies and field-specific guidelines, a Delphi survey, a face-to-face consensus meeting, pilot testing and dissemination. The group plans to publish the reporting guideline as an open access document in the end of 2024. 

The project is registered in the Open Science Framework platform.

 

SUMO-cross – Reporting cross-sectional SUrveys conducted in Multiple cOntexts (SUMO-cross) (registered 7 May 2024)

This project aims to develop a reporting guideline for cross-sectional surveys conducted in multiple contexts, such as multinational, multi regional, and multicultural situations. According to the developers, guidelines such as STROBE or PRICSA do not cover several aspects of surveys conducted in multiple contexts such as diverse healthcare systems, specific procedures for data management and sharing across countries/regions, or different languages.

The group is currently developing the study protocol and establishing the steering committee. The project is funded by by the Japan Society for the Promotion of Science (JSPS), KAKENHI Grant (number: JP24K20268). Developers plan to publish the reporting guideline as an open access document in 2028.

The group has registered this project on the Open Science Framework: https://doi.org/10.17605/OSF.IO/T6R98.

 

CRIMP – Case Reports in Mental Health and Psychiatry Reporting Guidelines (registered 29 July 2024)

Psychiatric case reports provide insights about atypical and rare case presentations, process of diagnostic evaluation, and therapeutic trials. A systematic appraisal of case reports can help in paying attention to different elements that may have a consequence on inference of the results in a different context. Uniform reporting with minimal defined standards also is helpful in ensuring the quality of scientific literature. As there are no specific case reports guidelines in psychiatry covering varied aspects of case reports, a group of researchers based in India will develop case report guidelines in the field of psychiatry and mental health.

A literature review will provide a preliminary list of items to undergo a Delphi process involving experts in the field of psychiatry and mental health, including researchers, clinicians, methodologists, and journal editors. A face-to-face online meeting will examine each item critically, and the developers also plan for piloting the reporting guideline in 10 case reports by 2 experts, with adjustments where necessary, and a further application in 100 case reports.

The project receives no funding so far. The steering group does not include patients representatives. They plan to start development in the en of July 2024 and to publish the reporting guideline as an open access document.

 

RECASE – Reporting Acupuncture-related Adverse Events following the CARE guidelines for case reports (registered 29 July 2024)

Acupuncture is a considerably safe intervention when it is administered in an appropriate clinical setting by well-educated and experienced practitioners. However, acupuncture-related adverse events (AEs) have been reported, in stable numbers over the years.  The most serious problem among these AE cases is that essential information for judging the appropriateness of the acupuncture practice is not reported clearly. According to this project leaders, case studies on acupuncture-related AEs are not regarded sufficiently informative to reduce errors or enhance safety in future acupuncture practice, and can lead to exaggeration of acupuncture-related harm among the general public. Reporting guidelines for accurate and transparent reporting in acupuncture-related AE case reports are needed to address these problems.

This group is developing a reporting guideline for case reports of AEs in acupuncture. Work started in 2023 with a review of case reports of AEs. A Delphi survey will be conducted, followed by a face-to-face consensus meeting. Next, the group will ask feedback from small numbers of potential guideline users and incorporate opinions. The guidance statement with explanatory documents will be published as an open access document. At the time of registration, the group is seeking ethical approval for the Delphi surveys.

The systematic review that will base the project has been registered in Research Registry.

Contact: Tae-Hun Kim, Kyung Hee University, South Korea. Contact: [email protected].

 

SAPI – Statistical Analysis Plan for Observational Studies with Initial Data Analysis (registered 31 July 2024)

The objective of this project is to develop a checklist for a statistical analysis plan (SAP) for observational studies that accounts for initial data analysis and records deviations from initial plans in one document. Initial data analysis is often performed, but it may not have been planned or conducted systematically. Revisions of SAPs are often necessary due to unforeseen issues with the data. Such changes should be documented with a rationale in an amended SAP.

The STRATOS Initiative plans to develop such reporting guideline starting with a review of related work, a Delphi survey, a consensus meeting, pilot testing and dissemination. Development started in June 2024, and the group obtained ethical approval to start the surveys already. This project is not yet receiving funding, but the group plans to publish the reporting guideline as an open access document in 2025.

 

NUR-Case – Nursing Case Reporting Framework (registered 6 February 2025)

The CAse REport (CARE) guidelines were developed to ensure transparency and precision in the reporting and publication of patient case studies; however, they are
not tailored to the specific characteristics of nursing clinical cases, nor have any extensions been developed to adapt them to the nursing process. The researchers therefore plan to develop a reporting guideline specifically focused on nursing clinical case reports.

A Delphi study with experts recruited through purposive sampling, all of whom have experience in publishing nursing clinical case reports, will be conducted. Following a literature review and analysis of the items included in the CARE guidelines, a list of items adapted to the nursing process will be proposed. Up to three successive Delphi rounds will be conducted until consensus is reached.

POCUS-REPORT: Reporting Guideline for Clinical and Research Studies Using Point-of-Care Ultrasound (registered 17 June 2025)

Recent literature has highlighted both the increasing use of POCUS and the need for greater methodological rigour and standardisation in the way these studies are conducted and reported . The use of bedside ultrasound has expanded significantly across various medical specialties, driven by its ability to provide rapid, non-invasive, and low-cost assessments at the point of care , . However, several authors emphasise the importance of appropriate professional training, standardisation of techniques, and the application of validated protocols to ensure the safety and effectiveness of the method.

Despite the existence of general reporting guidelines such as STARD, CONSORT, and PRISMA, these do not account for the methodological specificities associated with POCUS. This method possesses unique characteristics, such as strong operator dependence, variation in image acquisition protocols, different types of equipment, and the integration of the examination within the immediate clinical context. These particularities directly impact the internal and external validity of studies and, consequently, their applicability in clinical practice.
Given this scenario, the need for a new reporting guideline that addresses the specificities of POCUS is justified, with the aim of promoting greater transparency, standardisation, and methodological rigour in scientific communication. Such an initiative will contribute to improving the quality of published studies, facilitate the replication of research, strengthen the evidence base, and support clinicians, researchers, peer reviewers, and editors in the critical appraisal of studies involving bedside ultrasound.

POCUS-REPORT: The REporting a Time-to-onset Anaysis using Individual Case Safety reports in PharmacoVigilance (registered 18 June 2025)

As part of the utilization of the Individual case safety reports (ICSR) database, Time-to-Onset (TTO) analyses based on drug-related adverse event reports in the database is actively being performed in conjunction.
Several reporting guidelines have been developed for observational studies, including STROBE, RECORD-PE and READUS-PV. However, these guidelines are outside the scope of reporting TTO analyses. Therefore, TTO analyses are often poorly reported and interpreted.

COREMILK: COnsensus Guidelines for REsearch on Human MILK (registered 25 July 2025)

Human milk research is an expanding and critical field with important implications for maternal and infant health, yet methodological reporting across human milk composition studies is highly variable and frequently incomplete. The proposed reporting guideline, COREMILK (COnsensus Guidelines for REsearch on Human MILK), will provide a standardized framework for reporting research focused on human milk composition analysis.

This guideline will apply to studies investigating any component of human milk (macronutrients, micronutrients, bioactives, microbiota, contaminants, and other constituents) across different populations and contexts. It will cover observational studies, interventional studies, and method development or validation studies involving analysis of human milk composition. COREMILK will specify minimum essential reporting standards across several key domains, including participant demographics, lactation and feeding practices, milk sample collection, handling and storage methods, analytical procedures, and statistical reporting.

A new reporting guideline is urgently needed to address significant inconsistencies in current reporting practices. Critical methodological factors – such as sampling time postpartum, collection technique (hand expression vs. pumping), milk fraction analysed (whole vs. skim), and analytical validation details – are often inadequately described or omitted entirely. These omissions impair reproducibility, prevent robust meta-analyses, and limit the translation of findings into clinical and public health practice. Existing general reporting guidelines (e.g., CONSORT, STROBE) are not tailored to the unique challenges of human milk research and thus cannot fully meet the field’s needs.

By establishing consensus-based reporting standards, COREMILK will strengthen the transparency, comparability, and interpretability of human milk composition research. The guideline is intended to support researchers, reviewers, editors, and funders in improving research quality and accelerating progress in this vital area of maternal and child health science.

UNITE: Reporting guidelines for youth and family specific engagement in research (registered 25 July 2025)

In recent years, there has been growing emphasis on the importance of involving patients as active contributors to all stages of the research process. Aligning research with patients’ needs, values, and preferences can significantly enhance its relevance and impact. Within this broader shift, youth and families play an indispensable role in research, given their unique lived experiences and expertise, leading to more effective interventions, policies and services that are aligned with their lived experiences and developmental needs. Beyond improving research quality and impact, meaningful youth and family engagement also supports capacity building, empowerment, and fostering a sense of community and belonging among youth and families engaged in research.

However, despite its recognized benefits, the reporting of patient engagement in many peer-reviewed publications, including youth and family engagement in research remains inconsistent. This reporting gap hinders the transparency and reproducibility of patient engagement efforts and practices, limiting opportunities for research teams to learn from and build upon existing patient engagement efforts.

The current lack of reporting guidelines specific to youth and family engagement poses challenges for research teams to collaborate with youth and families in a consistent way. Thus, it has become increasingly apparent that explicit and systematic guidance on reporting of youth and family engagement in research is essential to advance the field and eventually promote the practice of meaningful and authentic research partnerships. The proposed reporting guideline will provide guidance for research teams to consistently report youth and family engagement in research. It will outline key elements to report—such as who was engaged, how they were engaged, the goals and outcomes of engagement etc. This guideline will be co-developed with youth, family caregivers, and researchers to ensure that it reflects their needs and priorities.

STROBE-D: Strengthening the Reporting og Observational Studies in Epidemiology for Drowning (STROBE-D): An extension of the STROBE statement for drowning research (registered 10 October 2025)

Drowning remains a significant global health issue, yet much of the research in this field is observational in nature due to ethical, practical, and logistical constraints. Despite the availability of the STROBE statement, adherence to these guidelines within the drowning research community has been inconsistent and often incomplete. A preliminary analysis from our ongoing systematic review indicates that fewer than 50% of published observational drowning studies fully comply with the original STROBE checklist.

This lack of adherence suggests that the current STROBE framework may not sufficiently capture the unique aspects of drowning-related research, which often includes highly context-specific variables such as environmental conditions, rescue logistics, water safety practices, resuscitation details, and outcome classification based on diverse international definitions. As a result, many key methodological elements and contextual factors are either underreported or inconsistently presented, hindering reproducibility, critical appraisal, and evidence synthesis.

To address these limitations, we propose the development of a STROBE extension specifically tailored to drowning-related observational studies. The goal is not to replace the core STROBE framework but to build upon it by incorporating drowning-specific reporting elements that improve clarity, transparency, and comparability across studies. Such an extension would provide structured guidance for authors, reviewers, and editors, helping to standardise reporting practices.

Consolidated Guidelines for Reporting and Evaluation of studies using Transcranial Electrical Stimulation (registered 10 October 2025)

Transcranial electrical stimulation (tES) encompasses non-invasive brain stimulation techniques that modulate cortical excitability by delivering low-intensity electric currents to the scalp. Common tES techniques include transcranial direct current stimulation (tDCS), transcranial alternating current stimulation (tACS), and transcranial random noise stimulation (tRNS). Over the past two decades, tES has gained considerable traction in both experimental and clinical research settings, with applications spanning neurological, psychiatric, cognitive, and musculoskeletal domains. Indeed, tES modalities have demonstrated effectiveness across a broad range of populations, including people with major depressive disorder, cognitive impairments, multiple sclerosis, stroke[9], and both experimental and chronic pain. More recently, there has been growing interest in the use of tES in home-based contexts, particularly in response to increasing demand for remote, accessible, and scalable interventions.

Despite its promise, methodological heterogeneity in tES trials has limited the reproducibility and interpretability of findings. Several systematic and narrative reviews have highlighted that there is variability in the efficacy of tES, which may be affected by substantial inconsistencies in how trials are reported and conducted, particularly in terms of stimulation parameters, adverse event monitoring, and blinding procedures. This problem is amplified in home-based studies, where methodological rigor is further challenged by the need for remote supervision, participant-led setup, and digital adherence strategies. Thus, there is a clear need for improved control and reporting of as many factors as possible in tES studies.

While position papers and technical guides provide valuable recommendations, these documents do not represent consensus-driven, standardised tools for assessing methodological and reporting quality. Previous tES studies have typically adapted existing methodological and reporting checklists developed for transcranial magnetic stimulation or concurrent tES and functional magnetic resonance imaging. This is a notable limitation, as tES has distinct mechanisms of effect, stimulation parameters, and safety challenges not reflected in other non-invasive brain stimulation methodologies. In addition, previous recommendations do not consider recent developments such as home-based protocols with varied levels of supervision. Other commonly used tools like the Consolidated Standards of Reporting Trials (CONSORT) and Template for Intervention Description and Replication (TIDieR) scales, while useful, are also not tailored to the unique methodological considerations inherent to tES trials. These gaps underscore the need for a dedicated, consensus-based methodological quality guideline that can be used to appraise both traditional laboratory-based tES trials and those employing remote, home-based delivery models.

Research reporting guidelines for health RESearch involving People who arE inCarceraTed: The RESPECT Guidelines (registered 10 October 2025)

The scope of this guideline is: Original research that involves people experiencing incarceration or detention in a correctional facility as participants and that includes a focus on health. The guidelines will apply to all methodologies. We define correctional facility as designated facilities that hold people remanded to custody or following sentencing related to the criminal legal system including jails, prison, penitentiaries, etc. We define health as per the World Health Organization: a state of complete physical, mental, and social well-being and not merely the absence of disease or infirmity. This includes studies of healthcare.

People who experience incarceration experience substantial health inequities. Research represents an important strategy to improve population health, but there are unique considerations and challenges inherent in conducting research involving people who are incarcerated. Research involving people in custody is often reported badly and missing information needed for appropriate interpretation and use such as project covernance (e.g. role of correctional authority), ethical issues (e.g. how participants were recruited) and sampling (e.g. whether purposive, or whole population). Research reporting guidelines are a proven strategy to strengthen research reporting, and may positively influence research standards and practices. Additionally, though less common than guidelines for methodologies or conditions, guidelines for research involving specific populations (such as the CONSIDER statement for strengthening reporting of health research involving Indigenous Peoples) are an important resource for addressing inequities in health and health research. However, there are currently no research reporting guidelines for research involving people who are incarcerated as participants.

Inclusivity Checklist for Clinical Research (registered 10 October 2025)

Under-representation in clinical research leads to evidence gaps and reduced generalisability of findings. The inclusion of under-represented groups has become a central priority for funding bodies, regulators, and patient communities worldwide. Most notably, research inclusion is now a key condition for National Institute for Health and Care Research (NIHR) funding; the Health Research Authority (HRA) and Medicines and Healthcare products Regulatory Agency (MHRA) are developing the “Inclusion and Diversity Plan” which sponsors and researchers will complete optionally as part of the approval process. Whilst guidance documents and policy statements exists, for example, the NIHR INCLUDE framework, implementation remains variable and operational tools to support researchers are limited.

Reporting research inclusion as part of the wider clinical study currently lacks transparency and remains inconsistent at best. Consensus-based checklists which have been successfully developed in other areas of research, such as CONSORT and PRIMSA, have demonstrably improved transparency, rigour, and reporting quality. As such, a consensus-driven tool focused specifically on inclusivity could play a critical role in bridging the gap between principle and practice, by providing a structured mechanism for researchers to embed inclusivity considerations across all stages of the research pathway.

Standards of reporting for studies on medical grade footwear for adults (registered 15 October 2025)

Medical grade footwear is frequently prescribed in the treatment and prevention of many different diseases, with the aim of increasing people’s capacity for mobility. This footwear, which is a combination of the shoes and its insole, can achieve improved mobility in many different ways, such as by enhancing stability, supporting deformities, reducing pain, protecting from trauma or redistributing plantar pressure. As medical grade footwear is also a device with many different components, entangling the beneficial, the non-effective and the potentially harmful effects of (components of) such footwear is complex, and requires careful and high-quality scientific studies.

Studies on medical grade footwear are ever more frequent. A quick search on PubMed on 10 October 2025 shows that at this moment 25% of all >15,000 publications in this field are from the last 5 years, while 55% of all >380 systematic reviews have been published after 2020. While these studies have generated important insights in the effectiveness of medical grade footwear, a consistent theme in the systematic reviews done is the lack of high-quality studies. Initiatives to improve scientific quality of studies on medical grade footwear are needed.

In various systematic reviews on medical grade footwear, it was concluded that study reporting could be improved. Large variations were especially seen in the descriptions of the footwear that investigated, while complete, clear and consistent reporting is required. This hampers risk of bias assessment of these studies, and limits the opportunities to adequately inform clinical decision-making. This has led to calls for the development of standards of reporting for studies on medical grade footwear interventions.

We have searched the EQUATOR-network, pubmed and grey literature, and currently no reporting standards for studies on medical grade footwear are available or under development. With millions of adult patients relying on medical grade footwear, with thousands of yearly publications, and with consistent calls for higher quality reporting of this complex medical device, our aim is to develop standards of reporting for studies on medical grade footwear.

Page last updated on 15 October 2025

Reporting guidelines for main study types