Enhancing the QUAlity and Transparency Of health Research

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Reporting guidelines under development for observational studies

Observational studies or STROBE extensions

(year of development in brackets)

 

GREEN – Guideline for Reporting Environmental Epidemiology aNalyses (2016)

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

FERITS – Framework for Enhanced Reporting of Interrupted TimeSeries (2018)

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)

EPI-FORGE – Epidemic Forecasting Reporting Guidelines (2019)

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

STROBE-MR – Guidelines for strengthening the reporting of Mendelian randomisation studies (2019)

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

RULER – Rasch Reporting Guideline for Rehabilitation Research (2020)

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

CEDRIC-HIV – ChEcklist for studies of Drug ResIstanCe in HIV (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)

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Guideline for Reporting Environmental Epidemiology aNalyses (GREEN) (registered 20 December 2016)

This guideline will encompass studies that report on the association between environmental exposures and health outcomes.

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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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Framework for Enhanced Reporting of Interrupted Time Series (FERITS) (registered 22 May 2018)

Reporting guidelines for interrupted time-series studies. These are generally applied for the evaluation of public health interventions.

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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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EPI-FORGE – Epidemic Forecasting Reporting GuidelinesEstablishing a set of standards for the reporting of epidemic forecasting/prediction studies (Registered on 25 February 2019)

There is a wide range of epidemic models which forecast epidemiological phenomena during epidemics. These are frequently published in peer-reviewed academic journals. Such forecasts are critical to inform response planning, risk communication and the use and intensity of interventions.

The EPI-FORGE guideline will establish a set of standards for the reporting of epidemic forecasting and prediction studies. The domains of reporting may include reproducibility, transparency, validity, interpretability, funding and sponsorship. EPI-FORGE aims to improve the consistency of epidemic forecasting reporting, the reproducibility of forecasting results, the quality of epidemic forecasting practice, and the transparency of forecasting practice.

The proposed target audience of these guidelines includes epidemic model developers and validators, journal reviewers, journal editors, and epidemiology and biostatistics training programs. These guidelines may also benefit end-users and other epidemic forecast stakeholders.

The EPI-FORGE development process will follow guideline development best practice as recommended by the EQUATOR network. The group plans to publish the guidelines 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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STROBE-MR – Guidelines for strengthening the reporting of Mendelian randomisation studies (Registered on 29 July 2019)

 

The STROBE-MR reporting guidelines cover studies that utilise the properties of germline genetic variants to verify causal inference regarding possible effects of potentially modifiable exposures on outcomes. This may include the performance of formal instrumental variable effect estimation.

The group established an executive group in 2018, involving experts in MR methodology, causal inference, reporting guidelines and journal editors and obtained funding for the work.  During 2019, they have prepared a literature review and developed the first and second drafts of a checklist, and the explanation and elaboration document. The group has published the third draft of the checklist on a preprint repository: https://peerj.com/preprints/27857v1/  for the collection of comments. Their intention is to publish the reporting guideline as an open-access document at the end of 2019.

 

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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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RULER – Rasch Reporting Guideline for Rehabilitation Research (registered on 22 July 2020)

The purpose of this guideline is to provide consistent guidance for reporting observational studies using psychometric techniques that specifically apply the Rasch Measurement (RM) Theory in a rehabilitation context. The six psychometric domains of the framework guiding this work are 1) content validity, 2) structural validity, 3) external validity, 4) consequential validity, 5) reproducibility and reliability, and 6) practical application and clinical implementation.

The task force members who are contributing to the development of this RM Reporting guideline are all members of the American Congress of Rehabilitation Medicine (ACRM)’s Measurement Networking Group (MNG). The Rasch Measurement Taskforce group was formed, with two co-chairs, and seven members. The task force is meeting monthly from November 2018 to August 2020. This website presents the timeline of planned and finished activities by the group.

 

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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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CEDRIC-HIV – ChEcklist for studies of Drug ResIstanCe in HIV (registered on 22 September 2020)

Heterogeneous and inadequate data reporting on HIV drug resistance across countries and populations challenge adequate monitoring of the problem and prevalence estimations and management strategies. The authors are working on a checklist designed for the reporting of studies on the prevalence of pretreatment HIV drug resistance. They conducted a systematic review to determine the need for a reporting guideline and the results informed the second phase of the study. They plan a survey on authors about their opinions on the essential items to be reported in future studies, they will create a list of potential items and a subset of 20 respondents will be selected to take part in focus groups to reach consensus and finalise wording. The group plans to finish the work on June 2021 and publish the reporting guideline as an open-access paper.

 

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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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Page last updated on 14 May 2021