Enhancing the QUAlity and Transparency Of health Research

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)

STROBE extension – Diagnostics involving metagenomics (2018)

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

CARE for Acupuncture (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-Equity extension (2021)

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

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

Trial Emulations (2021)

READUS-PV – The Reporting of A Disproportionality analysis for drUg Safety signal detection using spontaneously reported adverse events in PharmacoVigilance (2022)

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)

GROESBE – Guidelines for reporting oral epidemiologic studies to inform burden estimation (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)

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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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STROBE extension – Diagnostics involving metagenomics (registered 28 August 2018)

There has been an exponential increase in studies applying metagenomic diagnostics, such as 16S PCR and deep-sequencing. The aim of this extension is to adapt the STROBE statement to be more applicable to these types of diagnostics and to ensure transparency in publications on the same.

There will be a broad focus on metagenomics, and appendices on 1) Neurological infections, 2) Antimicrobial Resistance and 3) the Gut Microbiome.

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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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CARE for Acupuncture – Consensus-based Clinical Case Reporting Guideline Development Extension: CARE for Acupuncture (registered 26 October 2018)

Case reports are still an important source to provide evidence on acupuncture to clinicians and researchers. They can better present the real situation of clinical practice, reflect the individualized treatment characteristics of acupuncture treatment, and inherit the experience of prominent traditional medicine doctors.

CARE is a reporting guideline for case reports. The aim of the CARE for Acupuncture project is to develop an extension of CARE focused on acupuncture areas, which can enhance the transparency and quality of case reports on acupuncture.

The study design will refer to the methodology recommended by the EQUATOR Network, modified as appropriate. A literature review will be conducted, and an international multidisciplinary team is established, including a Development Group, a Delphi Panellists Group and an Advisory Group. From 1st October 2018, the group started a literature search and draft the item checklists. 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 are under development. The group plans to update the reporting guideline regularly. The group intends to publish the reporting guideline in 2019, as an open-access document.

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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-Equity extension (registered on 18 January 2021)

Health inequities can go frequently unreported in observational studies. This international group of scientists, educators, decision-makers, ethicists, funders, and patients, using an integrated knowledge translation approach, proposes to develop an extension to the STROBE (STrengthening the Reporting of OBservational studies in Epidemiology) guideline to deal specifically with these disparities. The project will embed a parallel stream focused on evidence related to Indigenous research. After assessing available guidance for reporting health equity in observational studies and assessing current reporting, they plan to seek international feedback, then conduct an evidence and consensus-driven process to develop a reporting guideline. The project started in January 2021. A series of empirical studies are planned, followed by a consensus meeting, with the final reporting guideline and statement expected in 2024.

Additional information:

Contact: Vivian Welch, Bruyère Research Institute, Ottawa, Ontario, Canada. E-mail: vwelch@campbellcollaboration.org

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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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READUS-PV – The Reporting of A Disproportionality analysis for drUg Safety signal detection using spontaneously reported adverse events in PharmacoVigilance (registered 7 March 2022)

The aim of this reporting guideline is to define a list of items mandatory to understand the methods used in studies using disproportionality analyses to evaluate “signals” of potential new adverse drug reactions in pharmacovigilance. According to the authors, this type of analysis allows quantifying the degree to which a drug–adverse event combination is reported as compared to the expected in the absence of any association between the drug and the event. The authors plan a literature review and a Delphi process to inform the checklist to be conducted in 2022. They plan to publish the reporting guideline in 2023.

 

 

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).

 

GROESBE – Guidelines for reporting oral epidemiologic studies to inform burden estimation (registered 2 October 2023)

This guideline aims to help with the reporting in the measurement of dental conditions for oral epidemiological studies and observational studies in odontology in general. The reporting guideline will be developed based on findings from systematic reviews, followed by a three-round Delphi survey. Developers plan to report on residual non-consensus and describe the nature of the dissent.

The reporting guideline development is starting in October 2023 after having received ethical approval from the Queen Mary University of London board. The project is funded by the Medical Research Council (MRC) Better Methods, Better Research call. This will cover open access publication, that the group expects to happen in 2024.

 

 

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.

 

Page last updated on 15 May 2024